India’s New Trade Deal Safeguards Generic Drug Industry, Rejects Patent Extensions and Data Exclusivity

India has reaffirmed its commitment to affordable medicines and public health safeguards in its latest Free Trade Agreement (FTA), signed on **July 24**. The government announced that the deal does **not include provisions** for **patent term extensions** or **data exclusivity**, commonly sought by multinational pharmaceutical companies to extend their market monopolies.

The **Ministry of Commerce and Industry** clarified that critical sections of the **Indian Patents Act, 1970** — notably **Section 3(d)** and **Section 3(b)** — will remain fully protected under the FTA. These provisions are key to India’s rejection of “**evergreening**” practices, which involve patenting minor modifications of existing drugs to delay generic competition.

> 🔗 [Section 3(d) – Indian Patents Act](https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Patent_Amendment_Act_2005.pdf)

**Section 3(d)** allows patents only for new drug forms that demonstrate **enhanced efficacy**, while **Section 3(b)** restricts patents for inventions that are **contrary to public interest** or lack significant therapeutic benefit.

> “India’s patent regime remains intact. There is no obligation under the new agreement to extend patent terms or introduce data exclusivity for pharmaceuticals or agrochemicals,” the ministry said in an official release.

The government emphasized that the FTA **does not include**:

* **Patent term extensions** to compensate for regulatory delays.
* **Data exclusivity** that would prevent Indian regulators from using innovator data to approve generics.
* **Patent linkage**, which ties drug approval to patent status.
* **Automatic injunctions** that delay generic entry during litigation.

> 🔗 [Understanding Data Exclusivity – WHO](https://www.who.int/news-room/questions-and-answers/item/intellectual-property-data-exclusivity)

These exclusions are a win for India’s **USD 25 billion generic drug industry**, which supplies nearly **50% of its pharmaceutical output** to global markets, including **life-saving drugs for HIV/AIDS, tuberculosis, and cancer** in low- and middle-income countries.

> 🔗 [India’s Generic Pharmaceutical Sector – Brookings](https://www.brookings.edu/articles/the-indian-pharmaceutical-industry/)

The deal follows similar resistance by India during talks with the **European Free Trade Association (EFTA)** — comprised of **Switzerland, Norway, Iceland, and Liechtenstein** — where India successfully opposed attempts to insert stricter IP protections in their FTA finalized in **March 2023**.

> 🔗 [EFTA–India FTA Overview](https://www.efta.int/free-trade/Free-Trade-Agreement/India)

Pressure to include such IP provisions often comes from countries with large pharmaceutical industries, including the **UK** and **Switzerland**, home to global players like **AstraZeneca**, **GlaxoSmithKline (GSK)**, **Novartis**, and **Roche**.

However, India’s stance remains consistent with its obligations under the **World Trade Organization’s (WTO) TRIPS Agreement**, which does not require countries to implement **data exclusivity** or **patent extensions**. Experts argue that such measures are “**TRIPS-plus**” provisions that go beyond international norms.

> 🔗 [WTO TRIPS Agreement](https://www.wto.org/english/tratop_e/trips_e/trips_e.htm)

India also draws strength from the **Doha Declaration on TRIPS and Public Health (2001)**, which affirms the right of WTO members to protect public health and promote access to medicines.

> 🔗 [Doha Declaration – WTO](https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm)

“This agreement reinforces India’s role as the ‘pharmacy of the developing world’ by ensuring that domestic laws prioritize **access to affordable medicines** over extended monopolies,” said a Delhi-based trade policy expert.

The FTA will undergo legislative procedures before coming into effect, expected within the next year. For now, the government’s firm stance is seen as a strategic move to protect its pharmaceutical export economy and uphold public health imperatives.

India Reiterates Ban on Patent Evergreening: Piyush Goyal Emphasizes Public Health Over Pharma Profits

Union Commerce and Industry Minister Piyush Goyal has reiterated that India will not allow evergreening of pharmaceutical patents. Speaking at a recent trade event, Goyal highlighted India’s commitment to affordable healthcare and equitable access to medicines. He firmly stated that evergreening contradicts Indian law and undermines public health.


🔍 What Is Evergreening?

Evergreening is a strategy where pharmaceutical firms seek new patents for minor changes to existing drugs. These changes often include alterations in formulation, dosage, or delivery methods. The intent is to extend monopoly rights and delay generic drug entry.

India’s Patents Act, 1970, under Section 3(d), prohibits such practices unless the new version offers significantly enhanced therapeutic efficacy.

👉 Read Section 3(d) of the Indian Patents Act
👉 What is Evergreening – WHO Definition


🗨️ Goyal’s Firm Stand Against Evergreening

Piyush Goyal emphasized that India has faced repeated pressure from multinational pharmaceutical companies to weaken its IP laws. He stated:

“India does not permit evergreening. We protect genuine patents. But we will not let companies misuse the system to maintain monopolies.”

He challenged critics to show a single instance where India violated intellectual property rights. According to Goyal, none have been able to do so.


⚖️ The Legal Foundation: Section 3(d)

India’s Section 3(d) is a globally recognized provision. It has prevented the misuse of the patent system and has been upheld by the Supreme Court of India in the Novartis vs. Union of India case.

In 2013, India’s top court rejected Novartis’ patent for a modified version of the cancer drug Glivec, ruling it lacked increased efficacy.

👉 Learn more about the Novartis Case

This ruling became a milestone in India’s public health jurisprudence and strengthened the nation’s stance on patent quality over quantity.


🌍 Public Health Over Profits

Goyal underlined that India’s patent system aims to balance innovation with access. He noted:

“Our goal is to make life-saving medicines available at affordable rates—not to support super-profits for a few companies.”

India’s approach supports global healthcare. The country is known as the “Pharmacy of the Global South”, supplying low-cost generics to over 200 nations.

The government also runs Ayushman Bharat, one of the world’s largest public health programs, covering more than 620 million people.

👉 Visit Ayushman Bharat official website


🌐 Global Support and Recognition

India’s position has gained support from global health advocates. Organizations like Médecins Sans Frontières (MSF) have praised Section 3(d) for preventing abusive patent extensions.

International forums including the World Trade Organization (WTO) have acknowledged India’s right to use TRIPS flexibilities to protect public health.

👉 TRIPS Agreement – WTO


🧾 Summary Table: India’s Policy on Patent Evergreening

IssueIndia’s Position
EvergreeningStrictly prohibited under Section 3(d)
Valid PatentsFully respected during legal term
TRIPS ComplianceYes, with use of flexibilities
Pressure to Amend IP LawsResisted to safeguard public health
Generic Medicine PromotionEncouraged for affordable drug access

🔑 Key Takeaways

  • India will not compromise its patent law to favor big pharma.
  • Section 3(d) remains the cornerstone of India’s patent policy.
  • The government remains committed to TRIPS-compliant innovation and global medicine accessibility.