August 3, 2013 12:53:24 am
The Intellectual Property Appellate Board (IPAB) has revoked GlaxoSmithKlines (GSK) patent in India for its breast cancer drug Tykerb,a decision that took its cue from a recent landmark Supreme Court ruling disallowing repetitive patents on the same drug.
The board has,however,upheld the patent for lapatinib,the original compound,citing innovative merit,which means GSKs exclusive rights on the basic drug would continue till the patent expires in January 2019.
However,the revocation of patent for Tykerb or lapatinib ditosylate monohydrate,a salt form of lapatinib,would however expose the company to likely generic competition.
The additional patent on the particular salt of lapatinib used in Tykerb,which has now been rejected,would have extended that protection to 2021.
The IPAB bench comprising Justice Prabha Sridevan,chairman,and DPS Parmar,technical member (patent),ordered that the claimed invention,the salt version of the original drug,is obvious and,therefore,has been revoked.
According to our Act,the patent is revoked if the invention is obvious. So the secondary considerations cannot change that, the order said.
This bears out Indias policy stance,denounced by global Big Pharma,that incremental inventions lacking enhanced therapeutic efficacy as assessed by the patenting authorities under Section 3(d) of the Patents Act wont qualify for patents.
We are pleased that the IPAB has upheld our basic patent for the lapatinib compound,the active ingredient in Tykerb, said a GSK spokesperson.
However,expressing disappointment over the revocation of the patent for the lapatinib ditosylate salt,the spokesperson added,We are studying the IPABs decision but maintain our belief in the inventiveness of the lapatinib ditosylate salt and will consider the possibility of taking further steps before the appropriate authorities to validate this.
In April,the Supreme Court,in a landmark ruling,rejected Swiss drug-maker Novartis plea for a patent for its anti-cancer drug Glivec beta crystalline of a known molecule called imatinib mesylate saying it lacked novelty and failed to meet the countrys patenting standards.
GSK said it had cut prices of Tykerb by about a third in India as part of a programme designed to make important drugs more affordable. We will continue to… ensure that Tykerb is available to women with breast cancer in India who need it, the company said.
The scrip of GSK Pharma,the Indian arm of GSK,ended Friday down 2.9 per cent on the BSE at Rs 2,265.
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