However, the Board has upheld the patent for Lapatinib compound, which is the active ingredient in Tykerb, citing innovative merit. Tykerb is the salt form of Lapatinib compound that is sold in the country.
The ruling was delivered on July 27 by Justice Prabha Sridevan, Chairperson of the Chennai Bench of the patent appeals agency which functions under the Commerce Ministry.
When contacted, a GSK Pharma India spokesperson said the Board's ruling was a mixed bag for the company.
"We are disappointed that the IPAB has revoked our expiring patent for the Lapatinib ditosylate salt. This 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,” he said.
"We are studying the IPAB 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," the spokesperson said in an e-mail response.
"The company, however, is happy that the IPAB has upheld our basic patent for the Lapatinib compound, which is the active ingredient in Tykerb. This patent has an expiry date in January 2019," the spokesperson said.
"Tykerb has been providing significant benefit to Indian women with HER-2 positive breast cancer for over four years it has been available here," the statement said.
"As part of our access strategy, we already offer significantly discounted prices for Tykerb here. We will continue to take steps to ensure that Tykerb is available to women with breast cancer," GSK added.
The Supreme Court in April had rejected a patent plea from Novartis AG's cancer drug Glivec, saying it was an amended version of a known molecule called Imatinib.


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