PHARMACEUTICAL PATENT STANDARDS AND REGULATORY APPROACHES: A COMPARATIVE ANALYSIS OF INDIA, THE UNITED STATES, AND THE EURO

AUTHOR – SUNDARAM* & EKTA GUPTA**

* STUDENT AT SCHOOL OF LAW, AMITY LAW SCHOOL, AMITY UNIVERSITY, UTTAR PRADESH

** PROFESSOR AT SCHOOL OF LAW, AMITY LAW SCHOOL, AMITY UNIVERSITY, UTTAR PRADESH

BEST CITATION – SUNDARAM & EKTA GUPTA, PHARMACEUTICAL PATENT STANDARDS AND REGULATORY APPROACHES: A COMPARATIVE ANALYSIS OF INDIA, THE UNITED STATES, AND THE EURO, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 6 (7) OF 2026, PG. 835-847, APIS – 3920 – 0001 & ISSN – 2583-2344.

ABSTRACT

At the intersection of intellectual property rights that seek to incentivise innovative activity (notably through patent law), the imperatives of public health that call for affordable access to essential medicines, and the requirements of international trade law that binds states to minimum standards of patent law protection. The ways, standards and tests of various jurisdictions with respect to the patentability of pharmaceuticals can have a serious impact not just on the commercial interests of pharmaceutical firms and generics but on the health and life of millions of human beings who rely on affordable medicines for treatment of life-threatening diseases. This article carries out a detailed comparative legal study of pharmaceutical patent standards and regulatory regimes of India, the US and the EU, which all stand at different poles in the international pharmaceutical patent debate. The purpose of the analysis is to examine how each jurisdiction interprets, and applies core patentability requirements to pharmaceutical inventions, how each jurisdiction addresses challenges that pharmaceutical patents pose including, evergreening, the patent-regulatory interface and so on, and how each jurisdiction uses compulsory licensing, opposition mechanisms and other features to manage the tension between the private rights of pharmaceutical patent holders and public health obligations of states. According to the article, the three jurisdictions have developed fundamentally different approaches reflecting their particular economic circumstances, public health priorities and positions in the global pharmaceutical value chain. Furthermore, the article makes evidence-based reform recommendations aimed at improving the alignment between pharmaceutical patent standards and global public health objectives.

Keywords: Pharmaceutical Patents; TRIPS Agreement; Section 3(d); Evergreening; Compulsory Licensing; Hatch-Waxman Act; Supplementary Protection Certificates; Data Exclusivity; Access to Medicines; Global Health Equity; Novartis AG v. Union of India.