Another blow for Pharma, as India revokes Tykerb patent

UK pharma giant GlaxoSmithKline (LSE: GSK) has confirmed that India’s Intellectual Property Appellate Board (IPAB) today (August 2) has issued an order revoking a patent on its breast cancer drug Tykerb (lapatinib), marking another setback for research-based drugmakers in protection their intellectual property in that country.

The move follows the end of the long-running landmark case settled earlier this year, when the Supreme Court of India rejected Novartis' application to patent an updated version of its cancer drug Glivec (imatinib; The Pharma Letter April 2). Others to have suffered as a result of Indian patent revocation – aimed at providing cheap generics for the country’s population – include Pfizer, Roche and Merck & Co. GSK had already cut prices of Tykerb by a third in India as part of a flexible pricing program for certain emerging markets.

However, the IPAB dismissed another revocation petition on the basic patent of the same drug. The orders came on applications filed by Fresenius Kabi Oncology, reported the local newspaper Business Standard. The IPAB ordered that the claimed invention of a salt variation of the drug, under Patent No IN221171, lapatinib ditosylate, "is obvious and is hit by Section 3(d) and Patent No 221171 is revoked."