Setback for Ranbaxy in Lipitor fight

NEW DELHI: In a setback to Ranbaxy, the Federal Court of Appeal of Canada on Friday overruled a lower court order that will prevent the Indian company from getting regulatory approval to launch a generic copy of Lipitor. This means the Gurgaon-based company cannot launch the drug until July, 2010.

���Federal Court of Appeal of Canada has reversed a lower court ruling that held that Pfizer���s enantiomer patent could not block generic manufacturer Ranbaxy Laboratories from obtaining approval for a competitor product to Lipitor. The appellate court issued an order prohibiting regulatory approval of Ranbaxy���s product in Canada until Pfizer���s enantiomer (calcium salt) patent-Canadian Patent No. 2,021,546-expires in July 2010, ��� a Pfizer release said.

However, Ranbaxy Laboratories may seek a review of the decision by the Supreme Court of Canada, the release added. When contacted, a Ranbaxy Laboratories spokesperson said the company ���will evaluate all options��� but declined to give details.

Terming today���s decision as ���not only an important one for Pfizer, but also for patients���, Pfizer senior VP and associate general counsel Peter Richardson said, ���This decision sends a strong signal about the importance of protecting intellectual property in Canada, which provides the incentive for research-driven pharmaceutical companies to make the significant high-risk investments necessary to develop new life-saving medicines.���

In September last year, a Canadian court had dismissed Pfizer���s appeal for an regulatory prohibition order to stop Ranbaxy Laboratories from launching its generic version in Canada. However, the same court had ruled that Ranbaxy Laboratories generic drug infringes upon a patent covering a crystalline form of atorvastatin - the active ingredient in Lipitor.

Ranbaxy Laboratories is fighting legal battle with Pfizer to sell its generic copy of Lipitor - the world���s best selling $13 billion drug - in over 17 countries. As the company is the first company to challenge the patent, it would therefore get a 180-day marketing exclusivity if it successfully challenge Pfizer���s patent.

In the US, the company is confident of invalidating Pfizer���s patent and hope to launch the generic copy in March, 2010. Ranbaxy Laboratories was successful in invalidating Pfizer���s patent in Norway and UK but received an adverse ruling in Spain.