India revokes GSK’s cancer drug patent
Mumbai: India has revoked a patent granted to GlaxoSmithKline for breast cancer drug Tykerb, a decision that follows a landmark India court ruling disallowing patents for incremental innovations that was a blow to global pharmaceutical firms.
However, the Intellectual Property Appellate Board (IPAB) upheld a patent granted on the original compound, or active pharmaceutical ingredient, lapatinib, citing innovative merit. As a result, a GSK spokesman said its medicine would remain subject to patent protection until 2019.
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 Supreme Court in April rejected a patent for Novartis AG’s cancer drug Glivec, saying it was an amended version of a known molecule called imatinib, setting the precedent for more such cases in the country.
GSK had cut prices of Tykerb by about a third in India as part of a flexible pricing programme designed to make important drugs more affordable in certain emerging markets.
Western drugmakers who covet a bigger share of India’s fast-growing $13 billion drugs market have been frustrated by a series 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 asthma treatment aerosol suspension formulation. All were revoked on grounds that included lack of innovation.
Fresenius Kabi Oncology, the Indian unit of German healthcare group Fresenius SE, had challenged patents granted for both the original molecule and its marketed salt version, saying both molecules lacked innovation.
“We are studying the IPAB’s decision but maintain our belief in the inventiveness of the lapatinib ditozsylate salt and will consider the possibility of taking further steps,” the Indian unit of GSK said. It can make an appeal on the decision to Supreme Court.
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