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04 October 2012
In a decision spanning nearly 200 pages, India’s Intellectual Property Appellate Board (IPAB) has denied a patent application by Novartis for its blood cancer drug Glivec, ruling that the drug “lacks innovation” and fails to satisfy the requirements under Section 3(d) of the Indian patents act, which requires that in order to be patentable, a pharmaceutical derivative must demonstrate significantly enhanced “efficacy” over and above the prior known molecule.
Novartis markets the drug as Glivec in most countries with the exception of the US, where the drug is known as Gleevec.
At the same time – and perhaps more interestingly – the IPAB also denied the patent application under Section 3(b) of the Act, calling the drug’s cost of Rs120,000 (US$2,480) per patient per month too high, opining that “any patent granted to support such a high monopoly price would be against ‘public order.’”
Section 3(b) says that patents may not be issued to an invention for which the primary or intended use or commercial exploitation of which could be contrary to public order, or morality, or which causes serious prejudices to human, animal or plant life or health or to the environment.
Observers have noted that the Section 3(b) ruling may have given Novartis new grounds to challenge Indian patent rules.
“We are reviewing the decision and will look at the various options available to us,” a company spokesperson said, without going into detail. Many expect the company to either take the case to a higher court in India or appeal to courts outside India.
The IPAB did agree with Novartis that the claim covering the form of the drug covered by the patent application is both novel and inventive, but commented that the drug fails the test under Section 3(d), which requires an application to demonstrate the “significantly enhanced efficacy” of a drug.
Writing on the Spicy IP law blog, which focuses on intellectual property issues in India, Shamnad Basheer, a chaired professor in IP law at the National University of Juridical Sciences in Kolkata, wrote that “it would appear that the reasoning of the IPAB is flawed in some aspects” and notes that it is unclear whether those flaws will impact their final conclusion that Novartis ought not to get the patent.
“The IPAB held that while the claim covering the beta crystalline (BC) version of IM (Imatinib Mesylate) is both novel and inventive, it fails the test under section 3(d), which requires a demonstration of ‘significantly enhanced efficacy,’” Basheer wrote. “If IM is indeed ‘known’ from the [1993] patent application covering the Imatinib free base, the key question would be: would a skilled person have found it obvious to get from IM to the BC version of IM? Or would the skilled person have been likely to pursue another polymorphic form or derivative? The IPAB holds that the skilled person might not have been motivated to get to the BC version specifically,” he says.
“However, their reasoning on this account is not completely convincing. Particularly in the light of expert evidence submitted by IICT (on behalf of the opponents) that when preparing IM, one would inevitably get the BC cystals. The IPAB rightly concluded that the ‘inevitability’ of always getting to the BC version was in doubt since there could be other processes by which one could make the BC version of IM (and not just the process used by IICT),” said Basheer.
“However, the fact that when some processes are used, one does get to the BC version should itself suggest that a skilled person may have been likely to get to the BC form when experimenting with IM. The court also suggests that Novartis may be entitled to a selection patent on this count. Here again, I'm not entirely convinced,” said Basheer. “But this [issue] will have to wait for another day.”
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