Mumbai: Adding fuel to an existing patent controversyinvolving Swiss drug maker F Hoffman-La Roche Ltd’s anti-infection drug Valcyte in India, the country’s largest drug company by revenue, Ranbaxy Laboratories Ltd, has legally challenged the Chennai patent office’s decision to grant a patent for the drug.
The Indian patent for Valcyte has been controversial as it was granted without hearing an opposition filed by two non-governmental organizations (NGOs)—the Indian Network for People Living with HIV/AIDS and the Tamil Nadu Networking People with HIV/AIDS.
Ranbaxy filed a post-grant opposition in the Chennai patent office last week questioning the validity of the Valcyte patent here as the drug was not proved for enhanced efficacy than what is already known.
Indian patent law, which was last amended in 2004 just before the country restarted product patents for drugs, doesn’t allow patent for drugs that are already known, unless they are proved for substantial improvement in treatment quality.
Mint had on 15 January first reported a US Patent and Trademark Office’s decision to deny a patent for valganciclovir back in 1994 because the drug had been in the so-called public domain for three years then, exposing the controversial decision of the Chennai patent office to grant a patent for the same drug here in 2007.
Valganciclovir, an anti-infection drug prescribed for HIV/Aids and organ transplantation-related infections, is the basic compound in Valcyte.
The US Patent and Trademark Office document also shows that while the original Roche claim for a comprehensive patent was indeed rejected, a patent was granted to the crystalline form of the drug based on findings that the crystalline modification eases the manufacturing process for the drug.
Ranbaxy’s patent attorney Laxmi Kumaran confirmed that a post-grant opposition has been filed at the Chennai patent office. This comes after the Mumbai-based law firm Lawyers Collective, which filed a pre-grant opposition to Roche’s patent application in 2006, contested the patent grant saying it was denied a hearing.
Another generic drug maker Cipla Ltd had also said that it would contest the patent by filing a post-grant opposition though it hasn’t yet done so.
Lawyers Collective is likely to contest the grant in the Madras high court.
Roche, which is currently fighting another patent case at the Delhi high court against Cipla for alleged infringement of its Indian patent for a cancer drug Tarceva, could not be contacted as its office was closed for the weekend.
Valcyte was granted a patent in India in June 2007.
An interested party has time until June to oppose the grant on valid grounds. Though there are no domestic generic brands of this drug launched in India so far, Cipla has plans to come out with a generic version soon, Cipla’s managing director Amar Lulla had said in an earlier interview.
A Ranbaxy executive, who doesn’t want to be identified, also said, “The company may launch a cheaper version of Valcyte in the domestic market.”
Roche charges around $9,900 (Rs3.92 lakh) for a three-month treatment of valganciclovir although it has reduced the price to $1,800 for NGOs and customers in Africa and some other countries in the developing world.