No Compromise: India Protects Patents Act in High-Stakes UK Trade Pact

India, the “pharmacy of the world,” has long been a lifeline for millions, churning out affordable generic medicines that make healthcare accessible across the Global South. With over $25 billion generic drug industry exporting half its production, India’s commitment to low-cost medicine is a global game-changer. Yet, this role has often pitted it against pharmaceutical giants and developed nations pushing for tighter intellectual property (IP) rules. The India-UK Free Trade Agreement (FTA), finalized on July 24, 2025, showcases India’s firm stand in safeguarding its generic drug industry while navigating complex trade dynamics. By rejecting patent evergreening and data exclusivity—tactics Big Pharma uses to prolong monopolies—India has struck a bold balance between public health and international trade. This article dives into how India’s resolute stance, as highlighted in a July 29, 2025, Economic Times report, reflects its dedication to affordable healthcare while addressing foreign pressures and trade opportunities.

The Stakes: Evergreening and Data Exclusivity:

Evergreening is a clever ploy: pharmaceutical companies tweak existing drugs—think new dosages or slight formula changes—and secure fresh patents to extend their market control beyond the standard 20 years. These tweaks rarely add meaningful therapeutic value but delay cheaper generics, keeping prices sky-high. Data exclusivity, meanwhile, blocks generic makers from using original clinical trial data for regulatory approval, forcing them to run costly, redundant trials. This stalls generic drug launches, hitting hardest in poorer nations where every dollar counts.

The Economic Times noted on July 29, 2025, that “the India-UK free trade agreement (FTA) does not mandate patent term extensions or data exclusivity, which are two common tools of evergreening of patents, the commerce and industry ministry said Monday, adding that this would protect the interests of the domestic generic drugs industry.” This clarity from the ministry signals India’s triumph in shielding its generic sector from provisions that could favor multinational giants like AstraZeneca or GSK, ensuring medicines remain within reach for millions.

Facing Down Foreign Pressure:

The UK, a hub for pharmaceutical innovation, pushed hard for data exclusivity during FTA talks, echoing demands made by the European Free Trade Association (EFTA) in 2024. These “TRIPS-plus” provisions, which go beyond the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, prioritize innovator companies but threaten India’s ability to supply affordable generics to its 1.4 billion people and countless others globally. An expert quoted in The Economic Times emphasized that “data exclusivity is beyond the provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the WTO,” giving India solid ground to push back.

India’s resistance isn’t just about principle—it’s about lives. The country’s generic industry has slashed costs dramatically, like when compulsory licensing in 2012 dropped Bayer’s cancer drug Nexavar from $5,500 to $175 a month. By rejecting data exclusivity and preserving Section 3(d) of the Indian Patent Act, which bars patents for minor drug tweaks unless they significantly improve efficacy, India ensures generics hit the market faster. The commerce ministry’s statement that “India’s patent law provisions on patentability criteria under Section 3(d) remain fully protected” is a clear signal: India won’t bend to foreign advocacy at the expense of public health.

A Global Health Lifeline:

India’s firm stand resonates far beyond its borders. Developing nations rely on its generics to combat diseases like tuberculosis and HIV. Médecins Sans Frontières (MSF) has flagged data exclusivity as a threat to drugs like delamanid, critical for multi-drug-resistant tuberculosis. In 2022, leaked FTA drafts raised red flags among activists, hinting at provisions that could curb pre-grant patent oppositions or weaken anti-evergreening measures. MSF’s Leena Menghaney warned, “India should stay vigilant and not allow barriers to affordable medicines to be written into FTA negotiations.” The final agreement’s rejection of these provisions proves India listened, cementing its role as a global health champion.

But the fight isn’t one-sided. The UK and other developed nations argue that stronger IP protections fuel innovation, enabling the development of new drugs. Without patents or data exclusivity, they claim, companies might hesitate to invest billions in research. India, however, counters that innovation shouldn’t come at the cost of access. The TRIPS agreement already balances these interests, and India’s generics don’t stop innovation—they democratize its benefits.

Trade Wins Without Compromise:

The FTA isn’t just about medicine; it’s a masterclass in balancing priorities. India secured zero-duty access for over 95% of its agricultural exports to the UK, boosting farmers and traders, while granting duty concessions on British niche products like cranberries and durians, which don’t compete with Indian crops. This give-and-take shows India’s knack for negotiating trade gains without sacrificing its generic industry.

