GSK loses breast cancer patent in India

India's Intellectual Property Appellate Board (IPAB) has revoked the patent for global pharmaceutical company, GlaxoSmithKline's anti-cancer drug Tykerb.

Tykerb (lapatinib) is a dual tyrosine kinase inhibitor that is used in combination therapy for HER2-positive breast cancer and is also used to treat patients with other solid tumours.

This decision follows India's recent landmark ruling disallowing patents for incremental innovations. GSK had already slashed prices of the anti-cancer drug by around a third in India as part of a flexible pricing programme to allow patients increased access to affordable drugs in emerging markets.

According to Reuters, GSK has said that Tykerb will remain subject to patent protection until 2019. The additional patent on the particular salt of lapatinib used in Tykerb, which has now been rejected by India's IPAB, would have extended that protection to 2021. GSK can make an appeal on the decision to India's Supreme Court.

"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.

"We are pleased that the IPAB in India has upheld our basic patent for the lapatinib compound, the active ingredient in Tykerb."

Indian GSK in an email to Reuters.

IPAB did, however, uphold GSK's patent on the original compound of lapatinib, citing innovative merit.