trips and ipr regime in india

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TRIPS And IPR Regime In India

The TRIPS regime has been developed as a fundamental instrument for assessing intellectual property rights worldwide. This is not the universal constant of intellectual property. Yet, it offers a fundamental structure that each member state of the World Trade Organization should incorporate within it’s domestic laws.

Table of Contents

Introduction

The TRIPS agreement came into effect on January 1, 1995. The TRIPS agreement, i.e. Agreement on Trade Related Aspects of Intellectual Property Rights, includes various categories of intellectual property that are patents, trademarks, copyrights, industrial designs, trade secrets, etc. The privileges granted to individuals and organizations for their originality and advancements are a form of intellectual property. Within a certain amount of time, such rights typically offer the producer an exclusive privilege to use his or her invention. Throughout all levels-statutory, bureaucratic and judicial-the value of intellectual property in India is quite well known. This sets up minimal rules for the treatment and promotion of the rights in the member States that, with a view to reduce distortions and hindrances to world commerce, are expected to facilitate effective and consistent protection of intellectual property. The responsibilities resulting from the TRIPS Agreement correspond to the establishment of basic requirements of security within the legal structures and procedures of the Member States.

Laws Conforming With The TRIPS Agreement

Following are the three laws brought into the Intellectual Property Rights regime of India in consonance with the TRIPS Agreement:

The Copyright Act, 1957

Like the title suggests, copyright law is the fundamental concept that indicates that if someone makes anything, they own it and then they can decide the outcome. The purpose of this copyright law is essentially twofold: first to guarantee the right of their original expression to writers, composers, musicians, creators and other creative minds who risk their resources in bringing their products well before world, and secondly to enable others to openly expand on the skills and theories expressed by a work.

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Works which are not established in a concrete form of speech under copyright law, such as a compositional work that is not registered or recorded in any form, titles, list of items, methods, principles, proposals, etc., really aren’t qualified for copyright law protections. In conjunction, creations consisting of knowledge widely accessible to all and absent of any actual writings are also not covered, such as schedules, height/weight graphs that can be obtained from relevant documentation and other common forms, etc.

The Trademarks Act, 1999

A trademark is a word, a string of words, a logo or a mixture thereof which separates one rival’s goods from those of other competitors in the industry. It must be special, distinctive and worthy of becoming visually depicted. In addition, a name can be licensed under trademark law and therefore should be able to differentiate the products or services of one seller from those of another. It preserves and assists in the development of a brand that is extremely critical for the development of a business.

The Act provides a full description of the word infringement that is often used. It offers sanctions and penalties for perpetrators under the Trademark Act. Where the registration of a trademark is legitimate, the registered owner shall have an exclusive privilege to use the trademarks in relation to the products and services in consideration of which the trademark is registered and also to claim compensation for the misuse of the trademark.

The patent act, 1970.

Among the most significant intellectual property rights that serve as an opportunity for companies to innovate is the patent. Not only do they help the developer earn money, they benefit the community in which the patented invention is produced. It gives the nation a push in terms of economic performance. It is essentially giving a monopoly offer to the creator through which the inventor regulates and governs the general accessibility of the innovation.

There are two categories of patents, namely product patents and process patents, under the Patents Act 1970. The product patent is the final outcome or creation of a product and the process patent is the direction of the development of a patent. Under the Patent Act, all methods and goods, if they are new, require an innovative phase and are worthy of practical use are qualified to register as inventions. For e.g., Tylenol pills can be treated as a product patent, whereas the process patent is the production of the pills. In a District Court with jurisdiction to prosecute the suit, a patentee has the option to initiate litigation for breach of the patent.

Impact Of TRIPS Agreement

The agreement brought in radical alteration to the Intellectual Property Regime in India. In addition, developments in the area of agriculture, pharmaceutical companies and non-natural and genetic modification living organisms have also been included into the scope of the patentable innovation, given that the discoveries illustrate attributes such as ingenuity, imaginative phase, usefulness and detailed descriptive definition. India was granted a waiver from the enforcement of patents for pharmaceutical and agrochemical products until 2005, but India was forced to introduce a ‘Mailbox’ clause throughout this conversion era to allocate a processing deadline to every request submitted throughout that implementation period. India was also obliged to award Exclusive Marketing Rights (EMR) in respect of certain patent claims in the mailbox.

However, the 2005 Indian Patent Amendment was not exempted from its dissensions, this involved clauses defining some of the matters as non-patentable, added a new meaning of ‘inventive step’ and also established a framework for the patent application before and after grant. Regulations underneath the copyright rules have been modified which included software programs under Article 10 of the deal there under copyright rules, these were altered to offer the copyright rules to the digital world. This also decided to grant the rightful claim of the commercial rental of computer software to the copyright owner, thereby recognizing that computer software not only have copyright, but also a commercial element.[1] Within trademarks, well-known trademarks, collective marks and service marks are included within their context, and the framework of trademarks has been expanded to also include symbolic features such as form, packaging and color variations.

The Doha Declaration

Through bringing pharmaceutical drugs underneath the range of patentable innovations, major pharmaceutical firms hurried to register patents in the lowest advanced and emerging nations, these being the regions that have the biggest demand for their products, the TRIPS agreement had a significant influence on the society and the drug industry. It was a major area of problem for developing countries, the consequence of the TRIPS deal on drug costs, it was the period where illnesses such as typhoid, malaria and tuberculosis were widespread. In foreign and national politics, pharmaceutical firms do seem to have an influence. Throughout the functions that these pharmaceutical companies do, they are accountable for raising the average life expectancy rates of the whole planet and are thus always progressing to fight against nature’s order and organisms that carry these diseases. The Doha Declaration recognized that all countries also had the responsibility to maintain population health through using processes such as mandatory licensing, the rights to choose the criteria upon which authorization will be issued, and to expand coverage for underdeveloped nations to medication.

The Provision of Trips Plus

Although emerging nations are still coming to terms with the TRIPS agreement, by means of free trade deals, developed economies already are setting the stakes for Intellectual property rights security. The leader here is nothing but the United States of America. These clauses allowing for better enforcement of intellectual property rights are being called the regulations of TRIPS plus. Another dimension of TRIPS plus agreements is the growing market for database exclusivity by emerging economies for security. In order to show the security, consistency and effectiveness of a new drug, data confidentiality clause intended to safeguard the medical performance data presented to the regulatory body. This will help discourage generic drug producers from depending on these details through their own request and then focusing upon these data when filing for licenses.[2] A booming market from the developing countries which typically does not fall within TRIPs seems to be the need for the security of exclusive content that has high economic value. Such a step sparks a much greater controversy here between exclusive rights of the creator and the principle of appropriate use for social benefit. India, as a developing economy, also managed to fight the introduction of TRIPS plus norms and has often stressed the requirement to find an equilibrium between both the creator’s own privilege and social welfare. And that’s apparent from the FTA negotiations between India and countries such as Japan.

Drawbacks Of TRIPS Agreement In India

The removal of the cultural heritage system could theoretically be detrimental to the status of India. The reason for it is that, for decades, agricultural practices have indeed been expanding around the globe, making it hard to know the sources of a plant and even to trace its original inhabitants for redress. This condition is aggravated by the fact that several assets have been gathered and stored in international gene banks over the ages. Anyone seeking to have entry would therefore have to compromise with a variety of nations, and therefore would note that they are not the only providers. The status of India is not merely that of a supplier. India will also need to deal for resources needed to fulfil its requirements as a source of genetic information from many other nations. Thus, it will appear to be a huge and massive task to the total legal and financial costs incurred on monitoring and prosecuting proceedings for Intellectual Property Rights.

Public suspects that the product patent could lead to higher prices, rendering medications prohibitively expensive to the impoverished. The creator would continue to increase his gain with the implementation of product patents and thus the product cost is higher if there would be no patents. Consequently, the drug’s intake would be less. This reflects an implicit deterioration of benefits for Indian customers’ high prices regarding the implementation of patents for products.

Partnership with international companies is the rule throughout the area of research and development, without any Indian pharmaceutical industry qualified to take a prospective product from the experimental way to the end product initiation stage, leading to prejudices in the preference of patient groups regarding lifestyle related diseases.[3] In developing nations like India, such diseases kill thousands of individuals every year. Instead of proceeding with all of those medicines previously created by industrialized nations in the past, the reform in intellectual property laws could enable many companies in India to carry out research than to develop more products.

The prospects for global drug manufacturers to operate in or partner with research and innovation units located in developing countries are not likely to be improved by TRIPS. This is clearly non likely to occur, but this does not happen because of some of the challenges involved with providing infrastructure, rapidly obtaining accurate data to ensure adherence to agreements.

In addition to the trade related elements of intellectual property, the new TRIPS agreement encompasses the entire framework of the intellectual property regime. Via the Doha Declarations, the developing countries articulated their fears and were active in safeguarding the global health element of pharmaceutical patents. Because industrialized nations need greater levels of security for intellectual property than any of those embodied in the TRIPS agreement, developing countries are now again experiencing extreme pressure. Nevertheless, developing countries such as India do have a chance to guarantee that their rights are secured. Countries like India have enormous manpower and labor and an even enormous foundation for intellectual growth. Emerging economies also require participating significantly in growing their nation’s skilled workforce.

References:

[1] TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights , Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994).

[2] Sandeep Mittal, “Effect of TRIPS plus provisions in International Trade Agreements upon access to medicines in Developing Countries”, JIPR, Vol 22 pp 295-302.

[3] Jha Ravinder, Options for Indian Pharmaceutical Industry in the Changing Environment- Review of industrial Management- VOL 42.

BY- TVISHA GUPTA | BENNETT UNIVERSITY

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Mahek Mantri

Trips And Ipr Regime In India

KEY TAKEAWAYS:

Article 2 of the World Intellectual Property Organization (WIPO) - Central Organization for the Protection of Intellectual Property laws and the UN expert organization states . The rights to literary, artistic, and scientific works; discoveries made in all fields of human endeavor; scientific advancements; industrial design rights; trademarks, service marks, and commercial names and designations; and protection from unfair competition are all considered to be part of intellectual property.
For the protection and enforcement of different types of intellectual property, such as patents, trademarks, copyrights, industrial designs, and trade secrets, TRIPS establishes minimum requirements. These norms must be followed by all member nations.
Intellectual property rights (IPR) are exchanged and valued globally. The significance of intellectual property in global trade is acknowledged by the WTO's TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement. Basic requirements for member governments' IPR protection are established by the TRIPS Agreement.
The IPR regime, as defined by TRIPS, gives creators and inventors temporary exclusive rights in an effort to promote innovation. Due to the exclusivity, which guarantees financial gains for innovators, research and development expenditures are encouraged.

INTRODUCTION

In force since January 1, 1995, is the TRIPS agreement. Trade secrets, patents, trademarks, copyrights, industrial designs, and other forms of intellectual property are all included in the TRIPS agreement, which stands for the Agreement on Trade Related Aspects of Intellectual Property Rights. Intellectual property refers to the rights that organizations and individuals are awarded for their innovations and achievements. These kinds of rights usually give the producer the sole right to use their invention for a predetermined period of time. India has a well-established recognition of the importance of intellectual property at all governmental, administrative, and legal levels. This establishes the bare minimum guidelines for the treatment and advancement of intellectual property rights in the member states, which should enable more efficient and uniform protection of intellectual property while reducing distortions and obstacles to global trade. The obligations arising from the TRIPS Agreement relate to the establishment of fundamental security requirements within the Member States' legal frameworks and protocols.

Member states of TRIPS are obliged to set up and uphold particular minimum standards for the protection of intellectual property on their soil. In an effort to balance the rights of creators and the public interest, this agreement lays out rules for granting patents and trademarks, defending copyrights, and stopping unfair competition.

By giving authors and inventors the exclusive right to use their creations for a predetermined amount of time, the intellectual property system outlined in the TRIPS Agreement seeks to encourage innovation. The goal of this exclusivity is to promote research and development spending while guaranteeing that these innovations enter the public domain after the protection period ends, thereby advancing society as a whole.

Additionally, the agreement creates procedures for member states to settle disputes pertaining to intellectual property rights. It also promotes technology transfer between developed and developing countries with the goal of making necessary technologies and medications more accessible, particularly for economically challenged nations.

In general, the TRIPS Agreement is essential to global trade because it promotes innovation, safeguards intellectual property, and strikes a balance between the interests of the general public and rights holders.

LAWS CONFORMING WITH THE TRIPS AGREEMENT

The three laws listed below were added to India's intellectual property rights framework in compliance with the TRIPS Agreement:

THE COPYRIGHT ACT, 1957

As the name implies, copyright law is the underlying theory that states that anyone who creates something has the right to own it and determine how it is used. This copyright law serves essentially two purposes: first, it protects writers, composers, musicians, artists, and other creative minds who risk financial ruin to bring their works to market well in advance of others, and second, it allows others to freely build upon the ideas and skills presented in a work.

Copyright law really does not apply to works that are not established in a concrete form of speech. Examples of such works include compositions that are not registered or recorded in any way, titles, lists of items, methods, principles, proposals, etc. These types of works are not eligible for copyright law protections. Furthermore, works that are composed of information that is publicly available to everyone and does not require any written works to be consulted, such as timetables, weight/height charts that are obtainable from pertinent records and other standard forms, etc., are also not included.

THE TRADEMARKS ACT, 1999

A trademark is a word, phrase, logo, or combination of these that distinguishes the products of one rival from those of other rivals in the market. It must be unique, exceptional, and deserving of being portrayed visually. Furthermore, a name should be able to distinguish the goods or services of one seller from those of another because it can be licensed under trademark law. It protects and fosters the growth of a brand, which is vital to the expansion of an enterprise.

The commonly used word "infringement" is fully defined in the Act. In accordance with the Trademark Act, it provides offenders with sanctions and penalties. If a trademark is legitimately registered, the registered owner will have the exclusive right to use the trademark in connection with the goods and services for which it is registered, as well as the right to compensation for trademark misuse.

THE PATENT ACT, 1970

The patent is one of the most important intellectual property rights that gives businesses the chance to innovate. They not only increase the developer's income but also improve the community where the patented invention is made. It boosts economic performance across the country. In essence, the inventor is granted a monopoly through which to control and direct how widely accessible the innovation is.

The Patents Act of 1970 divided patents into two categories: product patents and process patents. A process patent describes the path taken in the development of a patent, whereas a product patent is the result or creation of a product. All products and processes that are novel, need an innovative stage, and have potential applications are eligible to be registered as inventions under the Patent Act. For example, the manufacturing of Tylenol pills is the process patent, but the pills themselves can be considered a product. A patentee may file a lawsuit for patent infringement in a District Court that has the authority to hear the case.

IMPACT OF TRIPS AGREEMENT

India's intellectual property laws underwent a significant change as a result of the agreement. Additionally, since the discoveries demonstrate qualities like inventiveness, inventive phase, usefulness, and comprehensive descriptive definition, developments in the fields of agriculture, pharmaceutical companies, and non-natural and genetically modified living organisms have also been included into the scope of the patentable innovation. Up until 2005, India was given a waiver from the enforcement of patents on pharmaceutical and agrochemical products. However, during this conversion period, India was compelled to impose a "Mailbox" clause, which assigned a processing deadline for each request submitted during that implementation period. Additionally, India was required to grant Exclusive Marketing Rights (EMR) for a number of the patent claims in the mailbox.

Nonetheless, there were disagreements over the 2005 Indian Patent Amendment, which included provisions designating certain topics as non-patentable, giving a new definition to "inventive step," and creating a structure for patent applications both before and after they were granted. In order to bring the copyright laws to the digital sphere, regulations pertaining to the copyright rules have been updated. These regulations include software programs covered by Article 10 of the agreement.

Additionally, this determined to award the copyright owner's legitimate claim of commercial software rental, thereby acknowledging that computer software possesses both a commercial and copyright element. Symbolic elements like form, packaging, and color variations have been added to the framework of trademarks, and well-known trademarks, collective marks, and service marks are all included within their context.

THE DOHA DECLARATION

The TRIPS agreement had a significant impact on society and the drug industry by placing pharmaceutical drugs below the category of patentable innovations. As a result, major pharmaceutical firms rushed to register patents in the least developed and emerging nations, which are the regions with the highest demand for their products. The impact of the TRIPS agreement on drug prices was a significant issue for developing nations during a time when diseases like typhoid, malaria, and tuberculosis was common. It appears that pharmaceutical companies have a say in both domestic and international politics.

As a result of their constant efforts to combat the forces of nature and the organisms that spread these diseases, pharmaceutical companies are held responsible for increasing the average life expectancy rates on the planet. The Doha Declaration acknowledged that all nations also had a duty to protect the health of their citizens by implementing procedures like required licensing, the freedom to determine the standards by which authorization is granted, and expanding access to medication for less developed countries.

THE PROVISION OF TRIPS PLUS

Developed economies are already raising the stakes for the security of intellectual property rights through free trade agreements, even though developing countries are still coming to terms with the TRIPS agreement. The United States of America is the only entity in charge here. The TRIPS plus regulations are these sections that permit improved protection of intellectual property rights. The expanding market for database exclusivity by emerging economies for security is another aspect of TRIPS plus agreements. Data confidentiality clauses were designed to protect the medical performance data submitted to the regulatory body in order to demonstrate the security, consistency, and efficacy of a new medication.

This will serve as a deterrent to generic drug manufacturers relying on these details at their own request and using them as the basis for their license applications.[2] The need to secure exclusive content with high economic value appears to be a growing market from developing nations that are normally outside of TRIPs. This action ignites a much larger debate between the creator's exclusive rights and the idea of fair use for social good. India, a developing nation, successfully resisted the implementation of TRIPS plus regulations and has consistently emphasized the need to strike a balance between the rights of the creator and the interests of society. And the FTA talks between India and other countries such as Japan make that clear.

DRAWBACKS OF TRIPS AGREEMENT IN INDIA

Theoretically, India's standing could suffer if the cultural heritage system is abolished. The reason for this is that agricultural practices have been spreading throughout the world for decades, making it difficult to identify a plant's origins or even to locate its original occupants in order to seek justice. The fact that numerous assets have been amassed and kept in foreign gene banks over time exacerbates this condition. As a result, anyone attempting to gain entry would have to make concessions to multiple countries and acknowledge that they are not the sole suppliers. India's position extends beyond that of a supplier. India will also have to deal with the resources required to meet its needs as a supplier of genetic data from numerous other countries. Because of this, the entire task of tracking and pursuing intellectual property rights cases will seem overwhelming in terms of both legal fees and financial outlay.

The general public fears that the product patent may result in price increases, making prescription drugs unaffordable for those in poverty. If there were no product patents, the creator would continue to increase his profit, which would result in a higher product cost. As a result, less drug would be consumed. This illustrates an implicit decline in benefits for the expensive prices Indian consumers pay for the use of product patents.

In the realm of research and development, collaboration with foreign firms is the norm. The absence of qualified Indian pharmaceutical industry members to advance a potential product from the experimental phase to the launch stage results in biases in patient preferences with regard to diseases associated with lifestyle choices. These diseases claim thousands of lives annually in developing countries like India. The revision of intellectual property laws may allow numerous Indian companies to conduct research rather than continue producing more products, as opposed to continuing with the creation of all the medications that industrialized nations had previously produced.

TRIPS is unlikely to enhance the opportunities for multinational pharmaceutical companies to conduct business in developing nations or collaborate with research and innovation centers there. This is obviously unlikely to happen, but it doesn't because of some of the difficulties in delivering infrastructure and quickly obtaining correct data to guarantee agreement adherence.

CONCLUDING THOUGHTS

The comprehensive intellectual property regime is covered by the new TRIPS agreement, in addition to its trade-related components. The developing nations expressed their concerns and actively worked to protect the pharmaceutical industry's contribution to global health through the Doha Declarations. Developing countries are once again under tremendous pressure, as industrialized nations require higher standards of intellectual property security than any contained in the TRIPS agreement. However, developing nations like India do have an opportunity to ensure that their rights are upheld. Nations such as India possess copious amounts of labour and manpower, along with an even greater reservoir of intellectual capital. Emerging economies must also play a major role in increasing the number of skilled workers in their country.

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TRIPS Agreement and Its Effect on Intellectual Property Laws in India: An Analysis

The TRIPS Agreement is known to be a paradigmatic milestone in intellectual property law because it is the reason behind the way India is moving toward economic growth and global recognition. Signed in 1994, the agreement revolutionized India's IP policy, particularly the patent law , by creating a twist in the nation's approach to protecting and fostering innovation. So, are you ready to take a glimpse at the transformative impact of the TRIPS Agreement on India's intellectual property regime? Then let's begin with understanding the TRIPS Agreement and its intricate relationship with Indian IP law.

TRIPS Agreement: An Overview

On January 1st, 1995, the TRIPS Agreement which is considered to be the most comprehensive multilateral agreement on intellectual property rights to date, came into effect as a landmark move by the World Trade Organization (WTO) . The TRIPS Agreement, which stands for Trade-Related Aspects of Intellectual Property Rights has three significant roles to play:

helping trade with knowledge and innovation,
getting rid of trade disputes related to members,
and being flexible so they can get their own intellectual property and WTO policy objectives.

TRIPS is a set of rules concerning intellectual property rights that members of the World Trade Organization (WTO) must follow. A variety of intellectual property protections are included in these provisions, including patent protection, copyright , trademark protection, geographical indication protection, industrial design protection, and trade secret protection.

TRIPS stipulates several minimum standards for protecting and enforcing intellectual property rights. It aims to promote innovation, technology transfer, and the general public's welfare. There are also guidelines stating how member states of the WTO should protect and enforce intellectual property rights within their territories. These guidelines are designed to ensure that intellectual property rights are respected and protected within global trade and that the public is not adversely impacted by trade in intellectual property.

By delivering a collection of provisions, such as the right to prevent others from making, selling, or importing copies of a patented invention, the TRIPS Agreement provides a clear blueprint for how to harmonize intellectual property laws globally and facilitate international trade and ensure that member countries have consistent rules and obligations in place to protect intellectual property, thereby promoting fair competition and encouraging innovation and creativity.

TRIPS Agreement and Its Effect on Intellectual Property Laws in India

The TRIPS Agreement has had a big impact on India's intellectual property laws and regulations. As a member of the WTO, India had to make its intellectual property laws match the agreement's standards, which included giving patent protection for 20 years from the date of filing for any new invention, including pharmaceuticals. This provision has affected access to affordable medicines in India, as it has prevented the availability of generic drugs.

India's effort in complying with the TRIPS agreement is worth praising because several amendments and revisions were made to the Indian IP laws, especially in the patent law. Among such significant changes, a few that grabbed attention were - the introduction of product patent protection for pharmaceuticals and the establishment of a system for granting exclusive marketing rights for certain drugs, which were enforced with an aim to create a balance between incentivizing innovation and promoting access to affordable medicines.

In India, the patent registration process is governed by the Patents Act. Inventors or applicants have to follow a systematic procedure to obtain a patent which includes conducting a patent search, drafting a patent application with the help of a patent attorney, filing it with the Indian Patent Office, and undergoing examination and grant stages.

The Indian Patent Office plays a crucial role in the patent registration process. It examines patent applications for compliance with the statutory requirements and conducts a thorough review of the invention's novelty, inventive step, and industrial applicability. Once granted, the patent provides exclusive rights to the inventor, enabling them to prevent others from using, making, or selling the patented invention.

Challenges and Implementation Issues

Despite the collective and constant efforts to align Indian intellectual property laws with the WTO-negotiated TRIPS Agreement, India faces challenges and implementation issues. One of the main concerns is in forming a fair balance between protecting intellectual property rights and promoting access to affordable healthcare and essential medicines. In fact, India has been involved in patent-related disputes, particularly in the pharmaceutical sector, where the issue of affordable access to life-saving drugs arises.

In order to overcome these challenges, India is actively implementing a range of initiatives. conducting awareness campaigns, fostering capacity building, and streamlining enforcement mechanisms. Collaboration between stakeholders, including ‌ government, industry, and academia, is also essential to finding the right balance and fostering innovation in the country.

How TRIPS Affected the Indian Pharmaceutical Industry?

India had more flexible patent laws in the past that allowed for the production and sale of generic versions of patented drugs. Especially in countries with limited healthcare budgets, generic drugs which are lower-cost versions of brand-name drugs, provide affordable and accessible medicines

A system existed in India prior to the TRIPS Agreement that permitted generic manufacturers to manufacture and sell patented drugs by making small modifications to their manufacturing processes. In this way, "process patents" enabled India to produce affordable generic medicines and become a "pharmacy of the developing world." After the TRIPS Agreement was implemented, India switched to a "product patent" system, which granted exclusive rights to the specific drug, regardless of how it was manufactured.

The shift to product patents had a direct impact on the availability and affordability of medicines in India. The introduction of stronger patent protection increased the prices of patented drugs, making them less accessible to the general population. This posed challenges, particularly in the healthcare sector, where access to affordable medicines is crucial.

Access To Affordable Medicines In India Under Trips

The TRIPS Agreement included flexibilities and safeguards to address public health concerns. One such provision is the ability for countries to issue compulsory licenses, which allow the government to grant licenses to third parties to produce generic versions of patented drugs without the consent of the patent holder. This provision helps ensure access to affordable medicines, especially in situations of public health emergencies or when patented drugs are unaffordable or inaccessible to a significant portion of the population. This was demonstrated in 2012 when India granted a compulsory license for a patented cancer drug; to ensure its availability at an affordable price.

Furthermore, India has been supportive of efforts to promote access to affordable medicines globally. It has been actively involved in discussions at international forums, advocating for policies that prioritize public health and access to medicines, including initiatives like the Doha Declaration on TRIPS and Public Health.

Overall, the impact of the TRIPS Agreement on the Indian pharmaceutical industry can be best defined as an assortment of various things. While it has raised challenges for generic drug manufacturers and access to affordable medicines, it has also pushed India to widen its research and development capabilities and has opened up a door of opportunities for Indian companies to innovate and protect their own intellectual property. Additionally, the flexibilities within the TRIPS Agreement provide avenues for India to balance the protection of intellectual property rights with the goal of ensuring access to essential medicines for its population.

In Conclusion,

The TRIPS Agreement has significantly influenced intellectual property laws in India. Its implementation has brought about changes in the patent system, copyright protection, trademark regulations, and access to medicines. While it has provided a framework for protecting intellectual property rights, it has also posed challenges in balancing these rights with the need for affordable medicines and promoting innovation.

As India continues to navigate the complexities of intellectual property laws and the TRIPS Agreement, it is essential to strike a balance that promotes innovation, safeguards public health, and ensures access to essential medicines for its population.

To understand more about the TRIPS Agreement and its impact on Indian IP Law, get in touch with the IP lawyers of Parker and Paker Co. LLP .

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Patent Laws in India: compliance with the TRIPS Agreement

This article has been written by Lyngeolle Morris, pursuing a Certificate Course in Intellectual Property Law and Prosecution from LawSikho .

Table of Contents

Introduction

The patent law system in India has undergone significant changes and amendments since the country’s incorporation of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (‘WTO’s TRIPS Agreement, ‘TRIPS Agreement’ or ‘the Agreement’). The TRIPS Agreement became effective on 1 January 1995. The overarching aim of the TRIPS Agreement is to provide the appropriate standards and means for the use and enforcement of trade-related intellectual property rights (Article 1, TRIPS agreement) and the agreement has been considered the “most comprehensive multilateral agreement on intellectual property” (World Trade Organization, n.d).

