Monday, August 19, 2013

Roche relinquishes Trastuzumab patent in India

Swiss pharma major Roche has just announced that it is relinquishing the patent for its breast-cancer drug Trastuzumab in India. The announcement comes in the face of mounting challenges - from both civil society and the Ministry of Health -  to Roche's monopoly on this life-saving drug. 
The Campaign for Affordable Trastuzumab welcomes the announcement, which comes appropriately on India's Independence Day and brings hope of a disease-free life for the thousands of Indian women who are battling HER2+ breast cancer.
The Campaign for Affordable Trastuzumab - initiated in November 2012 and endorsed by over 200 Indian and global patient associations, cancer survivors, health movements, women's rights activists and eminent jurists – has been working to highlight the lethal impact of Roche's predatory pricing policy on women with HER2+ breast cancer, and has been urging the government to allow production of biosimilars of Trastuzumab. The Campaign's arguments were vindicated earlier this year with the recommendation for compulsory licensing for Trastuzumabby an Expert Committee set up by the Health Ministry to look into the issue.
The Campaign urges generic manufacturers to come forward immediately and apply for licences to manufactureand 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.
In the course of its research into the patent landscape for Trastuzumab, the Campaign 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. Our findings highlight the need for review and strengthening of the system for screening applications and awarding patents, as well as closer oversight of the functioning of patent officesThis is an issue that we intend to pursue,with support from all those who have endorsed our efforts on Trastuzumab.
We are well aware 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.
Trastuzumab is not the only case where patent barriers are violating the right to life of Indian citizens. We hopethe outcome of this case will strengthen the resolve of our government to resist arm-twisting by big pharma and their backers in the global North and continue to take a tough line on patent issues in international trade negotiations. Millions of people across the developing world look to India to defend and expand their access to life-saving medicines at affordable prices. The message is clear - the right to health cannot be held hostage to the greed for profits of pharma majors.