Court cancels Roche’s patent for anti-viral

New Delhi: In a first-ever instance of a patent being revoked after being granted, the Madras High Court has set aside pharma major Roche’s patent on key drug, valganciclovir on procedural grounds. A patent on valganciclovir was granted to the company in June 2007. Valganciclovir is a treatment for cytomegalovirus (CMV), a virus that often attacks the retina of people with lower immune systems, such as AIDS patients. In addition, it is crucial for prevention of CMV infection in patients who have received organ transplant. The court has cited the failure of the Indian patent office to comply with the patent law and remanded the matter back to the Patent Controller. The judgement was delivered on a petition filed by civil society groups — Indian Network for People Living with HIV/AIDS (INP+) and Tamil Nadu Networking People with HIV/AIDS (TNNP+), who had challenged the Indian Patent Offices decision to grant a patent without hearing the pregrant opposition filed by them. In July 2006, INP+ and TNNP+ had filed a pre-grant opposition before the Chennai Patent Office objecting to the grant of patent to Roche and requested for a hearing. Under the Indian law, if an opponent requests a hearing, the patent office is required to provide the opponent an opportunity to be heard. However, this was not done. At Roche’s maximum retail price of over Rs 1,000 per tablet, a patient who has to take a treatment course of approximately four months for CMV retinitis in India would have to pay over Rs 2.5 lakh. This puts the treatment unaffordable for those who need them. The grant of patent to Roche allowed it to continue charging exorbitant prices and also prevented the entry of generic versions of valganciclovir. However, in May this year, Cipla launched the generic valganciclovir in the domestic market at a price of Rs 245 for a tablet. Under law, a generic producer can challenge the patent by taking the risk of launching a generic version after obtaining marketing approval. In response, Roche filed an infringement suit against Cipla in the Bombay High Court in September seeking an injunction, which is till pending. The dispute between the companies hinges on “patentability’’ of the drug. The validity of the patent is in question under the country’s patent laws that do not allow patents on new forms of old drugs, also known as Section 3(d). Experts pointed out that valganciclovir is a hydrochloride salt of an old drug ‘ganciclovir’ and hence not patentable. The generic producers of the drug, Matrix, Ranbaxy and Cipla have also filed post grant oppositions. While the opportunity to oppose the application is only granted to the patient groups, it is likely that Roche’s injunction proceedings against Cipla for launching the generic version will no longer have a legal basis as the patent is now revoked. Whether the Mumbai court will keep the infringement proceedings pending remains to be seen, legal experts say.

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