While the agreement came into force in 1995, developing countries at the time such as India were given a ‘grace period of four years or up to 1 January 2000 to apply the Agreement within its domestic legal system, save Articles 3 – 5 of the Agreement. ( World Trade Organization, 2021 ). Despite this, several changes have been made to India’s patent regime even beyond this transition period. For the purposes of this article, reference will be made to the amendments made to India’s Patents Act in 1999 , 2002 , and 2005 .

To better understand whether India’s patent laws are in compliance with the TRIPS Agreement, I will firstly explore the theoretical concepts of monism and dualism in interpreting the relationship between India’s Patent system on a domestic level and the international legal regime as set out under the WTO’s TRIPS Agreement. Next, I will delve into the progression of India’s patent law regime following the incorporation of the TRIPS Agreement. Further, I will consider some case studies which will help to determine some of the underlying reasons behind India’s ‘non-compliance or ‘slow compliance’ with the TRIPS Agreement by looking into how India’s history, attitudes, and cultural norms play a role in the question of compliance. Finally, I will explore the ways in which India has built a sophisticated patent regime system post-TRIPS and how it can endeavor towards greater compliance with the TRIPS Agreement in the future while also balancing its own national interests.

Compliance in international law: understanding perspectives of monism and dualism in India

It is a fundamental principle of international law that when a State Party becomes a signatory to an international treaty, it should endeavor to incorporate the treaty into its domestic legal system, with the view of ensuring that there are no inconsistencies between the two. International treaties contain an article or clause which requires a State Party to refrain from any acts that would be in contravention of the Treaty’s object and purpose. This principle is enshrined in Article 18 of the Vienna Convention on the Law of Treaties (‘the Vienna Convention).

The Agreement on Trade-Related Aspects of Intellectual Property Rights encompasses this principle in Article 1 of the Agreement. Under the TRIPS Agreement, there is a generous wording of the incorporation of the TRIPS Agreement and indicates that State Parties “ …may, but shall not be obliged to, implement in their law more extensive protection than is required ” and further that State Parties shall have freedom to “…determine the appropriate method” in its implementation of the TRIPS Agreement.

Monistic perspective vs dualistic perspective

There has been exhaustive academic debate on whether the international and domestic legal system comprises one system under the perspective of monism or whether the international legal system and domestic legal system constitute separate systems, under the dualism principle (see Nijman, J. & Nollkaemper, A., 2007 ).

According to monist defenders, the law is to be considered as a unity and can only be deemed as deriving from one common source. As such, under the monistic perspective, the international legal regime is to be deemed as forming part of domestic law ( Gragl, 2018 ) and therefore a treaty may become operative once the State party has entered it into force and it is in accordance with the constitution (Aust, 2013). On the other hand, defenders of dualism posit that while a State party may respect international law, it must individually incorporate and sanction it within its own domestic legal regime by implementing legislation to that effect (Jyawickrama, 2009).

Chandra (2017) argues that while formally, India is deemed as a dualist state, in reality, it exhibits various monistic tendencies, based on its relationship with the power of the Executive in assuming international obligations without seeking Parliamentary approval in some instances, Parliament in its power to pass a law to reflect objectives of international law and the judiciary in interpreting and enforcing international law through the courts.

In light of the backdrop of this dualist-monist dichotomy, I will explore the changes over the years in India’s domestic law since the incorporation of the TRIPS Agreement .

India’s incorporation of the TRIPS Agreement

According to the World Trade Organization , with effect from 1 January 1995, India became a member of the World Trade Organization (WTO) and became a party to the TRIPS Agreement. This was met with much debate and opposition, as it took the stance during the negotiations that IPR protection was specifically within the purview of the World Intellectual Property Organization and not the WTO (Unni, 2012) . India argued during the negotiations that a country’s economic development should be taken into consideration when determining the extent of patent protection required, and therefore was a leading advocate on behalf of developing countries for the transition period approach as it relates to compliance with TRIPS (Foster, 1998). After the adoption of the TRIPS Agreement, India had undergone amendments to the Patents Act of 1970 (‘the 1970 Act’ or ‘the Principal Act’), culminating in the Patents (Amendment) Act, 1999 (‘the 1999 Act’, the Patents (Amendment) Act, 2002 (‘the 2002 Act’) and the Patents (Amendment) Act, 2005 (‘the 2005 Act’).

Progression of India’s patent law regime after the incorporation of TRIPS Agreement

Post-trips and the patents (amendment) act, 1999.

After the adoption of TRIPS, India was faced with two main issues that resulted in its amendment to the 1970 Act. These were that firstly, India needed the means to facilitate pharmaceutical and agricultural chemical product applications, also known as a ‘mailbox’ facility, and to have filing dates assigned to each application filed (see Article 70.8, TRIPS Agreement ). Secondly, under the TRIPS agreement, it was required that India provide for exclusive marketing rights (EMRs) in the instance of certain mailbox applications ( Article 70.9, TRIPS Agreement ), that is, the exclusive rights to sell or distribute the substance covered in a patent or patent application in the particular country.

Notwithstanding that India had brought an Ordinance into effect on January 1, 1995, to provide for the mailbox facility and the protection of EMRs, it had failed to pass the requisite legislation before Parliament (Chaudhuri, 2005) .

This act of non-compliance had consequences for India, as it resulted in the issue being addressed in the first case before the World Trade Organization’s Dispute Settlement Body in the well-known case of US v India (DS50) which commenced in 1996. The following documents relative to the case can be retrieved as follows:

A summary of the complaint can be found here.
The Consultation request by the United States can be found here .
The Report of the WTO Dispute Panel can be found here .
The Report of the WTO Appellate Body can be found here.
The Status Report by India on the recommendations and rulings can be found here .

A summary of the parties, the contravened clauses, and the timeline of the dispute are summarized below.

(World Trade Organization – INDIA – PATENTS (US) (DS50), https://www.wto.org/english/tratop_e/dispu_e/cases_e/1pagesum_e/ds50sum_e.pdf . Retrieved March 29 th, 2021.

In this case, the United States brought a complaint against India before the World Dispute Settlement Body and raised the issues that India had failed to provide a mailbox facility and EMRs into its domestic law rendering India to be non-compliant with Articles 70.8 and 70.9 of the TRIPS Agreement.

The Panel found that India was in breach of the obligations pursuant to Articles 70.8(a) or Article 63(1) of the TRIPS Agreement since it had not provided the means of allowing a product patent for pharmaceutical and chemical inventions to preserve novelty and priority, and further did not provide a mechanism for the grant of EMRs (see Panel Report, 1997). India subsequently appealed the decision before the WTO’s Appellate Body, and the Appellate Body upheld the main findings of the Panel, concluding that India’s patent filing system had been inconsistent with the above-said Articles (see Appellate Body Report, 1999).

India then subsequently brought its patent filing system into conformity with Article 70.8 and 70.8 of the TRIPS agreement, resulting in the Patents (Amendment) Act, 1999 being passed by Parliament. (See India’s Status Report, 1999 ).

The Patents (Amendment) Act, 2002

The Patents (Amendment) Act, 2002 (‘2002 Act’) brought about a number of changes to the patent regime in India. Below, I will explore some of the amendments that were brought about to India’s patent system in the 2002 Act.

Term of the patent extended

The 2002 Act introduced a new patent term of twenty (20) years, bringing this section in compliance with Article 33 of the TRIPS Agreement , which provides that the patent term of protection should be available for a period of twenty years from the date of filing. Unni (2012) describes this as one of the “most significant” changes to the 1999 Act.

Previously the term of the patent for inventions related to the method or process of manufacturing a substance being used or capable of being used as a food, medicine or drug was five (5) years from the date of sealing the patent or seven (7) years from the date of the patent, whichever is shorter ( Section 53 (1) of the Principal Act ). For other inventions, the patent term was previously fourteen (14) years from the date of the patent ( Section 53 (2) of the Principal Act ).

Definition of “invention” and “inventive step” amended

Under section 2(1)(j) of the Principal Act , the term “invention” was defined as an art, process, method, manner, substance, the machine, apparatus, or another article which was new and useful. This definition was amended to “…a new product or process which involves an inventive step and has industrial application”. The definition was also extended to include an “inventive step”. ( see Section 2 (j) and (ja), 2002 Act) . These new additions are in keeping with the definitions found under Article 27.1 of the TRIPS Agreement .

Definition of patentable subject matter

The 2002 Act brought about wide-sweeping changes to the kinds of inventions that would be defined as patentable subject matter. Amendments were made to section 3 of the Principal Act in which a more comprehensive list of what would be excluded from patentability as set out.

For instance, those inventions contrary to public interest have been extended to include inventions that are contrary to public order or morality and which cause prejudice to humans, animals, and plants ( see Section 3 (b) Principal Act , substituted by section 4 of the 2002 Act ).

Some examples of the exclusions in the 2002 Act are outlined as follows:

plants and animals other than micro-organisms;
mathematical methods, business methods, computer programs, algorithms;
scheme, rule, or method for performing a mental act or in respect of a game;
presentation of information;
topography of integrated circuits;
traditional knowledge or traditional known components.

This section therefore significantly harmonized with Article 27.1 and Article 27.2 of the TRIPS Agreement.

Compulsory licensing framework

Amendments were also made to India’s compulsory licensing framework under the 2002 Act. According to the WTO compulsory licensing exists when a third party is granted permission by the government to utilize a patented invention without the prior consent or confirmation of the patent owner.

The 2002 Act was also modernized to reflect the provisions and spirit of TRIPS ( see particularly Article 33 , TRIPS Agreement ), in which it set out three grounds under which a compulsory license would be granted ( Sections 84(1)(a),(b),(b), 2002 Act ) and the procedure to be applied where a compulsory license is being obtained ( see Sections 84 -92 of the 2002 Act ).

The 2002 amendment removed the concept of Licenses of Right which was previously found under section 86 of the Principal Act . Previously, a patent owner could apply to the Controller-General of Patents three years from the date of the patent grant, to have the patent in question made available to the public by having the patent endorsed with the term “license of right”.

The Patents (Amendment) Act, 2005

Patent protection for pharmaceuticals, foods, agro-chemicals.

Lee (2008) purports that perhaps one of the most significant changes under the Patent (Amendment) Act of 2005 was the extension of product patents to pharmaceutical substances. Previously, patents of this nature were not patentable, but this changed with the deletion of Section 5 of the Principal Act which previously provided that only the process or method of manufacturing such substances but not the substance themselves.

Other changes which were brought about by the 2005 Act were the definition of patentable subject matter and what is considered an inventive step. Of particular note is section 2 which was amended to qualify those discoveries of new forms of a known substance that would not be deemed patentable. The provision in the 2005 Act provides that such discoveries would only be those that “…result in the enhancement of the known efficacy of that substance”. Unni (2012) notes that the intention of this amendment is to prevent frivolous applications where there are only minor modifications of known inventions.

The other change found in the 2005 Act is found in respect of the amended definition of an ‘inventive step’. The definition was extended to include a feature that includes some “technical advance” or having some “economic significance” or both (section 2 (j)(a)). This broadened definition tends to inculcate similar phrasing as found in Article 31(l)(i) of the TRIPS Agreement.

Pre-grant and post-grant opposition

Under the provisions of the 2005 Act, there are certain pre-grant and post-grant opposition procedures that are set out under the Act. Section 23 of the 2005 Act substitutes sections 25 and 26 of the Principal Act and sets out the mechanism in which an opponent can put forward an opposition either before or after the grant of a patent. The grounds for opposition proceedings as outlined under Sections 25(1) and 25(2) are brought before the Controller-General of Patents, who may then submit the notice of the proceedings to an Opposition Board.

In the instance of opposition procedures, the TRIPS Agreement sets out the principles to be considered in such administrative decision-making, noting that decisions should be fair, equitable, carried out without unreasonable delay or unnecessary complications or costs. It further provides that decisions are to be provided in writing with reasoning provided (see Articles 41.2, 41.3, 62.4).

As such, in remaining compliant with TRIPS, the opposition procedures should have consideration for these general guidelines.

According to a 2020 Report by India’s Office of the Controller-General of Patents, Designs & Trademarks (hereinafter ‘IP Office’), there has been substantial modernization of the infrastructure of the IP Office which has significantly impacted the work-flow and processing of applications filed. Of particular note is that the IP Office has reported that the time for final disposal of patent applications is projected to reduce to 24-30 months from the filing date by the end of the year 2021, in comparison to previous years where the average time frame had been about 48 months from filing. This time frame is likely to encompass instances where oppositions are being requested. It is therefore purported that the reported reduction in the time for disposal has been a key focus of India, in keeping with the general principles under TRIPS.

Compulsory licensing requirements

Another significant amendment has been in the area of compulsory licensing in the 2005 Act in which there has been the inclusion of compulsory licensing for the export of certain patented pharmaceutical products ( insertion of Section 92A ). These products relate specifically to exportation to countries that have either zero or insufficient manufacturing capacities for the product in question to address a public health problem. In such an instance, the license must have been granted by the receiving country or must have permitted the importation of the product from India ( see Section 92A ).

Judicial interpretation of compliance with the TRIPS Agreement

Novartis ag v. union of india (2007).

The case of Novartis AG v. Union of India was the first instance in which questions regarding India’s compliance with the TRIPS Agreement were brought before the Indian courts. The complainant, in this case, was a Swiss pharmaceutical company, namely Novartis, which sought to patent a cancer drug called Glivec . However, after the Patent Office denied the application, the Complainant brought a claim before the Indian High Court of Madras, seeking a declaration that that Section 3(d) of the Patent Act of 1970 as substituted by the Patents (Amendment) Act, 2005 was not in compliance with the TRIPS Agreement and/or that it was (unconstitutional) or arbitrary, illogical, vague and offends Article 14 of the Constitution of India.

In this case, the court found that it did not have jurisdiction to interfere with the laws of Parliament (see para. 7, para. 8) by testing the validity of the section as being incompatible with Article 27 of the TRIPS Agreement. The Court, in making reference to the case of State of A.P. Vs. Mc Dowell & Co. emphasized the position taken in this case that there is a presumption that Parliament is aware of the needs of the people and therefore is not in a position to make a judgment on the legislature (para. 17). It further reiterated the settled position held in that case that there were two instances in which a law by Parliament could be struck down, namely: lack of competence by the legislature and a violation of the Constitution (para.18). The court was of the view that Section 3(d) contained ‘built-in measures’ that would allow the statutory authority to be guided in the exercise of its power (para. 18). The court also found that there was no instance of a violation of Article 14 of the Constitution of India (para. 19).

Conclusion – is the patent law in India compliant?

Having undergone a multi-stage approach in becoming TRIPS-compliant, it is evident that India has endeavored over the years to bring its patent legal regime in alignment with the TRIPS Agreement.

On the other hand, it should be noted that pursuant to Article 1 of the TRIPS Agreement, countries, in general, have an express reservation regarding the method of implementation within their domestic legal regime. As such, there still leaves some ‘wiggle room’ for India to retain a discretionary approach in harmonizing the provisions of the TRIPS Agreement provided that the patent regime in India does not contravene the spirit of the TRIPS Agreement.

The early changes to the Principal Act following the case of US v India were a clear indication that India was prepared to ensure that its laws were in harmony with the TRIPS Agreement. Reichman (1998) suggests that it is hoped that the findings in the case of US v India would help to “cool passions” between the developing and developed countries in the short and medium terms. He further posits that the benefits, in the long run, would seek to drive an environment that is more competitive post-TRIPS resulting in investment and technological innovation that would be beneficial to all.

Many of the changes to India’s patent system have not been met with smooth transitions and this may be explained based upon the country’s political, economic, and socio-cultural reasons for ‘slow’ compliance. The outcome of Novartis AG v. Union of India shed light on the prevailing circumstances in India, in which the country had developed what Mueller (2007) describes as having developed a “world-class generic drug manufacturing industry” through its exclusion of pharmaceutical products from patent protection. The findings of the case also revealed the need to balance the interests and history of a country and those of the international legal regime. Having a large generic drug industry, meant that India was able to provide affordable medicine to its citizens ( Lee, 2008). The decision in Novartis was evidence that member states under TRIPS maintain a certain level of flexibility in compliance, having consideration for the country’s unique social and economic circumstances.

The road ahead: India’s proposals for a TRIPS-compliant patent legal regime

Reichman (1998) suggests that while the TRIPS agreement may ultimately benefit developing countries through increased foreign investment, increased transfer of technology as well as drive local innovation, there will on the other hand be drawbacks in light of the high standards sets by the TRIPS Agreement such as the imposition of costs which will be required to obtain the tools and infrastructure need to bridge the technology ‘gap’ or standards.

Since the incorporation of the TRIPS Agreement, India has embarked upon developing a sophisticated patent regime over the past few decades. Some of the country’s patent achievements can be seen below.

Source: ‘Summary of Achievements by Office of the CGPDTM (2014-15 to 2019-2020’ by the Office of the Controller-General of Patents, Designs, and Trademarks. 2020, 18-8-2020_Achievements_of__CGPDTM_during_2014-15_to_2019-2020_and_Impact_of_steps_taken-converted.pdf (ipindia.gov.in) .

Furthermore, the country has modernized its IPR system by garnering support through obtaining technical assistance and cooperation from developed countries and intergovernmental organizations in light of Article 67 of the TRIPS Agreement which mandates that developed country Members are to provide technical and financial cooperation to help support developing and least-developed country Members.

Instances of such support can be found within the annual reports found at the E-Trips Gateway webpage: https://e-trips.wto.org/ , a screenshot of which can be seen below.

Source: ‘Reports by Developed Country Members on Technical Cooperation Activities Under TRIPS Art. 67 – Search’’ by the World Trade Organization 2021, Trade-Related Aspects of Intellectual Property Rights – Search the Entire e-TRIPS Database (wto.org)

Some of the activities which have been spearheaded by the World Intellectual Property Organization (‘WIPO’) would also prove useful in keeping with the WIPO-WTO Cooperation Agreement as part of a general initiative to harmonize intellectual property into the country’s national development policy and framework.

One of the projects conducted by WIPO in November 2019 is listed below and encompasses one of the many other initiatives which have taken place to engage in a collaborative and consultative approach of which India was a beneficiary.

In the final analysis, it is purported that the patent regime in India has been significantly transformed over the years since the incorporation of the TRIPS Agreement and has done so while also balancing its own national interests and needs. In the future, as the country continues to gain technical assistance and cooperation through education, training, and infrastructural development, it is inevitable that the country will have a more robust patent regime in years to come. It will therefore be critical for the country to ensure that the kinds of assistance it will receive moving forward are related to the specific technical areas where such assistance is appropriate so as to further propel the country’s patent system and ultimately to achieve the objectives under the TRIPS Agreement.

Agreement Between WIPO and WTO, 22 December 1995, World Intellectual Property Organization-World Trade Organization, 35 I.L.M. 754 (1996), https://www.wto.org/english/tratop_e/trips_e/wtowip_e.htm .Accessed 23 March 2021.
The Patents Act, No. 39 of 1970, Ministry of Commerce and Industry (Department of Promotion of Industry and Internal Trade), India, 19th September 1970, https://www.advocatekhoj.com/library/bareacts/patents/index.php?Title=Patents%20Act,%201970 . Accessed 17 April 2021.
The Patents (Amendment) Act, 1999, No. 17 of 1999, Acts of Parliament, Ministry of Law, Justice and Company Affairs (Legislative Department), New Delhi, 26 March 1999/Chaitra 5, 1921 (Saka), https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_34_1_patents-amendment-act-1999.PDF . Accessed 17 April 2021.
The Patents (Amendment) Act, 2002, Act No. 38 of 2002, Acts of Parliament, Ministry of Law, Justice and Company Affairs (Legislative Department), New Delhi, 25 June 2002/Asadha 4, 1924 (Saka), https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_125_1_THE_G.AZETTE_OF_INDIA.pdf . Accessed 17 April 2021.
The Patents (Amendment) Act, 2005, No. 15 of 2005. Ministry of Law and Justice (Legislative Department), New Delhi, 5 April 2005/Chaitra 15, 1926 (Saka), https://www.wipo.int/edocs/lexdocs/laws/en/in/in018en.pdf . Accessed 17 April 2021.
TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994), https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm . Accessed 23 March 2021.
Chandra, Aparna. “India and international law: formal dualism, functional monism.” Indian Journal of International Law, 2017, vol. 57, pp. 25–45. https://doi.org/10.1007/s40901-017-0069-0 .
“Compulsory licensing of pharmaceuticals and TRIPS”. World Trade Organization, https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm. Accessed 29 March 2021 .
“DS50: India — Patent Protection for Pharmaceutical and Agricultural Chemical Products”. World Trade Organization, https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds50_e.htm. Accessed 11 April 2021 .
“Frequently Asked Questions about TRIPS [ trade-related aspects of intellectual property rights in the WTO”. World Trade Organization http://www.wto.org/English/tratop_e/trips_e/tripfq_e.htm . Accessed 31 March 2021.
“Overview: the TRIPS Agreement”. World Trade Organization, https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm#patents . Accessed 23 March 2021.“Frequently Asked Questions about TRIPS [ trade-related aspects of intellectual property rights in the WTO”. World Trade Organization http://www.wto.org/English/tratop_e/trips_e/tripfq_e.htm .
Economic Law, 1998, vol. 1, issue 4, pp. 585-601. Oxford University Press , https://core.ac.uk/download/pdf/190526424.pdf . Accessed 15 March 2021.
Unni, V. K. “Indian Patent Law, and TRIPS: Redrawing the Flexibility Framework in the Context of Public Policy and Health.” Pacific McGeorge Global Business. & Development Law Journal, 2012, vol. 25, no. 1, pp. 323-342. Scholarly Commons, https://scholarlycommons.pacific.edu/globe/vol25/iss1/12 . Accessed 27 March 2021.

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Role of the TRIPS agreement and its scope in India

Trips agreement in india:, role of trips agreement in shaping india's intellectual property regime:.

Patents: One of the important impacts of the TRIPS Agreement on India's intellectual property command was in the area of patents. India had historically granted process patents in its place of product patents for pharmaceuticals, allowing local manufacturers to produce common versions of patented drugs at a lower cost. However, under TRIPS, India was required to evolve to a product patent regime and also this change led to challenges for the Indian pharmaceutical industry in terms of admission to affordable medicines and the convenience of generic drugs.
Copyrights: The TRIPS Agreement also influenced India's copyright law. It introduced minimum standards for copyright protection, including the term of protection, rights of authors, and limitations and exemptions and India amended its Copyright Act in 1999 to align with TRIPS requirements and extend copyright protection to computer software, digital works, and performances in the digital environment.
Trademarks and Industrial Designs: The TRIPS Agreement set minimum standards for the protection of trademarks and industrial designs and also required India to provide satisfactory protection to trademarks and establish a system for the registration and enforcement of industrial designs as India amended its Trademarks Act in 1999 to comply with TRIPS obligations and habituated provisions for the registration and guard of well-known trademarks.
Geographical indications: Customarily, some commercial items have been manufactured in a geographically defined territory and commercial relations, the geographical indicator becomes the dependable "carrier" of qualifying product features when these items are credited to certain criteria basically due to their geographical provenance. The purpose and value of geographical indications are subsequently given to trademarks, and they are allowable legal protection.

Importance of TRIPS

The unique aspect of the trips agreement in india, protection of traditional knowledge and geographical indications:, challenges and future directions:, case law: bayer corporation v. union of india (2012), law article in india, please drop your comments, you may like.

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An International Guide to Patent Case Management for Judges

Chapter 6 india, 6.1 overview of the patent system, 6.1.1 evolution of the patent system.

Intellectual property (IP) rights are governed by national law, which for members of the World Trade Organization (WTO), shall be in conformity with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). 1 The TRIPS Agreement sets out the objective of IP rights in Article 7:

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

As a member-nation of the WTO, India was required to amend or enact laws to conform to the TRIPS Agreement. However, this was a challenge for India. A significant reason was that, unlike many other countries, such as the United States of America (U.S.), where the Constitution recognizes the promotion and progress of science and arts and secures exclusivity granted to authors and inventors, the Constitution of India only encourages Indian citizens to have a scientific temper and prescribes a duty to develop the spirit of inquiry and reform. 2 The Constitution of India mandates that no one shall be deprived of “property” except with the authority of law. 3 Since patents are “property,” there is a positive constitutional entitlement to the grant and recognition of patents. The non-enforceable – but critical – chapter of the “Directive Principles of State Policy” in the Constitution of India further directs the Government to ensure the promotion of public health, 4 the reduction of inequalities 5 and the securing of systems that ensure ownership and control of resources for the common good. 6 The basis and limitations for IP rights are, therefore, the right to property, the directive principles of state policy and the fundamental duties of citizens, apart from the various laws enacted periodically.

The journey of the Indian patent regime is reflected in three different periods: colonization, post-independence and globalization. 7

Colonization . India inherited its patent regime from the British rule. When the British colonization of India ended, the Indian Patents and Designs Act, 1911, was in force and had created a system of patent administration in India under an administrative office – the Controller of Patents and Designs.

Post-independence. India enacted its first independent patent law in 1970. It came in the backdrop of two committees constituted to make recommendations: the Bakshi Tekchand Committee in 1949 and, later, the Justice Rajagopal Ayyangar Committee. Focusing on the special socioeconomic conditions in India, the recommendations of these two committees resulted in far-reaching changes in patent laws. Some of the significant changes introduced were with respect to food and drug patents, compulsory licensing, and connected working requirements. The law enacted in 1970 is credited with the growth of various industries, including the pharmaceutical industry, which, in two decades, gave India the distinction of being called “the pharmacy of the world” as Indian drug companies began exporting reasonably priced medicines to many countries.

Globalization. In 1991, India liberalized its economy and adhered to the General Agreement on Tariffs and Trade (GATT 1947), which was succeeded by the WTO, resulting in amendments being introduced in line with the TRIPS Agreement. These amendments saw India bring about fundamental changes permitting product patents in food, medicines and agrochemicals. The flexibilities in the TRIPS Agreement were used to maintain a balance: ensuring that the amendments would be gradually made systemic rather than forcing the closure of already-functioning industries. Statutory provisions relating to chemical and drug patents, patentability and other aspects of the amendments were tested repeatedly in the courts and were upheld as being within the Constitutional scheme while being fully compliant with the TRIPS Agreement. The judgment of the Supreme Court in Novartis v. Union of India 8 recognized the need to curb the “evergreening” of patents while acknowledging the need to grant patent protection to incremental innovations. After Novartis , Indian courts have granted interim injunctions to protect patentees’ rights in pharmaceutical 9 and agrochemical inventions. 10 The courts have also protected claims to standard-essential patents (SEPs) by granting interim injunctions to secure the patentee’s right to royalties even pending trial. 11 Courts have granted permanent injunctions 12 and damages (in quite significant amounts) 13 in cases of patent infringement and have also denied interim injunctions in appropriate cases. 14 Each case has been decided on its own facts on the basis of settled legal principles. A current review of decisions would show no pro- or anti-patentee bias in the adjudication of patent cases.

6.1.2 The Justice N Rajagopala Ayyangar Committee Report

In 1957, the Government of India appointed a committee led by a distinguished retired Justice of the Supreme Court of India, Justice N Rajagopala Ayyangar, to examine the revision of the Patents Act and advise the Government in this respect.

The Justice N Rajagopala Ayyangar Committee report stated, in no uncertain terms, that the patent system was a quid pro quo system: the monopoly that a patentee obtains is only in exchange for the disclosure of the invention to the public, free to be used after the monopoly period is over. The quid pro quo, according to the report, also included the obligation on the part of the patentee to work the invention in India. The report also underscored, rather emphatically, that the patent system had failed in India because it had failed to spark the kind of innovation that it sought to encourage – underdeveloped countries could not yield the same result from the patent system as their more developed counterparts could. The patent system was recommended to be continued only because there was no better alternative to achieve better results – in their form at the time, patents were the lesser evil. The report was unequivocal in its apprehension that foreign patentees could misuse the patent system to capture large markets in India at the cost of domestic innovation while simultaneously not investing in the manufacture of the patented product.

