The Intellectual Property Appellate Board in India is at it again -- this time ruling that GSK's breast cancer drug Tykerb is patent ineligible (thought it did maintain a patent on the active ingredient lapatinib). Once again, the fact that Tykerb was considered "incremental innovation" was cited as the reason for the ruling.
This is consistent with last years denial of patent rights to Novartis' Gleevec (imatinib). India, as a policy matter, wants to promote greater availability of expensive cancer drugs to the poor so is using its more restrictive definition of "incremental improvement" to make these drugs accessible to local generic manufacturers to produce. In this case, Fresenius challenged the GSK patent and is the likely benefactor now that it has been ruled invalid. See PharmaTimes.
Ironically, GSK had already reduced the price of Tykerb to make it more market available. Too little too late, I suppose. GSK issued a statement saying "we are studying the IPAB's decision but maintain our belief in the inventiveness of the lapatinib difosylate salt and will consider the possibility of taking further steps before appropriate authorities to validate this." Stay tuned. Same Bat time. Same Bat channel.
Postd by Bruce Lehr Aug 2nd 2013.