Glivec – what's at stake for Novartis and for India?
In the latest round of the fight in India over Glivec, Novartis challenges rejection of its Glivec crytalline form patent by the Indian Patent Office on two grounds.
(1) the patent was improperly rejected as being a new form of a known substance even though it has 30% greater bioavailability.
And, more interestingly;
(2) The Indian legislation does not comply with TRIPS. The section of interest is s 3(d), which was added in the much — heralded 2005 amendments.
Clearly this is important to Novartis — the Glivec market is enormous. (On that, Novartis has already commenced some important positioning in its objection to the composition of the newly formed Indian Patent and Trademark Appellate Board (IPAB).)
s 3(d) states:
‘the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.â€
Interestingly, to the best of my knowledge, India has never granted a compulsory license — no doubt that will be the next port of call if Novartis prevails in this case.
This is more important for India than for Novartis.
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