This article is written by Samiksha Tiwari, Renaissance Law College, B.A.LL.B.(Hons.), 9th Semester during internship at LeDroit India
Scope of Article
- Meaning and historical context of the TRIPS Agreement and why it is described as a minimum-standards agreement
- Core principles: national treatment, most-favoured-nation treatment, objectives and public-interest principles
- Minimum standards across copyright, trademarks, geographical indications, industrial designs, patents, trade secrets and enforcement
- Patent standards under Articles 27–34, including patentability, rights, exceptions and duration
- TRIPS flexibilities, compulsory licensing and the public-health balance
- India’s transition to TRIPS-compliant patent protection and the role of the Patents Act, 1970
- Landmark and recent Indian case law, including Novartis, Bayer–Natco and later Section 3(d) decisions
- Practical significance, criticisms and the continuing relevance of TRIPS for developing countries
Keywords
TRIPS Agreement; Intellectual Property Rights; Minimum Standards; Patent Law; TRIPS Flexibilities; Public Health
Abstract
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) brought intellectual property protection into the multilateral trading system and, in doing so, set a common minimum level of protection for WTO Members. The important point is that TRIPS is a floor, not a single model law. Countries are expected to meet the standards in the Agreement, but they can decide how those standards will be put into their own legal systems and can provide stronger protection if they wish.
This becomes especially important in developing countries, where intellectual property rights can sometimes come into conflict with concerns such as access to medicines, competition and public welfare. This article looks at the main standards created by TRIPS, with particular focus on patents and public-health safeguards. It also considers India’s amendments to the Patents Act, 1970, Section 3(d), compulsory licensing and important decisions such as Novartis AG v. Union of India and Bayer Corporation v. Union of India. The aim is to understand TRIPS not simply as an agreement that strengthened IP protection, but as a framework in which protection and public interest have to be balanced.
1. Introduction
When intellectual property is discussed in the context of international trade, the TRIPS Agreement is difficult to ignore. The Agreement came into force on 1 January 1995 as Annex 1C to the Marrakesh Agreement establishing the World Trade Organization. It covers a wide range of intellectual property rights, including copyright, trademarks, geographical indications, industrial designs, patents, layout-designs of integrated circuits and undisclosed information. It also contains rules dealing with enforcement and dispute settlement.
What makes TRIPS particularly important is the idea of a common minimum standard. Before TRIPS, international IP protection was largely shaped by separate conventions dealing with particular areas. TRIPS brought a much broader set of obligations into the WTO system. At the same time, it did not tell every country to copy the same intellectual property statute. Article 1 makes it clear that Members may provide protection that is more extensive than what TRIPS requires, as long as that protection is consistent with the Agreement. Members also have some freedom in deciding how they will implement their obligations domestically.
This distinction between a floor and a uniform code is important for countries such as India. India has had to strengthen its intellectual property framework to meet international obligations, but it has also tried to retain safeguards for matters such as public health, competition and access to medicines. The Indian experience therefore provides a useful way of looking at how international standards operate in practice.
2. Why Was TRIPS Needed?
The negotiations that eventually resulted in TRIPS took place during the Uruguay Round of GATT negotiations. One reason for bringing intellectual property into the trade discussions was the growing importance of technology, brands and creative works in international commerce. Businesses were operating across borders, and differences in national IP laws could create uncertainty. A product or invention might receive strong protection in one country and much weaker protection somewhere else.
Stronger and more predictable protection was therefore seen as useful for trade and investment. There was also an argument that better protection could encourage innovation and technology transfer. But the issue was never entirely one-sided. For developing countries, stronger patent protection could also mean higher prices for products that were socially important, particularly medicines. This tension was visible during the negotiations and continued after TRIPS came into force.
The final Agreement reflects that compromise. Article 7 connects intellectual property protection with technological innovation, transfer and dissemination of technology, social and economic welfare, and a balance between rights and obligations. Article 8 recognises that Members may adopt measures necessary to protect public health and nutrition and to prevent abuse of intellectual property rights, provided those measures remain consistent with TRIPS. These provisions later became especially relevant to debates about patents and access to medicines.
3. What Does “Minimum Standards” Actually Mean?
The simplest way to understand the expression “minimum standards” is to imagine a floor. TRIPS sets that floor for intellectual property protection. A WTO Member cannot normally go below the level required by the Agreement, but it is not prevented from going above it. This is why TRIPS should not be confused with a single international IP statute.
