Australian Full Federal Court upholds basic Lipitor patent
The Australian Full Federal Court in Victoria has upheld on appeal the exclusivity of Pfizer's basic patent covering atorvastatin, the active ingredient in Lipitor.
The Australian Full Federal Court in Victoria has upheld on appeal the exclusivity of Pfizer's basic patent covering atorvastatin, the active ingredient in Lipitor.
The ruling is the culmination of a lawsuit filed in 2005 by generic drug manufacturer Ranbaxy and preserves Lipitor's patent coverage in Australia through May 2012, effectively preventing the launch of a generic Ranbaxy product. Ranbaxy can appeal against the decision.
The court found that a proposed Ranbaxy generic product would infringe Pfizer's basic Lipitor patent (AU 601,981). A second patent covering the calcium salt of atorvastatin (AU 628,198), which expires in September 2012, was ruled invalid by the court. Pfizer has the opportunity to appeal against that ruling.
The Australian decision will not affect ongoing Lipitor patent actions in other countries, including the US. Pfizer said it would continue to vigorously defend itself against challenges to its intellectual property.