New Delhi / Mumbai: Mumbai-based Cipla Ltd is looking to launch a cheaper copycat version of Valcyte,a patented drug from the stable of Swiss firm F Hoffman-La Roche Ltd, a move that will likely intensify the fight between the two companies which are already battling it out in the Delhi high court over Cipla’s launch of another patented Roche drug, Tarceva.
“The company will be soon launching a cheap generic or off-patent version of valganciclovir (the generic name for Valcyte)... The price is going to be much lower compared to the available brand,” said a senior executive at Cipla who did not wish to be identified.
Girish Telang, managing director of Roche Scientific Co. (India) Pvt. Ltd, the Indian arm of F Hoffman-La Roche, declined comment on his company’s future course of action saying it would “be decided by the headquarters in Basel”.
He added that the “Indian patent law should be respected by everybody...”
The court battle over Tarceva, a cancer drug, has snowballed into a landmark patent litigation and the Delhi high court has refused to issue an order keeping generic copies of the drug off the market. A person familiar with the matter but who did not wish to be identified said that could have emboldened Cipla to test the waters with its copy of Valcyte.
Another person familiar with the matter, who also did not wish to be identified, said Cipla’s drug may be called Valcept. A pharma industry executive, who did not wish to be identified, said, “If Cipla were to sell Valcyte copies under its brand name Valcept, it will be a patent as well as trademark infringement due to ‘passing off’.”
“Passing off” is a term for companies using a trademark closely resembling another established trademark.
Public health groups are pleased with Cipla’s move.
An anti-infection drug used by HIV/AIDS patients, Valcyte was granted a patent in India in June 2007 by the Chennai patent office. Roche charges around $9,900 (Rs4.28 lakh) for a three-month treatment although it has reduced the price to $1,800 for non-governmental organizations and customers in Africa and some third-world countries.
“There is no basis for this (Valcyte) patent. It was wrongly granted...,” said Anand Grover, project director in the HIV/AIDS unit of activist group Lawyers’ Collective which had filed a pre-grant opposition in the case of Valcyte on behalf of the Indian Network of Positive People and the Tamil Network of People with HIV/AIDS. This was not heard before the grant of the patent. Subsequently, the office of India’s controller general of patents, based in New Delhi, conducted an investigation into whether the decision of the Chennai patent office violated Indian rules, the findings of which are yet to be made public.
Since then, Lawyers’ Collective, Ranbaxy Laboratories Ltd and Cipla have all independently filed post-grant oppositions and are awaiting a decision.
Shamnad Basheer, a patent expert and research associate at the Oxford Intellectual Research Centre, said: “If Roche seeks an injunction, the court is likely to sanction a stay on Cipla in view of the pending post-grant proceedings, unless it is very evident from the face of records that the patent is an invalid one.”
Mint had on 15 January first reported that the US Patent and Trademark Office had denied a patent for valganciclovir in 1994 because the drug had been in the “public domain” for three years. However, the office granted a patent to the crystalline form of the drug.
In India, the Roche patent covers both the basic compound as well as a crystalline form, giving the drug maker a much more formidable patent.