New Delhi/Mumbai: India’s apex court on Monday issued a stay order halting the hearing of Glivec’s patent appeal before a government board in response to a petition filed by Hyderabad-based Natco Pharma Ltd. The non-patented drug maker had challenged the Madras high court’s earlier decision.
The high court had, in November, allowed the appeal on patent refusal for the cancer drug to be heard without a technical member on the Intellectual Property Appellate Board (IPAB) at the behest of Novartis AG. The decision had come after the government presented a formula under which the IPAB bench would consist of only chariman M.H.S. Ansari and vice-chairman Z.S. Negi.
Swiss objection: Novartis AG had objected to the nomination of S. Chandrasekharan as technical member on IPAB because he was the patent controller in January 2006 when Glivec was refused patent in India.
The patent seeker and innovator of the drug, Novartis, had objected to the nomination of S. Chandrasekharan as technical member on IPAB because he was the patent controller in January 2006 when its $3.1 billion (Rs12,214 crore today) drug was refused patent here.
Indian drug makers such as Natco and patient groups had cited the “doctrine of necessity”, saying there was no immediate replacement to be found for Chandrasekharan.
After the high court decision, Natco alone petitioned the Supreme Court against it, saying it will be difficult for the board to take a proper decision without an expert on the panel since the matter was too technical and complicated.
Confirming the development on Monday, an industry official close to the litigation said, “IPAB can’t hear the case as of now. Four weeks have been given to the Indian government to respond on how the case could be heard without a technical member.”
IPAB’s first hearing on Glivec, with the newly constituted two-member board, was scheduled for Monday and got truncated in the afternoon with the Supreme Court order.
“This may delay the IPAB proceedings, but we have confidence in the Indian legal system,” said a Novartis India spokeswoman, adding that the company had agreed to the government’s formula only to expedite the hearing.
In a previous statement, Novartis had stated that it expected “the opportunity to explain our case clearly to an objective board” and believed that he (Chandrasekharan) couldn’t “act as an impartial member of the Appellate Board”.
Around 40 countries, including China, Russia and Taiwan, have given a patent for the beta crystalline form of imatinib mesylate, sold under the brand Glivec by Novartis, but India refused to grant one, citing a crucial provision in its patent law, Section 3(D), that disallows protection of tweaked versions of an existing drug with no substantial increase in efficacy.