Article 1 is central to this understanding. It allows Members to implement more extensive protection and leaves them free to choose the appropriate method of implementation within their own legal systems. India, France, Japan and Brazil, for example, do not have to use identical legislation simply because they are WTO Members. Their domestic systems have to satisfy the obligations they accepted under TRIPS.
TRIPS is also sometimes described as a “Berne and Paris-plus” agreement. Articles 2 and 9 incorporate substantial obligations from the Paris Convention and the Berne Convention, while TRIPS adds further obligations and makes them part of a broader trade-based framework. This wider structure is one of the reasons the Agreement has had such a lasting effect on national IP laws.
4. The Basic Principles Under TRIPS
4.1 National Treatment
National treatment means that, in the areas covered by TRIPS, a Member generally has to treat nationals of other WTO Members no less favourably than it treats its own nationals. In practical terms, a country cannot maintain an IP system that protects domestic right holders while putting foreign right holders at an unjustified disadvantage merely because they are foreign.
4.2 Most-Favoured-Nation Treatment
Most-favoured-nation treatment deals with a different kind of discrimination. It concerns the treatment of nationals of different foreign countries. If a Member gives an IP-related advantage to nationals of one WTO Member, the general rule is that the same advantage should also be available to nationals of other WTO Members, subject to the exceptions in TRIPS.
4.3 Objectives and Balance
Articles 7 and 8 are particularly important because they show that TRIPS is not intended to operate only in favour of intellectual property owners. Article 7 speaks about balancing rights and obligations, while Article 8 recognises public health, nutrition and other public-interest concerns. These provisions matter when governments and courts have to deal with intellectual property rights that have a direct effect on society, such as pharmaceutical patents.
5. The Main Minimum Standards of Protection
Part II of TRIPS contains the main substantive standards for different kinds of intellectual property. The Agreement does not prescribe every detail of national law. Instead, it identifies the subject matter that must receive protection, the basic rights associated with that protection, certain exceptions and, in some areas, minimum periods of protection.
5.1 Copyright and Related Rights
TRIPS requires protection for literary and artistic works within the framework of the Berne Convention. It also contains rules concerning computer programs and compilations of data. Article 9 incorporates the relevant substantive provisions of the Berne Convention, while excluding its provisions on moral rights. Article 12 generally provides for a minimum term of fifty years for certain works where the term is not calculated by reference to the life of a natural person. At the same time, copyright protection is not unlimited; TRIPS permits limited exceptions subject to the conditions laid down in the Agreement.
5.2 Trademarks
Article 15 deals with the subject matter of trademark protection, and Article 16 sets out important rights of trademark owners. TRIPS also contains rules concerning registration and renewal. The practical point is that protection of a mark in one country does not automatically create an identical right in every other country. Each Member still operates its own domestic system, but that system must meet the minimum standards required by TRIPS.
5.3 Geographical Indications
Geographical indications receive significant attention under TRIPS. Article 22 requires Members to provide legal means to prevent misleading use of geographical indications and acts of unfair competition. Article 23 provides additional protection for geographical indications relating to wines and spirits. India’s Geographical Indications of Goods (Registration and Protection) Act, 1999 can be viewed in this wider international context.
5.4 Industrial Designs
TRIPS requires protection for independently created industrial designs that are new or original, subject to the conditions of domestic law. The minimum term of protection is ten years. This can be important for products where appearance itself has commercial value, even though the underlying technology may not qualify for patent protection.
5.5 Undisclosed Information
Article 39 deals with undisclosed information, commonly referred to as trade secrets. Information is protected where it is secret, has commercial value because it is secret and has been subject to reasonable steps to keep it secret. The provision can also apply, in suitable circumstances, to certain regulatory test data.
6. Patents: The Most Contested Minimum Standard
Patent protection is probably the area in which the debate over TRIPS minimum standards becomes most visible. Article 27 generally requires patents to be available for inventions, whether they are products or processes, in all fields of technology, provided the requirements of novelty, inventive step and industrial applicability are met.
Article 27 also allows Members to exclude certain categories of subject matter. These include inventions where preventing commercial exploitation is necessary to protect ordre public or morality, human, animal or plant life or health, as well as certain medical methods. The provision therefore creates a general rule of patentability while leaving some defined space for national choices.
Article 28 sets out the main exclusive rights of a patent owner. These include rights relating to making, using, offering for sale, selling and importing a patented product. For process patents, the rights also extend to products obtained directly through the patented process. Article 33 establishes a minimum patent term of twenty years from the filing date.
