US Court rules Ranbaxy’s generic valganciclovir does not infringe Roche’s Valcyte patent

In a verdict on the patent litigation between Roche Palo Alto and the Daiichi-Ranbaxy on the former’s patent rights with crystalline valganciclovir, the active ingredient in anti-viral drug Valcyte, the District Court of New Jersey has ruled that Ranbaxy’s generic version does not infringe the patent even as Roche’s patent on the product is valid.

The verdict is on a complaint filed by Roche alleging Ranbaxy of patent infringement of the former’s US Patent No 6,083,953, following an Abbreviated New Drug Application filed by Ranbaxy on amorphous form of valganciclovir with the US Food and Drug Administration (FDA) in 2006. Roche argued that the amorphous form of valganciclovir would change to the crystalline form and thus will infringe the ’953 patent.

In its verdict issued of late, the Judge refused to agree with the argument stating that Roche failed to prove the spontaneous change of form in the generic product and that Ranbaxy’s product contained crystalline form of valganciclovir. However, the court also stated that the patent ’953 form crystalline form of the active ingredient is valid as Ranbaxy failed to prove that the patent is given on a known substance. The ’953 patent is valid till 2015.

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