Daiichi Sankyo-owned Ranbaxy Laboratories has won a decisive ruling from the District Court of New Jersey that its generic version of valganciclovir, prescribed for HIV/Aids patients and for organ transplantation-related infections, does not infringe the patent rights of Swiss drug maker Roche's anti-infection drug, Valcyte.
The court's decision this week favouring Ranbaxy is based on a case filed by Roche two years ago against Ranbaxy on grounds that the generic or copy-cat version of valganciclovir infringed the patent rights of Valcyte, which has annual sales of close to $300 million in the US.
Though the court said Ranbaxy's generic does not infringe the Valcyte patent, it ruled that Roche's patent is nevertheless valid. Ranbaxy had argued the drug is a known innovation and hence not patentable. The drug's patent is valid till 2015, said sources.
"We welcome the positive judgment," said a Ranbaxy spokesperson.
Industry sources said the court's decision will help Ranbaxy launch its generic version of the drug when Roche's patent expires in 2015. Alternatively, if the US Food and Drug Administration (FDA) gives Ranbaxy its final approval, the company will be able to launch the drug before that date with 180 days of marketing exclusivity under US rules, being what is known as a first-to-file product. Ranbaxy had applied to the FDA in June last year to manufacture and market valganciclovir in 450 mg tablet form, for which it has only received tentative approval so far.
However, sources said both Ranbaxy and Roche can approach a higher court in the US to reverse the District Court's decision. That is, Ranbaxy can challenge the ruling that Roche's patent is valid and Roche can challenge the ruling that Ranbaxy's drug does not infringe the Valcyte patent.
Significantly, Roche is fighting several legal battles to ensure patent rights for Valcyte in India, where some patient groups and activists have challenged its validity. Drug maker Cipla has also launched a generic version of the drug in the country.
Patent litigation is common in the US, the world's largest drug market with sales of about $280 billion.
Generic companies adopt an aggressive patent litigation strategy to either go for out-of-court settlements with innovators or win patent litigations to launch their product with exclusivity for six months.
In another development a month ago, Astellas US LLC, the US subsidiary of the Japanese drug major Astellas Pharma, sued Wockhardt Ltd and its US subsidiary for infringing the patent of its anti-stress drug, Adenosin. Wockhardt had filed a marketing application with the FDA in July and notified that it would challenge the patent.
According to US rules for generic drug sales, the innovator drug company has to sue the generic challenger within 45 days to trigger an automatic ban of approval for the generic for the next 30 months or till the court decides the litigation.
Sources said the drug has patent protection till 2015 and the patent under question is valid till 2015. Adenosin and its various forms have sales of close to $400 million in the US.
