The IPAB said Tykerb, the salt form of Lapatinib, GSK Pharma's original anti-cancer molecule, did not meet the basic invention criteria to qualify under section 3(d) of the Patent Act. (Agencies)
However, the IPAB upheld the patent of GlaxoSmithKline Pharmaceuticals's original compound Lapatinib, citing innovative merit. Lapatinib has a patent valid until 2019. The development follows Swiss drug maker Novartis losing the patent battle in April for its Glivec in the Supreme Court, which raised concerns among global pharma firms about India's patent regime. The Apex Court had prevented drug companies from claiming patents for incremental innovations.
The order was passed on a petition by Fresenius Kabi Oncology, which challenged the patents granted for the original molecule and its marketed version, Tykerb, saying both lacked innovation. The ruling was delivered on July 27 by Justice Prabha Sridevan, chairman of the IPAB's Chennai bench. The British drug major had slashed the price of Tykerb by more than a third recently.
A GSK Pharma India spokesperson said that the ruling is a mixed bag as the patent for its basic Lapatinib compound has been upheld, while that of Tykerb has been revoked. "We are disappointed that the IPAB has revoked our later expiring patent for the Lapatinib ditosylate salt. This latter ruling only relates to the Lapatinib ditosylate salt patent in the country and does not affect our basic patent for Tykerb or corresponding patents in other countries.
The IPAB ordered that Lapatinib ditosylate, the claimed invention of the salt variation of the drug under Patent No IN221171, "is obvious and is hit by section 3(d) and Patent No 221171 is revoked."
The board said, "According to the Patent Act of 1970, the patent is revoked if the invention is obvious and the applicant has failed to provide evidence on the contrary." GSK Pharma shares lost almost 3 percent to close at Rs 2,271.55 on the BSE on Friday.
The IPAB said Tykerb, the salt form of Lapatinib, GSK Pharma's original anti-cancer molecule, did not meet the basic invention criteria to qualify under section 3(d) of the Patent Act.