Victory for access to medicines as valganciclovir patent is rejected in India

Geneva/New Delhi - International medical humanitarian organisation Médecins Sans Frontières (MSF) welcomes the decision by the Indian Patent Office to reject the product patent it had previously granted to the pharmaceutical company Roche for the drug valganciclovir.

Valganciclovir is primarily used as treatment and prevention of an infection caused by cytomegalovirus (CMV) in organ transplant patients, a highly lucrative market which Roche has sought to defend by patenting the medicine. But CMV also affects people living with HIV and, if left untreated, can cause blindness and death.

“Roche was attempting to patent a new form of a drug that was really invented in the 1980s,” said Leena Menghaney, Project Manager of the MSF Campaign for Access to Essential Medicines in India. “This decision shows that Section 3(d) of India’s Patents Act, which prevents companies from filing unjustified patents, is working. Equally importantly, the Patent Office also found separately that the patent claims were obvious and therefore not patentable.”

Through this decision, the Indian Patent Office has also confirmed the right of patients groups to oppose a patent after it has been granted, a matter on which Roche claimed there was ambiguity. This follows a similar recognition in 2002 in Thailand of patients as ‘persons interested’ in the outcome of a patent application.

“For people living with HIV/AIDS in developing countries, accessing valganciclovir at Roche prices was difficult,” said Loon Gangte of the Delhi Network of Positive People (DNP ), one of the patient groups that filed an opposition to the patent. “The decision will provide much needed relief as it secures the way for generic competition, which is the most effective and sustainable way of bringing drug prices down.”

To date, the price of valganciclovir is prohibitively expensive – Roche markets the drugs for up to US$8,500 for a four-month treatment course in high-income countries. In India, the Roche price for a standard protocol is approximately $5,950. In December 2006, MSF approached Roche for a discount, but even the ‘discounted’ price was so high that some MSF AIDS projects opted out of providing this treatment for CMV.

“This is one victory for access to medicines, but we have to be careful not to lose an even bigger fight,” said Leena Menghaney. “India is currently negotiating a free trade agreement with the EU. If the country agrees to introduce stricter intellectual property provisions such as data exclusivity as a part of these talks, this would allow companies to create new monopolies on medicines – even where patents have been rejected as in the present case.”

MSF will continue to follow this issue closely should Roche decide to appeal.