The committee’s recommendations were a catalyst for wide changes in Indian patent law, eventually leading to the Patents Act of 1970, replacing the Indian Patents and Designs Act, 1911. The Patents Bill was introduced in 1965 and amended in 1967. The Patents Act, 1970, and Patents Rules, 1972 came into force on April 20, 1972.

6.1.3 The Patents Act, 1970 (pre–TRIPS Agreement)

The Patents Act, 1970, incorporated major provisions to reduce the social costs of foreign-owned patents. It prohibited patents on products useful as medicines and food, shortened the term of chemical process patents, and significantly expanded the availability of compulsory licensing. This spawned a powerful Indian pharmaceutical generic drugs industry.

In Bishwanath Prasad Radhey Shyam v. HM Industries , 15 deciding an appeal in a case for infringement of a patent called “Means for Holding Utensils for Turning Purposes,” the Supreme Court said:

The object of the patent law is to encourage scientific research, new technology and industrial progress. Grant of exclusive privilege to own, use or sell the method or the product patented for the limited period, stimulates new inventions of commercial utility. The price of the grant of the monopoly is the disclosure of the invention at the Patent Office, which after the expiry of the fixed period of the monopoly passes into public domain.

The salient features of the Act (as enacted) were:

the reduction of the term of patent from 16 to 14 years;
a maximum of seven years for the term of a patent for the processes for drugs and foods;
no product patents available for food, drugs and medicines, including the products produced or obtained by chemical processes;
provisions prescribing nonworking as a ground for the grant of compulsory licenses, licenses of right and the revocation of patents;
the empowerment of government to use inventions for its own use;
provisions for the use of inventions for government purposes, research or instruction to pupils;
the endorsement of a “license of right” to patents related to drugs, foods and products of chemical reactions;
the codification of certain inventions as non-patentable;
the expansion of the grounds for opposition to the grant of a patent;
exemption from anticipation in respect of certain categories of prior publication, prior communication and prior use;
provisions for the secrecy of inventions relevant for defense purposes;
the mandatory furnishing of information regarding foreign applications;
the prevention of abuse of patent rights by voiding restrictive conditions in license agreements and contracts;
a provision for appeal to the High Court from decisions of the Controller General of Patents, Designs and Trade Marks (“the Controller”); and
the separation of industrial designs from the law of patents.

However, many provisions changed after the TRIPS Agreement, as discussed in Sections 6.1.4.4.3 to 6.1.4.4.5 .

6.1.4 International obligations and commitments

India is a member of the WTO, which came into being on January 1, 1995. The WTO administers the General Agreement on Tariffs and Trade (GATT), 16 which is an international agreement among countries to promote free international trade in goods. The WTO is a package deal in that its members must abide by the GATT agreement and a series of other international agreements. One such agreement is the TRIPS Agreement. India is also a member of the Paris Convention for the Protection of Industrial Property, 17 the Patent Cooperation Treaty (PCT), 18 as well as the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.

6.1.4.1 The TRIPS Agreement

TRIPS is one of the most comprehensive multilateral agreements on intellectual property rights.

Section 5 of TRIPS deals with patents. Article 27(1) of TRIPS provides that patents will be available for products or processes of inventions in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application. This was a departure from what the Patents Act, 1970 allowed at the time since no patents were allowed for “substances intended for use, or capable of being used, as food or as medicine or as drug.” 19 In such cases, only method or process patents were allowed for such substances.

Article 70(8)–(9) of the TRIPS Agreement stipulates that, during the transition period, a country should provide a mechanism for patent protection for pharmaceutical and agricultural chemical products, including the grant of exclusive marketing rights (EMRs). On July 2, 1995, the U.S. alleged that India had not complied with these provisions. It requested the WTO for dispute consultations. A panel to hear the dispute issued a report on September 5, 1997, finding that India was indeed in violation of these TRIPS Agreement provisions. 20 India’s appeal also failed. The appellate body found that, as on January 1, 1995, India was required to have a legal mechanism for patent protection as provided under Article 70(8)–(9) of the TRIPS Agreement. 21

In 1997, the European Community requested another dispute consultation on similar grounds. The panel set up in this regard also ruled against India. 22 Accordingly, in 1999, India introduced an amendment to comply with these requirements. These, and other amendments of 2002 and 2005, are discussed in Sections 6.1.4.4.3 to 6.1.4.4.5 .

6.1.4.2 The Doha Declaration

Prior to the adoption of the TRIPS Agreement, most countries did not grant patents for medicines. This helped keep costs affordable and ensured access to medicines. The introduction of product patents for medicines under the TRIPS agreement was a matter of concern for developing countries and least-developed countries. Increasing the number of product patents for medicines implied that the cost of medications would increase and thwart access to medication.

The TRIPS Agreement required, among other things, that all WTO members introduce product and process patents in all fields of technology. Exceptions in fields related to the fulfillment of basic needs, such as in health, were not recognized or permitted.

In 2001, WTO members adopted a declaration at the WTO Ministerial Conference in Doha, Qatar, stating that it was important to interpret the TRIPS Agreement to support public health by promoting access to medicine and the creation of medicines. 23 This was important for developing economies, including India, which had stressed the need to expand public health coverage at low and affordable costs. The Doha Declaration agreed that the TRIPS Agreement did not and should not prevent WTO members from taking measures to protect public health. 24

The Doha Declaration recognized that the TRIPS Agreement should be interpreted and implemented in a manner conducive to its members, deploying the flexibilities built into the TRIPS Agreement. 25 Consequently, each WTO member was free to determine the grounds on which compulsory licenses were to be granted and what constituted a national emergency or other circumstances of extreme urgency for invoking compulsory licensing provisions. 26 The Doha Declaration also recognized that many countries had little or no manufacturing capacity in the pharmaceutical sector and might face difficulties in the effective use of the TRIPS Agreement’s compulsory licensing provisions. 27 Pursuant to this, an amendment was accepted in Article 31 bis of the TRIPS Agreement, permitting countries to grant compulsory licenses even for export to other countries with insufficient or no manufacturing capacity.

The Doha Declaration also clarified flexibilities for members to adopt an international principle of exhaustion of rights 28 in accordance with Article 6 of the TRIPS Agreement. 29 The principle of exhaustion means that, once patent holders sell a patented product, they cannot prohibit the subsequent resale of that product, since their rights in respect of that product have been “exhausted” by the act of selling the product. The Doha Declaration reaffirmed that members were free to establish their own regime for such exhaustion to ensure that patent rights did not impede legitimate products entering global supply chains.

6.1.4.3 The Patent Cooperation Treaty

The PCT provides a platform to facilitate the filing of a single international patent application to seek protection across PCT contracting states. This is beneficial for an applicant because, in the traditional system, separate applications for patents had to be made in each jurisdiction across the world. The international search reports and written reports generated by the International Searching Authorities as well as International Preliminary Reports on Patentability (Chapter II) drawn by the International Preliminary Examining Authorities assist the applicant in deciding whether to proceed with the national phase and, if so, in which countries, based on the likelihood of success as per the search report. The PCT system has also resulted in a considerable reduction in costs for applicants.

6.1.4.4 Amendments and implementation in India

6.1.4.4.1 patent cooperation treaty implementation in india.

India signed and acceded to the PCT in September 1998, which entered into force in India in December 1998. The provisions relating to applications under the PCT were incorporated under the Patents (Amendment) Act, 2002. Under the Patents Act, 1970, an “international application” was defined as an application made as per the provisions of the PCT. 30 Four offices in India (New Delhi, Kolkata, Chennai and Mumbai) and the International Bureau in Geneva, Switzerland were designated as receiving offices for international applications. Section 7 of Act prescribes the form in which an applicant makes an application for its invention and also provides for making a simultaneous application under both the PCT and the Act if a corresponding application has been filed before the Controller in India. 31

Chapter III of the Patents Rules, 2003, contains the provisions for filing an international application, the form in which an application is to be made, fees payable to the examining authority, time limits for establishing an international search report and other related rules for applications under the PCT. The term of a patent granted in India for a PCT international application is 20 years from the date of its filing under the PCT. 32

6.1.4.4.2 Patent prosecution highway

Apart from the PCT system, several countries and regions have recently created “patent prosecution highways” which provide for accelerated examination, the sharing of search reports and so on, which result in the speedier examination and grant of patents. Such prosecution highways can either be bilateral or multilateral. In India, the first patent prosecution highway was initiated in 2019 by the Indian Patent Office as a bilateral pilot patent prosecution highway program with the Japan Patent Office. Guidelines for the same were published, though the pilot is limited to 100 cases per year, on a first-come-first-served basis. Depending on the evaluation of this pilot highway, long-term patent prosecution highways with one or more patent offices across the country may be a reality.

6.1.4.4.3 The 1999 amendment, post–TRIPS Agreement

Upon coming into effect on January 1, 1995, the TRIPS Agreement provided for transitional periods for WTO members to introduce legislation complying with the obligations under the agreement. India has been a WTO member since January 1995.

For developing countries like India, the deadline for complying with the TRIPS Agreement was the year 2000. Article 65(4) of the TRIPS Agreement provided a special transitional provision for those countries that did not grant product patents. As per this provision, an additional period of five years (i.e., until 2005) on the initial TRIPS Agreement transitional period was permitted for introducing product patent protection.

India needed to provide a means for filing patent applications during the transitional period. The “mailbox provision” allowed applicants to file for patents, thereby establishing filing dates, while at the same time permitting members to defer the granting of product patents. In addition, India also needed to provide EMRs in exchange for permission to delay the grant of product patents until January 1, 2005.

Transitional arrangements were introduced through Section 2 of the Patents (Amendment) Act, 1999, through the insertion of Section 5(2) of the Patents Act, 1970, allowing product patent applications to be filed through a “mailbox,” while Chapter IVA provided for the grant of EMRs if certain conditions were fulfilled

EMRs were introduced as a transitory provision to help developing countries that followed a process patent regime to slowly phase into a product patent regime. In order to bring in transitional measures for the recognition of the TRIPS Agreement obligations, the Patents (Amendment) Act, 1999, introduced a system for the grant of EMRs. This allowed inventors to file early applications for the grant of patents and to establish filing dates so that, when patent protection was ultimately granted, these applications would be considered on the basis of the date of filing or priority dates. These provisions were considered necessary under the TRIPS Agreement, 33 pending the initiation of a streamlined process in India for granting product patents relating to drugs, pharmaceutical and agricultural chemical products.

EMRs are applicable where a patent is granted for the same product in another WTO member after 1995 (the date of entry into force of the TRIPS Agreement), provided marketing approval for the product was obtained in such other WTO member. However, EMRs are limited only to pharmaceutical and agricultural chemical products. From a simple dictionary definition of the term, the meaning of “exclusive marketing rights” appears to be very similar to that of patent rights; however, in theory, EMRs prevent others from making or using patented products. The rights holder can indirectly prevent others from marketing products based on such use since they would lack the authorization to do so. Patent protection and EMRs are alternatives to each other and are not used concurrently.

EMRs under the 1999 amendment could only be granted for products intended for or capable of being used as a medicine or drug. For an applicant to have the exclusive right to sell or distribute the product in India, pending the grant or rejection of the application for the product patent, the following conditions needed to be fulfilled:

a patent and approval to sell the same invention applied for (on or after January 1, 1995) in another WTO member had been granted after the date of making an application for the product patent; 34 or
a patent for the method, process or manufacture of the invention applied for (on or after January 1, 1995) and relating to the same product had been granted in India on or after the date of making an application for the product patent; 35 and
approval to sell or distribute the product had been received from the Central Government. 36

EMRs were granted for a period of five years from the date of such approval or until the grant or rejection of the application for the product patent, whichever was earlier.

As per the 1999 amendment, no application for the grant of a product patent could be referred by the Controller to an examiner for making a report until December 31, 2004. 37 For the said 10-year period, the applications were kept in a “black box,” a figurative expression for applications pending examination. After this date, the application would be referred to an examiner for a report on whether the claimed invention was within the meaning under Section 3 of the Patents Act, 1970, or whether the invention was such for which no patent could be granted under Section 4 of the Act. If the necessary preconditions were not met, the application would be rejected. 38 If the preconditions were fulfilled, the Controller could proceed to consider the application for the grant of a patent. 39

The 1999 amendment also included provisions authorizing the Central Government – under expedient circumstances and keeping in mind the public interest at large – to sell or distribute the product by itself or through an authority so empowered in writing. 40 Moreover, the Central Government also had the power to direct that the product be sold at a price determined by it after specifying its reasons and the public interest involved.

All suits relating to infringement under Section 24B of the Act would be dealt with in the same manner as suits concerning infringement of patents under Chapter XVIII.

In India, some EMRs were granted relating to medicinal products. Suits for infringement restraining violation of EMR rights were also instituted. However, all EMRs came to an end after the full-scale implementation of the amendments with effect from January 1, 2005. With the introduction of the 2005 amendments, all pending applications for the grant of EMRs were automatically considered as applications for product patents and dealt with accordingly.

6.1.4.4.4 The 2002 amendment, post–TRIPS Agreement

This 2002 amendment to the Patents Act, 1970, was introduced to (a) bring the patent regime in India in line with the TRIPS Agreement; (b) bring the law on patents in line with the increasing development of technological capability of India; (c) provide the necessary safeguards for the protection of public interest and national security; (d) harmonize the procedure for the grant of patents in accordance with the international practices; and (e) make the system more user-friendly.

Some of the salient features of the Patents (Amendment) Act, 2002, were as follows:

The term of every patent granted after the commencement of the Patents (Amendment) Act, 2002, was increased to 20 years from the date of filing of the application. 41
The time for restoration of a lapsed patent was increased to 18 months. 42
A new definition for “invention” was added: a patent could be for a process or product that was new, involved an inventive step or was capable of industrial application. 43
A new definition for “inventive step” was added. 44
The negative list of what were not considered inventions (i.e., non-patentable subject matter) was amended and expanded in light of Article 27(2)–(3) of the TRIPS Agreement. 45
The concept of a request for the publication of a patent application was introduced. 46
An onus-of-proof provision was introduced, requiring the defendant to prove that its process for obtaining the product in question was different from the patented process in cases where an identical final product was obtained from such a process. 47
The chapter on compulsory licensing was substituted with provisions and procedures consistent with the TRIPS Agreement, 48 and the provisions relating to the license of rights were omitted. 49
The Bolar exemption was introduced. 50
The parallel import of patented products was introduced. 51
All appeals under the Act were redirected from the High Courts to a specialized tribunal (i.e., the Intellectual Property Appellate Board (IPAB) 52 since abolished in 2021). 53
National security provisions were amended. 54

6.1.4.4.5 The 2005 amendment, post–TRIPS Agreement

The amendments of 2005 were introduced to bring Indian patent laws into further compliance with the TRIPS Agreement because the transitional period available to India was ending in 2005. Some of the salient features of the Patents (Amendment) Act, 2005, were as follows:

The definition of “inventive step” was amended. 55
The definition of “new invention” was added. 56
The definition of “patent” was amended. 57
The negative list of what were not considered inventions (i.e., non-patentable subject matter) was amended. 58
The provisions that provided that only the process and not the product itself would be patented in cases of inventions relating to food, drugs and medicines were deleted. 59 This ensured that product patent protection was available for all fields.
The chapter relating to EMRs was omitted, 60 and the provisions relating to it were modified.
Two levels of opposition were introduced – pre-grant and post-grant. All grounds available for pre-grant opposition were also made available to interested parties for challenging a patent in post-grant opposition within one year from the date of publication of the grant of patent. 61
Pursuant to the Doha Declaration, the grounds for seeking compulsory licensing were expanded by adding a provision for the issuance of compulsory licenses for the manufacture and export of patented pharmaceutical products to countries that had insufficient manufacturing capacity in the pharmaceutical sector if that country had allowed such importation by notification. 62
Jurisdiction for trying revocation petitions to revoke granted patents was shifted from the High Courts to the IPAB with a view to extending its jurisdiction to the revocation of patents. 63 This now stands reversed in 2021. 64
Certain provisions were amended to bring the patent regime in India in line with the PCT, to which India is a signatory. 65

6.1.5 Patent application trends

Figure 6.1 shows the total number of patent applications (direct and Patent Cooperation Treaty (PCT) national phase entry) filed in India from 2000 to 2021.

Source: WIPO IP Statistics Data Center, available at www3.wipo.int/ipstats/index.htm?tab=patent

6.2 Patent institutions and administrative review proceedings

6.2.1 patent institutions, 6.2.1.1 office of the controller general of patents, designs and trade marks.

The Office of the Controller General of Patents, Designs and Trade Marks is located in Mumbai. The Controller supervises the working of the Patents Act, 1970, the Designs Act, 2000, and the Trade Marks Act, 1999, and also renders advice to the Government on matters relating to these subjects.

The Central Government may appoint as many examiners and other officers with such designations as it thinks fit. 66 Minimum qualifications are prescribed. These officers function under the Controller’s superintendence. Higher qualifications are prescribed for the position of Senior Joint Controller of Patents and Designs. The organizational structure of the Office is shown in Figure 6.2 .

Source: Office of the Controller General of Patents, Designs and Trade Marks, About Us , ipindia.gov.in/about-us.htm

6.2.1.2 The Department for Promotion of Industry and Internal Trade

The Department for Promotion of Industry and Internal Trade was established in 1995 and reconstituted in 2000 when it was merged with the Department of Industrial Development. The department’s purpose is to promote and accelerate the industrial development of the country by facilitating investment in new and upcoming technologies, foreign direct investment and supporting the balanced development of industries.

The department is the nodal department for all matters related to the protection of IP rights in the fields of patents, trademarks, copyrights, industrial designs and geographical indications.

6.2.1.3 National Institute of Intellectual Property Management, Nagpur

The National Institute of Intellectual Property Management is a national center for excellence in training, management, research and education in IP rights. The institute trains examiners of patents and designs, examiners of trademarks and geographical indications, IP professionals and IP managers in the country. The institute also facilitates research on IP-related issues.

The Patent Information System was established by the Indian Government in 1980 to maintain a comprehensive collection of patent specifications and patent-related literature worldwide. It is also located in Nagpur within the premises of the National Institute of Intellectual Property Management.

6.2.1.4 Cell for IPR Promotion and Management, constituted under the National Intellectual Property Rights Policy

The Cabinet of Ministers of the Central Government approved the National Intellectual Property Rights Policy on May 12, 2016. 67 This policy drew a future roadmap for IP rights in India and made several recommendations. Following one of the recommendations of the 2016 policy, a specialized professional body – the Cell for IPR Promotion and Management – was created under the aegis of the Department for Promotion of Industry and Internal Trade, and it has been instrumental in taking forward the objectives and visions of the policy. Since the adoption of the policy, the cell has worked toward changing the IP landscape of the country, which among other things, has included:

IP rights awareness programs, which are conducted in over 200 academic institutions for the industry, police, customs and the judiciary;
reaching out to rural areas – awareness programs are being conducted using satellite communication (EduSat). In one such program, 46 rural schools, with a combined total of 2,700 students, were reached. Over 300 schools and more than 12,000 students have been reached;
more focus on developing e-content and disseminating content through online channels;
including content on IP rights in the National Council of Educational Research and Training commerce curriculum. Work is ongoing to include IP rights in other academic streams; and
conducting competitions in conjunction with industry for school and college students to develop the “innovative spirit.” Some competitions have included the development of mobile applications, videos and online games.

As part of the awareness campaign, the Cell for IPR Promotion and Management also launched India’s first IP mascot – “IP Nani” – in collaboration with the European Union Intellectual Property Office. IP Nani is an animated grandmother who sends out messages for the protection and enforcement of IP. There are also a series of animated videos on IP rights for school students. 68 These videos are available for viewing on platforms such as YouTube. 69

6.2.1.5 The Department of Science and Technology – Patent Facilitation Programme

The Department of Science and Technology, under the Ministry of Science and Technology, has been implementing its Patent Facilitation Programme since 1995. It has established a Patent Facilitating Cell at the Technology, Information, Forecasting Assessment Council (an autonomous body of the department) and, subsequently, 26 patent information centers in various states. The patent facilitating cells and patent information centers create awareness of and extend assistance in protecting IP rights at the state level, including for patents, copyright, industrial designs, geographical indications and so on.

These patent information centers have also established IP cells in universities in their respective states to enlarge the network. Today, more than one hundred such cells have been created in different state universities. In addition, these centers are also mandated to provide assistance to inventors from government organizations and from central and state universities. They also render ongoing technical and financial assistance in filing, prosecuting and maintaining patents on behalf of the Government, research and development institutes, and academic institutions. 70 The mandate of the program is:

providing patent information as a vital input to research and development;
facilitating patent and IP rights facilitation for academic institutions and Government research and development institutions;
providing IP rights policy input to the Government; and
conducting IP rights training and awareness programs in the country.

6.2.1.6 Traditional Knowledge Digital Library

The Traditional Knowledge Digital Library (TKDL) is a pioneering initiative in India to protect Indian traditional medicinal knowledge and prevent its misappropriation. It was set up in 2001 as a collaboration between the Council of Scientific and Industrial Research and the Ministry of Ayush, Government of India. The Council of Scientific and Industrial Research is a contemporary research and development organization and a pioneer in India’s IP movement.

The TKDL has overcome the language and format barrier by systematically and scientifically converting and structuring the available contents of ancient texts on Indian systems of medicine (i.e., Ayurveda, Siddha, Unani, Sowa Rigpa and Yoga) into five international languages – English, Japanese, French, German and Spanish – with the help of information technology tools and an innovative classification system called the Traditional Knowledge Resource Classification. More than 360,000 formulations and practices have been transcribed into the TKDL database.

The classification has also structured and classified the Indian traditional medicine system into several thousand subgroups for Ayurveda, Unani, Siddha and Yoga. The Traditional Knowledge Resource Classification has enabled the incorporation of about 200 subgroups under International Patent Classification A61K 36/00, more than the few subgroups earlier available on medicinal plants under A61K 35/00, thus enhancing the quality of search and examination of prior art for patent applications in the area of traditional knowledge.

The TKDL has also established international specifications and standards for setting up traditional knowledge databases based on TKDL specifications. These standards were adopted in 2003 by the committee in the fifth session of the World Intellectual Property Organization’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Expression of Folklore.

Currently, the TKDL is based on open-source and open-domain texts of Indian systems of medicine. The TKDL acts as a bridge between these books (prior art) and patent examiners. Access to the TKDL is available to 13 patent offices under the TKDL Access (Non-disclosure) Agreement, 71 which has inbuilt safeguards on nondisclosure to protect India’s interest against any possible misuse.

The TKDL is proving to be an effective deterrent against biopiracy and has been recognized internationally as a unique effort. It has set a benchmark in traditional-knowledge protection around the world, particularly in traditional-knowledge-rich countries, by demonstrating the advantages of proactive action and the power of strong deterrence. The key here is preventing the grant of incorrect patents conferring monopolies on aspects of traditional knowledge, by ensuring access to prior art relating to traditional knowledge for patent examiners without restricting the use of that traditional knowledge.

6.2.2 Administrative review proceedings

6.2.2.1 intellectual property appellate board.

Under the Patents Act, 1970, the appellate jurisdiction to hear appeals and the original jurisdiction to revoke patents was conferred on the High Courts in India. Both these jurisdictions were redirected to the IPAB as a specialized IP tribunal in 2002 and 2005. This was to enable the speedy disposal of such matters (see Figure 6.3 regarding the disposal of cases by the IPAB). 72 However, in 2021, the Central Government was of the view that this stated objective of speedy disposal was not being achieved and abolished the IPAB, redirecting such matters back to the High Courts. 73

Note : GI = geographical indication. Source: Jacob Schindler, Top Judge’s Blueprint for the Future in IP Litigation in India , IAM Media (May 5, 2021), www.iam-media.com/law-policy/specialised-ip-bench-in-india-long-overdue-says-delhi-high-court-veteran

6.2.2.2 Pre-grant opposition

The scheme of pre-grant oppositions was streamlined by the Patents (Amendment) Act, 2005. Prior to this, a pre-grant opposition could only be filed by a “person interested.” The amendment now allows any person to file a pre-grant opposition. It can be filed when an application for a patent has been published, but the patent has not yet been granted under Section 25(1) of the Patents Act, 1970. There is no time limit within which a pre-grant opposition must be filed after publication.

6.2.2.2.1 Procedure of pre-grant opposition

The pre-grant opposition procedure broadly follows these steps:

1. The pre-grant opposition is filed, along with evidence, if any. 74
2. The Controller forms a prima facie opinion on the pre-grant opposition filed. They decide either to issue notice of the opposition to the patent applicant or to reject the opposition prima facie without issuing notice to the patent applicant. 75
3. If notice has been issued, the patent applicant may reply (along with evidence, if any) within three months from the date of the notice by the Controller. 76
4. The Controller may hold a “hearing.” This is followed by a decision, ordinarily within one month. 77 The Controller is required to either reject or grant the patent.

6.2.2.2.2 Grounds on which pre-grant opposition can be filed

Section 25(1) of the Patents Act, 1970, provides a list of grounds on which a pre-grant opposition can be filed. The list is exhaustive:

(a) that the applicant for the patent or the person under or through whom he claims, wrongfully [emphasis added] obtained the invention or any part thereof from him or from a person under or through whom he claims; (b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim – (i) in any specification filed in pursuance of an application for a patent made in India on or after the 1st day of January, 1912; or (ii) in India or elsewhere, in any other document: Provided that the ground specified in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or subsection (3) of section 29; (c) that the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after priority date of the applicant’s claim and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the applicant’s claim; (d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim. Explanation. – For the purposes of this clause, an invention relating to a process for which a patent is claimed shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only; (e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant’s claim; (f) that the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act; (g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed; (h) that the applicant has failed to disclose to the Controller the information required by section 8 or has furnished the information which in any material particular was false to his knowledge; (i) that in the case of a convention application, the application was not made within twelve months from the date of the first application for protection for the invention made in a convention country by the applicant or a person from whom he derives title; (j) that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention; (k) that the invention so far as claimed in any claim of the complete specification is anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere, but on no other ground, and the Controller shall, if requested by such person for being heard, hear him and dispose of such representation in such manner and within such period as may be prescribed.

6.2.2.2.3 Locus standi to file pre-grant oppositions

Under Section 25(1) of the Patents Act, 1970, “any” person can file a pre-grant opposition. A pre-grant opposition is deemed to be an extension of the examination by the Patent Office, and, thus, the standing requirement is diluted. Nevertheless, precedents demonstrate that courts come down heavily against fake pre-grant oppositions or those filed by impostors solely to harass or to delay the grant rather than with any genuine intent to remove invalid patents. 78

6.2.2.3 Post-grant opposition

A post-grant opposition can be filed under Section 25(2) of the Patents Act, 1970, by a “person interested” after the grant of patent but within one year from the date of publication of the grant of a patent.

