In another high voltage patent dispute case involving multinational companies and Indian generic majors, the Bombay high court will start hearing the case of post-grant opposition to the patent on anti-infection drug valganciclovir, granted to Roche by Indian patent office in June 2007(IN207232). The court will also start hearing on October 21 the infringement suit filed by Roche for a permanent injunction, restraining Cipla from manufacturing, offering for sale, selling and exporting the drug.

The hearing is important as it will set a legal precedent. It will set precedence whether injunctive relief should be granted to the patent holder routinely, especially when it involves essential drugs. NGOs in the health sector are of the opinion that further granting injunctive relief to the patent holder without establishing the validity of the patent will adversely affect patients due to the non-availability of cheaper medicines.

The court will hear the post-grant opposition filed by the Indian Network for people living with HIV/AIDS (INP+), an organization representing the needs of people living with HIV/AIDS, and generic majors like Matrix, Ranbaxy and Cipla.

Valganciclovir, is an important anti-infection drug for the treatment of active cytomegalovirus retinitis (CMV) infection that people living with HIV are susceptible to. The infection can lead to blindness without treatment. The drug is also important for the prevention of CMV disease in patients who have received a kidney, heart, or kidney-pancreas transplant.

Expressing concern over the growing incidence of grant of evergreening patents in India, the Indian generic companies and NGOs seek revocation of the patent on Valganciclovir on the ground that the patent claims on Valganciclovir do not fulfill the patentability criteria under Indian law. They are of the view that new forms of an old drug including salts are not patentable under patent law. The patent claims 'valganciclovir hydrochloride' which is a hydrochloride salt of ganciclovir.

They argue that claims of the company do not fulfill the patentability criteria of 'novelty' under Indian law. Ganciclovir and its salts having anti-viral activity were known (first disclosed in US4355032, published on 19 October 1982) and thus fail the novelty test set under the law.

Meanwhile, Cipla has already launched a copycat version of valganciclovir, in Indian market under the brand name Valcept. While Valcept is priced at Rs 245 per tablet, Roche's maximum retail price for its medicine branded as Valcyte is over Rs 1,000, sources said.

To protect its patent monopoly, Roche has filed an infringement suit in the Bombay High Court and as interim relief sought a permanent injunction, restraining Cipla from manufacturing, offering for sale, selling and exporting the drug valganciclovir which the court will hear on October 21.

This is the second instance of Cipla launching a low-cost version of Roche's patent-protected drug. Earlier, in January this year, Cipla had launched a copycat version of erlotinib, a lung cancer medicine, on which Roche has patent protection in India. The price tag was one-third of Roche's branded medicine Tarceva. Roche had sued Cipla for infringement of patent in the Delhi High Court. The high court, which completed hearing on the case on September 15, is expected to announce its verdict soon.