Patent rights, however, are not absolute. Articles 30 and 31 permit certain exceptions and uses without the consent of the patent holder, subject to conditions. Article 31 is especially significant because it provides the international basis for compulsory licensing and government use. Article 31bis later added a mechanism dealing with compulsory licences for the production and export of medicines to countries that lack sufficient manufacturing capacity.
7. TRIPS and Public Health: Flexibility Within the Minimum Standard
One common misunderstanding about TRIPS is that it gives pharmaceutical patent owners unlimited control over medicines. That is not what the Agreement says. Patent rights are protected, but TRIPS also contains provisions that allow governments to respond to public-health concerns.
The 2001 Doha Declaration on the TRIPS Agreement and Public Health was an important development in this area. WTO Members affirmed that TRIPS should be interpreted and implemented in a way that supports the ability of Members to protect public health and promote access to medicines. The Declaration also confirmed the ability of Members to use the flexibilities available under TRIPS.
Compulsory licensing is one of the clearest examples. Under the conditions in Article 31, a government can authorise the use of a patented invention without the consent of the patent owner. This does not mean that patents disappear whenever a public-interest argument is made. There are legal requirements that have to be met. The point is that the patent right has to operate alongside wider public interests.
The public-health debate is therefore really about balance. Pharmaceutical innovation requires investment and incentives, but medicines also have an immediate social importance. TRIPS tries to accommodate both concerns rather than treating either one as irrelevant.
8. India’s TRIPS Journey
India entered the TRIPS era with a patent system that, particularly in the pharmaceutical sector, had historically limited product-patent protection. Meeting the new international obligations required changes to the Patents Act, 1970. The Act was amended in stages, notably in 1999, 2002 and 2005.
The 2005 amendment was particularly important because it brought product-patent protection back for areas such as pharmaceuticals and chemicals. This was a major change in Indian patent law and brought the system into line with the central patentability requirements of Article 27.
India did not simply reproduce the TRIPS Agreement word for word in domestic legislation. It used the flexibility available within the Agreement to shape its own patent policy. Section 3(d) of the Patents Act is the most familiar example. It prevents the patenting of a new form of a known substance unless the statutory requirement relating to enhanced efficacy is satisfied. One of the main concerns behind this provision is evergreening, while still allowing genuine pharmaceutical innovation to receive protection.
9. Landmark Case: Novartis AG v. Union of India
The Supreme Court’s decision in Novartis AG v. Union of India is one of the best-known Indian patent decisions of the post-TRIPS period. The dispute involved Novartis’ attempt to obtain a patent for the beta-crystalline form of imatinib mesylate, a substance associated with the cancer medicine Glivec.
The Supreme Court examined Section 3(d) closely. It held that the claimed form had to show enhanced therapeutic efficacy over the known substance. The Court did not accept the argument that improvements in physicochemical properties alone were enough to satisfy the statutory requirement. The decision therefore gave Section 3(d) real significance as a filter against patents based only on changes to known substances.
The case is important in the TRIPS context because it shows how an international minimum standard can be implemented through a more specific domestic rule. India did not reject pharmaceutical patents altogether. Instead, it created an additional statutory requirement for a particular category of claims. A genuine invention can still receive patent protection, but the applicant has to meet the requirements of Indian law.
Seen this way, Novartis also helps explain why the words “minimum standards” matter. TRIPS establishes the international framework, while domestic legislation and courts determine many of the practical questions that arise within that framework.
10. Landmark Case: Bayer Corporation v. Union of India
The compulsory-licensing dispute involving Bayer’s cancer drug Nexavar provides another useful example. Natco Pharma applied for a compulsory licence under Section 84 of the Patents Act. The Controller granted the licence, and the Intellectual Property Appellate Board upheld the grant with a modification relating to royalty. Bayer then challenged the decision before the Bombay High Court.
In 2014, the Bombay High Court dismissed Bayer’s petition. The Court considered the statutory requirements concerning the reasonable requirements of the public, reasonably affordable pricing and the working of the patented invention in India. The Court also discussed the relationship between Indian compulsory-licensing law, TRIPS and the Doha Declaration.
The case is significant because it shows that compulsory licensing is not simply a response to the fact that a patented product is expensive. The statutory conditions still have to be examined. At the same time, Section 84 reflects the kind of policy space that TRIPS, particularly Article 31, allows Members to use in appropriate circumstances.
