FDAnews
www.fdanews.com/articles/90628-australian-court-rules-for-ranbaxy-in-lipitor-case

AUSTRALIAN COURT RULES FOR RANBAXY IN LIPITOR CASE

December 21, 2006

Indian drugmaker Ranbaxy Laboratories announced that the Federal Court of Australia has handed down a favorable decision in the company's case against Pfizer regarding Pfizer's Australian atorvastatin patent 628198. Atorvastatin is a cholesterol-lowering drug marketed by Pfizer as Lipitor.

The judge ruled that one of Pfizer's patents is invalid for false suggestion and misrepresentation in obtaining the grant of Australian patent 628198, but also said that Ranbaxy's atorvastatin product infringes on another Pfizer patent.

The invalidity of Pfizer's 628198 patent was principally based on Pfizer's representation to the Australian Patent Office that the potency of the R-enantiomer (atorvastatin) in relation to its ability to inhibit production of cholesterol was unexpectedly 10-fold more than that of the corresponding racemic material. This representation was held to be false and misleading.

In October the European Patent Office issued an opinion upholding Pfizer's Lipitor patent in another patent infringement case filed by Ranbaxy.