Still, there’s a shadow of concern. Some experts worry the FTA’s focus on voluntary licensing—where generic makers negotiate with patent holders—could weaken compulsory licensing, a TRIPS tool allowing governments to authorize generic production in emergencies. The agreement’s nod to “adequate remuneration” for patent holders raises questions about potential hurdles. While the government insists compulsory licensing rights are untouched, full transparency in the IP chapter’s terms would ease these concerns.

Conclusion:

A Purposeful Advance – Guiding Progress with Balance:

India’s firm stand in the UK FTA is a compelling narrative of principle meeting pragmatism. By blocking evergreening and data exclusivity, India protects not just its citizens but millions worldwide who depend on its generics. Yet, the tension between trade and health equity looms large. Can India keep fending off Big Pharma’s influence while forging global partnerships? The UK FTA suggests it can, blending trade wins with a fierce defense of affordable healthcare.

This isn’t just a policy win—it’s a moral statement. ‘India’s vigilance is critical to keeping medicines accessible’. In a world where healthcare is often a luxury, India’s fight to make it a right is both a challenge to global powers and an inspiration. As more FTAs loom, India’s ability to hold this line will shape not just its future but the health of nations worldwide.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Robust Patents, Not Tweaked Monopolies: India’s Practical Route to Affordable Medicines

In April 2025, the United States Trade Representative (USTR) released its annual Special 301 Report, once again placing India on its “Priority Watch List” for intellectual property (IP) concerns. The report highlights persistent issues, particularly in the pharmaceutical sector, citing challenges such as potential patent revocations, discretionary application of patentability criteria under the Indian Patents Act, and prolonged patent grant processes.

While the USTR acknowledges India’s efforts to modernize its patent system—such as the finalization of the Patents (Amendment) Rules, 2024, aimed at reducing burdens on patent applicants—it maintains that significant concerns remain. These include high customs duties on IP-intensive products and inadequate IP enforcement mechanisms.

India, however, defends its stance, emphasizing that its IP regime is fully compliant with the World Trade Organization’s TRIPS Agreement and is designed to balance innovation incentives with public health needs. The country asserts that its legal provisions, particularly Section 3(d) of the Patents Act, are crucial in preventing “evergreening” – a practice where pharmaceutical companies make minor modifications to existing drugs to extend patent monopolies without significant therapeutic benefits.


Balancing Innovation and Access:

India’s approach to pharmaceutical patents is rooted in its commitment to public health. The Patents Act, 1970, particularly Section 3(d), prevents the patenting of new forms of known substances unless they result in enhanced efficacy. This provision aims to curb “evergreening,” where minor modifications are used to extend patent monopolies without significant therapeutic benefits.

India’s patent regime also includes mechanisms like pre-grant opposition, allowing stakeholders to challenge patent applications, ensuring that only genuine innovations receive protection.


Some Recent Case Studies: Upholding the Balance:

1. Johnson & Johnson’s Bedaquiline Patent Rejection (2023):
The Indian Patent Office rejected J&J’s attempt to extend its patent on bedaquiline, a critical tuberculosis drug, citing lack of enhanced efficacy. This decision paved the way for generic versions, improving access for patients.

2. Novartis’ Entresto Application Denied (2022):
Novartis’ patent application for the heart failure drug Entresto was denied due to lack of inventive step, preventing potential market monopolization.

3. Roche’s Trastuzumab (Herceptin) Patent Lapse:
Facing legal challenges, Roche allowed its patent on the breast cancer drug Herceptin to lapse in India, enabling the production of affordable biosimilars by Indian companies.


Global Pressures vs. Domestic Realities:

Despite international pressure, India’s IP policies prioritize access to affordable medicines. The country’s stance is not anti-innovation but seeks to prevent monopolistic practices that hinder public health.

India’s role as a major supplier of generic medicines globally underscores the importance of its balanced IP approach. Diluting these safeguards could adversely affect access to essential medicines worldwide.


The Way Forward:

To strengthen its position, India should:

  • Enhance R&D Investment: Boost funding for pharmaceutical research, particularly in neglected diseases.
  • Streamline Patent Processes: Implement measures to reduce patent grant delays while maintaining rigorous examination standards.
  • Maintain Legal Safeguards: Preserve provisions like Section 3(d) to prevent patent evergreening. It ensures that only real therapeutic advances get patents, preserving access to affordable medicines while still rewarding meaningful R&D.
  • Engage Internationally: Continue constructive dialogues with global partners to address IP concerns without compromising public health priorities.

