India revokes Roche’s Valcyte patent
pharmafile | May 19, 2010 | News story | Sales and Marketing | India, Roche, patents
Indian authorities have revoked a patent granted in 2007 for Roche’s brand Valcyte, saying it had been wrongly granted.
The decision was welcomed by patient groups and aid agencies, and opens the way for cheaper generic versions of Valcyte (valgancilovir) to enter the market.
The drug is primarily used in organ transplant patients to prevent an infection caused by cytomegalovirus (CMV), but can also be used to treat CMV retinitis, a condition that people living with HIV are prone to, and which has the potential to blind.
The patent challenge was made on the grounds that valgancilovir was simply an improved form of an existing drug called ganciclovir.
“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 Médecins Sans Frontières (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.”
The authorities ruled that the drug did not show increased therapeutic efficacy, something it needed to do under section 3(d).
The manufacturer may decide to appeal against the Indian Patent Office’s judgment, but at the time of writing had not returned Pharmafocus’ call.
Patient groups which filed an opposition to the patent were pleased by the decision, arguing that it makes access to cheaper drugs possible.
“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.
“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.”
MSF said Roche markets a four-month course of the drug in India for up to $5,950, and even when this was discounted rate it was still high enough to cause some of its AIDS projects to opt out of providing it.
Adam Hill
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