Novartis cancer drug not innovative enough for patent, India Supreme Court rules

India seeks to prevent companies from extending patent life for drugs through incremental modifications

Pharmaceutical companies looking to protect their intellectual property in India will be none too pleased with a ruling today by the country’s Supreme Court. It found that Novartis AG’s Gleevec cancer drug wasn’t innovative enough to be awarded a patent, upholding regulatory rulings from 2006 to the present that found the same. This means that drug makers in India can continue selling generic versions of Gleevec.

Novartis argued that it invested years of research into Gleevec, specifically on modifying the molecule imatinib, to make it a safe treatment for leukemia. In denying Novartis’s patent application in 2006, the Indian Patent Office relied on a section of Indian law forbidding “evergreening,” or slightly changing the chemical makeup of a drug to extend its patent life without adding any medical benefits.  Novartis appealed this decision to India’s Supreme Court, only to have it affirmed.

Bloomberg reports that while decisions like this may be intended to expand access to drugs, they may end up hurting India’s drug industry, as companies will be reluctant to invest in research and development in the country if they can’t be sure their intellectual property will be protected.

 

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