Conclusion:

Let me reemphasize here that Section 3(d) does not prohibit incremental innovation – it simply filters out superficial tweaks that offer no therapeutic benefit and are aimed primarily at extending monopolies and delaying broader patient access to medicines.

Thus, in my view, India’s pharmaceutical IP regime exemplifies a pragmatic approach that balances the protection of genuine innovations with the imperative of public health. By resisting patent abuses and ensuring access to affordable medicines, India sets a precedent for equitable healthcare globally.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Balancing Strong IP Protection, Public Health Safeguards and Declining R&D Productivity – A Crafty Gutsy Ball Game

Pharmaceutical innovation has always been considered the lifeblood for the pharmaceutical industry and very rightly so. However, many studies do point out that such innovation has benefited the developed world more than the developing world.

Product Price and Access:

In the paper titled ‘TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond’, published in ‘Chicago Journal for International Law, Vol. 3(1), Spring 2002’, the author argues, though the reasons for the lack of access to essential medicines are manifold, there are many instances where high prices of drugs deny access to needed treatments for many patients. Prohibitive drug prices, in those cases, were the outcome of monopoly due to strong intellectual property protection.

The author adds, “the attempts of Governments in developing countries to bring down the prices of patented medicines have come under heavy pressure from industrialized countries and the multinational pharmaceutical industry”.

While the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) of the World Trade Organization (WTO) sets out minimum standards for the patent protection for pharmaceuticals, it also offers adequate safeguards against negative impact of patent protection or its abuse in terms of extraordinary and unjustifiable drug pricing. The levels of these safeguards vary from country to country based on the socio-economic and political requirements.

The Doha Declaration:

Many independent experts in this field consider the Doha Declaration as an important landmark for recognizing the primacy to public health interest over private intellectual property and the rights of the members of WTO to use safeguards as enumerated in TRIPS, effectively.

To protect public health interest and extend access to innovative medicines to majority of their population whenever required, even many developed/OECD countries do not allow a total freehand for the patented products pricing in their respective countries.

Early signals of global empathy:

While expressing similar sentiment ‘The Guardian’ reported that Andrew Witty, the global CEO of GlaxoSmithKline, has decided to slash prices on all medicines in the poorest countries, give back profits to be spent on hospitals and clinics and more importantly share knowledge about potential drugs that are currently protected by patents.

Witty further commented that he believes, drug companies have an obligation to help the poor patients getting appropriate treatment and reportedly challenged other pharmaceutical giants to follow his lead.

An interesting study:

A study titled, ‘Pharmaceutical innovation and the burden of disease in developing and developed countries’ of Columbia University and National Bureau of Economic Research, to ascertain the relationship across diseases between pharmaceutical innovation and the burden of disease both in the developed and developing countries, reported that pharmaceutical innovation is positively related to the burden of disease in the developed countries but not so in the developing countries.

The most plausible explanation for the lack of a relationship between the burden of disease in the developing countries and pharmaceutical innovation, as pointed out by the study, is weak incentives for firms to develop medicines for the diseases of the poor.

Point – Counterpoint:

A contrarian view to this study argues that greater focus on the development of new drugs for the diseases of the poor should not be considered as the best way to address and eradicate such diseases in the developing countries. On the contrary, strengthening basic healthcare infrastructure along with education and the means of transportation from one place to the other could improve general health of the population of the developing world quite dramatically.

The counterpoint to the above argument articulates that health infrastructure projects are certainly very essential elements of achieving longer-term health objectives of these countries, but in the near term, millions of unnecessary deaths in the developing countries can be effectively prevented by offering more innovative drugs at affordable prices to this section of the society.

A solution emerging:

Responding to the need of encouraging pharmaceutical innovation without losing focus on public health interest, in 2006 the ‘World Health Organization (WHO)‘ created the ‘Inter-governmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)‘. The primary focus of IGWG is on promoting sustainable, needs-driven pharmaceutical R&D for the diseases that disproportionately affect developing countries.

Declining R&D productivity:

Declining R&D productivity adds another dimension to this raging debate with a snowballing effect, as it were.

