The Hindu Business Line : Lipitor case: Ranbaxy to contest Canadian court ruling

New Delhi, Sept. 13 In a temporary set back, a Canadian Federal Court has ruled that Ranbaxy Laboratories Ltd’s cholesterol lowering drug, atorvastatin, was infringing Pfizer’s patent (CA 2,220,018) for its registered drug Lipitor.

Ranbaxy is contesting Pfizer’s patent on the world’s largest selling drug — with sales close to $13 billion — which is due to expire in 2016 in 20 countries around the world. The Gurgaon-based company said in a statement that it would appeal against the decision. It has, however, said that the court’s dismissal of Pfizer’s application on another patent (CA 2,220,455) was in its favour.

The court has reportedly asked the Canadian Minister of Health not to issue a Notice of Compliance until the expiry of the patent (CA 2,220,018), thus allowing Ranbaxy to introduce its drug until 2016.

Looking forward

According to an analyst, although this is a small set back to the company, in the long run Ranbaxy, with its first-to-file strategy in the US, and 180-day market exclusivity for atorvastatin, can only look forward to a significant commercial benefit.

Last month, the US Patent and Trademark Office rejected Pfizer application to reissue a Lipitor patent extending protection till June 2011. Ranbaxy has brought forward the launch of the drug, and said it expected to introduce its generic version in March 2010, 15 months before the patent expiry in June 2011.

Ranbaxy has about 20 first-to-files and expects significant gains from at least one successful application each year.