PATENT LINKAGE: NEXUS BETWEEN INNOVATION, ACCESS, AND REGULATORY AUTHORITY
AUTHOR – S.RENUKA, ASSISTANT PROFESSOR AT GOVERNMENT LAW COLLEGE, TRICHY
BEST CITATION – S.RENUKA, PATENT LINKAGE: NEXUS BETWEEN INNOVATION, ACCESS, AND REGULATORY AUTHORITY, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (14) OF 2025, PG. 1135-1143, APIS – 3920 – 0001 & ISSN – 2583-2344. DOI – https://doi.org/10.65393/QCPR1945
ABSTRACT
This paper examines patent linkage mechanisms—regulatory frameworks that condition pharmaceutical marketing approval for generic and biosimilar drugs on patent status assessments—as a critical intersection between intellectual property protection and public health access. Through comparative jurisdictional analysis of the United States (Hatch-Waxman Act), Canada (PM(NOC) Regulations), China (recent 2021 implementation), and Japan (administrative discretion model), alongside India’s principled rejection of linkage, the article evaluates the empirical consequences of patent linkage systems on generic drug market entry timelines, pricing accessibility, and compulsory licensing effectiveness. The analysis demonstrates that while patent linkage theoretically balances innovation incentives with generic competition, empirical evidence reveals systematic delays in generic market entry (2–8 years post-patent expiration in Canada), facilitation of patent evergreening strategies, and measurable healthcare cost increases exceeding $1.5 billion in select drug categories. The paper situates patent linkage within broader TRIPS-plus normative frameworks arising from bilateral trade negotiations, identifies institutional competence conflicts between patent offices and drug regulators, and proposes policy alternatives—including functional separation of patent validity determination and pharmaceutical safety-efficacy assessment—to preserve access-to-medicines objectives while maintaining intellectual property protections. The study concludes that jurisdictions prioritizing pharmaceutical accessibility should maintain institutional boundaries between intellectual property and regulatory authorities while preserving compulsory licensing flexibilities under international law.
KEYWORDS Patent linkage-Generic drug approval-Pharmaceutical regulation- Intellectual property and access to medicines- TRIPS-plus agreements- Patent evergreening-Hatch-Waxman Act- Data exclusivity-Compulsory licensing- Regulatory authority separation- Pharmaceutical policy-Drug control authority.