Flexibilities Under the Indian Patents Act for Use of Pharmaceutical Inventions

Abstract

Prior to 2005, the Indian Patents Act, 1970 (hereinafter ‘the Patents Act’) did not provide for patent protection on pharmaceutical products; an important consequence of such a patent regime was the growth of a robust generics drug industry in India which earned India the title of the ‘pharmacy of the developing world’. In 2005, India amended its Patents Act to provide patent protection to pharmaceutical products. This had a direct consequence on generic drug manufacturers in India who can no longer commercially sell generic versions of patented drugs in India until the drugs go off patent. On the other hand, access to medicines (the right of the public to affordable medicines) is a key concern for India and other developing and least developed countries. Certain provisions in the Indian patent law are aimed at ensuring access to medicines by striking a balance between patent-holders’ rights and public interest. This chapter focusses on the flexibilities in the Patents Act, such as compulsory licensing and section 107A of the Patents Act, which allow for certain uses of patented drugs by third parties, and section 3(d) of the Patents Act which prevents ever-greening of pharmaceutical patents. The chapter discusses landmark judgments such as Bayer Corporation v. Union of India, Novartis v. Union of India and the more recent judgment of the Delhi High Court in Bayer Corporation v. Natco Pharma Ltd. and Alembic Pharmaceuticals Ltd. The chapter concludes with the role of public interest in guiding the interpretation of patent law provisions by Indian courts and the issues surrounding the court’s interpretation of these provisions.