6.2.2.3.1 Procedure in filing post-grant opposition

The post-grant opposition procedure broadly follows these steps:

1. A post-grant opposition is filed, along with evidence, if any. 79 A copy must be supplied to the patentee. 80
2. The Controller constitutes an opposition board of three examiners (other than the examiner who examined the patent). 81
3. The patent applicant may reply to the opposition, providing evidence, if any, within two months. 82 If no reply is filed, the patent is deemed to be abandoned. 83 The Controller also notifies the patentee. 84 The time for this reply begins from the date the patent applicant is served with the opposition by the opponent.
4. The opponent then has one month to respond to the patent applicant’s reply statement. 85
5. The opposition board prepares a report with reasons on each ground taken in the notice of opposition. The report contains the board’s joint recommendation and is made within three months of the date on which the documents were forwarded to the board. 86
6. The Controller schedules a hearing. This is followed by a decision. 87 At the hearing, the Controller may require members of the opposition board to be present. If either of the parties wishes to be heard, this is permitted on payment of a fee and after notice. If no notice to attend the hearing is received from either party, the Controller can decide the opposition without a hearing. The order must be reasoned. The recommendation of the opposition board is not binding, though it is of persuasive value. Thus, the board’s recommendation should not be lightly ignored without stated reasons.

A party can also file new documents before the scheduling of the hearing, provided prior leave of the Controller is obtained. 88 Further, a party can rely upon “any publication” that may not have been filed earlier, provided that there has been five days’ notice and that the details of the publication are given to the other party. 89

In Cipla Ltd v. Union of India , the Supreme Court held that it would be mandatory to issue a copy of the recommendation of the Opposition Board to the parties, so that the principles of natural justice are duly adhered to. 90

6.2.2.3.2 Grounds on which post-grant opposition can be filed

The grounds for post-grant opposition are the same as those for pre-grant opposition. The grounds are exhaustive.

6.2.2.3.3 Locus standi to file post-grant oppositions

Section 2(1)(t) of the Patents Act, 1970, defines “person interested” in an inclusive manner to include a person engaged in or promoting research in the same field as that to which the invention relates. Precedents have interpreted the term “person interested” broadly to cover any person who has a direct, present and tangible interest in the patent and those whose interests are adversely affected because of the patent. 91 The term has been construed to include even nongovernmental organizations that have an interest or stake in the existence or invalidity of the patent – commercial interest is not a necessary condition. 92

6.2.2.3.4 Appeals from pre-grant and post-grant oppositions

An appeal lies to the jurisdictionally competent High Court from an order of rejection of a patent application in a pre-grant opposition and from an order revoking or maintaining the grant of patent in a post-grant opposition. No appeal lies from the grant of a patent in a pre-grant opposition. 93

6.3 Judicial institutions

6.3.1 court system in india, 6.3.1.1 hierarchy of courts.

There is a common court structure across India, with the Supreme Court of India at its apex. The Supreme Court of India is a court established under the Constitution of India. It is located in New Delhi and is the final appellate authority in the Indian judicial system. The Supreme Court has appellate, constitutional, review and special jurisdictions. It also has limited original jurisdiction for constitutional matters, though not for IP matters.

Below the Supreme Court of India are the various High Courts of India. The Supreme Court exercises appellate jurisdiction over High Court decisions. However, all High Courts and the Supreme Court of India occupy equal constitutional status. While, typically, each federal Indian state has a designated High Court, some states share a High Court. There are 24 High Courts in India.

All High Courts have appellate, constitutional and review jurisdiction. A few High Courts also have “original” jurisdiction – civil cases, including IP suits, can be directly filed in these High Courts, subject to a certain minimum pecuniary value that may vary from one state to another. Such High Courts are those of Delhi, Bombay (Mumbai), Madras (Chennai), Calcutta (Kolkata) and Himachal Pradesh (Shimla). All appeals from a High Court lie to the Supreme Court, though some High Courts also possess an intracourt appeal system from a single judge of the High Court to a bench comprising two judges (i.e., division bench). 94

Each federal Indian state is typically divided into several districts. Below the High Courts of each state are the district and sessions courts for each such district. The district court is for civil matters, and the sessions court is for criminal matters. Below these courts are the courts of sub-judges for civil matters and the magistrates’ courts for criminal matters.

6.3.1.2 Commercial courts

The Commercial Courts Act, 2015, was enacted to provide fast-track courts for the resolution of certain commercial disputes, which includes IP rights disputes. All commercial disputes beyond a certain minimum specified value must be filed under the fast-track system of the Commercial Courts Act, 2015. Each district now has designated commercial courts for such disputes. Each High Court having original jurisdiction also has a Commercial division to hear such fast-tracked commercial disputes. Further, every High Court has a Commercial Appellate division to hear appeals for fast-tracked commercial disputes.

6.3.1.3 Appointment and tenure of judges

Judges of the High Courts and the Supreme Court of India are selected by a committee (called “the Collegium”) consisting of the three or five seniormost judges of the Supreme Court and headed by the Chief Justice. The executive can give its views on specific candidates, though the Collegium has the final say. A High Court judge could be from the district judiciary 95 (or a practicing advocate with a minimum of 10 years’ practice).

Appointments to the subordinate judiciary (i.e., lower than the district court: the Provincial Civil Service–Judicial) are made by either the state public service commissions or the High Court concerned. The selection process involves written tests and an interview. Selected candidates are appointed as judges in the subordinate judiciary as sub-judges. High Courts also conduct the selection process for the Higher Judicial Service’s appointment of district judges. Candidates for the Higher Judicial Service are sub-judges and advocates with a minimum of seven years’ practice.

6.3.2 Judicial education on intellectual property

The National Judicial Academy (NJA) is a training institute located in Bhopal, Madhya Pradesh, established and fully funded by the Government of India. The NJA is an independent society established in 1993 under the Societies Registration Act, 1860. The Honorable Chief Justice of India is the Chairman of the General Body of the NJA and the Chairman of the Governing Council, the Executive Committee and the Academic Council of the NJA.

The NJA’s academic programs are guided by the National Judicial Education Strategy, launched in 2007. Under this strategy, the NJA has established a national system for judicial education. The NJA conducts a vibrant training program for judges at all levels throughout the year. The program is addressed by speakers who may be lawyers or people with specialized knowledge, including economists and foreign experts.

As a joint initiative of the World Intellectual Property Organization and the NJA, seminars, talks and so on are organized by the NJA for the benefit of lawyers, academics and students.

6.4 Challenges to patents

Under Section 13(4) of the Patents Act, 1970, the grant of a patent does not guarantee its validity. 96 The underlying principle is that allowing an invalid patent to continue on the register is against the public interest, so every opportunity is provided to remove invalid patents. There are various levels of challenges provided in the Act against a patent application or a granted patent. Such challenges can be made either prior to or after the grant:

Pre-grant opposition under Section 25(1);
Post-grant opposition under Section 25(2) before the Patent Office, introduced in 2005;
revocation under Section 64(1) before the High Court; 97 and
a counterclaim seeking revocation in a suit for infringement under Section 64(1), in which case the infringement suit and the counterclaim are both transferred to the relevant High Court. 98

Other challenges to patents or the exercisable rights are compulsory licenses and government use (under Sections 84, 92, 102 and others) and revocation (under Section 66).

There has been significant discontent – especially after the 2002 and 2005 amendments – about the multitude of challenge avenues. These provisions for patent challenges may appear to encourage abuse by patent opponents and result in patent grants being held up or delayed almost indefinitely. These apprehensions have been assuaged to a large extent by judicial precedents, which have streamlined the filing of oppositions and dealt with challenges to orders passed in oppositions. In UCB Farchim v. Cipla Ltd , 99 the Delhi High Court confirmed that, once a pre-grant opposition is dismissed and the patent is granted, the order granting the patent cannot be challenged by way of an appeal. The only remedy available is to file a post-grant opposition or a revocation. In Snehlata C Gupte v. Union of India , 100 the practice of filing serial oppositions to hold up the grant of a patent was stopped by the Delhi High Court. The court issued a series of directions preventing delays in patent grants. In Aloys Wobben v. Yogesh Mehra , 101 the Supreme Court categorically held that one person cannot pursue both a revocation application and a counterclaim seeking revocation. These and other decisions have ensured that duplicity and parallel proceedings are avoided to the extent possible.

6.5 Patent infringement

The ability to enforce patents is a crucial right for any patentee. Chapter XVIII of the Patents Act, 1970, addresses infringement, forums, remedies, defenses and counterclaims.

6.5.1 Claim construction

Claim construction forms a critical component of patent enforcement and invalidity challenges. Claim construction is a prerequisite for infringement analysis because the claims determine the scope of protection afforded to the patentee. Similarly, only after claims are construed to determine the invention can invalidity analysis proceed.

6.5.1.1 Procedure

Unlike the mechanism of a “ Markman ” hearing in the U.S., there is no separate procedural step for claim construction. Instead, claim construction is handled as part of the trial. Any disputes concerning the construction of claims will be framed as issues during the case management hearing. In the High Court of Delhi Rules Governing Patent Suits, 2022, it has been recommended that parties file a claim-construction brief before the case management hearing to enable courts and parties to assess whether there are any disputes in relation to the claims. 102

6.5.1.2 Principles

In the context of India’s predecessor legislation, the Supreme Court of India has held that claims must be given an effective meaning and that the specification and claims must be examined and construed together. 103 The Supreme Court followed English precedents when coming to this conclusion.

Under the Patents Act, 1970, the Delhi High Court, in F Hoffmann-La Roche Ltd v. Cipla Ltd , 104 held that one must undertake a “purposive construction” of the claims. The Delhi High Court drew inspiration from the concept of purposive construction that was formulated in the seminal English judgment Catnic Components Ltd v. Hill and Smith Ltd 105 This principle is captured in the following two dicta in the Catnic Components case:

whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked. No plausible reason has been advanced why any rational patentee should want to place so narrow a limitation on his invention. On the contrary, to do so would render his monopoly for practical purposes worthless, since any imitator could avoid it and take all the benefit of the invention by the simple expedient of positioning the back plate a degree or two from the exact vertical. 106

This principle of purposive construction was streamlined in the form of “ Improver ” questions in a subsequent judgment in the United Kingdom (U.K.) 107 and later approved by the House of Lords. 108 However, the U.K. Supreme Court, in Actavis UK Ltd v. Eli Lilly and Co. , 109 disagreed with the earlier line of cases. According to the U.K. Supreme Court, this earlier line of case law on purposive construction conflated the issue of claim construction and infringement analysis.

The current standard in the U.K. requires a court to adopt a “normal interpretation” approach. For infringement purposes, according to the U.K. Supreme Court, one must examine whether the infringing device or process infringes the claim as construed by such normal interpretation. If not, the U.K. Supreme Court dictates that a court must thereafter assess whether the claim is infringed by equivalents. It has formulated a test for assessing such equivalents. The U.K. Supreme Court’s judgments in Actavis UK Ltd and subsequently in Icescape Ltd v. Ice-World International BV 110 have clarified that the normal interpretation of claims is also purposive. Such interpretations are purposive because courts are to construe claims as per their ordinary language, in their context (description and drawings) and in the light of the factual background (common general knowledge in the art).

There has been no subsequent judgment in India addressing these jurisprudential developments. However, since even the earlier rulings of the Supreme Court of India and the Delhi High Court were guided by the English precedents, it is expected that Indian courts will take a similar approach to claim construction.

6.5.2 Infringement analysis

6.5.2.1 what is “infringement”.

The Patents Act, 1970, does not separately define “infringement,” but courts regard any violation of the rights accorded under Section 48 of the Act as an infringement. Like most international jurisdictions, and consistent with Article 28 of the TRIPS Agreement, Section 48 of the Act confers an exclusive right on the patentee to prevent third parties from “making, using, offering for sale, selling or importing for those purposes” the patented product. 111 In the case of process patents, the patentee has the exclusive right to prevent third parties from using the process and from “using, offering for sale, selling or importing for those purposes” the “product obtained directly by the patented process.” 112 Committing these acts without the patentee’s consent constitutes infringement.

6.5.2.2 Exports as infringement

The Delhi High Court has held that the term “sale,” in the context of another provision of the Patents Act, 1970, includes “exports.” 113 The Delhi High Court has also recently granted an interim injunction because exports from India would have also amounted to use in India. 114

6.5.2.3 Proving infringement

A plaintiff must compare the alleged infringing product or process with the granted claim or claims to prove infringement. 115 Claim construction precedes this exercise of comparison. 116

The Patents Act, 1970, is silent on the doctrine of equivalence and other analogous concepts. The predecessor legislation allowed patentees to sue for infringement even when the infringers counterfeited or imitated the invention. 117 Case law under the predecessor legislation suggested that courts would ignore “trifling or unessential variation.” 118 Defendants were guilty of infringement if they made “what is in substance the equivalent of the patented article.” 119 Case law under the current Act suggests that a similar approach may be followed. 120

6.5.3 Defenses to infringement

The rights under Section 48 of the Patents Act, 1970, are expressly subject to other provisions of the Act. Section 107(1) states that all the grounds for revoking a patent for invalidity can be used as defenses to a claim for patent infringement. Defendants can, thus, contest the suit patent’s validity even without filing a counterclaim.

Section 107A recognizes the Bolar exception for defendants to use the patented product or process for developing information for regulatory filings both in India and abroad. The Delhi High Court’s judgment in Bayer Corp. v. Union of India 121 carries a detailed discussion of the Bolar exception.

India follows the rule of international exhaustion regarding patents. Under Section 107A(b) of the Act, importing a duly authorized product from a foreign jurisdiction is not an infringement. Thus, the position is similar to that under the Trade Marks Act, 1999, 122 but different from the domestic exhaustion rule followed under the Indian Copyright Act, 1957. 123

Section 107(2), read with Section 47, contains well-known exclusions from the scope of a patent’s exclusivity, such as the research exemption, educational use and governmental use.

6.5.4 Counterclaim of invalidity

Defendants invariably file a counterclaim seeking revocation under Section 64(1) of the Patents Act, 1970. The grounds provided for revocation under Section 64(1) are exhaustive. There is a view that courts retain the discretion not to revoke a patent despite the fulfillment of one or more of the grounds under Section 64(1), 124 though this does not seem to be the correct position in law. Proving any one of the grounds under Section 64(1) ought to lead to revocation of the patent.

The grounds for revocation usually taken in a counterclaim include lack of novelty or inventive step and non-patentable subject matter. It is also usual for defendants to support the grounds for revocation, especially in respect of lack of novelty and inventive step, by relying upon claims granted in other jurisdictions. If, in any other foreign jurisdiction, claims granted in corresponding patents are narrower than those granted in India, it is common for defendants in India to question the validity of the Indian patent by referring to such claims. Thus, it is advisable for patentee-plaintiffs in infringement actions in India to check whether the scope of claims in other significant jurisdictions differs, at least broadly, from that of the claims in India. If the patentee narrows the claims in other jurisdictions, it is advisable to make similarly narrower claims in India at the prosecution stage.

The citing of corresponding claims from foreign jurisdictions relates to the concept of “file-wrapper estoppel.” Although patent rights are strictly territorial, defendants argue that the patentee ought to be bound by statements, concessions and amendments made by the patentee before foreign patent offices concerning the same invention. Usually, such narrowing amendments in foreign jurisdictions, without corresponding Indian amendments, could adversely impact the grant of interim relief.

Another ground that defendants often rely upon is noncompliance with Section 8 obligations. Section 8(1) of the Act requires mandatory disclosure of the details of all corresponding foreign applications. Section 8(2) requires the filing of the prosecution history of corresponding foreign applications if so directed by the Indian Patent Office.

An issue frequently agitated in Indian courts, in invalidity challenges to pharmaceutical patents, concerns coverage and disclosure. In Novartis AG v. Union of India , 125 the Supreme Court held that a patentee cannot contend that a patent’s coverage is more expansive than its disclosure. The following observation by Justice Jacob in the English case of European Central Bank v. Document Security Systems Inc. is often cited in the Indian context:

Professor Mario Franzosi likens a patentee to an Angora cat. When validity is challenged, the patentee says his patent is very small: the cat with its fur smoothed down, cuddly and sleepy. But when the patentee goes on the attack, the fur bristles, the cat is twice the size with teeth bared and eyes ablaze. 126

Since claims are granted only upon an enabling disclosure, courts must presume that a prior patent discloses the claimed subject matter in an enabling manner. However, there have been various opinions expressed that the patent coverage could be wider than the disclosure, leading to multiple patents thereafter. The Delhi High Court has recently considered this issue in a series of interim orders, wherein the preponderance of the view favored the interpretation in Novartis . 127 This view is presently the prevalent one.

6.6 Judicial patent proceedings and case management

6.6.1 key features in patent proceedings.

As in all civil cases, the onus of proving infringement is on the plaintiff suing for infringement. 128 The court may shift the evidentiary burden and call upon the defendants to establish the noninfringement of process claims in specific circumstances consistent with Article 34 of the TRIPS Agreement. Section 104A of the Patents Act, 1970, provides for two situations in which the defendant can be asked to prove noninfringement of a process claim. One condition precedent common to both situations is that the defendant’s product must be identical to the product directly obtained by the patented process. Once this condition is fulfilled, the court retains the power to demand that the defendant prove noninfringement if the process is for obtaining a new product 129 or if the plaintiff shows a substantial likelihood that the defendant is using the patented process and is unable to determine the defendant’s process despite reasonable efforts.

The court may not require the defendant to disclose its process if such disclosure would result in the disclosure of any trade, manufacturing or commercial secrets that form part of the defendant’s process, but only if the disclosure appears reasonable to the court. 130 The use of confidentiality clubs, however, may aid even in such disclosure. 131

6.6.2 Forum and locus standi to initiate infringement actions

A patent enforcement action under Section 104 of the Patents Act, 1970, can be initiated before a district court or higher. The court will try a patent suit as a commercial suit under the Commercial Courts Act, 2015. 132 This also applies to a suit seeking a declaration of noninfringement. 133 However, if a defendant in an infringement action counterclaims the patent’s invalidity, the suit and the counterclaim are automatically transferred to the High Court for further adjudication. 134 A declaratory suit for noninfringement cannot question the patent’s validity. 135 The registered owner of the patent, or the assignee thereof, is entitled to sue for infringement. Section 109 of the Patents Act, 1970, provides that an exclusive licensee may sue for patent infringement but must implead the patent’s registered owner as a defendant. Under Section 110 of the Act, a person who has been granted a compulsory license may also sue for patent infringement if, upon notification of infringement to the patentee, the patentee fails to take action within two months.

6.6.3 Early case management

Once all pleadings are complete, the suit is listed before a designated commercial court single-judge bench in a case management hearing for framing issues. The court identifies, as precisely as possible, the issues that arise for determination; directs the filing of witness statements; and sets the schedule for trial. The Commercial Courts Act, 2015, prescribes short time limits for completing pleadings. Pending interim applications do not (and should not) delay the case management hearing for framing issues.

6.6.3.1 Pleadings and overall case schedule

The Commercial Courts Act, 2015, fixes mandatory timelines for filing all pleadings. The Supreme Court of India, in SCG Contracts India Pvt. Ltd v. KS Chamankar Infrastructure Pvt. Ltd , 136 confirmed that the timelines fixed under the Act are mandatory. The Act also prescribes a schedule for the entire case (see Figure 6.4 ).

Note : ADR = alternative dispute resolution.

The rigidity of timelines under the Act has been of some concern in patent litigation, given the technical complexity involved. However, most practitioners and litigants agree that, without fixed timelines, litigation tends to become unnecessarily protracted. The strict scheduling ensures that pleadings are completed on time and that trials are expedited. The real bottleneck is the final arguments post-trial, which has systemic causes: chiefly, the enormous number of unfilled positions of judges. Recent trends in filling these vacancies, coupled with specialized training in IP-related matters of judges rostered to IP cases, ought to address the bottleneck problem.

6.6.3.2 Case management hearing

Case management is mandatory under the Commercial Courts Act, 2015. The first case management hearing must be mandatorily held not later than four weeks from the date of filing of an affidavit of admission or denial of documents by the parties. It is intended for the court to engage in the early identification of disputed issues of fact and law, the establishment of a procedural calendar for the entire case (including trial and final hearing), and the exploration of the possibility of dispute resolution other than by trial.

6.6.4 Provisional measures

As a common-law jurisdiction, Indian courts are vested with extensive discretionary powers to grant interim relief. The usual determinants apply: whether the plaintiff has a prima facie case, where the balance of convenience lies, and to whom irreparable injury is likely if the order is or is not granted. An interim order may subject the plaintiff to conditions, including security. Injunctions can be tailored to suit the remedy. 137

In general, interim reliefs can be in various forms, including interim injunctions; Mareva orders or freezing orders; Anton Piller orders, where local commissioners (LCs) are appointed with powers of search and seizure; and directions for keeping accounts. Under Order XXXIX(1)–(2) of the Code of Civil Procedure, 1908 [hereinafter the “Code of Civil Procedure”], patentees may also seek interim and ad interim injunctions. Indian courts have regularly considered the grant of interim injunction orders, Anton Piller orders, Mareva orders, Norwich Pharmacal orders or John Doe orders in fitting cases.

It is usual to seek even ex parte ad interim relief in suits for patent infringement. In some cases, where the patent has been tested multiple times in litigation, courts usually even grant the ad interim injunction ex parte ; there is no strict rule. For instance, in the case of SEPs, defendants are usually called upon before the grant of an injunction for a response as to whether they are willing to take a license on fair, reasonable and nondiscriminatory terms.

Irrespective of the outcome of the interim proceedings, the parties (usually the unsuccessful party at the interim stage) usually seek an expeditious trial and final hearing. In fact, in one case where the interim injunction was granted in favor of the patentee (i.e., Merck Sharp and Dohme Corp. v. Glenmark Pharmaceuticals ), 138 the Supreme Court allowed the sale of the existing stock already manufactured by the defendant and directed a day-to-day trial, saying that this was in the national interest, one that demanded a suitable commercial environment for the immediate resolution and adjudication of contentious commercial cases. 139 In that case, due to the intervention of the Supreme Court, the time from the suit’s filing to final judgment was only about 30 months. The trial concluded in a record time of less than 30 days. Final arguments were heard for three weeks, and judgment followed very soon thereafter. The Supreme Court has also issued general directions for such expedited hearings in other patent matters. 140

In cases where a patent has been tried and tested in prior litigation, courts have not hesitated to grant interim injunctions, though the defendant may be permitted to exhaust existing stocks along with accounts. Some perceive the Delhi High Court to be quite liberal in granting interim injunctions to patentees, though there have been some instances in which the court has refused interim injunctions owing to the complexity of the invalidity defense. In other cases, the court has crafted alternative arrangements for the interim period. Where an interim injunction is refused, courts almost always direct the defendant to maintain and file accounts.

6.6.4.1 Governing legal standards and burdens

Courts see growing numbers of patent litigation, with a corresponding increase in the grant of injunctions (both permanent and interlocutory). Temporary injunctions are regulated by Sections 94 and 95 and Order XXXIX of the Civil Procedure Code. The substantive law on temporary and perpetual injunctions can be found in Sections 36–42 of the Specific Relief Act, 1963.

The general principles for grant or denial of such interim orders are well known: a prima facie case, the balance of convenience, irreparable injury and public interest factors. 141 Indian courts have derived principles following the decision of the House of Lords in American Cyanamid v. Ethicon Ltd , 142 though the Supreme Court of India has observed that the relatively diluted standard of “ prima facie case” in American Cyanamid will not apply in India. 143 Similarly, whereas American Cyanamid suggests that more weight must be attached to patents granted after a detailed examination procedure, Section 13(4) of the Patents Act, 1970, and some judicial precedents in India suggest that this proposition is inapplicable to Indian patent law. 144

6.6.4.1.1 Prima facie case

The prima facie case requirement is used to discern whether the plaintiff has a reasonable case on merits. It does not finally or conclusively decide issues of fact. It weeds out frivolous or vexatious claims – ones manifestly without merit. As part of this assessment, courts also assess whether defendants have a credible challenge to the suit patent’s validity. 145

Initially, in India, a few judicial pronouncements referred to a six-year rule (i.e., a presumption that there could be an increased probability a patent could be treated as valid on the expiry of six years from the date of grant). The genesis of the six-year rule approach can be traced to the Madras High Court’s ruling in Manicka Thevar v. Star Ploro Works case, 146 which was subsequently picked up in other judgments. 147 However, none of the provisions of law appears to suggest or support this numerical fixation with six years. The Manicka Thevar case was subsequently held not to be correct law by another division bench of the Madras High Court. 148 In F Hoffmann-La Roche Ltd v. Cipla Ltd , a single judge of the Delhi High Court also held that there was no basis for the six-year rule and rejected the application of the said rule in patent cases. 149 Thus, one will not find a discussion of any such six-year rule in most recent patent cases across India.

6.6.4.1.2 Balance of convenience and public interest

The second requirement for the grant or denial of an interim injunction is that the balance of convenience must be in favor of granting an injunction. The court, while granting or refusing to grant an injunction, should exercise sound judicial discretion to compare and determine the amount of mischief or injury likely to be caused to the respective parties if the injunction is refused and if it is granted. The court would weigh competing possibilities or probabilities.

In India, public interest has been recognized both as a separate factor and as a factor read into the test for the balance of convenience. 150 For instance, the public interest in enabling access to lifesaving drugs (both supply and pricing considerations) has been considered a relevant factor when deciding on an application for an interim injunction. 151 Recently, given the influence of comorbidity factors such as diabetes and obesity in the severity of COVID-19 infections, the pricing of antidiabetic medications was considered one of the relevant factors when assessing interim injunction applications. 152

The defense of public interest is not a complete exception to a legally valid patent and must not be too broadly interpreted, as it would undermine “the rights granted by the sovereign towards monopoly.” 153 The Delhi High Court has recognized that upholding the enforcement of patents is also in the public interest. 154 Thus, often, public interest factors are considered along with the prima facie strength of the infringement case or the invalidity defense. 155

Public interest forms part of the matrix considered by the court and need not always be a dispositive factor in every case. For instance, in Bayer Intellectual Property GmbH v. Ajanta Pharma Ltd , 156 factors such as loss of employment and revenue earned by the state – even in cases where the patented drugs were not of a lifesaving nature – were considered by the Delhi High Court. However, in a subsequent decision, Bayer Intellectual Property GmbH v. BDR Pharmaceuticals International Pvt. Ltd , 157 another judge of the same High Court held that the export of non-lifesaving drugs would not qualify under the test of public interest merely due to encouraging economic activity and the country earning foreign exchange revenue.

The Delhi High Court, in Merck Sharp and Dohme Corp. v. Glenmark Pharmaceuticals , 158 invoked several equitable principles to guide the exercise of discretion in granting injunctions. These included an assessment of the parties’ conduct, whether the defendant attempted to clear the way by filing oppositions or seeking revocation, and so on.

It is also common for defendants to raise pleas of nonworking of patents or nonfiling of working statements to defend against interim injunctions as part of the balance of convenience and public interest factors. The working requirements under the Patents Act, 1970, are stringent. The legislative history shows that the nonworking of patents by foreign companies was one of India’s most significant concerns when drafting the legislation. In a case concerning a patented respiratory disorder drug, the Delhi High Court, in Cipla Ltd v. Novartis AG , 159 held that the mere nonmanufacturing of sufficient quantities in India alone could not result in the denial of an interim injunction. However, defendants are free to apply for a compulsory license in such cases. There is an earlier opposing view suggesting that the nonworking of a patent could lead to denial of injunctive relief. 160 The later view in Cipla is now the more prevalent view. Though no compulsory license was granted during the COVID-19 pandemic, in dealing with cases relating to shortages of essential medicines used in the treatment of COVID-19, both the Supreme Court and the High Court have made observations favoring such steps being taken by the Government. 161

6.6.4.1.3 Irreparable injury

The third and equally important consideration is the condition of irreparable injury. This refers to the patentee having no other remedy available other than an injunction. Irreparable injury, however, does not mean that there must be no physical possibility of repairing the injury. Instead, it means only that the injury must be a material one – namely, one that cannot be adequately compensated in damages.