Over a period of decades, the business models for small-molecule based blockbuster drugs have successfully catapulted the global pharmaceutical business to a high-margin, dynamic and vibrant industry. However, a time has now come when the golden path from the ‘mind to market’ of the drug discovery process is becoming increasingly arduous and prohibitively expensive.

Deploying expensive resources to discover a New Chemical Entity (NCE) with gradually diminishing returns in the milieu of very many ‘me too’ types of new drugs, does no longer promise a strong commercial incentive.

The impact of the above scenario also gets reflected in the status of International patent filings under the Patent Cooperation Treaty (PCT) of the ‘World Intellectual Property Organization (WIPO)’ as follows:

A. Last five years, PCT filings:

The last five years’ PCT filing status does not seem to be encouraging either.

Year

PCT Filings

Change %

2007

159,926

2008

163,240

2.1

2009

154,406

(5.4)

2010

164,316

6.4

2011

181,900

10.7 *(E)

* Estimate

B. Country-wise PCT Filing in 2011:

While having a closer look at the data, it becomes quite evident that in terms of percentage increase in the PCT filings two Asian countries, China and Japan, have registered their overall dominance. However, in terms of absolute number USA still ranks first.

County

No. Of PCT Filings

% Increase

USA

48,596

8

China

16,401

33.4

Japan

38,888

21

Germany

18,568

5.7

South Korea

10,447

8

C. Technical-field-wise PCT Filing in 2011:

In terms of the technical fields, pharmaceuticals ranked fifth in 2011.

Rank

Industry

No. Of PCT Filings

1.

Electrical Machinery, Apparatus, Energy

11,296

2.

Digital Communication

11,574

3.

Medical technology

10,753

4.

Computer technology

10,455

5.

Pharmaceuticals

7,683

6.

Organic fine chemistry

5,283

7.

Biotechnology

5,232

D. Biotech/Pharma companies featuring in WIPO’s Top 100 filers list:

Very few biotech and pharmaceutical companies featured in the Top 100 PCT filers’ list of WIPO as follows:

Company
1. Procter & Gamble
2. Sumitomo Chemical
3. DuPont
4. Dow Global
5. Novartis AG
6. Roche
7. Merck GmbH
8. Sanofi-Aventis GmbH
9. Bayer CropScience AG

E. The top five university PCT filers in 2011:

Universities of the US dominated among the PCT filings by the Academic institutions as follows:

University

No. Of PCT Filings

University of California, US

277

Massachusetts Institute of Technology, US

179

University of Texas System, US

127

Johns Hopkins University, US

111

Korea Advanced Institute of Science and Technology, South Korea

103

Need to encourage pharmaceutical innovation:

Based on the WIPO data, as mentioned above, the current status of the global pharmaceutical innovation does not seem to be very encouraging.

That said, in the environment of declining R&D productivity of the global pharmaceutical industry, there is indeed a strong requirement to encourage pharmaceutical innovation across the globe, based on the socio-economic environment of each country, together with adequate safeguards in place to protect public health interest.

Why protect patent?

The pharmaceutical major Eli Lilly has very aptly epitomized the reason for patent protection in their website called ‘LillyPad’, as follows:

“Pharmaceutical companies continue to invest in innovation not only because it is good for business, but it is what patients expect. If we want to continue to have breakthrough products, we need patent protection and incentives to invest in intellectual property.  The equation is simple, patents lead to innovation – which help lead to treatments and cures”.

Conclusion:

Currently, various socio-economic expectations, demands and requirements, not just for the poor, but also of the powerful growing middle class intelligentsia are gradually getting unfolded on this subject from many parts of the globe. These collective demands cannot be either wished away or negotiated with a strong belief that the future should be a replication of the past.

There should be full respect, support and protection for innovation and the product patent system in the country. This is essential not only, for the progress of the pharmaceutical industry, but also to alleviate sufferings of the ailing population, effectively.

At the same time, available indicators point out that the civil society would continue to expect in return just, fair, responsible and reasonably affordable prices for the innovative medicines, based on the overall socio-economic status of the local population. Some experts have already opined that prices of life saving innovative drugs, unlike many other patented products, will no longer remain ‘unquestionable’ in increasing number of countries.

Thus, even at the time of declining pharmaceutical R&D productivity, striking a right balance  between a strong patent regime and safeguarding overall health interest of its population, particularly of those with a very high ‘out of pocket’ expenditure towards healthcare, will indeed be a crafty gutsy ball game for a country.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.