11. Recent Judicial Developments: Section 3(d) Continues to Matter
Section 3(d) did not lose its importance after the Novartis judgment. Indian courts have continued to deal with questions concerning pharmaceutical and chemical inventions, especially where the claim involves a modified form of an already known substance. These disputes can be difficult because the line between genuine incremental innovation and evergreening is not always obvious.
In Natco Pharma Ltd. v. Novartis AG, decided by the Delhi High Court in April 2024, the Court again considered issues relating to patentability and Section 3(d), including questions around therapeutic efficacy and modified forms of a known active pharmaceutical ingredient. The decision shows that Section 3(d) continues to raise practical questions even after the Supreme Court’s guidance in 2013.
These later decisions are relevant to the TRIPS discussion because they demonstrate the role of domestic courts. TRIPS provides the international framework, but national courts still have to interpret the statutory language used to implement that framework. In India, Section 3(d) remains an important part of that process.
12. Enforcement: Minimum Standards Do Not End with Grant of Rights
Having an intellectual property right on paper is not enough if there is no effective way to enforce it. TRIPS therefore contains a separate part dealing with enforcement. Part III requires Members to provide procedures and remedies capable of addressing infringement, while also requiring those procedures to be fair and equitable and not create unnecessary barriers to legitimate trade.
Article 41 sets out general enforcement obligations. Other provisions deal with civil and administrative procedures, provisional measures, border measures and criminal procedures. The Agreement does not require every country to establish identical courts or use identical procedural rules. The basic requirement is that the domestic system should provide an appropriate level of effectiveness and fairness.
13. TRIPS and India: Has the Balance Been Achieved?
It is difficult to describe the effect of TRIPS on developing countries in completely positive or negative terms. Much depends on how a country uses the policy space that remains available under the Agreement. India is a useful example because it accepted stronger patent protection while retaining several safeguards aimed at public health and competition.
TRIPS compliance has given India a more predictable framework for patents, trademarks, copyright and other forms of intellectual property protection. This can help research, investment and technology-based industries. It is also worth remembering that Indian companies themselves now own and use intellectual property around the world. The debate is therefore no longer simply a matter of foreign patent holders against Indian businesses.
At the same time, stronger patent rights can create serious concerns when the protected product is something people need immediately, such as a medicine. India has retained mechanisms including Section 3(d), compulsory licensing, pre-grant and post-grant opposition and other statutory controls. These measures show that complying with TRIPS does not necessarily mean giving up domestic public-interest considerations.
The difficult part is deciding where the balance should lie. If patentability requirements become too strict, genuine incremental innovation may be discouraged. If they become too weak, repeated patents over minor changes may delay competition. Compulsory licensing raises a similar question. If it is used too aggressively, investment incentives could be affected; if it is made too difficult to use, the flexibility may exist only on paper.
14. TRIPS-Plus Standards and the Future of IP Protection
TRIPS is a minimum floor, but international intellectual property protection has continued to develop beyond it. Bilateral and regional trade agreements sometimes contain what are called TRIPS-plus obligations. These may require stronger protection in areas such as patent terms, data protection, copyright or enforcement.
This matters because being TRIPS-compliant does not necessarily mean that a country will face no further pressure to strengthen IP protection. A country may satisfy TRIPS and still be asked, during another trade negotiation, to accept obligations that go beyond it. For developing countries, such decisions can have wider economic consequences.
The question therefore changes. Instead of asking only whether a proposed rule is consistent with TRIPS, governments may also have to ask whether accepting protection beyond TRIPS is actually in the country’s interest and what benefits will come in return. In this sense, TRIPS continues to matter not just because of the rules it contains, but because it remains the baseline against which later international commitments are considered.
15. Conclusion
The TRIPS Agreement created a common international floor for intellectual property protection. Its importance comes from the fact that it combines substantive standards with enforcement obligations within the WTO system. At the same time, it does not require every country to adopt identical IP laws. Members retain room to decide how they will implement the standards and, within the limits of the Agreement, can provide stronger protection.
India’s experience makes this flexibility particularly clear. The country moved towards product-patent protection in pharmaceuticals and other areas, but it also retained domestic mechanisms intended to prevent abuse of patent rights and protect public interests. Section 3(d), compulsory licensing and the decisions in Novartis and Bayer show how these choices have worked in practice.
Ultimately, TRIPS is best understood as a framework for balancing competing interests. Innovation needs protection and investment incentives, but intellectual property rights do not exist separately from competition, access and social welfare. The continuing Indian debate over pharmaceutical patents shows that the most important questions are often not about whether protection should exist, but about how much protection is appropriate and how it should operate in the real world.
