Cipla, NGO to contest patent grant to Roche

Cipla, NGO to contest patent grant to Roche

The patent office at Chennai is headed for a new controversy over a patent it granted to an anti-HIV drug made by Swiss drug maker F. Hoffman-La Roche Ltd, with an Indian pharma firm and a local voluntary organization planning to challenge this.

The patent office has been in the news for refusing a patent to Novartis AG’s anti-cancer drug Glivec in 2006, a refusal that resulted in a court battle.

This time, the drug involved is Roche’s anti-HIV one, valganciclovir. As reported by Mint on 26 September, the Chennai patent office granted a patent to the drug without hearing groups opposed to this—the first time such a thing was done. Lawyers Collective, a Mumbai-based non-governmental organization (NGO) is moving the Madras high court against the patent office’s decision. And domestic drug maker Cipla Ltd plans to challenge the patent by filing a post-grant opposition.

Girish Telang, managing director, Roche Scientific Co. (India) Pvt. Ltd, Roche’s Indian arm, declined comment.

“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 Lawyers Collective.

“We had written to the patent officer for an explanation soon after the office published this patent. However, he has not responded to the letter," he added. Cipla’s managing director Amar Lulla said the firm was preparing a post-grant opposition that will be filed at the Chennai patent office.

The patent awarded to Roche in September prevents makers of off-patent, or generic, drugs in India from copying the drug. 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.

On the basis of that provision, Cipla is developing a copy of valganciclovir, which, according to Lulla, “is expected to get a marketing approval from the drug controller shortly and available in the market by early 2008."

Currently, there is no other generic version of the drug, an important medicine used by HIV patients to ward off infection. Valganciclovir, sold by Roche as Valcyte, was invented by the company in 1994. This drug was patented first in the US the same year.

Anand Grover, project director, Lawyers Collective, claimed valganciclovir is an important drug for HIV patients and that Roche had priced it exorbitantly. Roche charges about $9,900 (nearly Rs3.96 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 third world countries.

An official at the Chennai patent office, who is not authorized to speak to the media, said in an earlier phone interview that the office was not required to listen to pre-grant opposition before granting a patent. However, legal experts differ. “There is no precedent in India so far where a patent is granted without hearing a pre-grant opposition," said Gopakumar Nair, a senior patents lawyer.

In the Glivec case, Novartis has appealed against its patent being rejected to the country’s Intellectual Property Appellate Board, or IPAB.