Role of Patents in Biosimilar Drug Development and Public Interest

The innovation in the field of biotechnology has opened up new venues in the field of drug development like biosimilar drugs. The expiry of patents for many biopharmaceutical substances in various jurisdictions paved the way for the introduction of biosimilars in the market with reduced prices. The grant of patents for drugs as well as biopharmaceutical drugs act as an incentive for the developers to recoup their investment. But this has resulted in creating obstacle for access to medicine. The legislators have intervened in such situations by coming up with new statute for balancing public interest and interest of patent holders of these drugs. This paper explores whether patents on biologics facilitates competition or retard competition or it require any other mechanisms to balance the interest of patent holders and users/public interest. It explores how it has been regulated through legislative intervention in United States and protected public interest. In this context, examines the legislative attempts to protect public interest, by curbing anticompetitive practices of the patent holder in case of chemical drugs and bio pharmaceutical drugs, by exploring the Hatch Waxman Act and BPCIA of United States. It delves in to judicial decisions on patentability of biological materials and analyses its impact on biosimilar drugs. It also examines the challenges faced by the biosimilars in the Indian markets and the adequacy of the safety requirement of biosimilars in India