PATENT BARRIERS AND THE ACCESSIBILITY OF BIOSIMILARS: A HUMAN RIGHTS PERSPECTIVE ON AFFORDABLE BIOLOGIC MEDICINES IN INDIA

AUTHOR – AKHILA ANAND, LLM (INTELLECTUAL PROPERTY & TRADE LAW) SCHOLAR AT CHRIST (DEEMED TO BE) UNIVERSITY BANGALORE

BEST CITATION – AKHILA ANAND, PATENT BARRIERS AND THE ACCESSIBILITY OF BIOSIMILARS: A HUMAN RIGHTS PERSPECTIVE ON AFFORDABLE BIOLOGIC MEDICINES IN INDIA, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (4) OF 2025, PG. 1109-1120, APIS – 3920 – 0001 & ISSN – 2583-2344.

ABSTRACT:

The accessibility of biosimilars presents a critical challenge in the global healthcare landscape, particularly in developing economies such as India, where affordability and equitable access to life-saving biologic medicines remain significant concerns. The author of this paper examines the patent barriers impeding the widespread availability of biosimilars and explore the human rights implications of limited access to these essential drugs. Biologics, which play a crucial role in the treatment of cancer, autoimmune disorders, and other chronic diseases, are often subject to complex and expensive manufacturing processes, leading to high costs and restricted availability. Biosimilars, approved based on demonstrated similarity in quality, safety, and efficacy to reference biologics, offer a viable alternative. However, the regulatory and patent landscapes continue to pose formidable obstacles to adoption.

This study investigates how patent thickets, extended exclusivity periods, and strategic litigation by originator companies delay the market entry of biosimilars, thereby affecting accessibility and affordability. A comparative analysis of biosimilar patent assertions in India and other jurisdictions reveals that while some countries have established streamlined approval pathways, significant legal and regulatory gaps persist. The paper argues that the current intellectual property regime disproportionately favors innovator companies at the cost of public health, necessitating reforms that balance innovation incentives with broader access to critical medicines.

A significant gap exists in reconciling intellectual property rights with the fundamental right to health, especially in low- and middle-income countries. This paper contributes to the ongoing discourse by proposing legal and policy recommendations to overcome patent-related hurdles and promote the ethical imperative of equitable healthcare access. The study seeks to bridge the gap between biopharmaceutical innovation and the right to affordable treatment by advocating for regulatory clarity, competitive pricing mechanisms, and strengthened global cooperation.

Keywords: Biopharmaceuticals, Biosimilars, Patent law, Human rights, Regulatory framework