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IN A setback for Ranbaxy in its global battle over the patent of Lipitor, a Canadian Federal court has ruled the company’s generic drug atorvastatin infringes upon one of Pfizer’s Lipitor patent. However, the court dismissed Pfizer’s appeal for a prohibition order for another patent of the same drug in Canada.

“The court has ruled that Pfizer’s patent covering a crystalline form of atorvastatin, the active ingredient in Lipitor, would be infringed by Ranbaxy’s process for making their proposed generic atorvastatin product,“ a Pfizer release said. The court ruling means that Ranbaxy cannot launch atorvastatin in Canada until Lipitor’s patent (Canadian Patent Number 2,220,018) expires in July 2016.

However, the court dismissed Pfizer’s appeal to deny issue of notice of compliance (NoC) for Atorvastatin patent CA 2,220,455 to generic companies such as Ranbaxy. “The Federal Court has dismissed Pfizer’s application to deny issuance of a NoC for Pfizer’s Atorvastatin patent CA 2,220,455, finding that Pfizer failed to meet its burden of showing that Ranbaxy’s allegation of invalidity is not justified,” a Ranbaxy statement said.

Ranbaxy said it will appeal against the adverse decision for CA 2,220,018 and remain confident in its position. “In particular, Ranbaxy was successful in Norway on a similar issue regarding extra territorial coverage of a patent, other than a process patent, outside of the country in which the patent is issued,” the statement added. The court ordered the Canadian health ministry not to issue a notice of compliance for patent 2,220,018.

Ranbaxy has been fighting legal battle with Pfizer for its best-selling $13-billion drug Lipitor in over 15 countries. In the US, the company is confident of invalidating Pfizer’s patent and hope to launch the generic copy in March 2010.

Ranbaxy was successful in invalidating Pfizer’s patent in Norway but it received an adverse ruling in Spain.

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