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.
On 1 April 2013 a two-judge bench of the Supreme Court dismissed Novartis's decade-long campaign for an Indian patent on the beta-crystalline form of Imatinib Mesylate — sold abroad as Glivec (and as Gleevec in the United States). The Court read *Section 3(d)* of the *Patents Act 1970* as a heightened patentability filter for incremental pharmaceutical claims, glossed 'efficacy' as 'therapeutic efficacy', and held that improvements in bioavailability, hygroscopicity and flow are physico-chemical attributes that do not, without more, cross the s.3(d) threshold. The judgment supplied the doctrinal architecture for India's post-TRIPS anti-evergreening regime and remains the anchoring authority on incremental-pharma patentability.