Victory for Access to Medicines as Patent Rejected in India

May 5, 2010Geneva/New Delhi —The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) welcomed the May 5 decision by the Indian Patent Office to reject a product patent it had previously granted to 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 that Roche has sought to protect 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.

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