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Fading history of Novartis v Union of India

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April 01, 2023

The 2013 landmark Supreme Court judgement offers critical lessons on the intent behind crucial aspects of India's key patent law

- LATHA JISHNU

Fading history of Novartis v Union of India

EXACTLY TEN years ago, the Supreme Court of India delivered a landmark judgement on a crucial case involving under the patent protection for pharmaceuticals country's new intellectual property rights regime. It was a case that had riveted the world since the outcome had major implications for the pharma industry and for patients. It was the first test of the country's patent law, which had been amended to comply with World Trade Organization (WTO) rules, and specifically of a particular part of the law, Section 3d, which delineated what was not patentable in India. This section deals with patents for derivatives of known substances and new uses of a known substance, a hugely contested domain.

The legal challenge had come from Swiss drug giant Novartis which had filed a special leave petition (SLP) in the apex court; its final attempt to get a patent for a new form of its anti-cancer medicine Glivec after several courts had rejected the claim. The claim was for a beta crystalline version of its base compound imatinib mesylate, which had been patented much earlier. A division bench of the Supreme Court rejected the SLP and Justice Aftab Alam, who wrote the carefully nuanced judgement, laid down the fundamental reasoning for the law and its application. While the court considered the counter arguments-generic companies, patient groups and lobbyists had also filed SLPS-it was not unduly swayed by the argument for access to the medicine.

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