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Abstract: Through the Patents (Amendment) Act of 2005, the Indian Parliament revised the Patents Act of 1970 to permit the grant of patents for pharmaceutical 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 application for the final form of its drug Gleevec. The court engaged in an unreasonably narrow analysis of enhanced efficacy, potentially stifling secondary patents on important drugs and creating significant uncertainty for pharmaceutical companies going forward. Novartis AG evinces the ongoing tension between maintaining 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 Office's rejection of Novartis's patent application for the final form of its therapeutic 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 monopolistic protection to the producers of novel drugs, in keeping with India's obligations under international treaties. 4 On the other hand, nongovernmental organizations and legal-aid societies implored the court to protect India's generic drug producers and thus maintain India's status as the "pharmacy of the world."5
Novartis AG v Union of India is significant because it tests the ambit and purpose of the Indian Patents (Amendment) Act of 2005 (2005 Amendment).6 One of the core issues of the case is whether, under Section 3(d) of the 2005 Amendment, the final version of Gleevec enhances the "known efficacy" of the previous form of the drug.7 Novartis contended that Section 3(d) was immaterial to the case, but the court did not find this argument persuasive.8 It ruled that Section 3(d) serves as an additional bar for drugs to clear...