Victory for access to medicines as Valaganciclovir patent is overturned

International medical humanitarian organisation Médecins Sans Frontières (MSF) welcomes the decision by the Indian Patent Office to set aside the 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 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. Read more



"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 obtaining 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.

Background
In June 2007, Roche was granted a patent for valganciclovir in India, but the Chennai Patent Office (one of four offices that make up the Indian Patent Office) took this decision without hearing the arguments of public interest groups, including the Indian Network for People Living with HIV/AIDS (INP+) and the Tamil Nadu Networking People with HIV/AIDS (TNNP+), that opposed the granting of the patent.


In December 2008, the Madras High Court in Chennai therefore decided to set aside Roche's patent until these arguments could be heard. The Chennai Patent Office, during the course of this hearing, refused to hear all the arguments made by the oppositionists and rejected the pre-grant opposition, after which the public interest groups approached India's Supreme Court.


The Supreme Court directed the groups to join the post-grant opposition proceedings that were already taking place through oppositions filed by generic companies and the Delhi Network of Positive People (DNP+). At this stage Roche challenged the legal standing of DNP+ to oppose the patent after it had been granted, claiming an ambiguity in India's patent law.


Having heard the arguments of all the public interest groups and the generic companies, the Indian Patent Office has now determined that Roche's claims for a product patent on valganciclovir were invalid and recognised only the validity of one of the process claims made by Roche. It has also held that patients groups can file post-grant oppositions.

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