Giuseppe Morgese

TRIPs Agreement and the Exclusion of Some Pharmaceutical Inventions from Patentability in India: Remarks on the Indian "Novartis" Decision

  • Abstract

Informations and abstract

Keywords: TRIPs agreement; Patents; Evergreening; Novartis; Pharmaceutical Products; Section 3(d).

Based on Section 3(d) of the Patents Act, on April 1st, 2013, the Indian Supreme Court has denied the drug company Novartis a patent on a new form of a known substance whose therapeutic efficacy did not differ significantly from the latter. In my opinion, Section 3(d), as interpreted by the Supreme Court, meets the flexible standard of Article 27 of the TRIPs Agreement, which requires WTO Members States to grant patent protection for any inventions, provided that they are new, involve an inventive step and are capable of industrial application, but does not define what is meant by these terms. This leaves WTO Member States a wide room of maneuver to fine-tune their (pharmaceutical) patent systems on their own needs, banning frivolous invention without preventing the patenting of genuine incremental innovations. In addition, Section 3(d) clearly is a measures to protect public health as reaffirmed by the 2001 Doha Declaration on TRIPs and Public Health.

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