IN A setback for Ranbaxy in its global battle over the patent of
Lipitor, a Canadian Federal court has ruled the companyâ€™s generic drug
atorvastatin infringes upon one of Pfizerâ€™s Lipitor patent. However,
the court dismissed Pfizerâ€™s appeal for a prohibition order for another
patent of the same drug in Canada.
â€œThe court has ruled that Pfizerâ€™s patent covering a crystalline form of atorvastatin, the active ingredient in Lipitor, would be infringed by Ranbaxyâ€™s process for making their proposed generic atorvastatin product,â€œ a Pfizer release said. The court ruling means that Ranbaxy cannot launch atorvastatin in Canada until Lipitorâ€™s patent (Canadian Patent Number 2,220,018) expires in July 2016.
However, the court dismissed Pfizerâ€™s appeal to deny issue of notice of compliance (NoC) for Atorvastatin patent CA 2,220,455 to generic companies such as Ranbaxy. â€œThe Federal Court has dismissed Pfizerâ€™s application to deny issuance of a NoC for Pfizerâ€™s Atorvastatin patent CA 2,220,455, finding that Pfizer failed to meet its burden of showing that Ranbaxyâ€™s allegation of invalidity is not justified,â€ a Ranbaxy statement said.
Ranbaxy said it will appeal against the adverse decision for CA 2,220,018 and remain confident in its position. â€œIn 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,â€ 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 Pfizerâ€™s patent and hope to launch the generic copy in March 2010.
Ranbaxy was successful in invalidating Pfizerâ€™s patent in Norway but it received an adverse ruling in Spain.
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