NOVARTIS MOVES SUPREME COURT IN GLIVEC PATENT CASE

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SWISS major Novartis AG has moved the Supreme Court challenging Intellectual Property Appellate Board (IPAB) decision to reject its patent application of blood cancer drug Glivec in India.

   In July, the IPAB had turned down Novartis’ patent claim observing that the drug cannot be granted patent under Section 3(d) of the Indian Patent Law because it was a new form of a known compound which does not have significantly enhanced therapeutic efficacy.

   “Novartis has filed a special leave petition (SLP) with the SC challenging the denial of Glivec patent. The denial was based on Sections 3(d) and 3(b) of the Indian Patent Law,“ the company said in a press release. It also said IPAB’s contention, citing Section 3(b) that the price of the drug is too unaffordable in refusing the patent, is irrelevant. It claimed that 99% of all Glivec patients in India (more than 11,000) receive their medicine free of cost through the company’s patient assistance program. Novartis drugs cost Rs 1, 20,000 per patient per month compared with generic version which costs Rs 8,000–10,000.

   Some patent experts have pointed out the wording used by the IPAB in rejecting Glivec’s case, such as pricing, was expected to invite a legal challenge.

   The Swiss firm’s move is seen as a second round of legal battle in the high profile case that began in 2003. Health activists and Indian companies were quick to retaliate. An official of Natco Pharma, who was the first to oppose Glivec’s patent, termed Novartis’ move as uncalculated as it had the option to challenge the order in Madras HC.

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