The country's Intellectual Property Appellate Board upheld a GSK patent granted on the active pharmaceutical ingredient in Tykerb, lapatinib, citing innovative merit. However Tykerb is the salt form of lapatinib and the board decided it represents an incremental innovation, so patent protection for the drug has been pulled.
The move follows the end of the long-running landmark case settled in April when the Supreme Court of India rejected Novartis' application to patent an updated version of its cancer drug Glivec (imatinib). The Tykerb case was brought by Fresenius which had challenged patents granted to GSK for both the original molecule and Tykerb, saying both lacked innovation.
GSK issued a statement, reported by Reuters, said that "we are studying the IPAB's 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". However the firm added that it is pleased the board upheld the basic patent for the lapatinib compound, which expires in January 2019.
GSK had already cut prices of Tykerb by a third in India as part of a flexible pricing programme for certain emerging markets. Reuters reported that a strip of 10 Tykerb tablets costs about 4,160 rupees (about £45) and a patient should take five tablets a day for 21 days if the cancer is in an advanced stage.
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