Mumbai: Swiss drug maker F Hoffmann-La Roche Ltd may move the Madras high court against patent infringement of its anti-infection drug Valcyte by Cipla Ltd, intensifying an ongoing legal battle between the two companies over patented drugs and their copycat versions.
The multinational firm has engaged a senior lawyer practising in the Madras high court to argue the case, said a person familiar with the development who asked not to be identified.
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If it is filed, the suit will be Roche’s second in India related to patent infringement. In the first case, now pending with the Delhi high court, the company had sought an injunction on patent infringement on its cancer drug Tarceva, also by Cipla.
Mint reported in July that Cipla had launched a cheap, generic version of valganciclovir (the active ingredient of Valcyte) in India under the brand name Valcept.
Valcyte is widely prescribed for infections related to HIV/AIDS.
The person familiar with the development said Roche could prefer filing the case in the Madras high court due to two reasons: “Firstly, the patent of Valcyte, which is in question in this matter, was granted by the Chennai patent office. The other reason is obviously its bad experience in the Delhi high court as far as the Tarceva patent infringement was concerned.”
A Roche executive in Mumbai declined to comment on the planned suit.
“We know that litigations are costly, but our intention here is to address the need of Indian patients and public interest is what matters in such cases. So we are not worried,” Cipla’s managing director Amar Lulla said.
Roche was granted a patent for valganciclovir by the Chennai patent office in June 2007.
The grant ran into trouble after the New Delhi-based Lawyers’ Collective petitioned against it because a pre-grant opposition filed by the legal activist group was not heard before the issue of the patent.
Roche charges around $9,900 (Rs4.19 lakh) for a three-month treatment using Valcyte. It has reduced the price to $1,800 for non-governmental organizations and customers in Africa and some third-world countries.
The patent has been opposed by at least five interested parties using a provision to oppose a patent after it is granted.
Apart from the Lawyers’ Collective, Ranbaxy Laboratories Ltd and Cipla have filed oppositions and are awaiting a decision.
Meanwhile, Roche’s court battle over Tarceva has snowballed into a landmark patent litigation after the Delhi high court refused to issue an order to keep generic copies of the drug off the market.
“Since the patent for valganciclovir is not very strong as it already has been opposed by multiple parties, and because a drug prescribed for HIV/AIDS infections has larger, social implications, Cipla may have a strong argument for a generic copy,” said a Chennai-based lawyer who did not wish to be identified.
Mint had in January 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.