EVERGREENING AT THE GATE: SECTION 3(D) OF THE PATENTS ACT, 1970, THIRTEEN YEARS AFTER NOVARTIS

Section 3(d) of the Patents Act, 1970 was rewritten in 2005 to stop pharmaceutical companies from extending monopolies through minor changes to known substances, a practice known as evergreening. The Supreme Court’s 2013 decision in Novartis AG v. Union of India read “efficacy” to mean therapeutic efficacy and made the clause a second, stricter threshold for pharmaceutical inventions. This article revisits Section 3(d) thirteen years later. It traces how the Delhi High Court, now the main forum for patent disputes after the abolition of the Intellectual Property Appellate Board, has applied the clause in cases such as Natco v. Novartis, the risdiplam litigation, Syngenta and Intra-Cellular Therapies. It finds that the substance of the provision has held firm and in some respects grown stricter. The real pressure lies in procedure. Higher pre-grant opposition fees, less frequent working disclosures, hurried examination guidelines and commitments in recent trade agreements could each weaken the clause in practice. After a brief comparison with the United States, Europe and the United Kingdom, the article proposes four reforms aimed at protecting the procedures on which Section 3(d) depends.