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39 B. C. Int'l & Comp. L. Rev. 40 (2016)
Novartis AG v. Union of India: Why the Court's Narrow Interpretation of Enhanced Efficacy Threatens Domestic and Foreign Drug Development

handle is hein.journals/bcic39 and id is 528 raw text is: NOVARTISAG v. UNION OF INDIA: WHY THE COURT'S NARROW INTEPRETATION OF ENHANCED EFFICACY THREATENS DOMESTIC AND FOREIGN DRUG DEVELOPMENT KEvIN TARSA* Abstract: Through the Patents (Amendment) Act of 2005, the Indian Parlia- ment revised the Patents Act of 1970 to permit the grant of patents for pharma- ceutical products. A core provision in the 2005 Amendment was Section 3(d), which prohibited granting patents to a new form of a known substance that did not enhance the efficacy of that substance. In Novartis AG v. Union of India, the Supreme Court of India applied this new provision to Novartis's patent applica- tion for the final form of its drug Gleevec. The court engaged in an unreasona- bly narrow analysis of enhanced efficacy, potentially stifling secondary patents on important drugs and creating significant uncertainty for pharmaceutical com- panies going forward. Novartis AG evinces the ongoing tension between main- taining India's status as the pharmacy of the world and promoting scientific innovation in South Asia. INTRODUCTION In April 2013, the Supreme Court of India upheld the Indian Patent Of- fice's rejection of Novartis's patent application for the final form of its thera- peutic drug Gleevec. 1 Gleevec, which comprises the beta crystalline form of a chemical compound called imatinib mesylate, is a drug that treats chronic myeloid leukemia and certain tumors.2 In deciding whether to grant Novartis a patent, the Supreme Court of India faced tremendous pressure to satisfy competing interests: encouraging scientific innovation and making life-saving drugs available to the world's neediest citizens.3 On the one hand, the court was urged to promote scientific research and development by affording mo- nopolistic protection to the producers of novel drugs, in keeping with India's * Kevin Tarsa is a Staff Writer for the Boston College International & Comparative Law Review. 1 Novartis AG v. Union of India, AIR 2013 SC, App. No. 2706-2716 of 2013, 3, 14, 195, http://supremecourtofindia.nic.in/outtoday/patent.pdf [https://perma.cc/53RA-2LDX]. 2 Id. 3. ' See id. 4.