In Merck Sharp and Dohme Corp. v . Glenmark Pharmaceuticals , 162 the Delhi High Court recognized that, in cases where the patentee has been the sole supplier of the patented technology, allowing a defendant to enter the market may cause irreparable injury.

6.6.4.2 Other preliminary reliefs

6.6.4.2.1 local commissioners.

Order XXVI(9) of the Code of Civil Procedure provides for the appointment of LCs. Such LCs are appointed upon the establishment of a strong prima facie case. In cases of a patent infringement action, LCs have been appointed by the Indian courts to record evidence.

An order for the appointment of an LC is usually made in patent litigation if, for example, the manufacturing processes need to be ascertained. The LC is then appointed by the court with strict terms and conditions. Typical conditions imposed include: 163

that the LC visits the premises of the defendant or plaintiff, as the case may be;
that the LC ascertain the manufacturing process being used, including inspection of the raw material registers, excipient data, the quantum of manufacturing and so on;
that the accounts of manufacture, sales and so on are inspected;
that the LC visits the Customs authorities to retrieve samples of alleged infringing products;
permitting the LC to take photographs and videotape the proceedings; and
permitting party representatives to accompany the LC, including counsel, to render assistance.

At the end of the execution of the commission, a memorandum of proceedings is prepared by the LC, recording the chronology of events that transpired in the commission and the observations of the LC. This is signed by the LC and the parties, and the LC must give copies of the same to each party. Thereafter, a report is filed before the court, giving a full account of the proceedings. Such a report filed by the LC can be read in evidence without the statement of the LC being recorded in terms of Order XXVI(14)(2) of the Code of Civil Procedure. So long as the court can confirm that the report is genuine and authentic, it forms part of the record. Parties may have objections to the contents of the LC’s report, in which case they can file objections. The objections are then adjudicated by the court before the report is fully read as evidence.

The LC so appointed is not performing a judicial act but a “ministerial act.” Nothing is left to the discretion of the LC, and there is no occasion to use judgment or adjudicate the issues involved. The LC only notes details and reports the actual state of affairs. The LC cannot decide the dispute, but their report helps the court in doing so. 164 In short, the LC’s report is one of fact-gathering, not adjudication or determination.

6.6.4.2.2 Interim deposits and other ad interim arrangements

The interim injunction stage may become protracted owing to the technical issues surrounding patents. In such instances, and in a fitting case, courts usually put in an ad interim arrangement. In general, courts enjoy extensive discretion to mold the interim relief to suit the circumstances. For example, courts have directed interim deposits by defendants in SEP cases or have directed the submission of bank guarantees or some form of security to secure the plaintiff’s interest. 165 In the recent non-SEP case of Communication Components Antenna Inc. v. Ace Technologies Corp. , 166 the High Court’s interim direction to secure the plaintiff by way of a deposit of royalties and bank guarantee was upheld by the Supreme Court of India. 167

Equally, in such cases of interim deposits, courts have required the patentee to furnish surety bonds for the amount received on a quarterly basis with advance copies. 168

6.6.5 Discovery and gathering of information

At or before the case management hearing, it is usual for parties to admit and deny the respective documents filed by the other party and to also seek discovery, inspection or the production of documents from the other party. 169 Upon an appropriate application by one party, the court may direct the other party to respond to written interrogatories on affidavit, 170 permit the inspection of documents relied upon or referred by the other party, 171 allow discovery of relevant documents on affidavit, 172 or direct the production of documents. 173

Courts are always empowered to dismiss the suit or defense for want of prosecution if a party does not comply with an order to answer interrogatories or the order for discovery, inspection or the production of documents. 174 For instance, in SEP cases, the defendants or the plaintiff would be made to share the claim-mapping charts as part of the exchange of documents to prove that the patents map the standards for which they are sought to be enforced.

Often, discovery and inspection procedures are used to seek irrelevant information and protract litigation. For instance, defendants may seek entire file wrappers from all jurisdictions just as a matter of course. However, courts do not permit such a roving inquiry or fishing expedition, and the party concerned is entitled to move the court to curtail the kind of information or type of documents being sought. The other side of this is “data-swamping” or “data-flooding,” whereby a party against whom disclosure is ordered inundates the other party with all manner of documentation in an attempt to bury the crucial material in a mountain of irrelevance. The Code of Civil Procedure enables parties to seek and defend against any discovery tool, with the courts being the final arbiter if disputes arise in this context. Again, this process demands judicial time (and enough human resources on the bench) and well-honed forensic skills on all sides.

Courts also retain wide discretion in directing the production of documents under certain conditions. To enable discovery and inspection of license agreements, manufacturing processes followed and so on – which may be confidential – courts usually constitute confidentiality clubs to maintain the confidentiality of the information disclosed. 175 There has been recent debate as to whether litigants can be part of these confidentiality clubs. 176 However, as far as the constitution of the clubs is concerned, there appears to be no dispute; the confidentiality club, once constituted, considerably streamlines the process of discovery and inspection of documents.

Recently, the High Court of Delhi Rules Governing Patent Suits, 2022 have been notified. These rules provide for a minimum mandatory content for pleadings in patent suits, 177 a minimum set of mandatory documents to be filed by the parties, 178 and specific tweaks in patent suit procedures. For instance, in addition to regular pleadings, the rules provide that parties be allowed to file claim construction, invalidity, infringement briefs and technical primers based on which the court is to frame issues in the first case management hearing. 179 A second case management hearing is provided for streamlining the recording of evidence, including the protocol for a hot-tubbing mechanism. 180 A reserve third management hearing is provided to address any pending pre-trial concerns. 181 Importantly, the rules contemplate the creation of a panel of scientific experts to assist the court. 182 While setting the calendar and protocols for a final hearing, the court may also direct that a technical expert of each party may also be present to assist the court. 183

6.6.6 Summary proceedings

The Commercial Courts Act, 2015, through its amendment to the Code of Civil Procedure, permits parties to seek summary adjudication. 184 Either party may seek such summary disposal if the other party has no real prospect of succeeding and if there is no other compelling reason why the claim should not be disposed of before recording oral evidence. 185

Such summary adjudication under Order XIII-A of the Code of Civil Procedure can be sought by filing a specific application and setting out the specific grounds. 186 The application is to be filed before issues are framed. 187 When adjudicating such an application for summary disposal, courts enjoy broad discretion to pass a variety of orders, including, for instance, conditional orders that require the deposit of money or furnishing security. 188

Another possibility of summary disposal is under Order XII(6), by which the court is empowered to pass judgment based on admissions of fact made either in the pleading or even otherwise. The admissions made by patentees during prosecution, whether in India or any foreign jurisdiction, can be construed as admissions under the Code of Civil Procedure and result in summary disposals. The logic is straightforward and self-evident: no patentee should be permitted to make conflicting claims in different jurisdictions. A patentee must be held to be bound by statements made with regard to that specific patent claim, irrespective of where and when that claim is made. This is a species of estoppel.

Such summary procedures help the court to considerably narrow the scope of controversy. For instance, in negotiations for licensing, defendants usually admit that they need the license, and the only dispute that remains is about the licensing amount. In such suits, the court can rely on the correspondence between the parties to issue summary judgments.

Similarly, such summary adjudication has proved workable in SEP litigation: for example, where an ex-licensee of the SEP has refused to renew the license due to a failure of commercial discussions. The dispute is then restricted only to the monetary claim of the licensing fee, and other issues, such as infringement or validity, do not arise. While an ex-licensee is not estopped or precluded from challenging the validity of a patent at any time, courts are reluctant to entertain validity challenges when an erstwhile licensee elects to challenge the patent’s validity only at the time of a license renewal agreement after having enjoyed a license for several years. A court will permit such a challenge to proceed only on a demonstration of some glaring fact that goes to the root of validity and which was noticed at the time of the original licensing.

6.6.7 Evidence

6.6.7.1 oral evidence and trial.

The examination in chief (direct examination) of witnesses is compulsorily on affidavit. 189 Cross-examination and reexamination (“redirect”) are taken orally live and transcribed. Often, to save the court’s time, the recording of the oral evidence is done either before the registrar of the court or before an LC. Unlike a court, LCs and registrars are not empowered to rule on objections raised during the evidence. 190 However, the commissioner is entitled to enter notes they think material, about a witness’ demeanor so that the same is available to the court at the time of final hearing. 191

Usually, trials take between three and five years from the date of filing to conclude, though there have been some patent cases where the trial concluded in six months to a year. Under the Commercial Courts Act, 2015, the court schedules the entire trial so that the recording of evidence is not drawn out. The trial could be day-to-day, and it is common for the courts to explicitly direct as such to reduce inconvenience to witnesses. 192 Once the trial of a suit concludes, the matter proceeds to a final hearing.

It is usual for witnesses from foreign jurisdictions to record their statements through videoconferencing. Following the COVID-19 pandemic, virtual courts and online platforms are usually used even for court hearings. Litigants can join proceedings physically, and, if the court has the facility, they can also join the hearing through a videoconferencing facility.

Witnesses are usually in-house representatives or attorneys from the respective parties who have themselves dealt with the litigation and the correspondence between the parties. A witness is not expected to have direct personal knowledge of every part of the deposition; it is enough if the witness can depose to company records and the record of the suit. In some areas, the testimony of people with personal knowledge is preferred – for example, for evidence about discussions in negotiations, the exchange of correspondence, some technical knowledge leading to the grant of the patent and so on.

Other witnesses are usually technical witnesses. In some cases, the inventor is also produced as a witness to strengthen the case of the plaintiff. Experts such as doctors, specialists, economists and accountants have also been produced in the court to establish other aspects of the litigation, such as the calculation of damages, distinguishing the prior art, mapping standards and so on. The inquiry into damages is crucial at the final stage, and, therefore, economists, financial experts or accountants who can analyze and depose to the computation of damages or royalties payable are vitally important in establishing the monetary aspect of the infringement case. Thus, the general practice is to have both in-house and expert witnesses.

6.6.7.2 Who leads evidence first? Can a defendant be directed to lead evidence first?

The Patents Act, 1970, does not specifically provide a procedure for evidence in cases of patent infringement. Instead, the procedure adopted for leading evidence in suits for infringement is in accordance with the Code of Civil Procedure 193 and the Indian Evidence Act, 1872. Under the latter, the onus of proof is on the person making a positive assertion. Thus, the patentee-plaintiff must lead evidence first to establish infringement. The defendant leads evidence thereafter to support its defenses or its counterclaim of invalidity. However, this is not a rigid rule. In a case where the defendant admits infringement, and the only question for decision is validity, the court may direct the defendant to lead evidence first. Thus, as provided under Order XVIII, the right to begin is generally granted to the plaintiff:

1. Right to begin. – The plaintiff has the right to begin unless the defendant admits the facts alleged by the plaintiff and contends that either in point of law or on some additional facts alleged by the defendant the plaintiff is not entitled to any part of the relief which he seeks, in which case the defendant has the right to begin. 2. Statement and production of evidence. – (1) On the day fixed for the hearing of the suit or on any other day to which the hearing is adjourned, the party having the right to begin shall state his case and produce his evidence in support of the issues which he is bound to prove. (2) The other party shall then state his case and produce his evidence (if any) and may then address the Court generally on the whole case. (3) The party beginning may then reply generally on the whole case.

Moreover, where a process claim is asserted, depending on the facts, the burden of proof may shift to the defendant to prove non-infringement. This exceptional situation is provided for under Section 104A of the Patents Act, 1970:

Burden of proof in case of suits concerning infringement. (1) In any suit for infringement of a patent, where the subject matter of patent is a process for obtaining a product, the court may direct the defendant to prove that the process used by him to obtain the product, identical to the product of the patented process, is different from the patented process if, – (a) the subject matter of the patent is a process for obtaining a new product; or (b) there is a substantial likelihood that the identical product is made by the process, and the patentee or a person deriving title or interest in the patent from him, has been unable through reasonable efforts to determine the process actually used: Provided that the patentee or a person deriving title or interest in the patent from him first proves that the product is identical to the product directly obtained by the patented process. (2) In considering whether a party has discharged the burden imposed upon him by subsection (1), the court shall not require him to disclose any manufacturing or commercial secrets, if it appears to the court that it would be unreasonable to do so.

Subject to the fulfillment of the condition precedents noted in Section 104A, this is another circumstance in which the defendant may be asked to lead evidence first. 194

In Bajaj Auto Ltd v. TVS Motor Co. Ltd , 195 the Madras High Court was confronted with a unique situation – a suit against the groundless threat of infringement and non-infringement against the patentee, as well as a subsequent suit for infringement by the patentee. On the limited issue of who should lead evidence first, the court held that the plaintiff in the earlier suit must lead the evidence first since the subsequent suit was more in the nature of a counterclaim of infringement by the patentee. This is yet another unique situation wherein the alleged infringer led evidence first.

6.6.7.3 Filing of affidavits of witnesses in evidence: not treated as evidence till tendered

According to Order XVIII(4) of the Code of Civil Procedure:

Recording of evidence. (1) In every case, the examination-in-chief of a witness shall be on affidavit and copies thereof shall be supplied to the opposite party by the party who calls him for evidence: Provided that where documents are filed and the parties rely upon the documents, the proof and admissibility of such documents which are filed along with an affidavit shall be subject to the orders of the Court. (1A) The affidavits of evidence of all witnesses whose evidence is proposed to be led by a party shall be filed simultaneously by that party at the time directed in the first Case Management Hearing. (1B) A party shall not lead additional evidence by the affidavit of any witness (including of a witness who has already filed an affidavit) unless sufficient cause is made out in an application for that purpose and an order, giving reasons, permitting such additional affidavit is passed by the Court. (1C) A party shall however have the right to withdraw any of the affidavits so filed at any time prior to commencement of cross-examination of that witness, without any adverse inference being drawn based on such withdrawal: Provided that any other party shall be entitled to tender as evidence and rely upon any admission made in such withdrawn affidavit.

As per Section 1 of the Indian Evidence Act, 1872, affidavits are not included in the ambit of “evidence.” Thus, typically, the affidavit of the witness goes through the process of “tendering” – the witness is put on oath and affirms the contents of the affidavit, and, thus, the affidavit contents effectively become oral evidence. Such oral evidence is normally taken into consideration by the court when facts need to be proved.

6.6.8 Experts

6.6.8.1 role of experts and expert bodies and institutions.

Although not strictly a separate institution, experts and expert bodies and institutions play a key practical role in patent matters. In this context, the Supreme Court of India, in Monsanto Technology LLC v. Nuziveedu Seeds Ltd , 196 held that:

Summary adjudication of a technically complex suit requiring expert evidence also, at the stage of injunction in the manner done, was certainly neither desirable or permissible in the law. […] […] We are therefore satisfied that the Division Bench ought not to have disposed of the suit in a summary manner by relying on documents only, extracted from the public domain, and not even filed as exhibits in the suit, much less examination of expert witnesses, in the facts of the present case. There is no gain saying that the issues raised were complicated requiring technological and expert evidence with regard to issues of chemical process, biochemical, biotechnical and micro biological processes and more importantly whether the nucleic acid sequence trait once inserted could be removed from that variety or not and whether the patented DNA sequence was a plant or a part of a plant etc. are again all matters which were required to be considered at the final hearing of the suit.

Thus, experts and expert bodies and institutions are a critical component of proceedings where a patent’s validity is questioned. Most oppositions and revocations typically involve one or more opinions from experts or expert bodies, and the legal framework contains sufficient provisions to deal with expert opinions and evidence. For instance, under the Patents Act, 1970, the Indian Patent Office has the power to receive evidence on affidavits, issue commissions for the examination of witnesses or documents and so on. 197 The Indian Patent Office may also allow any person to be cross-examined on the contents of their affidavit. 198

6.6.8.2 Expert evidence under the Indian Evidence Act, 1872

The Indian Evidence Act, 1872, governs the rules of evidence applicable to enforcement proceedings under the Patents Act, 1970. It applies to all civil and criminal proceedings. This legislation has been amended and updated from time to time, including on the use of electronic documents and evidence.

Section 45 of the Indian Evidence Act, 1872, declares that the opinions of experts are “relevant facts.” Therefore, these opinions must be considered by courts in patent matters when forming an opinion on the point of science or art. The law only requires such experts to be “especially skilled” in the relevant area of science or art without specifying a minimum threshold. The Supreme Court of India has held that an individual could be an expert not just by the special study of the subject but also by acquiring experience in the field. 199 Similar is the view of the Delhi High Court which, in a patent case where the expert witness produced did not hold a technology or engineering degree but had proven experience, held that an expert could be a person who possesses experience even if they did not have the educational qualification. 200 What is relevant is whether the person is skilled and has adequate knowledge of the subject. The observation of the court reads as follows:

Be that as it may, it is accepted and recognised that a person could be an expert in an area of specialised knowledge by experience and he or she need not hold a degree in the field of specialised knowledge . A person can also become an expert by virtue of one’s avocation or occupation. 201

It is generally understood that, in patent matters, the opinions of experts are critical to understanding the background in the art, as well as to appreciating the contents of the prior art and the invention. An expert could also testify as to the meaning of the terms in the claim as understood in the art. Typically, both parties to a patent enforcement action will produce such expert evidence on infringement, novelty and inventive step.

The expert will usually be highly qualified and would exceed the threshold of a person having ordinary skill in the art.

There is a view expressed that the expert in a patent matter must have personal knowledge of the prior arts, 202 though this view is not correct. In law, all aspects of patent matters are viewed through the lens of a hypothetical person skilled in the art, who is normally deemed in law to automatically have knowledge of the prior arts. The correct view appears to be that the expert could testify as to their opinion on how a person skilled in the art would consider the matter.

The opinions of such experts are meant for matters of science or art, but, usually, such experts also give their opinions on infringement, novelty, obviousness and other grounds of invalidity. Even though such statements or conclusions on obviousness, novelty or infringement may also involve matters of law, it is not fatal to the admissibility of the expert opinion. Courts will focus more on the reasoning offered by the expert in the opinion. Expert opinions of the experts are not binding on the court.

6.6.8.3 Court-appointed scientific advisers

Section 115 of the Patents Act, 1970, empowers the court to appoint an independent scientific adviser to assist the court or to enquire and report upon any question of fact or opinion (but not involving a question of interpretation of the law). The Indian Patent Office maintains a roster of such scientific experts. 203 Courts usually resort to these scientific experts to gain an independent assessment. These assessments are considered valuable in highly contested matters where the parties’ expert testimonies have offered widely disagreeing opinions. Like any other expert opinion, the opinion of a court-appointed scientific adviser is also not binding on the court.

As per Rule 103 of the Patents Rules, 2003, the Controller is to maintain a roll of scientific advisers, to be updated annually. The roll contains the names, addresses, specimen signatures and photographs of scientific advisers; their designations; and information regarding their educational qualifications, the disciplines of their specialization and their technical, practical and research experience.

A person must possess the following qualifications to be enrolled as a scientific adviser:

a degree in science, engineering or technology or equivalent;
at least 15 years of technical, practical or research experience; and
holds or has held a responsible post in a scientific or technical department of the central or state governments or in any organization. 204

The law provides that the fee or remuneration for such scientific advisers be provided by the Parliament, by law, for this purpose. However, usually, the parties share the costs of independent scientific experts.

The recently notified draft of the High Court of Delhi Rules Governing Patent Suits, 2020, also proposes the maintenance of a panel of scientific advisers to assist the court.

6.6.8.4 Hot-tubbing procedure

The procedure of hot-tubbing, where multiple expert witnesses give their evidence concurrently – and which has its origin in Australian law – is also permissible in India and has recently been ordered in some cases. 205 The procedure for recording expert evidence through a hot-tubbing protocol was specified in Micromax Informatics Ltd v. Telefonaktiebolaget LM Ericsson . 206 The Delhi High Court Rules have also been amended to incorporate this procedure, 207 including its protocol. 208

Though there has yet to be a patent infringement action concluded in which evidence has been given by the hot-tubbing procedure, hot-tubbing is expected to be applied more frequently in the future.

6.6.9 Alternative dispute resolution: pre- and post-litigation mediation

Under the Commercial Courts Act, 2015, parties are usually expected to explore pre-litigation mediation. If the plaintiff does not seek urgent relief, Section 12A of the Commercial Courts Act, 2015, mandates pre-litigation mediation.

Section 89 of the Code of Civil Procedure also recognizes courts’ inherent power to refer parties to arbitration, conciliation, mediation or other forms of alternative dispute resolution. A court can exercise this power at any stage if there exist elements of an acceptable settlement. The parties may also request such a referral themselves.

Almost all district courts and High Courts in India have mediation centers for pre- and post-litigation mediation. These mediation centers are usually attached to each of the High Courts or district courts and are managed by a fully functional secretariat. The mediators at these centers are trained professionals. It is also possible for parties to seek the appointment of an expert mediator with specialized technical learning, skills, experience and domain knowledge. Mediation proceedings have proved to be quite efficient in almost all parts of the country. Significant success has been generally observed in resolving IP rights disputes and, most recently, in the resolution of certain SEP-related disputes. 209

6.7 Civil remedies

In a suit for patent infringement, plaintiffs are entitled to seek both interim remedies and final remedies. Section 108 of the Patents Act, 1970, concerns final remedies, whereas Section 94(c) and Order XXXIX of the Code of Civil Procedure concerns interim remedies. The usual types of interim and final remedies – and their governing standards – are discussed in Sections 6.6.4 and 6.7.1 –6.7.4 of this chapter, respectively.

6.7.1 Permanent injunction

Under Section 108(1) of the Patents Act, 1970, a patentee may seek a permanent injunction as a final remedy. The Specific Relief Act, 1963, regulates the relief of permanent injunction, and courts retain discretion to deny permanent injunctions in some cases. For instance, in F Hoffmann-La Roche Ltd v. Cipla Ltd , 210 a permanent injunction was not granted because the defendant had already been in the market for several years, and the patent was about to expire. Usually, however, permanent injunctions follow a finding of infringement and validity in favor of the patentee.

The court may grant relief by way of an injunction for infringement of a partially valid specification where the invalid claim was framed in good faith and with reasonable skill and knowledge. 211 A permanent injunction may be granted only in cases where there is a valid patent, and the defendant has infringed that patent.

6.7.2 Damages or an account of profits

Under Section 108(1) of the Patents Act, 1970, the patentee has the choice of seeking either damages or an account of profits. 212 Plaintiffs cannot claim both as per settled law. The Act is silent on the quantification of damages. Unlike the US statute, for instance, the Act does not prescribe a lower threshold of reasonable royalty that has been interpreted to involve the application of the Georgia-Pacific factors. 213

The general principle under Indian law is that damages will be compensatory in nature (i.e., the patentee should be restored to the position if the wrongful acts of the defendant had not occurred). Consequently, the measure of the damages is to be, as far as possible, akin to the sum of money that puts the plaintiff in the same position as they would have been in had they not sustained the wrong. Thus, for instance, if the patentee has shown a propensity to license the patent in the past, such licensing arrangements can become the guiding basis in assessing damages.

The reluctance of Indian courts to grant high-value damages is a thing of the past. It is usual, especially in pharmaceutical and SEP cases, for courts to grant damages or accounts of profits determined by the evidence, even if they seem of high value. In a few recent SEP disputes, the royalties payable ran into millions of dollars, even in interim arrangements, though this has not been made known internationally. 214 Thus, even in non-SEP cases, damages or accounts of profits are reasonable possibilities, especially if infringement is established by the patentee.

The purpose of an account of profits is to prevent the unjust enrichment of the defendant by the use of the patented invention. The patentee is treated as if they are conducting the business of the defendant and made the profits that the defendant made. As such, the upper limit of an award is the sum of profits made by the patent-infringing defendant. In most cases, an award of damages will equal or exceed the maximum award in an account of profits; however, an account of profits may greatly outstrip an award of damages in the right case.

For an account of profits, the profits must have been earned from the use of the patentee’s invention, and, if the infringed invention formed only part of the overall product or process, then only that part of the profit attributable to the patented invention is recoverable. This is where the most difficulty is experienced in assessing the profits earned by the defendant, and a number of approaches may be taken during the assessment. Courts take the view that it would be unfair to the defendant to award a claim for all the profits where attribution of profits is possible. Where it is appropriate to apportion losses, the reference for the assessment will involve splitting the profits between the infringing and non-infringing parts of the process. Conversely, the patentee could also recover all of the profits of an invention; however, this turns on the facts of the case.

In the event that an infringer makes a loss in a manufacturing process, the sum by which the infringing process reduces those losses are recoverable on account.

Sometimes the patented invention has a readily discernible impact on profits, either positively or negatively. For instance, the patented invention may reduce the costs associated with the manufacturing process, making the process more efficient. In this case, a larger share of the profits would be payable to the patentee on an empirical basis. This would involve a comparison between the profitability achieved when the patented invention was used and when it was not. This brings the efficiencies introduced by the invention into consideration for the calculation of the portion of the profits to be awarded to the patentee.

As per Section 62(2) of the Act, no suit or other proceeding in respect of an infringement of a patent can be instituted during the period between the lapse of the patent (i.e., it had ceased to exist) and the publication of the application restoring the patent. 215 A patentee enjoys all entitlements and rights from the date of the patent’s publication. 216 However, this right does not extend to instituting any proceedings for infringement until a patent has been validly and finally granted. 217 Nevertheless, the claim for damages would also be subject to the laws of limitation.

6.7.2.1 Punitive damages

Along with an account of profits or damages, courts can also impose punitive damages in the following exceptional circumstance: “wrongful conduct by the defendant, which has been calculated by him for himself, which may well exceed the compensation payable to the claimant.” 218

The above principle was applied by a single judge of the Delhi High Court recently in Koninklijke Philips NV v. Amazestore , 219 which was an SEP case. Indian courts have granted punitive damages in many other cases. 220

6.7.2.2 Defenses to avoid damages or an account of profits

Courts refuse a grant of damages or an account of profits if the defendant proves that, at the date of the infringement, they were not aware and had no reasonable grounds for believing that the patent existed. 221

The court may also refuse a grant of damages or an account of profits:

“in respect of any infringement committed after a failure to pay any renewal fee within the prescribed period and before any extension of that period”; 222 or
“where an amendment of a specification by way of disclaimer, correction or explanation is allowed under [the Patents Act] after the publication of the specification […] in respect of the use of the invention before the date of the decision allowing the amendment.” However, damages or an account of profits may be granted if “the court is satisfied that the specification as originally published was framed in good faith and with reasonable skill and knowledge.” 223

6.7.3 Other remedies

The patentee may further seek the seizure, forfeiture or destruction of infringing articles, as well as of materials and implements predominantly used for the infringing activities. 224

6.7.4 Costs

The court may, in its discretion, order the unsuccessful party to pay costs to the successful party in an infringement suit. The Code of Civil Procedure provides for the recovery of costs by and under Sections 35 and 35A.

While imposing costs, the court may weigh several factors: for instance, (i) the conduct of the parties; (ii) whether a party has succeeded only in part, even if that party has not been wholly successful; and (iii) whether the party had made a frivolous claim or counterclaim leading to delay in the disposal of the case, or had instituted a vexatious proceeding wasting the time of the court.

Certain guidelines have been laid down in the case of Ten XC Wireless v. Mobi Antenna 225 for determining costs in patent infringement suits, including that

the parties shall submit their estimated future cost at the commencement of trial;
the parties and court master shall maintain a record of the court time consumed; and
the unsuccessful party is liable to pay costs to the successful party.

Costs awarded by the court may include:

the actual costs of litigation; 226
a proportion of another party’s costs;
a stated amount in respect of another party’s costs;
costs from or until a certain date;
costs incurred before proceedings began;
costs relating to particular steps taken in the proceedings;
costs relating to a distinct part of the proceedings; and
interest on costs from or until a certain date.

