Roche India gives up patent for breast cancer drug

Breast cancer drugs

A victorious Campaign for Affordable Trastuzumab calls for generic manufacturers to come forward and apply for licences to manufacture biosimilars of Trastuzumab so as to provide affordable medicines for women who are battling HER2+ breast cancer

By Team FI

The Campaign for Affordable Trastuzumab came to fruition on 15 August, 2013, when the Swiss pharmaceutical company Roche declared that it is relinquishing the patent for its breast-cancer drug Trastuzumab in India. The announcement was welcomed by the Campaign which was initiated in November 2012 and endorsed by several Indian and global patient associations, cancer survivors, health movements, women’s rights activists and eminent jurists.

A press release from the Campaign stated that this decision, “…brings hope of a disease-free life for the thousands of Indian women who are battling HER2+ breast cancer.” The campaign had been working to bring awareness of the Roche’s “predatory pricing policy on women with HER2+ breast cancer,” and urged the Indian government to allow production of biosimilars of Trastuzumab. The press release stated that its research into the issue has “uncovered serious anomalies and irregularities in the Indian patent, which appears to have been granted in violation of Sections 3(d) and 3(e) of the Indian Patent Act and is therefore unlikely to survive a legal challenge. Our inquiries also reveal a consistent pattern of bureaucratic manoeuvres to delay and deflect legal challenges to the Roche patent.”

Earlier this year an Expert Committee set up by the Health Ministry had recommended for compulsory licensing for Trastuzumab. The Campaign opined that, “…the decision to relinquish the patent on Trastuzumab is a tactical move by Roche to avoid compulsory licensing, which would have much more serious and far-reaching implications for its plans in the Indian market. Roche is already questioning the approval given to Dr Reddy’s Laboratories for the production of a biosimilar version of the lymphoma drug Rituximab, which will pose stiff competition to Roche’s MabThera. Roche is also planning to launch successors to Trastuzumab in the US and European markets before 2014, when biosimilars can be expected to enter the market.”

The Campaign urges generic manufacturers in India to come forward immediately and apply for licenses to manufacture and market biosimilars of Trastuzumab. The Campaign also urges the government to ensure a fast-track process for regulatory approval of biosimilars, and make Trastuzumab available through the public health system.

One comment


    Thanks for carrying this story.

    Just to point out that this is not the end of the Campaign – only the first step forward in what promises to be a long struggle. Roche has relinquished the patent, but we still need to get the government to step in with support for biosimilar manufacturers to develop their products, conduct clinical trials and obtain regulatory approval for production and marketing. We also need to build pressure for Trastuzumab to be made available through the public health system. For prices to be kept low, we have to see that one or two big players like Biocon and Reliance don’t step in and monopolise the market – they would be no better than Roche. We are in touch with several of the other credible generic manufacturers and are trying to push their case with the government.

    These are the demands with which we launched our Campaign, and we will continue to mobilise public support around them.

    As we have said in our press release, Trastuzumab is not the only drug where patent barriers stand between us and our right to a healthy life. We have decided to set up a “Pharma PatentWatch” to monitor the activity around the 50 or so Indian patents on so-called “blockbuster drugs”. We are finding a lot of dubious claims and irregularities in the grants of many of these patents, and are now working on a strategy to challenge these en bloc rather than one by one.

    We will keep yu posted on developments, and look forward to the continued support of everyone on the Feminists India list as we move into Phase-II of the Campaign.

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