ISAS Insights

The debate on India’s intellectual property (IP) regime and its implications for pharmaceutical innovations and generic drugs has come into sharp focus following the Supreme Court of India’s recent judgement on the global pharmaceutical major Novartis’s appeal for patenting and exclusive marketing of Glivec in India. Glivec is a drug administered on patients suffering from Chronic Myeloid Leukemia (CML), a rare form of blood cancer. The Court judged that Glivec does not satisfy the patentability criteria of ‘enhanced efficacy’ as mentioned in Section 3(d) of the Patents Act of 2005 and hence Novartis cannot be granted patent on Glivec in India. The decision has been widely hailed as a victory for domestic manufacturers, particularly generic drug producers. Generic drugs are those that are introduced after patents expire on their original formulations. Novartis’s patenting of Glivec in India would have implied that Indian producers could not have produced generic versions of the drug, which they are able to do now.