Expanding the reach of India’s ‘Bolar’ exemption

In November 2014, the scope of the regulatory review exemption contained in section 107A(a) of the Indian Patents Act was considered by the Delhi High Court in the case of Bayer Corporation v Union of India. In this case, which is a sequel to the compulsory licence that was earlier granted to Natco in respect of Bayer's patented drug in 2012, Natco sought to export 1 kilogramme of the patented active pharmaceutical ingredient to a company in China. Bayer contended that this was in breach of the terms of the compulsory licence and equally outside the scope of section 107A(a). Natco however argued for a broader interpretation of section 107A(a) in a manner that will permit the exportation of patented active pharmaceutical ingredients to producers of generic drugs solely for the purposes of generating information required for obtaining regulatory approval. In accepting Natco's broader interpretation of section 107A(a), the Delhi High Court incorporated a model of human rights into its decision by being mindful of the implications that a restrictive interpretation of section 107A(a) could have on the production of cheaper generic drugs and access to medicines. This decision reinforces India's crucial position as the ‘pharmacy of the developing world’.