Swiss drug multinational Roche AG suffered yet another setback in its ongoing patent fights in India after the Chennai patent office rejected its claim over Valcyte (valganciclovir).
The decision, which came on April 30, marks an end to one of the toughest patent battles between Roche, Indian generic drug makers and groups of patients.
Valganciclovir is an important drug for the treatment of severe eye infection that people living with HIV (the AIDS virus) are susceptible to. It is also used in post-operative treatment for patients who have received an organ transplant.
Valcyte is priced at Rs 1,040 for each 450 mg tablet, while generic equivalents are available at a fourth of its cost. The Chennai office rejected the patent claim primarily on the grounds that valganciclovir lacked the novelty that merits protection.
Anand Grover, Lawyers Collective HIV/AIDS Unit, who represented the patient groups in the litigation, welcomed the decision. "This underscores the importance of oppositions in ensuring that the Patent Office interprets the patentability criteria strictly, to prevent new forms of old drugs from being patented. This decision will have implications for patients not only in India but also in other developing countries," he said.
Roche is entitled to now approach the Intellectual Property Appellate Board for a review of the patent office decision.
It had initial success with Valcyte when the Chennai office granted a patent to the medicine in 2007. Since the decision was taken without hearing a pre-grant opposition filed by some patient groups, it was challenged in the High Court there.
The court set aside the order and asked the patent office to hear the pre-grant opposition, which was rejected by the latter. The matter came before the Supreme Court that directed the patent office to club all opposition - by patient groups, post-grant opposition from generic companies - and give its verdict.