6.8 Other actions

6.8.1 cases involving groundless threats of illegal proceedings, 6.8.1.1 what constitutes a “threat”.

Keeping in mind the serious negative effects and consequences associated with infringement proceedings, the stated policy of the law is that no person should unnecessarily be subjected to baseless threats of infringement. Under the Patents Act, 1970, groundless threats of infringement are considered civil wrongs.

A “groundless threat” under the Act is an unjustified or wrongful threat by which any person, whether having an interest in the patent or not, 227 threatens another with legal proceedings without a reasonable basis. It is important to note that the mere notification of the existence of a patent does not constitute a threat of proceedings within the meaning of the relevant section. In LG Electronics India Pvt. Ltd v. Bharat Bhogilal Patel , 228 the Delhi High Court clarified that

if any proprietor or the right holder issues a notice to the custom officials and the custom officials act upon the same by restricting the imports of consignments of any party without the determination (prima facie or otherwise) of the factum of infringement of patent by the appropriate designated authority, then such notice by the right holder to the customs and the actions thereof by the customs either in the form of notice to that party or otherwise calling upon the party to explain its stand are all unnecessary illegal threats to that party.

In Bata India Ltd v. Vitaflex Mauch GmbH , 229 even a legal notice was considered a “threat,” and, on facts, it was concluded that threats made by the defendant to the plaintiff were groundless, unjustifiable and wrongful.

6.8.1.2 Remedies

The court typically considers the grant of the following reliefs:

(a) a declaration to the effect that the threats are unjustifiable; (b) an injunction against the continuance of the threats; and (c) such damages, if any, as he has sustained thereby. 230

The court is also empowered to pass interim orders, as in any other civil suit. For instance, in LG Electronics , 231 a suit was initiated on the basis that the filing of a border enforcement action with customs without a finding of infringement from the court amounted to a groundless threat. In the facts of the case, the Delhi High Court passed an interim order staying the operation of a border enforcement action to stop the import of allegedly infringing goods, pending a final decision from a civil court on the issue of infringement.

6.8.2 Declaration of non-infringement

Declaration of non-infringement refers to an application to the court for a declaration that any new process or article does not infringe an existing patent. 232 Under Section 105 of the Patents Act, 1970, in order to object to declaratory relief, the following conditions precedent need to be fulfilled:

The plaintiff has applied in writing to the defendant for a written acknowledgment to the effect of the declaration claimed.
The plaintiff has furnished to the defendant the full particulars in writing of its products or process in question.

The defendant has refused or neglected to give such an acknowledgment. Normally, in civil suits, the plaintiff who has sought the relief of non-infringement bears the burden of proof. This was confirmed by the Madras High Court in Bajaj Auto Ltd v. TVS Motor Co. Ltd , 233 which went on to hold that, even though the defendant-patentee in the non-infringement filed a counterclaim of infringement, the burden of proof on the person seeking the declaration of non-infringement cannot be reduced or changed.

If the plaintiff in such a declaratory suit is successful, the court can issue a declaratory judgment that the specific product or process of the plaintiff does not infringe the identified patent. At the same time, Section 105(3) of the Patents Act, 1970, stipulates that the court cannot examine the patent’s validity in such proceedings.

6.9 Appellate review

This section is limited to the miscellaneous aspects of review and appeal procedures not otherwise covered in Section 6.2.2 . Appeals from orders of the Controller lie to the High Court. Appeals from the orders of a single judge of the High Court usually lie before the division bench of that court or the Supreme Court. Appeals from a commercial court (below the rank of the High Court) lie to the High Court.

Review, in Indian law, is only in case of an error apparent on the face of the record. A party who feels that the forum that rendered the judgment or order committed an error apparent on the face of the record can seek review.

6.9.1 Power of review of the Controller

The Controller has the powers of a civil court in any proceedings filed before it under the Patents Act, 1970, in respect of, among other things, reviewing 234 their own decision on an application made 235 within one month from the date of communication of such a decision or within an extended period not exceeding one month thereafter as the Controller may allow 236 in a prescribed manner. 237

6.9.2 Review against civil court orders

Even in civil suits dealing with infringement, review applications may be preferred by parties when the condition for filing a review under Section 114 of the Code of Civil Procedure is fulfilled 238 . Section 114 of the Code provides as under:

Subject as aforesaid, any person considering himself aggrieved— (a) by a decree or order from which an appeal is allowed by this Code, but from which no appeal has been preferred. (b) by a decree or order from which no appeal is allowed by this Code, or (c) by a decision on a reference from a Court of Small Causes, may apply for a review of judgment to the Court which passed the decree or made the order, and the Court may make such order thereon as it thinks fit.

6.9.3 Grounds for review

A review can be filed by any person aggrieved by an order or decree of the Controller or court from which an appeal is allowed, but no appeal has been preferred, or from which no appeal is allowed:

and who, from the discovery of new and important matter or evidence which, after the exercise of due diligence was not within his knowledge or could not be produced by him at the time when the decree was passed or order made, or on account of some mistake or error apparent on the face of the record or for any other sufficient reason, desires to obtain a review of the decree passed or order made against him. 239

An application for review must be accompanied by a statement setting forth the grounds on which the review is sought. Where the decision in question concerns any other person in addition to the applicant, the Controller shall forthwith transmit a copy of the application and the statement to the other person concerned.

6.9.4 Appeals from review

No appeal lies from the decision of a Controller rejecting an application for review. 240 Even under the Code of Civil Procedure, while an order allowing an application for review is appealable, an order rejecting an application for review is not. 241

6.10 Selected topics

6.10.1 compulsory licenses and public prejudice.

Compulsory license is not directly relevant to the revocation of a patent. However, unlike voluntary licensing, it is a form of licensing that is involuntary and coercive in nature. Consistent with Article 31 of the TRIPS Agreement and the Doha Declaration, where there is a failure to fulfill the reasonable demand for the patented invention, or in a case of unreasonable pricing or failure to work the invention on a commercial scale, an interested person can seek a compulsory license. 242 The conditions for invoking compulsory licensing provisions are strict and must be fulfilled before such a license can be issued. Thus, there are hardly any compulsory licenses issued in India. The rare occasion when such a license was issued is a case of a cancer drug in which the courts came to the conclusion that the requirements of the public were not being met. 243

Such compulsory licenses, if issued, would ordinarily only be for the domestic market and, among other stipulations, upon payment of a reasonable royalty. 244 Pursuant to Article 31 bis of the TRIPS Agreement, a compulsory license can also be granted for the export of pharmaceutical products to countries with insufficient or no manufacturing capacity for that product. Although it is directed toward the greater public interest, compulsory license proceedings are adversarial in nature, and a detailed procedure complying with natural justice has been prescribed, 245 as have appeals from such decisions. 246 Under Section 92(3), the Central Government may notify the existence of a national emergency, extreme emergency or a case of public noncommercial use, and the detailed procedure would stand suspended.

However, in the unique and exceptional situation where the underlying cause resulting in the compulsory license is not addressed even after two years from the date of granting the compulsory license, the Central Government may, for any interested person, apply to the Controller to revoke the patent. 247 Interestingly, the Justice N Rajagopala Ayyangar Committee had proposed this provision on the logic that the threat of revocation was a sufficient incentive for the patentee to share any know-how associated with the working of the invention. This relation between the working of the invention and the sharing of associated know-how has been raised in the context of COVID-19 vaccination. 248

Similarly, the Patents Act, 1970, also empowers the Central Government to use the invention for the purposes of the Government, 249 and, if the patentee refuses to comply with the Government’s request and on unreasonable terms, the Central Government is authorized to seek revocation of the patent before the High Court. 250

Independently, Section 66 of the Act reserves to the Central Government the residual power to declare a patent as revoked if the patent or the mode in which it is exercised is mischievous to the state or generally prejudicial to the public. This provision requires an opportunity for hearing being granted to the patentee before any such declaration or decision.

6.11 Key challenges and efforts to improve patent case management

6.11.1 lack of uniformity in decisions and specialized knowledge.

Infringement cases are heard by judges of either the district courts or the High Courts not specially trained in the subject of patent law. A challenge that arises under the current regime of trial, especially before the district courts, is that the judges are not equipped to understand technical issues that arise in respect of patents. As the disputes arising under the Patents Act, 1970, are often highly technical in nature, a higher degree of understanding of the subject matter is required to ascertain a question of infringement or lack thereof. 251 For this purpose, specific rules of procedure, including for leading and examination of evidence, are desirable.

6.11.2 Delays in disposing of suits

The Supreme Court has held, pertaining to the issue of delays in the hearing and disposal of matters, that, in matters of patents, trademarks and copyrights, the state of affairs due to such delays is unsatisfactory. 252 It was held that there is a need to adhere to the provisions of Order XVII(1)(2) of the Code of Civil Procedure, whereby proceedings are to be held on a daily basis for quick disposal of the suit. The streamlined and expedited procedure under the Commercial Courts Act, 2015, has significantly helped in reducing delays, though more groundwork is needed. A recent development which has given further impetus to speedier adjudication of IP disputes is the establishment of the Intellectual Property Division in the Delhi High Court.

6.11.3 The IP Division, Delhi High Court

Post the abolition of the IPAB, 253 all pending cases before the IPAB were transferred to High Courts. The High Courts were thus faced with the task of managing both the already pending IPR cases before them as well as the transferred IPAB cases. In the Delhi High Court, this number of pending IP cases was expected to be around 4,000–5,000. With a view to streamlining dispute resolution of IP cases, including patent litigation, the Delhi High Court constituted India’s first “IP Division,” 254 The Division uses specialized sets of Rules, specifically, the Delhi High Court Intellectual Property Rights Division Rules, 2022 255 and the High Court of Delhi Rules Governing Patent Suits, 2022. The Division is vested with various jurisdictions, including the original jurisdiction, the infringement jurisdiction, commercial suits, the appellate jurisdiction from the IP offices, the revisional jurisdiction from the commercial courts, and the extraordinary writ jurisdiction supervising all IP offices, including the Controller of Patents’ Office. 256 Further, the Division provides for various novel features which are, illustratively, as under:

(i) New forms of evidence recording such as hot-tubbing and remote recording of evidence. 257
(ii) Preservation of evidence and litigation hold notice. 258
(iii) Guidance on computation of damages. 259
(iv) Direction of consolidation of cases. 260
(v) Constitution of Confidentiality Clubs and redaction of information. 261
(vi) Summary adjudication of disputes. 262
(vii) Panel of experts and recruitment of law researchers who are technically qualified like engineers, chemists, pharmacists, or civil engineers, to assist the IP Division. 263
(viii) Mediation and Early Neutral Evaluation. 264

While the creation of the Division on a non-exclusive basis was notified in July, 2021, 265 the Rules for the Division in its current form, that is the Delhi High Court Intellectual Property Rights Division Rules, 2022, vesting exclusive jurisdiction in the IP Division and laying down procedure for IP disputes, were notified in February 2022. This Division now consists of three Single Judge Benches exclusively dealing with IPR disputes. Since the setting up of the Division, the disposal rate for IP cases, specifically in patent matters, has witnessed substantial improvement. In addition the Delhi High Court has also nominated a non-exclusive IP Appellate Division consisting of a Bench of two Judges which hears appeals from the IP Division.

As of July 2022, the IP Division of the Delhi High Court has approximately 4,000 pending IP disputes out of which a substantial number are trademark and copyright disputes. Patent cases account for approximately 600–650 cases, most of which are appeals transferred from the IPAB. Notably, the filing of patent infringement actions has risen in recent times and approximately 50–60 actions are filed annually before the Court. In the IP Division, trends show that the disposal figures are rising and it is estimated that the Division should bring in greater efficiency.

The IP Division of the Delhi High Court has also been received well internationally. The recent USTR 2022 Special 301 Report discusses the establishment of the Delhi High Court’s IP Division as a positive development and emphasizes continued engagement of the U.S. with India on IP matters. 266

As far as other states are concerned, in the Bombay High Court and the Madras High Court, post the abolition of the IPAB, the total number of pending patent disputes is, approximately, around 450–500 cases and 264 cases respectively. The Gujarat High Court has in fact nominated a non-exclusive bench for adjudication of all IP disputes.

On this note, a testament to the Delhi High Court IP Division’s efficacy in streamlining dispute resolution of IP cases may also be found in the fact that the Parliamentary Committee which had been set up to look into IP issues in India had earlier recommended (in 2021), to re-establish the IPAB, stating that the abolition decision was one taken in a hurry and there should have been stakeholder consultation. 267 However, post-establishment of the IP Division in the Delhi High Court, in April 2022 the Committee revised its recommendation 268 and recommended that IP divisions like at the Delhi High Court should be established in all High Courts in the country. The relevant observations of the Report dated April 6, 2022 read:

3.12 The Committee notes that the dissolution of IPAB would lead to transferring of all IP-related appeals including the pending cases to High Courts and Commercial Courts (in copyright matters). This may create additional burden on such courts which are already reeling under huge backlog of cases with inadequate expertise in hand to deal with IPR matters. It, therefore, opines that establishing an Intellectual Property Division (IPD) with dedicated IP benches as done by Delhi High Court in the wake of abolition of IPAB would ensure effective resolution of IPR cases on a timely basis. The Committee, therefore, recommends that the Government should take appropriate measures to encourage setting up of IPD in High Courts for providing alternative solution to resolve IPR cases.

Thus, the constitution of specialized IP Divisions for speedier and efficacious resolution of IP disputes, specifically patent litigation, seems to be the way forward for India.

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Trade Related Aspects Of Intellectual Property Rights Trips

Trade Related Aspects of Intellectual Property Rights (TRIPS)

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is in the news now because of the recent US decision to support the temporary waiver of patent rules for the coronavirus vaccines. This is an important topic from multiple perspectives for the UPSC exam including economy, international relations, current affairs, etc.

TRIPS Agreement

Trade Related Aspects of Intellectual Property Right (TRIPS) is an agreement on international IP rights.

TRIPS came into force in 1995, as part of the agreement that established the World Trade Organisation (WTO) .
TRIPS establishes minimum standards for the availability, scope, and use of seven forms of intellectual property namely, trademarks, copyrights, geographical indications, patents, industrial designs, layout designs for integrated circuits, and undisclosed information or trade secrets.
It applies basic international trade principles regarding intellectual property to member states.
It is applicable to all WTO members.
TRIPS Agreement lays down the permissible exceptions and limitations for balancing the interests of intellectual property with the interests of public health and economic development.
TRIPS is the most comprehensive international agreement on IP and it has a major role in enabling trade in creativity and knowledge, in resolving trade disputes over intellectual property, and in assuring WTO members the latitude to achieve their domestic policy objectives.
It frames the IP system in terms of innovation, technology transfer and public welfare.
The TRIPS Council is responsible for administering and monitoring the operation of the TRIPS Agreement.
TRIPS was negotiated during the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1986–1994.
The TRIPS Agreement is also described as a “Berne and Paris-plus” Agreement.

Read about other WTO Agreements in the link.

What are Intellectual Property Rights?

Intellectual property rights are the rights given to persons over the creations of their minds. Intellectual property rights (IPRs) are legal rights that protect these creations. In contrast to rights over tangible property, IP rights give their owners rights to exclude others from making use of their creations only for a limited period. IP rights entitle the owners to receive a royalty or any sort of financial compensation or payment when another person uses their creations.

What is Intellectual Property?

“Intellectual property” refers to creations of the mind. These creations can take many different forms, such as artistic expressions, signs, symbols and names used in commerce, designs and inventions.

IP rights are generally classified into two categories:

Copyright and rights related to copyright: This rights relates to rights protecting art works, literary works, computer programmes, films, musical compositions, sculptures, paintings, etc. Related rights also include rights of performers, broadcasting organisations, and producers of phonograms (sound recordings). The main purpose of protection of copyright and related rights is to encourage and reward creative work.
The protection of distinctive signs, especially trademarks (which differentiate the goods or services of one organisation/establishment from those of other undertakings) and geographical indications. These rights are aimed at protecting and ensuring fair competition consumer protection.
The second type of industrial property rights are protected primarily to stimulate innovation, design and the creation of technology. These rights protect innovations by patents, trade secrets and industrial designs.

Read more on intellectual property rights in the linked article.

TRIPS Significance

The TRIPS Agreement makes protection of intellectual property rights an integral part of the multilateral trading system, as embodied in the WTO. The agreement is often termed one of the three “pillars” of the WTO, the other two being trade in goods (the traditional domain of the GATT) and trade in services.

Before TRIPS, the extent of protection and enforcement of IP rights varied widely across nations and as intellectual property became more important in trade, these differences became a source of tension in international economic relations. Therefore, it was considered prudent to have new trade rules for IP rights in order to have more order and predictability, and also to settle disputes in an orderly manner.

TRIPS Agreement Latest News

In view of the COVID-19 pandemic, India and South Africa had proposed to the WTO in October 2020 that the TRIPS Agreement (that included patent protection to pharmaceutical products including COVID vaccines) be waived off for COVID vaccines, medicines and diagnostics for the time period of the pandemic in order to make vaccines and drugs for COVID available to a maximum number of people worldwide.

If the vaccines are patent protected, only a few pharmaceutical companies from developed western countries would be able to manufacture it, making such drugs unavailable or inaccessible due to the high costs to people of other countries, especially, developing and least developed countries.

The US, which was opposed to any TRIPS waiver, has backed this proposal, along with the EU. This move has been welcomed by many since it might lead to the manufacture of more volumes of COVID vaccines enabling the whole world to get rid of the coronavirus at the earliest. However, pharmaceutical companies have protested the move saying this would not necessarily ensure vaccine availability since developing countries did not have the capability to produce the vaccines.

Arguments in favour of relaxing TRIPS rules

This would make the vaccines more available to people of developing countries and also LDCs.
Life-saving drugs and vaccines should be made available to everyone and pharmaceutical companies should not be looking to make profits out of these. There is an ethical and moral issue here.
With particular reference to the COVID-19 pandemic, it is said that no one is safe unless everyone is safe. In this respect, it is imperative that vaccines are made available to everyone in countries affected since it can easily spread to all countries as seen in the first wave.
Rules granting monopolies that place the right to access basic healthcare in a position of constant peril must end.

Arguments made by opponents of TRIPS waiver

Unless corporations are rewarded for their inventions, they would be unable to recoup amounts invested by them in research and development.
Without the right to monopolise production there will be no incentive to innovate.
They also claim that companies in the developing world do not have the capacity to manufacture vaccines or drugs on a large scale.

Just a waiver of the IP rights rules without further assistance such as technology transfer to generic pharmaceutical companies in developing countries would render the move useless. This is because there would also necessitate tech transfer for the pharmaceutical companies to start the production since vaccines like the mRNA vaccines require highly sophisticated manufacturing equipment. Not only technology and equipment, raw materials and probably personnel would also need to be transferred for developing countries to be able to produce vaccines on a large scale.

It could also take several years before the generic pharmaceutical companies’ plants become operational at optimal capacity and produce vaccines, which is a problem because it is doubted whether vaccines produced today would be effective against any new strain of the virus.

TRIPS Agreement:- Download PDF Here

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Among the major world economies, India is one of the most challenging with respect to the protection and enforcement of intellectual property (IP) rights. Despite some recent efforts and the Indian government’s many positive statements and initiatives, concrete developments have been few, and the pace of reform has not matched repeated high-level calls to foster innovation and promote creativity. India has yet to take meaningful steps to address longstanding IP issues faced by innovation-driven industries. In 2023, India remains on the Priority Watch List in USTR’s Special 301 report.

Developments Over the Last Five Years

India announced its first National IPR policy in 2016. Today, the portfolios of Patents, Designs, Trademarks, Copyright, Geographical Indications, and Semiconductor Integrated Circuits Layout Design all fall under the Department for Promotion of Industry and Internal Trade (DPIIT). Under DPIIT, the Cell for IPR Promotion and Management is tasked with implementing India’s National IPR Policy. It spearheads the Indian government’s efforts to streamline IP processes, increase IP awareness, promote commercialization, and enhance enforcement.

Over the past five years, the Indian government has taken positive steps to strengthen its IPR regime, such as efforts to modernize its IP offices; increase manpower; use IT and technology in e-filing of applications; deliver certificates of grant and registration of patents, trademarks and designs in a digital format; reduce the number of trademarks forms; use video conferencing for hearing of IP applications; create expedited examination procedures; and spread awareness on IP issues.

DPIIT, in association with the Federation of Indian Chambers of Commerce and Industry, launched an IPR enforcement toolkit to aid police with handling IP crimes, in particular counterfeiting and piracy. The Maharashtra IP Crime Unit (MIPCU), formerly Maharashtra Cyber Digital Crime Unit (MCDCU), was established in August 2017, as a public-private partnership to enable industry to work directly with state police to combat theft of IP on digital platforms particularly digital piracy. The Unit serves as a potential model for digital enforcement that other Indian states can emulate and replicate.

The Ministry of Education’s Innovation Cell has also taken steps to foster innovation and promote IP literacy and awareness in classrooms across the country.

U.S. Government Engagement

Engagement with India on IPR continues, primarily through the U.S.-India Trade Policy Forum’s Working Group on Intellectual Property, which restarted in June 2021 after a gap of nearly three years. Under the Forum, working-level engagements between the United States and India have also been positive and focus on helping India develop a more transparent, predictable, and reliable enforcement environment. Further, the United States and India continue to actively engage across various platforms, such as the U.S.-India IP Dialogue, and routinely through bilateral interactions on specific IP issues. In addition, the United States maintains positive working relationships with Indian customs, police, and judiciary officials, as well as with industry representatives to discuss ways to strengthen India’s important enforcement ecosystem.

To further bilateral engagement on intellectual property matters, in December 2020, the United States Patent and Trademark Office and DPIIT signed a Memorandum of Understanding relating to IP technical cooperation mechanisms and the promotion of IP, which is guided by a biennial work plan.

Legislative Climate

While India has laws covering almost all types of intellectual property rights and enforcement procedures, the legislative process is often lengthy and uncertain, and the same issues can remain pending for many years. This can create uncertainty for industries and complicate their strategic IP enforcement decisions.

The Commercial Courts Act, enacted in 2015 and amended in 2018, was established to help reduce delays and increase expertise in judicial IP matters. However, to date only a limited number of courts have benefited under the Act. Rights holders report jurisdictional challenges have reduced the effectiveness of the commercial courts, and inadequate resources for staffing and training continue.

Pharmaceutical and agrochemical products can be patented in India. Plant varieties are protected by the Protection of Plant Varieties and Farmers’ Rights Act, 2001. However, Indian law does not protect against unfair commercial use, nor against the unauthorized disclosure of undisclosed test or other data submitted to the Indian government during the application for market approval of pharmaceutical or agrochemical products.

The Designs Act, 2000 allows for the registration of industrial designs. The current Designs Rules detail classification of designs, largely to conform to international standards, and are intended to address the proliferation of design-related activities. India’s Semiconductor Integrated Circuits Layout Design Act, 2000 is based on standards developed by the World Intellectual Property Organization; however, the law remains inactive due to a lack of implementing procedures as well as lack of interest in filings.

A June 2018 amendment to the Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007, removed patents from the scope of customs protection. Accordingly, the new customs recordation system permits owners of trademarks, designs, copyrights, and geographical indications to record their IPR with Indian customs authorities and seek enforcement actions for any related counterfeit activity. Customs officers have ex-officio authority to suspend the clearance of suspect imported goods when they believe that such goods are counterfeits. They subject these goods to examination, seizure, and destruction when rights holders join the proceedings, though rights holders will have to bear these costs. Also, the goods may subsequently be released after suspension of clearance if rights holders do not comply with the customs record requirements.

Protection and enforcement of trade secrets is challenging as there are no civil or criminal laws in India that specifically address their protection. While India relies on contract law to provide some trade secret protection, this approach is effective only in situations in which a trade secret owner and a party accused of misappropriation have a contractual relationship. Criminal penalties are not expressly available for trade secret misappropriation in India and civil remedies are reportedly difficult to obtain and often do not have a deterring effect.

India does not provide data protection for the registration of new agricultural products. Despite previous attempts to introduce data protection provisions into the Pesticides Management Bill, the pending bill, introduced in 2020, does not provide for data protection for the registration of new pesticides. Foreign industries were surprised by the December 2021 Standing Committee on Agriculture, Animal Husbandry and Food Processing Report on the Pesticide Management Bill, 2020, which noted that not including data protection provisions in the Bill will benefit domestic industry and farmers.

In a positive step to curb the menace of film piracy, including by transmission of unauthorized copies on the internet, GoI amended the Cinematograph Act, 1952 via the Cinematograph (Amendment) Act, 2023, which contains strict penal provisions to prohibit unauthorized recording and exhibition of films. Unfortunately, the Act also created new concerns for right holders by applying a broad set of exceptions to infringement from the Copyright Act to film recording or exhibition activities.

In June 2021, India’s Department Related Parliamentary Standing Committee on Commerce presented its 161st Review of the Intellectual Property Rights Regime in India Report. The Report emphasizes that the IPR regime should comply with international agreements, rules, and norms, and be compatible with those of other nations and foreign entities. While many of the recommendations in the report, such as those relating to trade secrets protection, IP enforcement, and dedicated IP benches at the High Courts, are welcomed, some recommendations, such as those relating to compulsory licenses and statutory licensing under Copyright law for online broadcasting, raise serious concerns and are regarded as problematic for IP rights holders.

In July 2022, the Ministry of Health and Family Welfare released a draft Drugs, Medical Devices and Cosmetics Bill, 2022 for public consultation. The Bill seeks to amend and consolidate the laws relating to the import, manufacture, distribution and sale of drugs, medical devices, and cosmetics to ensure their quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of investigational medical devices. A 2023 revision of the Bill has yet to be approved by the Cabinet.

In August 2022, the Economic Advisory Council to the Prime Minister (EAC-PM) released a Report titled “Why India Needs to Urgently Invest in its Patent Ecosystem.” The Report stressed the urgent need to ramp up the manpower of the Indian IP Office, especially for Patent Office to help boost its operations. In addition, the Report recommended that the IP Office have more autonomy for financial and staffing flexibility to help enable it to catch up with its global peers. The Report also flagged procedural issues in the patent application and trademark registration processes creating extensive delays in the grant of IP rights to the innovators in the country. In a positive step, the Indian IP Office has been taking steps in line with many of the report’s recommendations.

In August 2023, the Digital Personal Data Protection Act, 2023 received the assent of the President of India. Its enforcement will be determined by the GoI through notification. It excludes non-personal data or anonymized personal data which was a key demand from various stakeholders. The 2023 Act refers to IP primarily within the concept of “certain legitimate uses.” Processing of the personal data of a data principal for the purposes of employment or those related to safeguarding the employer from loss or liability, such as prevention of corporate espionage, maintenance of confidentiality of trade secrets, IP etc. is one of the nine grounds the 2023 Act provides for where use of the personal data would be a considered legitimate use. This may enable technology and IP-focused entities to better shield disclosure of sensitive information, which is a positive step. However, in the absence of any context in the Act, it is not clear how such provisions will be implemented.

In August 2023, the Biological Diversity (Amendment) Act, 2023 received the assent of the President of India. Its enforcement will be determined by the GoI through notification. It would introduce extensive changes to the Biological Diversity Act, 2002. It would amend the definitions of non-Indian entities and biological resources, require National Biodiversity Authority pre-approval for IPR applications for foreign entities and Indian entities before grant of such IPR and at the time of commercialization respectively, add restrictions on IPR application activities on biological resources when normally traded as commodities, and decriminalize cognizable and non-bailable offences. Overall, the compliance requirements for foreign entities seeking protections in India under the Act would remain strict.

