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* Patent appeal board revokes patent on GSK's Tykerb
* Board upholds patent on original compound lapatinib
* GSK says considering taking further steps, may appeal
* Ruling follows Supreme Court decision on Glivec in April
By Kaustubh Kulkarni
MUMBAI, Aug 2 (Reuters) - India has revoked a patent grantedto GlaxoSmithKline Plc for breast cancer drug Tykerb, adecision that follows a landmark India court ruling disallowingpatents for incremental innovations that was a blow to globalpharmaceutical firms.
However, India's Intellectual Property Appellate Board(IPAB) upheld a patent granted on the original compound, oractive pharmaceutical ingredient, lapatinib, citing innovativemerit.
As a result, a GSK spokesman said its medicine would remainsubject to patent protection until 2019. The additional patenton the particular salt of lapatinib used in Tykerb, which hasnow been rejected, would have extended that protection to 2021.
India's Supreme Court in April rejected a patent forNovartis AG's cancer drug Glivec, saying it was anamended version of a known molecule called imatinib, setting theprecedent for more such cases in the country.
GSK had cut prices of Tykerb by about a third in India aspart of a flexible pricing programme designed to make importantdrugs more affordable in certain emerging markets.
Western drugmakers who covet a bigger share of India'sfast-growing $13 billion drugs market have been frustrated by aseries of decisions on intellectual property and pricing.
Last year, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's hepatitis C drug Pegasys, and Merck & Co's asthmatreatment aerosol suspension formulation. All were revoked ongrounds that included lack of innovation.
Fresenius Kabi Oncology, the Indian unit of Germanhealthcare group Fresenius SE, had challenged patentsgranted for both the original molecule and its marketed saltversion, saying both molecules lacked innovation.
"This decision is just like the landmark Glivec ruling. TheIPAB has said that the salt version of lapatinib cannot hold apatent," said lawyer Dominic Alvares of S. Majumdar & Co, whichrepresented Fresenius Kabi in the case.
The IPAB rulings for both the patent disputes were uploadedon its website late on Thursday.
Shares in GlaxoSmithKline Pharmaceuticals, the UKcompany's Indian unit, fell 2.8 percent on Friday.
The company can make an appeal on the decision to India'sSupreme Court.
"We are studying the IPAB's decision but maintain our beliefin the inventiveness of the lapatinib ditosylate salt and willconsider the possibility of taking further steps before theappropriate authorities to validate this," the Indian GSK unitsaid in an email to Reuters on Friday.
"We are pleased that the IPAB in India has upheld our basicpatent for the lapatinib compound, the active ingredient inTykerb." GSK said. The patent expires in January 2019.
A strip of 10 Tykerb tablets costs about 4,160 rupees ($69)in India and a patient is expected to take five tablets a dayfor 21 days if the cancer is in an advanced stage.
Western pharmaceutical companies, looking to emergingmarkets such as India to help drive growth, have run intovarious obstacles recently, ranging from corruption and pricingprobes in China to stock management problems in Brazil.
