The subsidiary of the largest Indian pharmaceutical company Ranbaxy Laboratories Limited, Ranbaxy Pharmaceuticals Inc. has won the ruling of a US Court in New Jersey to manufacture the generic version of the compound Valganciclovir, on which the patent is held by Roche, and sold as Valcyte. The US arm of RLL is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system. It had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Corporation for manufacture of the amorphous form of valganciclovir hydrochloride, used to treat CMV Retinitis in patients suffering with AIDS. Roche’s patent is on the crystalline form and it had argued that the amorphous form would change into crystalline form and infringe the patent. The drug is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk.

The court vindicated that the generic version of Ranbaxy does not infringe the patent rights of Roche, who had filed the infringement suit two years ago. The court upheld the validity of Roche’s patent and allowed Ranbaxy to manufacture the generic only after 2015, when the patent expires. 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. Interestingly, Cipla also had launched the generic of Valganciclovir in India last year named Valcept and got embroiled in a trademark suit with Roche. A number of pre-grant oppositions against the drug were also filed in India and it awaits a grant from the Patent Office.

In June 2008, Ranbaxy had received a tentative approval from USFDA to manufacture and market the 450 mg tablets of valganciclovir hydrochloride. The formulation will further expand Ranbaxy’s portfolio of affordable generic medicines and will be available to all classes of trade. According to the USFDA rules, upon final approval, Ranbaxy can even launch the drug before 2015, with a 180 days exclusivity period, because of its first to file status. At the same time, it is open to Roche to challenge the decision of non-infringement in the higher court similarly, as it is open to Ranbaxy to challenge the validity of Roche’s patent.