In August 2023, the Jan Vishwas (Amendment of Provisions) Act, 2023 received the assent of the President of India. Its enforcement will be determined by the GoI through notification. It would amend 42 Acts for decriminalizing and rationalizing offences to further enhance trust-based governance for ease of living and doing business. Patents Act, 1970, Trade Marks Act, 1999, Copyright Act, 1957, and Geographical Indications of Goods (Registration and Protection) Act, 1999 would also be amended. Under the Jan Vishwas Act, several offences with an imprisonment term in certain Acts would be decriminalized by imposing only a monetary penalty. One of the positive amendments it would introduce would be to substantially reduce the penalty for failure or refusal to file Form 27 under the Patents Act and to do away with the provision for imprisonment.

Regulatory Climate and Hurdles

Despite several positive developments, there are also many regulatory hurdles and challenges that affect the commercialization of IP in India. For instance, the interpretation and application of patent law can be unpredictable and inconsistent, particularly in important areas such as determining the scope of patentable subject matter, pre-grant opposition proceedings, and provisions governing the granting of compulsory licenses.

In 2016 and 2017, the Patents Rules and the Trade Marks Rules were revised, adopting strict timelines to dispose of cases, streamline examinations, and reduce certain filing fees to incentivize start-up activity. In 2019, the Patents (Amendment) Rules further expanded the categories of applicants eligible for expedited examination of their patent applications. The 2017 examination guidelines for Computer Related Inventions removed all examples of what can and cannot be patentable, deferring to the patent examiner’s discretion and raising concerns about the consistency of patentability decisions. In September 2021, the Indian government notified the Patents (Amendment) Rules, 2021, extending the benefit of fee reduction for patent application filings to all recognized educational institutions, including foreign institutions. In a positive step in August 2023, the GoI published the Draft Patents (Amendment) Rules, 2023 for public input. The key proposed amendments in the Draft Rules aim to streamline and expedite patent procedures, including those relating to pre-grant opposition, statement and undertaking regarding foreign patent applications, and annual patent commercial working statement (Form 27).

India’s Copyright (Amendment) Rules, 2021, became effective in March 2021. These rules introduced a host of changes regarding copyright societies, including their registration, management, and functions.

The Delhi High Court’s direction to the Office of the Controller General of Patents, Designs, and Trade Marks (CGPDTM) i.e., IP Office to resolve trademark opposition backlog and continuous monitoring has been a positive step though concerns remain with the excessive delays in trademark opposition proceedings.

Pharmaceutical and Medical Devices

The lack of coordination between DPIIT and the Central Drugs Standard Control Organization through either patent linkages or an effective notification system invites abusive infringing activities, which compromises the ability of innovative industries to effectively commercialize and enforce their IPR in India. Liberal price controls, coupled with the potential abusive use of procedures such as pre-grant and post-grant opposition proceedings, further complicate an effective IPR regime for the pharmaceutical and medical device industries.

In April 2017, the Ministry of Health and Family Welfare removed the requirement for companies to inform whether a new drug is under patent at the time of filing for a manufacturing license. This is viewed as a regressive step and goes against India’s National IPR Policy, which calls for better central and state coordination on IP issues. India still lacks a system for notifying interested parties of marketing approvals for follow-on pharmaceuticals, which would allow for the early resolution of potential patent disputes.

The threat of price controls for patented pharmaceuticals continues to concern rightsholders. The National Pharmaceutical Pricing Authority previously made efforts to invoke emergency provisions to issue price control orders to fix prices for several non-scheduled drugs, including patented drugs. The 2015 National List of Essential Medicines included several patented drugs. The List is currently under revision again, and the threat of patented drugs being added to the list remains a significant concern. There are also strong concerns over the unpredictable and opaque application and implementation of the Trade Margin Rationalization formula for price monitoring of the non-scheduled market, including for patented drugs. In January 2019, the Department of Pharmaceuticals amended its 2013 Drugs (Prices Control) Order to exempt manufacturers producing a new drug patented in India from price controls for five years from commencement of their commercial marketing of the drug in India. While this is viewed as a positive development, serious concerns remain over its implementation or potential dilution. Industry continues to seek clarity from the Department of Pharmaceuticals on how the amendment is to be implemented.

In the pharmaceutical sector, the absence of clear guidance in implementing Section 3(d) of the Indian Patents Act has restricted patent-eligible subject matter in a way that fails to incentivize innovation by hindering the development of improvements to benefit Indian patients.

In December 2020, the Department of Pharmaceuticals issued guidelines for implementation of the provisions of the 2017 Public Procurement Order, specifying a minimum of 80 percent local component requirement for a Class I local supplier and 50 percent to qualify as a Class II local supplier. The guidelines effectively disqualify non-local bidders from Indian government tenders.

Technology, Brand, and Intellectual Property Licensing

In 2018, the Indian government formed an inter-ministerial group to investigate reinstating royalty caps for all technology collaborations and brand licensing, limiting the amount of foreign exchange that can leave the country. If implemented, such caps would negatively affect all sectors of the economy in which a company licenses its brand name or enters a technical collaboration. Prior to 2009, India had a similar provision, but it was abandoned in favor of attracting higher levels of foreign investment.

India generally has adequate copyright laws, barring some exceptions. A July 2021 Parliamentary Committee report recommended an amendment to the Copyright Act to extend statutory licensing to include internet and digital broadcasters for certain works. DPIIT has taken this recommendation into consideration, which has deeply concerned companies in the music, entertainment, and creative industries. Amending the Copyright Act to permit statutory licensing for interactive transmissions would be inconsistent with India’s obligations under relevant international treaties and would have severe implications for rights holders that make their content available online. The lack of predictability around this issue, along with the expansive granting of licenses under Chapter VI of the Indian Copyright Act and overly broad exceptions for certain uses, have raised concerns about the strength of copyright protection in India and complicated the functioning of the market for music licensing. India’s commitment at the United States–India Trade Policy Forum in November 2021 to comply with the World Intellectual Property Organization Internet Treaties was a positive step, though respective amendments to bring India’s Copyright Act into alignment with international best practices has not yet been made.

The Indian Patents Rules require Form 27 to be filed annually by patentees and licensees on the details of their commercial activities for all their patents in force in India. While the annual requirement was initially created to ensure that patentees are working their inventions in India, the form may be hindering innovation. In October 2020, revisions to Form 27 improved the situation, though it still places significant risks and undue burden on rights holders and may compromise their confidential business information and strategies. In addition, failing to comply with Form 27 requirements can create grounds for seeking a compulsory license and could lead to loss of patent, substantial penalties, and imprisonment.

Enforcement Climate

The Intellectual Property Appellate Board (IPAB) was abolished in 2021, transferring jurisdiction to adjudicate appeals over patents, trademarks, copyrights, and other IPR matters to the High Courts. India’s decision to abolish the IPAB and redirect matters to the courts has created uncertainty around adjudication of IP cases and the setting of copyright royalty rates. In July 2021, the Delhi High Court created a dedicated Intellectual Property Division (IPD) to hear IPR matters, including those previously before the IPAB. The Delhi High Court recently nominated three Judges to exclusively function as the IPD, and in February 2022 the Court notified its comprehensive rules for the IPD. At the same time, the Court notified its rules governing patent suits. The April 2022 Parliamentary Committee Report recommended that the Indian government encourage High Courts across the country to follow suit and establish their own IPDs.

In 2021, India continued to take steps against websites with pirated content. Despite positive steps taken in online copyright enforcements, such as “dynamic injunctions” for repeat offenders, copyright holders continue to report high levels of piracy, particularly online and through commercial broadcasts. This includes unauthorized file sharing of videogames, signal theft by cable operators, commercial scale photocopying, unauthorized reprints of academic books, and circumvention of Technology Protection Measures.

While there has been some progress, weak enforcement of IP by the courts and police, a lack of familiarity with investigative techniques, and the absence of a centralized IP enforcement agency, combined with failure to coordinate actions on both the national and state level, threaten to undercut progress.

See the India IPR Snapshot for more information.

In any foreign market, U.S. companies should consider several general principles for effective protection of their IP. Please see Protecting Intellectual Property and visit Stopfakes.gov for additional resources.

See the 2023 Investment Climate Statement , which includes information on the protection and enforcement of IPR in India.

For more information, contact U.S. Intellectual Property Counselor for South Asia John Cabeca at the U.S. Embassy in New Delhi or the International Trade Administration’s Office of Intellectual Property Rights Director Stevan Mitchell .

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intellectual property

UNDERSTANDING THE WTO: THE AGREEMENTS

Intellectual property: protection and enforcement

More introductory information

> The WTO in Brief

back to top Origins: into the rules-based trading system....

The idea of trade, and what makes trade valuable for societies, has evolved beyond simply shipping goods across borders. Innovation, creativity and branding represent a large amount of the value that changes hands in international trade today. How to enhance this value and how to facilitate the flow of knowledge-rich goods and services across borders have become integral considerations in development and trade policy.

The TRIPS Agreement plays a critical role in facilitating trade in knowledge and creativity, in resolving trade disputes over intellectual property, and in assuring WTO members the latitude to achieve their domestic objectives. The Agreement is legal recognition of the significance of links between intellectual property and trade.

"Intellectual property" refers to creations of the mind. These creations can take many different forms, such as artistic expressions, signs, symbols and names used in commerce, designs and inventions. Governments grant creators the right to prevent others from using their inventions, designs or other creations — and to use that right to negotiate payment in return for others using them. These are “intellectual property rights”. They take a number of forms. For example, books, paintings and films come under copyright; eligible inventions can be patented; brand names and product logos can be registered as trademarks; and so on. Governments grant creators these rights as an incentive to produce and spread ideas that will benefit society as a whole.

The extent of protection and enforcement of these rights varied widely around the world; and as intellectual property became more important in trade, these differences became a source of tension in international economic relations. New internationally-agreed trade rules for intellectual property rights were seen as a way to introduce more order and predictability, and to settle disputes more systematically.

The Uruguay Round achieved that. The WTO’s TRIPS Agreement is an attempt to narrow the gaps in the way these rights are protected and enforced around the world, and to bring them under common international rules. It establishes minimum standards of protection and enforcement that each government has to give to the intellectual property held by nationals of fellow WTO members.

Under the TRIPS Agreement, WTO members have considerable scope to tailor their approaches to IP protection and enforcement in order to suit their needs and achieve public policy goals. The Agreement provides ample room for members to strike a balance between the long term benefits of incentivising innovation and the possible short term costs of limiting access to creations of the mind. Members can reduce short term costs through various mechanisms allowed under TRIPS provisions, such as exclusions or exceptions to intellectual property rights. And, when there are trade disputes over the application of the TRIPS Agreement, the WTO’s dispute settlement system is available.

The TRIPS Agreement covers five broad areas:

back to top Basic principles: national treatment, MFN, and balanced protection

As in the General Agreement on Tariffs and Trade (GATT) and the General Agreement on Trade in Services (GATS), the starting point of the TRIPS Agreement is basic principles. And as in the two other agreements, non-discrimination features prominently: national treatment (treating foreign nationals no less favourably than one’s own nationals), and most-favoured-nation (MFN) treatment (not discriminating among nationals of trading partners). National treatment is also a key principle in other intellectual property agreements outside the WTO.

The TRIPS Agreement has an additional important general objective: intellectual property protection should contribute to technical innovation and the transfer of technology. Both producers and users should benefit, and economic and social welfare should be enhanced, the TRIPS Agreement says.

back to top How to protect intellectual property: common ground-rules

The second part of the TRIPS Agreement looks at different kinds of intellectual property rights and how to protect them. The purpose is to ensure that minimum standards of protection exist in all WTO members. Here the starting point is the obligations of the main international agreements of the World Intellectual Property Organization (WIPO) that already existed before the WTO was created:

Some areas are not covered by these agreements. In some cases, the standards of protection prescribed were thought inadequate. So the TRIPS Agreement adds significantly to existing international standards.

back to top Copyright

Copyright usually refers to the rights of authors in their literary and artistic works. In a wider sense, copyright also includes ‘related rights’: the rights of performers, producers of phonograms and broadcasting organizations.

During the Uruguay Round negotiations, members considered that the standards for copyright protection in the Berne Convention for the Protection of Literary and Artistic Works were largely satisfactory. The TRIPS Agreement provisions on copyright and related rights clarify or add obligations on a number of points:

The TRIPS Agreement ensures that computer programs will be protected as literary works under the Berne Convention and outlines how databases must be protected under copyright;
It also expands international copyright rules to cover rental rights. Authors of computer programs and producers of sound recordings must have the right to prohibit the commercial rental of their works to the public. A similar exclusive right applies to films where commercial rental has led to widespread copying, affecting copyright-owners’ potential earnings from their films; and
It says performers must also have the right to prevent unauthorized recording, reproduction and broadcast of live performances (bootlegging) for no less than 50 years. Producers of sound recordings must have the right to prevent the unauthorized reproduction of recordings for a period of 50 years.

back to top Trademarks

A trademark is a sign or a combination of signs used to distinguish the goods or services of one enterprise from another.

The TRIPS Agreement defines what types of signs must be eligible for protection as trademarks, and what the minimum rights conferred on their owners must be. It says that service marks must be protected in the same way as trademarks used for goods. Marks that have become well-known in a particular country enjoy additional protection.

back to top Geographical indications

A name or indication associated with a place is sometimes used to identify a product. This “geographical indication” does not only say where the product comes from. More importantly, it identifies the product’s special characteristics, which are the result of the product’s origins.

Well-known examples include “Champagne”, “Scotch Whiskey”, “Tequila”, "Darjeeling" and “Roquefort” cheese.

Using the indication when the product was made elsewhere or when it does not have the usual characteristics can mislead consumers, and can lead to unfair competition. The TRIPS Agreement says members have to provide ways to prevent such misuse of geographical indications.

For wines and spirits, the TRIPS Agreement provides higher levels of protection, i.e. even where there is no danger of the public being misled.

Some exceptions are allowed, for example if the term in question is already protected as a trademark or if it has become a generic term.

The TRIPS Agreement provides for further negotiations in the WTO to establish a multilateral system of notification and registration of geographical indications for wines, which was subsequently extended to include spirits. The question of whether to negotiate extending this higher level of protection beyond wines and spirits is also being discussed in the WTO.

back to top Industrial designs

Industrial design is generally understood to refer to the ornamental or aesthetic aspect of an article rather than its technical features.

Under the TRIPS Agreement, original or new industrial designs must be protected for at least 10 years. Owners of protected designs must be able to prevent the manufacture, sale or importation of articles bearing or embodying a design which is a copy or substantially a copy of the protected design for commercial purposes.

back to top Patents

The TRIPS Agreement says patent protection must be available for eligible inventions in all fields of technology that are new, involve an inventive step and can be industrially applied. Eligible inventions includee both products and processes. They must be protected for at least 20 years. However, governments can refuse to issue a patent for an invention if its sale needs to be prohibited for reasons of public order or morality. They can also exclude diagnostic, therapeutic and surgical methods, plants and animals (other than micro-organisms), and biological processes for their production (other than microbiological processes) from patent protection.

Plant varieties, however, must be protectable by patents or by a special system (such as the breeder’s rights provided in the conventions of UPOV — the International Union for the Protection of New Varieties of Plants ) or by both.

The TRIPS Agreement describes the minimum rights that a patent owner must enjoy, and defines the conditions under which exceptions to these rights are permitted. The Agreement permits governments to issue “compulsory licences”, which allow a competitor to produce the product or use the process under licence without the owner's consent. But this can only be done under specific conditions set out in the TRIPS Agreement aimed at safeguarding the interests of the patent-holder.

If a patent is issued for a process invention, then the rights must extend to the product directly obtained from the process. Under certain conditions alleged infringers may be ordered by a court to prove that they have not used the patented process.

Compulsory licences for export of medicines

back to top Layout designs of integrated circuits

An integrated circuit is an electronic device that incorporates individual electronic components within a single ‘integrated’ platform configured to perform an electronic function.

The protection of layout designs of integrated circuits (“topographies”) in the TRIPS Agreement is provided through the incorporation of the Washington Treaty on Intellectual Property in Respect of Integrated Circuits, a treaty that was concluded under the World Intellectual Property Organization in 1989, but has not yet entered into force. The TRIPS Agreement adds a number of provisions: for example, protection must be available for at least 10 years.

In practice, layout designs of integrated circuits are commonly protected under patents.

back to top Undisclosed information

Undisclosed information includes trade secrets and test data. Trade secrets must be protected against unauthorized use, including through breach of contract or confidence or other acts contrary to honest commercial practices. Such protection is conditional upon the information being secret, having commercial value and reasonable steps having been taken by its owner to keep the information secret.

Test data submitted to governments in order to obtain marketing approval for new pharmaceutical or agricultural chemicals must also be protected against unfair commercial use and disclosure. Extended transition periods continue to apply to least developed country members (see section below on transitional arrangements).

back to top Anti-competitive practices in licensing

One way for a right holder to commercially exploit his or her intellectual property rights includes issuing a licence to someone else to use the rights. Recognizing the possibility that right holders might include conditions that are anti-competitive, the TRIPS Agreement says that under certain conditions, governments have the right to take action to prevent anti-competitive licensing practices. It also says governments must be prepared to consult each other on controlling anti-competitive licensing practices.

More generally, the TRIPS Agreement recognizes that right holders could use their rights to restrict competition or impede technology transfer. The Agreement gives governments the right to take action against anti-competitive practices. In certain situations, the TRIPS Agreement also waives some conditions required for the compulsory licence of a patent in cases where the government grants the compulsory licence in order to remedy a practice determined to be anti-competitive.

back to top Enforcement

In order for the protection of intellectual property rights to be meaningful, WTO members must give right holders the tools to ensure that their intellectual property rights are respected. Enforcement procedures to do so are covered in part III of the TRIPS Agreement. The Agreement says governments have to ensure that intellectual property rights can be enforced to prevent or deter violations. The procedures must be fair and equitable, and not unnecessarily complicated or costly. They must not entail unreasonable time-limits or unwarranted delays. People involved must be able to ask a court to review an administrative decision or to appeal a lower court’s ruling.

The TRIPS Agreement is the only international agreement that describes intellectual property rights enforcement in detail, including rules for obtaining evidence, provisional measures, injunctions, damages and other penalties. It says courts must have the right, under certain conditions, to order the disposal or destruction of goods infringing intellectual property rights. Wilful trademark counterfeiting or copyright piracy on a commercial scale must be subject to criminal offences. Governments also have to make sure that intellectual property rights owners can receive the assistance of customs authorities to prevent imports of counterfeit and pirated goods.

back to top Technology transfer

Developing country members in particular see technology transfer as part of the bargain in which they have agreed to protect intellectual property rights. The TRIPS Agreement aims for the transfer of technology (see above) and requires developed country members to provide incentives for their companies to promote the transfer of technology to least-developed countries in order to enable them to create a sound and viable technological base. More on technology transfer .

back to top Transitional arrangements: One year, 5 years or more

While the WTO agreements entered into force on 1 January 1995, the TRIPS Agreement allowed WTO members certain transition periods before they were obliged to apply all of its provisions. Developed country members were given one year to ensure that their laws and practices conform to the TRIPS Agreement. Developing country members and (under certain conditions) transition economies were given five years, until 2000. Least-developed countries initially had 11 years, until 2006 — now extended to 1 July 2034 in general.

In November 2015, the TRIPS Council agreed to further extend exemptions on pharmaceutical patent and undisclosed information protection for least-developed countries until 1 January 2033 or until such date when they cease to be a least-developed country member, whichever date is earlier. They are also exempted from the otherwise applicable obligations to accept the filing of patent applications and to grant exclusive marketing rights during the transition period.

Institutional arrangements

The main forum for work on the TRIPS Agreement is the Council for TRIPS, which was created by the WTO Agreement. The TRIPS Council is responsible for administering the TRIPS Agreement. In particular, it monitors the operation of the Agreement. In its regular sessions, the TRIPS Council mostly serves as a forum for discussion between WTO members on key issues. The TRIPS Council also meets in “special sessions”. These are for negotiations on a multilateral system for notifying and registering geographical indications for wines and spirits.

Cooperation with other intergovernmental organizations

The preamble to the TRIPS Agreement calls for a mutually supportive relationship between the WTO and WIPO as well as other relevant international organizations. Cooperation between the WTO and WIPO covers notifications of laws, technical assistance and implementing the TRIPS obligations that stem from Article 6 ter of the Paris Convention for the Protection of Industrial Property.

The WTO also coordinates with a wide range of other international organizations, in particular as regards the organization of symposia, training activities and other events on intellectual property and trade and how these relate to other policy dimensions, such as public health and climate change.

Types of intellectual property

The areas covered by the TRIPS Agreement

Whats the difference?

Copyrights, patents, trademarks, etc apply to different types of creations or inventions. They are also treated differently.

Patents, industrial designs, integrated circuit designs, geographical indications and trademarks have to be registered in order to receive protection. The registration includes a description of what is being protected the invention, design, brandname, logo, etc and this description is public information.

Copyright and trade secrets are protected automatically according to specified conditions. They do not have to be registered, and therefore there is no need to disclose, for example, how copyrighted computer software is constructed.

Other conditions may also differ, for example the length of time that each type of protection remains in force.

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THE AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS (TRIPS)

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), negotiated during the Uruguay Round, introduced intellectual property rules for the first time into the multilateral trading system. The Agreement, while recognizing that intellectual property rights (IPRs) are private rights, establishes minimum standards of protection that each government has to give to the intellectual property right in each of the WTO Member countries. The Member countries are, however, free to provide higher standards of intellectual property rights protection. The Agreement is based on and supplements, with additional obligations, the Paris, Berne, Rome and Washington conventions in their respective fields. Thus, the Agreement does not constitute a fully independent convention, but rather an integrative instrument which provides “Convention–plus” protection for IPRs. The TRIPS Agreement is, by its coverage, the most comprehensive international instrument on IPRs, dealing with all types of IPRs, with the sole exception of breeders’ rights. IPRs covered under the TRIPS agreement are: (a) Copyrights and related rights; (b) Trade marks; (c) Geographical Indications; (d) Industrial Designs; (e) Patents; (f) Layout designs of integrated circuits; and (g) Protection of undisclosed information (trade secrets). The TRIPS agreement is based on the basic principles of the other WTO Agreements, like non-discrimination clauses – National Treatment and Most Favoured Nation Treatment, and are intended to promote “technological innovation” and “transfer and dissemination” of technology. It also recognizes the special needs of the least-developed country Members in respect of providing maximum flexibility in the domestic implementation of laws and regulations. Part V of the TRIPS Agreement provides an institutionalized, multilateral means for the prevention of disputes relating to IPRs and settlement thereof. It is aimed at preventing unilateral actions. The text of the agreement can be downloaded here (Hyperlink ANNEX IV A)

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What is Trade Related Intellectual Property Rights (TRIPs)?

TRIPs provide minimum standards in the form of common set of rules for the protection of intellectual property globally under WTO system.
The TRIPs agreement gives set of provisions deals with domestic procedures and remedies for the enforcement of intellectual property rights.
Member countries have to prepare necessary national laws to implement the TRIPs provisions.
TRIPs cover eight areas for IPRs legislation including patent, copyright and geographical indications.

The TRIPs regime

A breakthrough of the GATT signed in 1994 was that it brought TRIPs as a common standard for the protection of intellectual property globally. Implication of TRIPs is that member countries should design domestic intellectual property legislations on the basis of the TRIPs provisions.

TRIPs as WTO’s IPR regime

TRIPs is considered as a major achievement of the Uruguay Round as an international trade agreement. At the trade negotiations, the developed countries were succeeded in linking intellectual property rights with trade. Until then, the World Intellectual Property Organisation (WIPO) was the exclusive international institution dealing with intellectual property. With TRIPs, the WTO also emerged as the institution for the protection and promotion of intellectual property globally.

What TRIPs instructs to member countries?

As per the TRIPs provisions, the member countries are required to prepare the necessary legal framework spelling out the scope and standards of protection for rights in regard to intellectual property. Or in other words, the member countries have to adopt TRIPs provisions in their domestic intellectual property legislations like Patent Act, Copyright Act etc.

WTO advocate necessary amendments to national IPR laws to accommodate the TRIPs provisions. TRIPs agreement is an effort to bring national legislations under common international rules. An important feature of TRIPs is that it is more specific and hard on ‘patents’ -the most important form of intellectual property. In the case of plant rights, geographical indications etc., members can adopt a sui-generis (own designed) IPR regime.

WTO gives following areas of intellectual property – copyright and related rights, trademarks, protection of undisclosed information (trade secrets), geographical indications, industrial designs, integrated circuits, patents, and control of anti-competitive practices in contractual licences. Signing TRIPs means countries have to modify their Patent Act, Copy Right Act, Trade Mark Act etc., in accordance with the provisions of the TRIPs. In India, the government has made a major amendment to the 1970 Patent Act in 2005 to accommodate the TRIPs provisions. In 2010, the Copyright Act was amended and enforced from 2012. Other legislations with respect to Industrial designs also have been made.

The rationale for WTO’s effort to bring an intellectual property protection regime globally

The WTO supports IPR regime under its leadership on the ground that intellectual property is a trade related asset. It asserts that an international attempt is needed because of the wide differences existing in the intellectual property regime across the world.

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National IPR policy

Last updated on October 2, 2023 by ClearIAS Team

The government has announced the National IPR policy to advance the IPR regime.

The strategy will promote entrepreneurship, creativity, and innovation in India.

Let us discuss more on India’s IPR policy.

Table of Contents

Regarding the Policy

The policy’s slogan is “ Creative India, Innovative India”. The main aim is to discourage the production and selling of fake goods and to encourage entrepreneurship, creativity, and innovation.

The intellectual property encourages advancement in S&T, art and culture, traditional knowledge, and biodiversity resources; knowledge is the primary driver of development, and knowledge owned is transformed into knowledge shared. This promotes an India where creativity and innovation are encouraged by IP for the benefit of all.
It establishes a formal system for implementation, oversight, and evaluation. It tries to adapt and modify best practices from around the world for the Indian context.
IPRs in India are being implemented and will continue to develop under the direction of the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce, Government of India.
The WTO’s agreement on Trade-Related Aspects of Intellectual Property Rights is upheld by India’s IPR regime (TRIPS).
The National IPR Policy’s goals are to be carried out by the “Cell for IPR Promotion & Management (CIPAM),” which was established under the supervision of DPIIT.

Goals of the IPR policy

There are seven main goals:

IPR, outreach, and promotion—raising public understanding of IPRs’ positive effects on the economy, society, and culture.
Encourage the creation of IPRs by cultivating an environment that is inventive and innovative.
Replace obsolete rules with strong, effective IPR laws that combine the rights holders’ interests with the broader public interest.
Human Capital Development for Intellectual Property Education, Research, and Skill Building Human resources, institutions, and capacities are strengthened and expanded by rights.
Modernize and improve service-oriented IPR administration through the administration and management of innovation
IPR commercialization – Commercialization can be used to maximise IPR value.
Strengthening the enforcement and adjudicative processes to combat IPR infringements

The policy established a legal framework that will support the IPR regime and shorten the time it takes for a trademark to be approved by the government to one month. At the moment, the procedure takes longer than a year.

Requirement of an IPR Policy

It is crucial for the government to offer incentives in the form of tax breaks in order to promote research and development.
The US Trade Representative (USTR) kept India on its “Priority Watch List” in its annual Special 301 Report (on the Global State of IPR Protection and Enforcement) for the 2016 edition.
To protect innovations so that there are fewer legal disputes in this area.
It will aid in preserving Indian traditional knowledge.
It will contribute to the improvement of the Startup, Make In India , and Digital India programs.

