Patentability Standards For Biotechnological And Pharmaceutical Inventions
- IJLLR Journal
- Apr 11
- 1 min read
Abhijeet Singh Thakur, LL.M. (IP), Amity Law School, Amity University, Noida, Uttar Pradesh
ABSTRACT
This chapter examines the patentability standards governing biotechnological and pharmaceutical inventions under Indian patent law, with comparative reference to the legal frameworks of the United States and the European Union. It begins by interrogating the conceptually fraught distinction between discovery and invention as applied to modern biological subject matter including isolated gene sequences, genetically modified organisms, and pharmaceutical derivatives and traces the statutory architecture through which Indian law navigates this distinction. Central to the analysis is Section 3 of the Patents Act, 1970, particularly Sections 3(b), 3(c), and 3(j), which together establish a multi-layered exclusionary framework for biological and pharmaceutical inventions. The chapter gives sustained attention to Section 3(d) India's globally unique efficacy threshold for new forms of known pharmaceutical substances and provides a detailed analysis of the Supreme Court's landmark ruling in Novartis AG v. Union of India (2013), which authoritatively interpreted "efficacy" to mean therapeutic efficacy and affirmed Section 3(d)'s compatibility with the TRIPS Agreement. Post-Novartis doctrinal developments, including the evolving evidentiary standards and the growing role of pre-grant opposition as a civil society instrument, are also examined. The chapter situates Indian law within broader debates on TRIPS flexibilities, access to medicines, and the governance of agricultural biotechnology.
