Atorvastatin (Lipitor): Australian court upheld Pfizer's basic patent

The Australian Federal Court in Victoria has upheld the basic patent AU601981 covering Atorvastatin racemic form, the active ingredient in the cholesterol-lowering drug Lipitor, preserving the product's patent coverage in Australia through May 2012, informed Pfizer Inc. The court, however, ruled a second patent AU 628198 covering the hemicalcium salt of atorvastatin, which expires in September 2012, as invalid. The Federal court had ruled that one of Pfizer's patents was invalid for inutility, false suggestion and misrepresentation in obtaining the grant of the second Australian patent, said Ranbaxy. The court found that a proposed Ranbaxy generic product would infringe Pfizer's basic Lipitor patent ‘981. A second patent covering the calcium salt of atorvastatin ‘198, which expires in September 2012, was ruled invalid by the court. Pfizer has the opportunity to appeal that ruling. The ruling, the culmination of a lawsuit filed in 2005 by generic drug manufacturer Ranbaxy. Ranbaxy can appeal the decision of upholding the basic patent of Lipitor, even as Pfizer can appeal against the court's decision on its patent covering the calcium salt of atorvastatin.By this ruling Ranbaxy will get advantage of 4 months early launch in Australian market.