Details of IPR policy

The IPR policy was developed, following extensive stakeholder consultation with close to 300 organizations and people by an IPR Think Tank, as well as with 31 departments of the Government of India.

Approved by the Indian government on May 12th, 2016.
In order to create and utilise synergies between all types of intellectual property (IP), relevant statutes, and agencies, a vision statement that embraces and unifies all IPRs must take into account all interlinkages within the Indian IP ecosystem.
Attempts to incorporate and adapt international best practices to the Indian situation by establishing an institutional system for implementation, monitoring, and review.
Reiterates India’s adherence to the TRIPS agreement and the Doha Development Agenda
Recognizes that India has a solid legislative, judicial, and administrative framework for protecting IPRs that comply with TRIPS.
Balances the greater public interest with the rights holders’ interests
In order to assure the monetization of India’s “frugal engineering” strength, it is necessary to raise awareness about IPRs as a marketable financial asset and economic tool.
Ensures that the IP regime in India is characterised by a single-mindedness of goal and direction, serving as a guide for the IPR regime in India for times to come.
Positions India as an innovation-friendly country and allows for the effective use of the strengths of all stakeholders.
To promote innovation and creativity by presenting the world with a dynamic and predictable IP regime that includes a stable, transparent, and service-oriented IPR administration.
Five-year reviews of the IPR Policy will be conducted by a committee under the Secretary of the DIPP.

Benefits of IPR policy

The proposed IPR policy regime has the following benefits:

It is a vision plan that seeks to build connections among all types of intellectual property, relevant laws, and government organisations.
It would harmonise India’s IP regime with international standards and raise India’s Ease of Doing Business score on the World Bank.
The policy promotes investments in India by potential investors and strategic partners while ensuring credibility.
It will decrease the amount of time needed to process the backlog of IPR applications.
It works to improve access to healthcare, food security, and environmental protection while preventing the piracy of movies and music.
A stable, open, and service-oriented IPR administration in the nation is made possible by policy, which also encourages creativity and innovation across industries.
It will raise awareness, which will contribute to creating a culture that supports innovation and creativity and produce commercially viable, protectable intellectual property.
Industry and people would gain from the Copyright Act and Semiconductor Integrated Circuits Layout-Design Act being brought under DIPP.
Due to better administrative convergence, the commercial relevance of IPRs will be better affected when they are housed under one roof.
All facets of society are to be made aware of the social, economic, and cultural benefits of IPRs.

Disadvantages

The proposed national IPR policy also has some disadvantages like the following.

The Doha Declaration on World Trade Organization (WTO) TRIPS (Trade-Related IPR Agreement) and Public Health is a commitment made by India, according to the IPR Policy. However, there was some concern that the inclusion of the Doha Declaration and flexibility would lead to attempts to undermine TRIPS in order to benefit pharmaceutical firms.
In the absence of financing and programmes to enable universal access to healthcare, any change in the legal system would be detrimental to both the generic industry and the Indian populace.
Traditional knowledge and the informal creativity/innovations based on it are not addressed in the policy.
Absence of proof supporting the value of current trade secret and utility model legislation in fostering unofficial innovation.
Even while it claimed that the primary responsibility for securing IP rights was on the IP owner, it envisions significant government investment in protecting and promoting foreign IP in India.
Furthermore, the mention of State laws in the context of copyright protection demonstrated how the policy was biased in favour of IP owners rather than society.
Few experts believe that the National IPR strategy is insufficient for promoting innovation since it lacks specificity.
It presupposes that greater IP leads to greater innovation. It fails to comprehend that IP is merely a means to an end and not an end in and of itself.
The policy urges that all knowledge be turned into IP.
Corporates have also acknowledged that certain technical industries, where a free flow of open knowledge is more appropriate, do not work well with IP.
Experts are also dubious about the policy’s application to the rural informal economy.
Because rural economies and creativity are not well understood. In rural places, adopting a formal IP policy may cause more harm than good.
Lastly, making violations of the Indian Cinematograph Act illegal is excessively harsh and unjust. IP wrongs are essentially civil wrongs, so they shouldn’t be made illegal.

Major outcomes of the new National IPR policy

The following are the major outcomes of the new IPR policy.

India’s position in the WIPO-issued Global Innovation Index (GII) rose from 81st in 2015 to 48th in 2020.
Compared to the same period in 2017–18, patent filings climbed by about 7% in the first eight months of 2018–19. Over this time, there has been an almost 28% increase in trademark filings.
Enhancing institutional mechanisms for promoting and protecting IP
The government’s increase in technical manpower has led to a significant decrease in the amount of time that IP Applications are pending.
Another innovation is the automatic issuance of the electronically created patent and trademark certificates.
Processes have been streamlined and made more user-friendly in accordance with the IP Process Re-engineering Patent Rules, 2003. Trademarks Rules have been updated and announced in 2017.
IPR Awareness-Building IPR Awareness seminars have been carried out for businesses, law enforcement, the judicial system, and even rural schools using satellite communication.
Centers for Technology and Innovation Support (TISCs) have been set up in numerous universities across various states in conjunction with WIPO.

The IPRs policy would go a long way toward encouraging the Indian sector to develop as well as to preserve and enforce their innovations, but other areas still need more examination, such as the idea of information sharing and knowledge access.

The expansion of the innovation ecosystem with improved IPR protection is necessary for the success of India’s flagship initiatives, Make in India and Startup India. The expansion of the protection to include items that are in the public domain is also causing some worry. More foreign investment in the nation could be attracted with better policy enforcement.

It appears that the policy’s approach to copyrights and trademarks is designed to meet the interests of foreign businesses. They will be more motivated if rights are granted more quickly and are strictly enforced. The policy’s approach to digital piracy, which suggests harsher measures for addressing the problem, is one of its main features.

Article Written By: Atheena Fathima Riyas

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Cabinet approves National Intellectual Property Rights Policy

“Creative India; Innovative India: रचनात्मक भारत; अभिनव भारत”

The Union Cabinet approved the National Intellectual Property Rights (IPR) Policy that will lay the future roadmap for intellectual property in India. The Policy recognises the abundance of creative and innovative energies that flow in India, and the need to tap into and channelise these energies towards a better and brighter future for all.

The National IPR Policy is a vision document that aims to create and exploit synergies between all forms of intellectual property (IP), concerned statutes and agencies. It sets in place an institutional mechanism for implementation, monitoring and review. It aims to incorporate and adapt global best practices to the Indian scenario. This policy shall weave in the strengths of the Government, research and development organizations, educational institutions, corporate entities including MSMEs, start-ups and other stakeholders in the creation of an innovation-conducive environment, which stimulates creativity and innovation across sectors, as also facilitates a stable, transparent and service-oriented IPR administration in the country.

The Policy recognizes that India has a well-established TRIPS-compliant legislative, administrative and judicial framework to safeguard IPRs, which meets its international obligations while utilizing the flexibilities provided in the international regime to address its developmental concerns. It reiterates India’s commitment to the Doha Development Agenda and the TRIPS agreement.

While IPRs are becoming increasingly important in the global arena, there is a need to increase awareness on IPRs in India, be it regarding the IPRs owned by oneself or respect for others’ IPRs. The importance of IPRs as a marketable financial asset and economic tool also needs to be recognised. For this, domestic IP filings, as also commercialization of patents granted, need to increase. Innovation and sub-optimal spending on R&D too are issues to be addressed.

The broad contours of the National IPR Policy are as follows:

Vision Statement: An India where creativity and innovation are stimulated by Intellectual Property for the benefit of all; an India where intellectual property promotes advancement in science and technology, arts and culture, traditional knowledge and biodiversity resources; an India where knowledge is the main driver of development, and knowledge owned is transformed into knowledge shared.

Mission Statement:

Stimulate a dynamic, vibrant and balanced intellectual property rights system in India to: o foster creativity and innovation and thereby, promote entrepreneurship and enhance socio-economic and cultural development, and o focus on enhancing access to healthcare, food security and environmental protection, among other sectors of vital social, economic and technological importance.

Objectives:

The Policy lays down the following seven objectives: i. IPR Awareness: Outreach and Promotion – To create public awareness about the economic, social and cultural benefits of IPRs among all sections of society. ii. Generation of IPRs – To stimulate the generation of IPRs. iii.Legal and Legislative Framework – To have strong and effective IPR laws, which balance the interests of rights owners with larger public interest. iv. Administration and Management – To modernize and strengthen service-oriented IPR administration. v. Commercialization of IPRs – Get value for IPRs through commercialization. vi. Enforcement and Adjudication – To strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements. vii.Human Capital Development – To strengthen and expand human resources, institutions and capacities for teaching, training, research and skill building in IPRs.

These objectives are sought to be achieved through detailed action points. The action by different Ministries/ Departments shall be monitored by DIPP which shall be the nodal department to coordinate, guide and oversee implementation and future development of IPRs in India.

The National Intellectual Property Rights (IPR) Policy will endeavor for a “Creative India; Innovative India: रचनात्मक भारत; अभिनव भारत”.

Popular News

Modi govt 3.0: Making Incredible India tourism a national priority

A s a first, budgetary allocation for the Union ministry of tourism must be enhanced. A National Tourism Policy must be launched with much fanfare at the earliest. There is need for tourism synergy at the national level, and the government should consider putting tourism on the Concurrent List. An open skies policy and enhanced air connectivity across the country will expedite the intended boost for tourism.Â

Visitor experience

The 'visitor experience' in India must be taken to the next orbit. As per Indian travel industry estimates, approximately 200 tourism products provide 80 per cent of the business. We need to focus on these products and make them the best in the world. Let us make 'Incredible India' speak for itselfâa safe, clean and transformational experience. Enhance connectivity and facilities at tourist destinations, including better roads, airports and public amenities, to provide seamless travel and showcase India as an emerging global power.Â

We must leverage our rich cultural, natural and historical heritage, identify 100 new tourism products, and develop them to international standards in a sustainable manner while being mindful of the carrying capacity. As an example, the Harappan site Dholavira near the Rann of Kutch in Gujarat could be developed into an international tourism hub.

The Himalayan region has huge potential for adventure tourism, which must be developed in a sustainable manner. Expediting the mega trails for trekking and adventure in the Himalayan region and the Ganga nature and heritage trail will be game changers. After 'Swachh Bharat', 'Surakshit Bharat' is the way forward. India must become the safest place in the world for travellers, especially women.Â

Ease of travel

India must become a 'hassle-free travel experience'. Our online visa process needs an urgent review. Â The government could consider offering visa-on-arrival facilities and shortening of processing time. This will attract more international tourists. The governments of Thailand and Sri Lanka have recently waived visa fees for Indian tourists. To expedite the post-pandemic recovery of the sector, the government could consider free visa on arrival for tourists from the top 10 source countries and top 10 emerging countries for the next three years. Entry and exit from India, safety and security of travellers, road, rail and air travel infrastructure, and health and hygiene have to add up to make 'Incredible India' a seamless travel experience.Â

WEF ranking

India's ranking in the World Economic Forum's Travel and Tourism Development Index has improved to 39 in 2024, from 54 in 2021. While our natural, cultural and non-leisure resources are ranked in the first 10, India must endeavour to be among the top 10 on the index by 2030. The ranking is based on five dimensions, 17 pillars and 102 indicators, and we must focus on each of these to create a world-class tourism experience. Skill development, capacity building, digital transformation, leveraging technology and focused masterplans for niche tourism segments, such as adventure, MICE (meetings, incentives, conferences and events), wellness, cruise, heritage, wildlife, medical, and special interest tourism, are critical.Â

Major promotion

The Incredible India campaign needs a makeover, besides a global launch of Incredible India 2.0. Major tourism promotion in our missions abroad, appointing marketing agencies, reopening our overseas tourism promotion offices, focus on tourism promotion in 20 key source markets and 10 emerging markets, digital marketing, electronic media promotion, roadshows, marketing incentives for tourism MSMEs and support for tourism promotion must be high-priority areas.Â

Sustainable tourism

The tourism ministry has set up the National Board for Sustainable Tourism. Sustainable practices in tourism, carrying capacity determination, and implementation of policies that promote eco-friendly tourism in order to protect natural and cultural heritage while ensuring long-term viability of tourism destinations must be a priority. The government should encourage tourism enterprises to adopt sustainable practices, offer incentives for eco-friendly initiatives and enforce environmental regulations. Government initiatives, such as the Sustainable Tourism Criteria for India and Travel for LiFE, must be promoted.

Miles to go

Streamlining and simplifying regulatory processes at the national and state levels will significantly enhance ease of doing business, policy consistency, easier access to finance, creating a nurturing and supportive ecosystem for tourism MSMEs, simplifying taxation, providing data and insights, digital transformation of the tourism sector, a resolute crisis management mechanism, infrastructure and incentives for rural tourism, tourism to border areas and vibrant villages.

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US, India share unique bond of friendship: White House

Nsa sullivan is visiting new delhi from june 17 to 18, in the first trip to india by a senior biden administration official after the modi government came to power for the third term..

As the world's two oldest and largest democracies, the United States and India share a unique bond of friendship and National Security Advisor Jake Sullivan's visit will further deepen the partnership to create a safer and more prosperous Indo-Pacific, the White House has said.

Sullivan is visiting New Delhi from June 17 to 18, in the first trip to India by a senior Biden administration official after the Modi government came to power for the third term.

Sullivan met Prime Minister Narendra Modi and his Indian counterpart Ajit Doval on Monday.

"As the world's two oldest and largest democracies, the United States and India share a unique bond of friendship, and Mr Sullivan's trip will further deepen the already strong US-India partnership to create a safer and more prosperous Indo-Pacific,” John Kirby, White House National Security Communications Advisor told reporters at his daily news conference on Monday.

In New Delhi, Kirby said, Sullivan will co-chair the US-India Initiative on Critical and Emerging Technology, also known as iCET, a landmark partnership to expand strategic cooperation across key technology sectors including space, semiconductors, advanced telecommunications, artificial intelligence, quantum technology, biotechnology and clean energy.

Kirby did not respond to questions on Indian national Nikhil Gupta who has been accused of being involved in a murder-for-hire plot against Khalistani separatist Gurpatwant Singh Pannun on American soil and has been extradited to the US from the Czech Republic.

"I don't have more to add on the conversations that Jake's having. He's still over there having these conversations. But the main focus of his visit, as I said, was to look for ways to deepen the US-India bilateral relationship, particularly when it comes to emerging technology," he said. Gupta was produced before a federal court in New York on Monday, where he pleaded not guilty.

India has publicly said a high-level inquiry is looking into the evidence shared by the US in the alleged plot to kill Pannun.

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Canada announces new pilot programs to support caregivers and Canadian families, intends to make the caregivers program permanent

From: Immigration, Refugees and Citizenship Canada

News release

Caregivers from abroad are invaluable to Canadian families. Their hard work makes a difference in the lives of those they care for, including children, seniors and persons with disabilities.

June 3, 2024—Toronto— Caregivers from abroad are invaluable to Canadian families. Their hard work makes a difference in the lives of those they care for, including children, seniors and persons with disabilities.

As the Home Child Care Provider Pilot and the Home Support Worker Pilot come to a close later this month, the Honourable Marc Miller, Minister of Immigration, Refugees and Citizenship, today announced new, enhanced caregiver pilots. This will allow caregivers to continue to come to Canada, as we work toward making the caregiver pilot programs permanent.

The new pilot programs will provide home care workers with permanent residence (PR) on arrival in Canada. They will also be allowed to work for organizations that provide temporary or parttime care for people who are semi-independent or recovering from an injury or illness. This new pathway means that caregivers can more easily find proper work with reliable employers and have clear, straightforward access to permanent resident status as soon as they arrive in Canada.

Through these new pilot programs, candidates interested in working in Canada’s home care sector will be eligible to apply if they meet the following criteria:

attain a minimum of level 4 based on the Canadian Language Benchmarks (CLB)
hold the equivalent of a Canadian high school diploma
have recent and relevant work experience
receive an offer for a full-time home care job

These new PR on arrival pilot programs mark an important step forward in Canada’s efforts to meet the evolving home care needs of its diverse population. More information will be available before the full launch of the pilots, including full eligibility criteria and details on how to apply.

“Caregivers play a critical role in supporting Canadian families, and our programs need to reflect their invaluable contributions. As we work to implement a permanent caregivers program, these two new pilots will not only improve support for caregivers, but also provide families with the quality care they deserve.” – The Honourable Marc Miller, Minister of Immigration, Refugees and Citizenship

“After hearing stories and feedback from caregivers across Canada, I am proud that we are taking concrete action to create policies to support the caregiver community. Generations of women and men have advocated for this important pathway and have cared for our families and loved ones here in Canada. Now is the time to return the care they deserve." – The Honourable Rechie Valdez, Minister of Small Business

Quick facts

In June 2014, there was an inventory of over 60,000 persons for the Live-in Caregiver Program. Today, less than 1% of that Live-in Caregiver Program inventory remains.

As part of the 2024–2026 Immigration Levels Plan, Canada will admit over 15,000 caregivers as permanent residents.

As of April 30, 2024, nearly 5,700 caregivers and their family members have become permanent residents since the launch of the Home Child Care Provider Pilot and the Home Support Worker Pilot in 2019.

Associated links

Existing Canadian caregiver programs

Contacts for media only:

Bahoz Dara Aziz Press Secretary Minister’s Office Immigration, Refugees and Citizenship Canada [email protected] Media Relations Communications Sector Immigration, Refugees and Citizenship Canada 613-952-1650 [email protected]

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Top Ten changes the agreement on TRIPS brought to the IPR regime in
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Trips and its Impact on the Indian IP Regime
TRIPS AND ITS IMPACT. The nature and scope of the obligations under the TRIPS agreement, hereinafter referred to as the 'agreement', permits the implementations of more extensive provisions for the protection of Intellectual Property Rights, than the ones provided in the agreement. [viii] The agreement is meant as a framework for minimum ...
TRIPS And IPR Regime In India
TRIPS And IPR Regime In India. By Abhilasha Bhatia / 8 February 2021. The TRIPS regime has been developed as a fundamental instrument for assessing intellectual property rights worldwide. This is not the universal constant of intellectual property. Yet, it offers a fundamental structure that each member state of the World Trade Organization ...
Trips And Ipr Regime In India
The IPR regime, as defined by TRIPS, gives creators and inventors temporary exclusive rights in an effort to promote innovation. Due to the exclusivity, which guarantees financial gains for innovators, research and development expenditures are encouraged. ... The three laws listed below were added to India's intellectual property rights ...
Top Ten changes the agreement on TRIPS brought to the IPR regime in India
On 1 January 1995, The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into force. This was to be implemented within 6 years i.e 31 December 2000 for developed countries and within 10 years for developing countries i.e. 31 December 2004. India being a developing country had a 10-year window for such a step.
PDF One Hundred and Sixty First Report
1.7 India has a Trade Related Aspects of Intellectual Property Rights (TRIPS) compliant, robust, equitable and dynamic IPR regime. India has a well-established legislative, administrative and judicial framework to safeguard Intellectual Property Rights (IPRs), which meets its international
The Impact Of The TRIPS Agreement On Indian IP ...
The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement was a landmark agreement signed by member states of the World Trade Organization (WTO) in 1994. ... India had a more lenient patent regime, which allowed for the grant of patents for new uses or forms of known substances, as well as for methods of treatment. However ...
TRIPs and India's intellectual property rights regime
The intellectual property right regime of the country has been modified by a number of legislation since 1995. For India, the WTO's TRIPs agreement became binding from 2005 onwards as the country has got a ten-year transition period (1995-2005) to make the domestic legislation compatible with TRIPs. Here, India has got additional five-year ...
TRIPS Agreement
The TRIPS Agreement is known to be a paradigmatic milestone in intellectual property law because it is the reason behind the way India is moving toward economic growth and global recognition. Signed in 1994, the agreement revolutionized India's IP policy, particularly the patent law, by creating a twist in the nation's approach to protecting ...
Patent Laws in India: compliance with the TRIPS Agreement
The patent law system in India has undergone significant changes and amendments since the country's incorporation of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights ('WTO's TRIPS Agreement, 'TRIPS Agreement' or 'the Agreement'). The TRIPS Agreement became effective on 1 January 1995.
Role of the TRIPS agreement and its scope in India
The TRIPS Agreement protects intellectual property in trade-related areas to a large extent and is started as an inclusive new framework for intellectual property standards protection. The agreement has played an important role in shaping India's intellectual property scenery and has had a logical effect on the country's economy, innovation ...
Patent System of India
6.2.1.4 Cell for IPR Promotion and Management, constituted under the National Intellectual Property Rights Policy. The Cabinet of Ministers of the Central Government approved the National Intellectual Property Rights Policy on May 12, 2016. 67 This policy drew a future roadmap for IP rights in India and made several recommendations. Following ...
PDF NATIONAL INTELLECTUAL PROPERTY RIGHTS POLICY
TRIPS compliant, robust, equitable and dynamic IPR regime. An all-encompassing IPR Policy will promote a holistic and conducive ecosystem to catalyse the full potential of intellectual property for India's economic growth and socio-cultural development, while protecting public interest.
Intellectual Property Rights
The 'Cell for IPR Promotion & Management (CIPAM)', setup under the aegis of DIPP, is to be the single point of reference for implementation of the objectives of the National IPR Policy. India's IPR regime is in compliance with the WTO's agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Objectives
Trade Related Aspects of Intellectual Property Rights (TRIPS)
The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is in the news now because of the recent US decision to support the temporary waiver of patent rules for the coronavirus vaccines. This is an important topic from multiple perspectives for the UPSC exam including economy, international relations, current affairs, etc.
India
In June 2021, India's Department Related Parliamentary Standing Committee on Commerce presented its 161st Review of the Intellectual Property Rights Regime in India Report. The Report emphasizes that the IPR regime should comply with international agreements, rules, and norms, and be compatible with those of other nations and foreign entities.
WTO
National treatment is also a key principle in other intellectual property agreements outside the WTO. The TRIPS Agreement has an additional important general objective: intellectual property protection should contribute to technical innovation and the transfer of technology. Both producers and users should benefit, and economic and social ...
PDF Trips and Its Impact on The Indian Ip Regime
intellectual property, in the first part of this research paper the researcher analyses the method of implementation of the obligations laid upon India through this agreement, the researcher touches upon the concepts of Mail Box, and Exclusive marketing rights granted by the Indian IPR regime during the transitional phase.
The Agreement on Trade-related Aspects of Intellectual Property Rights
The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), negotiated during the Uruguay Round, introduced intellectual property rules for the first time into the multilateral trading system. The Agreement, while recognizing that intellectual property rights (IPRs) are private rights, establishes minimum standards of protection that each government has to give to the ...
What is Trade Related Intellectual Property Rights (TRIPs)?
TRIPs agreement is an effort to bring national legislations under common international rules. An important feature of TRIPs is that it is more specific and hard on 'patents' -the most important form of intellectual property. In the case of plant rights, geographical indications etc., members can adopt a sui-generis (own designed) IPR regime.
Intellectual Property Rights Policy Management Framework
The framework was launched in the form of National IPR (Intellectual Property Rights) Policy 2016 encompassing all IPRs into a single vision document setting in place an institutional mechanism for implementation, monitoring and review of IP laws. Patent Act, 1970 & Patent Rules, 2003 amended in 2014, 2016, 2017, 2019, 2020 and 2021.
National IPR policy
The WTO's agreement on Trade-Related Aspects of Intellectual Property Rights is upheld by India's IPR regime (TRIPS). The National IPR Policy's goals are to be carried out by the "Cell for IPR Promotion & Management (CIPAM)," which was established under the supervision of DPIIT. Goals of the IPR policy. There are seven main goals:
Cabinet approves National Intellectual Property Rights Policy
The Union Cabinet approved the National Intellectual Property Rights (IPR) Policy that will lay the future roadmap for intellectual property in India. The Policy recognises the abundance of creative and innovative energies that flow in India, and the need to tap into and channelise these energies towards a better and brighter future for all.
PDF Intellectual Property Rights Regime In India: Government Policies
The Government of India constituted a Patents Enquiry Committee (PEC) in 1949 under the Chairmanship of Justice (Dr.) Bakshi Tek Chand, a retired Judge of Lahore High Court, to review the patent law in India. Based on the recommendations of the ommittee's report, the 1911 Act was amended in relation to working of inventions and compulsory licence/revocation, in
Modi govt 3.0: Making Incredible India tourism a national priority
WEF ranking. India's ranking in the World Economic Forum's Travel and Tourism Development Index has improved to 39 in 2024, from 54 in 2021. While our natural, cultural and non-leisure resources ...
US, India share unique bond of friendship: White House
News; World; US, India share unique bond of friendship: White House; US, India share unique bond of friendship: White House NSA Sullivan is visiting New Delhi from June 17 to 18, in the first trip to India by a senior Biden administration official after the Modi government came to power for the third term.
Canada announces new pilot programs to support caregivers and Canadian
"Caregivers play a critical role in supporting Canadian families, and our programs need to reflect their invaluable contributions. As we work to implement a permanent caregivers program, these two new pilots will not only improve support for caregivers, but also provide families with the quality care they deserve."

TRIPS And IPR Regime In India

Introduction

Laws Conforming With The TRIPS Agreement

The Copyright Act, 1957

The Trademarks Act, 1999

Impact Of TRIPS Agreement

The Doha Declaration

The Provision of Trips Plus

Drawbacks Of TRIPS Agreement In India

Related Posts

Trips And Ipr Regime In India

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TRIPS Agreement and Its Effect on Intellectual Property Laws in India: An Analysis

TRIPS Agreement: An Overview

TRIPS Agreement and Its Effect on Intellectual Property Laws in India

Challenges and Implementation Issues

How TRIPS Affected the Indian Pharmaceutical Industry?

Access To Affordable Medicines In India Under Trips

In Conclusion,

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We Connect To Collaborate

Patent Laws in India: compliance with the TRIPS Agreement

Introduction

Compliance in international law: understanding perspectives of monism and dualism in India

Monistic perspective vs dualistic perspective

India’s incorporation of the TRIPS Agreement

Progression of India’s patent law regime after the incorporation of TRIPS Agreement

The Patents (Amendment) Act, 2002

Term of the patent extended

Definition of “invention” and “inventive step” amended

Definition of patentable subject matter

Compulsory licensing framework

The Patents (Amendment) Act, 2005

Pre-grant and post-grant opposition

Compulsory licensing requirements

Judicial interpretation of compliance with the TRIPS Agreement

Conclusion – is the patent law in India compliant?

The road ahead: India’s proposals for a TRIPS-compliant patent legal regime

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6.1.2 The Justice N Rajagopala Ayyangar Committee Report

6.1.3 The Patents Act, 1970 (pre–TRIPS Agreement)

6.1.4 International obligations and commitments

6.1.4.1 The TRIPS Agreement

6.1.4.2 The Doha Declaration

6.1.4.3 The Patent Cooperation Treaty

6.1.4.4 Amendments and implementation in India

6.1.4.4.2 Patent prosecution highway

6.1.4.4.3 The 1999 amendment, post–TRIPS Agreement

6.1.4.4.4 The 2002 amendment, post–TRIPS Agreement

6.1.4.4.5 The 2005 amendment, post–TRIPS Agreement

6.1.5 Patent application trends

6.2 Patent institutions and administrative review proceedings

6.2.1.2 The Department for Promotion of Industry and Internal Trade

6.2.1.3 National Institute of Intellectual Property Management, Nagpur

6.2.1.4 Cell for IPR Promotion and Management, constituted under the National Intellectual Property Rights Policy

6.2.1.5 The Department of Science and Technology – Patent Facilitation Programme

6.2.1.6 Traditional Knowledge Digital Library

6.2.2 Administrative review proceedings