Patent Evergreening and Access to Medicines in India

This Blog is Written by Shreya Prajapati, 4th Year, BA LLB, CMP Degree College, University of Allahabad.

Introduction

Access to affordable medicines is not merely a public health imperative — it is, increasingly, a constitutional one. In a country where a significant proportion of the population remains dependent on generic medicines for the treatment of chronic and life-threatening conditions, the practice of patent evergreening poses a direct threat to the equitable delivery of healthcare. Evergreening, broadly understood, refers to the strategy employed by pharmaceutical originators to extend the effective market exclusivity of a drug beyond the standard twenty-year patent term by securing successive patents over incremental modifications — new salt forms, polymorphs, dosage formulations, or methods of administration — that offer no meaningful therapeutic advancement. India's legislative and judicial response to this practice, particularly through Section 3(d) of the Patents Act, 1970, represents one of the most significant experiments in calibrating intellectual property law against public health in any jurisdiction globally.

Understanding Patent Evergreening

The mechanics of evergreening are rooted in the breadth of patentability criteria under conventional intellectual property frameworks. Once a blockbuster drug molecule approaches patent expiry, originator pharmaceutical companies routinely file applications for derivative patents covering modifications to the original compound. These modifications — a different crystalline structure, a new ester or salt, an altered delivery mechanism — may attract independent patent protection without demonstrating any clinically superior outcome for the patient. The cumulative effect is a patent thicket that delays generic entry, sustains high originator prices, and denies affordable treatment to millions. In high-income jurisdictions, regulatory and intellectual property frameworks have historically been more permissive of such practices, enabling pharmaceutical multinationals to maintain pricing power well beyond the intended term of exclusivity. India, by contrast, made a deliberate legislative choice at the time of amending its Patents Act in 2005 to conform with the TRIPS Agreement — a choice that placed it at the forefront of developing-country resistance to evergreening.

Section 3(d): India's Legislative Shield

The centrepiece of India's anti-evergreening architecture is Section 3(d) of the Patents Act, 1970, as amended by the Patents (Amendment) Act, 2005. The provision excludes from patentability the mere discovery of a new form of a known substance — including salts, esters, ethers, polymorphs, metabolites, and isomers — unless such new form demonstrates a significant enhancement in known efficacy. This efficacy filter imposes a substantive threshold that goes materially beyond the novelty and inventive step requirements applicable elsewhere, demanding proof of clinical or therapeutic superiority rather than mere chemical distinction. The constitutional validity and interpretive scope of Section 3(d) was authoritatively settled by the Supreme Court of India in Novartis AG v. Union of India (2013). The Court refused patent protection for the beta-crystalline form of imatinib mesylate — the active ingredient in the cancer drug Gleevec — holding that the applicant had failed to demonstrate enhanced efficacy over the known free-base compound. The judgment was globally significant: it confirmed that India's efficacy standard was a legitimate exercise of the policy space available under the TRIPS Agreement, and that therapeutic efficacy — not merely physicochemical properties such as improved bioavailability — was the relevant metric for Section 3(d) compliance.

Compulsory Licensing as a Complementary Mechanism

Beyond Section 3(d), the Patents Act provides for compulsory licensing under Sections 84 to 92, permitting third parties to manufacture patented drugs without the consent of the patentee where specified public interest conditions are met. The sole compulsory licence granted in India to date — issued by the Controller General of Patents in 2012 to Natco Pharma in respect of Bayer's sorafenib tosylate (sold as Nexavar) — illustrated both the promise and the limitations of this mechanism. The Controller found that the drug was not available to the public at a reasonably affordable price and that Bayer had not worked the patent sufficiently within Indian territory. Natco was permitted to manufacture and sell the drug at a fraction of the originator price. However, compulsory licensing has remained a remedy of last resort rather than a routine policy instrument. Diplomatic pressure from originator-country governments, the threat of trade retaliation, and procedural requirements that demand proof of prior failed negotiations with the patentee have collectively constrained the practical utility of this mechanism. The proposed amendment to the compulsory licensing framework to include export of medicines to countries with insufficient manufacturing capacity — as contemplated under the Doha Declaration — remains incompletely operationalised in Indian law.

Ongoing Challenges and the Road Ahead

Despite the robustness of Section 3(d), challenges persist. Patent examination capacity at the Indian Patent Office remains stretched, and pre-grant oppositions — a critical civil society tool for challenging evergreening attempts — are not always adjudicated with the rigour and speed that public health demands. The interface between data exclusivity proposals under free trade agreement negotiations and India's generic manufacturing ecosystem continues to be a site of contestation. Additionally, the emergence of biologics and biosimilars introduces new evergreening-adjacent concerns — particularly around the patenting of manufacturing processes and delivery devices — that Section 3(d), drafted primarily with small-molecule drugs in mind, may not fully address.

Conclusion

India's confrontation with patent evergreening represents a principled assertion that intellectual property protection must serve innovation rather than entrench monopoly. Section 3(d) and the Novartis judgment together constitute a landmark contribution to global pharmaceutical IP jurisprudence. Yet legislative vigilance, institutional capacity, and strategic trade policy engagement remain essential if India is to preserve its role as the pharmacy of the world — and, more fundamentally, to honour the right to health of its own population.