Valcyte is the name Roche uses to market valganciclovir, a medicine that prevents infections in people who suffer from HIV/AIDS and patients who have undergone organ transplants.
The Chennai patent office granted a patent for Valganciclovir in 2007 without hearing a pre-grant opposition filed by non-profit organization the Lawyers Collective.
Ranbaxy launched a post-grant opposition to the patent grant on February 12 2008 and in June the Delhi Network of Positive People, an organisation representing the needs of people living with HIV/AIDS, also filed an opposition.
Leena Menghaney, a campaigner for humanitarian organisation Médecins Sans Frontières, told Managing IP that the NGO launched the post-grant opposition because of the increasing importance of the drug for preventing infection in AIDS and organ-transplant patients and because the decision to grant the patent "was a clear case of not implementing the legal safeguards against evergreening a new form of an old drug - ganciclovir was granted a patent. The implementation of Section 3(d) was something we fought for and we have to defend".
The term evergreening refers to the practice of extending the lifespan of drugs by filing minor variations on the original patent. Section 3(d) of India's Patent Act is designed to prevent this by setting out what is not patentable subject matter, including "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance".
Post-grant oppositions take a long time to be decided, according to Menghaney, who claims that in another opposition that MSF is following it took more than a year between the filing of the opposition and the first hearing.
Rather than waiting for the opposition to run its course, Cipla decided earlier this month that it would start making a generic version of the drug under the brand name Valcept.
This is the second patent infringement suit Roche has brought against Cipla. In January this year the company brought a case against Cipla in the Delhi High Court over the anti-cancer drug erlotinib, which Roche sells under the name Tarceva, and asked for an interlocutory interim injunction. Cipla had launched a generic version called Erlocip.
On March 19 Judge Ravindra Bhat denied the injunction request but asked Cipla to keep record of the money it makes from selling its version of erlotinib so that damages can be calculated if the decision is different after a full trial.
Roche appealed and a division bench of the High Court finished hearing the arguments on September 15 this year. A verdict is expected within two months.
The News Focus in the May edition of Managing IP looks at India's pharmaceutical patent litigation in more detail.
