Mumbai: The office of India’s controller general of patents has ordered an inquiry into the decision of the Chennai patent office to grant a patent to F Hoffman-La Roche Ltd, for its drug valganciclovir, which the Swiss drug maker sells under the brand Valcyte, without hearing an opposition filed by a patient group as mandated under Indian patent rules.
The drug is used to treat infection related to HIV/AIDS and organ transplants.
The inquiry will study whether procedures were flouted by officials in granting the patent. The Chennai patent office had in September granted a patent for Roche’s drug, despite a pre-grant opposition filed by the Mumbai-based lawyers body, Lawyers Collective, on behalf of its clients. The patent awarded to Roche in September prevents makers of off-patent or generic drugs in India from copying it. Lawyers Collective had filed a pre-grant opposition to the valganciclovir patent application of Roche in 2006 on the ground that the drug was a pre-1995 molecule. Drugs patented elsewhere 10 years before the Indian Patents Act of 2005 are not eligible for patent protection in India.
Trouble brews: The F Hoffman-La Roche office building in Basel, Switzerland.
A person familiar with the development, who didn’t want to be identified, said: “A departmental enquiry, ordered on the basis of newspaper reports, is currently on and the officials concerned at the Chennai patent office have been questioned.”
V. Rangaswami, chief patent controller at Chennai, confirmed discussions at his office “after the centre asked for an explanation for not giving a hearing to the opponents”.
Mint on 26 September first reported that the Chennai patent office had granted a patent to Roche without hearing groups opposed to it; this was a first time ever a patent had been granted without listening to the opposition.
Lawyers Collective plans to legally challenge the decision. “We are filing a petition in the Madras High Court against the Chennai patent office as it failed to give us an explanation for granting the patent without hearing us,” said Chan Park, a senior technical and policy adviser at the lawyer group, adding it had written to the patent officer for an explanation soon after the Chennai office published the Roche patent, but was yet to receive a response.
Domestic drug maker Cipla Ltd plans to challenge the patent by filing a post-grant opposition.
“Denying the opponent an opportunity to present his/her objection is a violation of fundamental rights,” said Mumbai patent attorney Gopakumar Nair. “In the case of a pre-grant opposition of patents, it is a violation of patent law, provided the opponent had asked for a hearing.”
Although there are no local generic versions of this drug yet launched here, Cipla is currently developing a copy of valganciclovir, which, according to its managing director Amar Lulla “is expected to get a marketing approval from the drug controller shortly and ...be available in the market by early 2008.”
Girish Talang, managing director, Roche Scientific Co. (India) Pvt. Ltd, the Indian subsidiary of Roche, said on phone that “all questions (put to Roche) by the Chennai patent officer were answered before the patent grant” and declined further comment.