Swiss pharma major Roche
Holding AG today said it won't pursue the secondary patent
for its breast cancer
' in India.
"Regular reviews of our patent portfolio are a routine business practice. In this connection, Roche has come to the conclusion not to pursue Indian Patent No 205534 (the secondary patent for Trastuzumab
) and the related divisional applications," a spokesperson of Roche Holding AG told PTI in an emailed response.
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This decision takes into account the strength of the particular rights and the Intellectual Property
(IP) environment in India in general, the spokesperson added.
Earlier this month, Indian government had "treated as withdrawn" patent applications by Roche Holding for offshoot medicines of its drug 'Herceptin' because the company did not comply with local norms.
"While the patent for Trastuzumab (also known Herceptin) may no longer be in force, it is important to note that there are currently no approved biosimilars of trastuzumab in India," the company said.
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Herceptin, used to treat a particularly aggressive form of breast cancer, is Roche's third-biggest seller and notched up global revenues of 3.08 billion Swiss francs in the first half of the year.
"We support the Indian government's leadership in establishing a pathway and guidelines for the introduction of biosimilars onto the market that is based on science and is designed to ensure product quality and patient safety," the company said.
The government is looking at a possible issuance of compulsory licence for Roche's Herceptin. The Health Ministry in July submitted to the DIPP
all the details of the drug, amid calls to make it affordable.
In January, the Health Ministry had approached the DIPP for issuance of compulsory licences (CLs) for three anti-cancer three drugs -- trastuzumab, ixabepilone and dasatinib -- which are very expensive.