India patent law

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

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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.

How India’s Evolving Patent Law Transformed Its Pharma Industry from Generics to Innovation Powerhouse

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India’s pharmaceutical landscape has undergone a seismic transformation over the past two decades, evolving from a generics powerhouse to a burgeoning hub for global research and development (R&D). Central to this shift has been the country’s evolving patent regime—particularly the changes ushered in by the Patents (Amendment) Act, 2005—which reshaped industry strategies, attracted global collaborations, and propelled Indian companies onto the global innovation map.

A Generics Legacy Rooted in Policy

Until the early 2000s, India’s pharmaceutical industry thrived on the back of a legal framework that permitted the manufacture of generic versions of patented drugs through a process patent regime. Introduced by the Indian Patents Act of 1970, this approach enabled Indian firms to reverse-engineer drugs and develop cost-effective alternatives, making life-saving medicines affordable domestically and in developing countries worldwide.

By the late 1990s, Indian pharmaceutical companies like Cipla, Dr. Reddy’s Laboratories, and Ranbaxy had become synonymous with generic drug manufacturing, supplying affordable antiretrovirals during the global HIV/AIDS crisis.

WTO Obligations and the 2005 Patent Shift

India’s accession to the World Trade Organization (WTO) in 1995 came with commitments under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. A critical requirement was to transition to a product patent regime, granting stronger intellectual property protection for pharmaceuticals.

The watershed moment came with the Patents (Amendment) Act, 2005. The Act introduced product patents for pharmaceuticals, thereby aligning India’s patent laws with TRIPS. The legislation marked a paradigm shift—no longer could Indian firms freely replicate patented drugs without licensing.

However, the amendment also included critical public interest safeguards. Section 3(d) of the Act, for instance, disallowed patents on “incremental innovations” unless they showed enhanced efficacy. This clause became pivotal in landmark cases such as Novartis v. Union of India, where India’s Supreme Court denied patent protection to the cancer drug Glivec in 2013.

The R&D Pivot

With limitations on reverse engineering, Indian pharma companies began investing more heavily in original drug discovery and innovation. The post-2005 environment incentivized a shift from pure generics manufacturing to novel drug development, biosimilars, and proprietary research.

Companies like Sun Pharma, Biocon, and Glenmark Pharmaceuticals ramped up their R&D budgets and established global partnerships to tap into advanced therapeutic areas such as oncology, biologics, and immunotherapy. India’s Contract Research Organizations (CROs) also gained prominence, supporting global pharma firms with clinical trials and drug development services.

The government reinforced this innovation-centric approach by launching schemes like the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) and strengthening IP awareness through initiatives under the National IPR Policy (2016).

Global Collaborations and Patent Filings Surge

India’s R&D-driven strategy yielded tangible results. According to the Indian Patent Office, pharma-related patent applications by Indian entities have grown steadily, with a 2.3x increase between 2015 and 2023. Multinational companies, recognizing India’s scientific talent and cost efficiencies, expanded R&D collaborations and opened innovation centers in cities like Hyderabad, Bengaluru, and Ahmedabad.

Moreover, Indian pharmaceutical innovators have gained recognition in advanced markets. Biocon’s approval for biosimilars in the US and EU, and Zydus Cadila’s development of India’s first DNA-based COVID-19 vaccine, ZyCoV-D, stand as testament to the country’s growing scientific capabilities.

Balancing Innovation and Access

Despite this transition, India continues to balance innovation with public health needs. Compulsory licensing provisions and the continued application of Section 3(d) ensure that patent rights do not come at the cost of affordable healthcare. Critics from the global pharmaceutical lobby often view these safeguards as hurdles to innovation, but public health advocates argue they are necessary for equitable access.

The Road Ahead

India’s pharmaceutical evolution is far from complete. With 6G connectivity, AI-driven drug discovery, and personalized medicine on the horizon, the next frontier for Indian pharma will likely involve deep tech and cross-disciplinary innovation. Government initiatives like the Bulk Drug Parks and the PLI (Production-Linked Incentive) Scheme for pharmaceuticals are expected to accelerate this transformation.

India’s patent law has not merely redefined legal boundaries; it has charted a new course for the pharmaceutical industry—one where affordable medicine and cutting-edge innovation can, and must, coexist.