Compulsory Licensing of Pharmaceutical Patents in India: Whether the Natco Decision Will Meet the Global Benchmarks?

Abstract

The need to find a balance between the rights of pharma patent holders and public health has triggered some highly passionate debates in the last three decades. India provides a good case study which shows that the flexibilities under TRIPS Agreement can be efficiently utilised by developing countries without compromising their interests. The decision by the India Patent Office to grant a compulsory licence in favour of an Indian pharmaceutical company, Natco, has triggered lot of criticism and concerns. This article analyses the soundness of the decision in the light of global practices dealing with compulsory licensing which is reflected in international agreements, the Indian Patent Law provisions and the conduct of the Indian Patent Office in subsequent applications for such licences. It highlights some important factors which justify the grant of a compulsory licence in order to prove that the compulsory licence so granted is not anti-TRIPS and meets all the global benchmarks.

Keywords: ;Comparative law; Compulsory licensing; Generic medicines; India; Patents; Pharmaceuticals; TRIPs; Natco case

JEL Classification: O34, K33