The Intellectual Property Appellate Board (IPAB) in India has cancelled the patent for GlaxoSmithKline's (GSK) anti-cancer drug Tykerb in its salt form over failure in demonstrating significant improvement in the efficacy.
Fresenius Kabi's Indian subsidiary challenged the patent of lapatinib and the key ingredient in Tykerb, lapatinib ditosylate salt. While IPAB upheld lapatinib patent, salt version of the ingredient was revoked.
GSK spokesperson was quoted by The Economic Times as saying that the IPAB in India has upheld basic patent for the lapatinib compound, the active ingredient in Tykerb.
"We are, however, disappointed that the IPAB has revoked our expiring patent for the lapatinib ditosylate salt," spokesperson added.
"This latter ruling only relates to the lapatinib ditosylate salt patent in India and does not affect our basic patent for Tykerb or corresponding patents in other countries."
Used in the treatment of breast cancer, Tykerb's patent is valid until 2019 and the company believes that the patent for the salt is also holds good and will consider appealing the case.
Declaration by the IPAB on some drugs that do not meet the standards was based on Section 3 (d) of the Act.
