MUMBAI: The Intellectual Property Appellate Board (IPAB) has upheld a patent granted on the original compound (lapatinib) of GSK’s breast cancer drug , Tykerb , which ensures monopoly rights on the drug till 2019 in the domestic market. The IPAB however rejected the patent on the salt formulation of lapatinib used in Tykerb, which would have further extended that protection to 2021.

The orders came on the applications filed by Fresinius Kabi Oncology Ltd.

On July 27, the IPAB held that the main compound patent was valid, while revoking the second one, the patents watchdog held that that the invention is obvious and is hit by Section 3(d).

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.

"This decision is just like the landmark Novartis 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.

Elaborating on the case, Leena Menghaney, a lawyer with international humanitarian agency MSF said, "this was a classic case of evergreening, and that is why Indian law on patentability is important as it creates an opportunity to address this problem. In this case more than two years of patent extension - blocking generic entry till 2020 - has been avoided".