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In a development that will bring some relief to breast cancer patients, Swiss drug-maker Roche has said that it will not pursue the patent on Trastuzumab, used to treat women with HER2-positive breast cancer.
Marketed as Herceptin, the drug has been in the spotlight as pro-health campaigners urged the Government to issue a compulsory licence on the drug, so that other companies would be able to make less-expensive versions.
Misses renewal date
A Roche spokesperson said, “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 "Trastuzumab" patent) and the related divisional applications. This decision takes into account the strength of the particular rights and the IP (intellectual property) environment in India.” The development comes against the backdrop of Roche reportedly losing its patent on Herceptin since it had missed the annual renewal date. In fact, Roche’s divisional patents on the drug too were treated as withdrawn by the Kolkata patent office due to non-adherence to procedure or incorrect filing.
The Herceptin imbroglio notwithstanding, Roche said it would “continue to enforce other patents covering our drugs in India”. The Herceptin patent expires in 2019 and media reports peg local sales from Herceptin at Rs 130 crore.
On a more ominous note, Roche pointed out, “While the patent for Trastuzumab may no longer be in force, it is important to note that there are currently no approved biosimilars of Trastuzumab in India.”
Reliable drug
An estimated 25,000 new cases of HER2-positive breast cancer are added every year, according to health campaigners.
Women with breast cancer are put through the HER2 test and if they are positive, the drug is given to them, both as a first line or advanced form of treatment depending on the spread of the cancer, explains Kumar Prabhash, a medical oncologist with Mumbai’s Tata Memorial Hospital for cancer.
Herceptin costs about Rs 6 lakh for a course of 12 injections.
The company has a tie-up with Pune’s Emcure to sell the drug at a lesser price.
Roche further pointed out that Trastuzumab's patent status had no effect on the availability of the product in India.
“We have already introduced a local pricing and branding structure, in partnership with the local company, for a number of our drugs, including Trastuzumab, and are reviewing the impact of this programme,” it added.
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