ValkyaEditorial

Tagged “nexavar”

1 article on nexavar.

Landmark JudgmentBombay High Court

Bayer Corporation v. Union of India: India's first compulsory licence and the patient-perspective reading of Section 84

On 15 July 2014 a two-judge Division Bench of the Bombay High Court (Mohit S. Shah, C.J., presiding, with M.S. Sanklecha, J.) affirmed India's first — and to date only successful — compulsory-licence grant under *Section 84* of the *Patents Act 1970*. The decision sustained the Controller's 9 March 2012 order granting Natco Pharma a compulsory licence over Bayer's IN 215758 (Sorafenib Tosylate, sold as Nexavar) on all three independent grounds under *Section 84(1)* — reasonable requirements of the public unmet, price not reasonably affordable, and patent not worked in India. The Special Leave Petition was dismissed on 12 December 2014 with the questions of law left open. The judgment, read with the subsequent rejections of the BDR Pharma (Dasatinib) and Lee Pharma (Saxagliptin) applications, defines the practical contours of Indian compulsory licensing in the post-TRIPS public-health architecture.

Valkya Editorial··14 min