GlaxoSmithKline plc (GSK) has received major setback today after India's Patent Appeals Board (IPAB) revoked a patent granted to GSK's breast cancer drug Tykerb, which is a salt form of the original compound, lapatinib. The orders came on applications filed by Fresinius Kabi Oncology Ltd., the part of Fresenius SE & Co KGaA, Germany.
GlaxoSmithKline Pharma, the Indian arm of GSK, scrip closed down today by 2.9 per cent or Rs.67.25 on BSE to Rs.2,265. The scrip touched to its yearly high at Rs.2,899 on June 3, 2013.
According to reports GlaxoSmithKline Pharma India is looking at the IPAB's this decision and taking further steps to put up the case before the appropriate authorities. Currently, a strip of 10 Tykerb tablets costs about Rs. 4,160 in India.
However, the IPAB has upheld a patent granted to the original compound, or active pharmaceutical ingredient, citing innovative merit. GSK expressed pleasure regarding upheld of its basic patent for the lapatinib compound, the active ingredient in Tykerb by the IPAB in India The patent is set to expire in January 2019.
Fresenius Kabi Oncology, had challenged patents granted for both the original molecule and it's marketed version Tykerb, saying both molecules lacked innovation.
During April 2013, the Supreme Court of India rejected a patent for Novartis AG's cancer drug Glivec in April on ground that it was an amended version of a known molecule called imatinib. During 2012, Pizer, Roche Holding AG and Merck & Co also received same treatment for Sutent, Pegasys and asthma treatment aerosol suspension formulation on grounds that these drugs lack any innovation.
"This decision is just like the landmark Glivec ruling. The IPAB has said that the salt version of lapatinib cannot hold a patent," said lawyer Dominic Alvares of S. Majumdar & Co, which represented Fresenius Kabi in the case.