NEW DELHI: India has revoked a local patent granted to Britain’s GlaxoSmithKline for a breast cancer drug in the latest blow to global companies seeking a bigger presence in the country’s $13bn medicine market.
Tykerb, one of the most widely prescribed breast cancer treatments in India used to treat advanced forms of the disease, is a newer version of GlaxoSmithKline’s (GSK) original anti-breast cancer drug lapatinib.
The patent board revoked the patent for Tykerb, calling it an incremental improvement of the original compound and not sufficiently innovative to warrant a patent.
The ruling, underscores Indian authorities’ tough stance against what is called “evergreening” or minor changes to a drug to extend its patent shelf life, said lawyer Dominic Alvares, part of the team which challenged GSK’s Tykerb patent.
“India has some of the toughest patent laws — and they are based on public interest,” Alvares, of S. Majumdar and Co, said.
Once drugs go off patent, they can be sold more cheaply.
The latest ruling only affects GSK’s newer patent, not the original patent for the main active ingredient in the drug, lapatinib, which expires in 2019.
For the first time, the patent board acted on a complaint filed by another international pharmaceutical firm rather a local company.
The challenge to GSK’s patent was launched by an Indian subsidiary of German health group Fresenius. It had disputed the patents both for the original molecule and Tykerb.
“We are pleased that the Intellectual Property Appellate Board in India has upheld our basic patent for the lapatinib compound, the active ingredient in Tykerb,” said a GSK official who did not wish to be named.
“We are, however, disappointed that the board has revoked our later expiring patent (in 2021) for the lapatinib ditosylate salt,” the official said, adding GSK was considering an appeal.
Western drug-makers are seeking to win a larger part of India’s rapidly expanding drugs market, valued at around $13bn.
AFP
