Victory for Access to Medicines as Patent Rejected in India

The international medical humanitarian organization Doctors Without
Borders/Medecins Sans Frontieres (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.