Mumbai: The Bombay high court on Monday asked generics drug maker Cipla Ltd to reply in two weeks to a patent and trademark infringement suit, filed last week by Swiss drug maker F Hoffman La Roche Ltd, over anti-infection drug Valcyte.
Bitter pill: Cipla’s manufacturing unit in Kurkumbh, Pune. The Valcyte case is the second suit filed against Cipla by Roche this year. Santosh Verma / Bloomberg
A Cipla executive, who is not authorized to speak to the media and so declined to be named, said the company will file a reply on 16 October. The case is expected to come up for hearing in the third week of October.
The case, being heard by justice Abhay Oka, is the second patent infringement suit against Cipla by Roche this year. The Swiss firm had moved a similar petition in the Delhi high court in January against Cipla’s decision to sell a copy of its patented lung cancer drug Tarceva. The court had then refused to restrain Cipla from selling the drug. Roche has appealed against the ruling.
Valcyte, a formulation of valgancyclovir, is used for treating patients undergoing organ transplants as well as HIV/AIDS related infections. Cipla had in September launched a generic version of this drug under the brand name Valcept. Roche was granted an Indian patent for Valcyte last year, and has sought an injunction to immediately stop Cipla selling the copy.
Despite the patent, Roche faces five post-grant complaints pending with the Chennai patent office. The oppositions have been filed by Cipla, Ranbaxy Laboratories Ltd, and the Delhi Network of Positive People, a group representing the needs of people living with HIV/AIDS.
The opposition petitions claim that the current patent is for a previously known compound and that it violates Section 3(d) of the Patent Act, 2005, which prevents a patent grant to merely modified drugs. Roche is expected to file its reply to the fifth post-grant opposition, filed by a Chennai based drug firm, in November. An order is expected in three-four months.