IN THE CHANGING WORLD OF INTELLECTUAL PROPERTY RIGHTS: PATENTABILITY AND MARKET EXCLUSIVITY FOR ORPHAN DRUGS

AUTHOR – AKRITI SHUKLA, LLM SCHOLAR AT AMITY LAW SCHOOL, AMITY UNIVERSITY UTTAR PRADESH (AUUP)

BEST CITATION – AKRITI SHUKLA, IN THE CHANGING WORLD OF INTELLECTUAL PROPERTY RIGHTS: PATENTABILITY AND MARKET EXCLUSIVITY FOR ORPHAN DRUGS, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (8) OF 2025, PG. 776-786, APIS – 3920 – 0001 & ISSN – 2583-2344

Legislative Measures and Their Impact

4.1. The Orphan Drug Act of 1983:-

The Orphan Drug Act (ODA) of 1983 is a major piece of legislation in the United States that was enacted expressly to address the lack of incentives for discovering therapies for rare diseases. These uncommon diseases, sometimes known as “orphan diseases,” afflict a small percentage of the population—usually less than 200,000 persons in the United States at any given time. Prior to the ODA, pharmaceutical firms had little financial incentive to invest in research and development (R&D) for such tiny patient groups, owing to the high expenses and poor economic returns. The ODA attempted to address these issues by offering a variety of financial and regulatory incentives to support the development of orphan medications.