The Hindu Business Line : US Court denies review of Ranbaxy's plea on patent

Setback
The latest decision on atorvastatin's main patent echoes the earlier ruling.
The main patent on atorvastatin expires in March 2010.

Mumbai , Oct. 24

The battle for a slice of Pfizer's $12-billion cholesterol drug Lipitor was expected to be a fight to the finish. And Lipitor's patent-challenger, Ranbaxy is not flinching despite reports that a US appeals Court had denied its petition to review an earlier decision that had upheld Pfizer's main patent on atorvastatin, which is an active ingredient in Lipitor.

Patent on Atorvastatin

In August, the US Court of Appeals for the Federal Circuit had upheld Pfizer's main patent on atorvastatin (US Patent No 4,681,893), while invalidating another (US Patent No 5,273,995) whose patent-life was to expire in June 2011.

On the court's latest decision not to review the August ruling on Pfizer's main patent, Ranbaxy's Chief Executive Officer and Managing Director, Mr Malvinder Mohan Singh, told Business Line there was no change in status. Ranbaxy had succeeded in invalidating one of the patents (`995) on atorvastatin and was working at a possible launch of this product in the US by March 2010.

Settlement

The court decision had shorn 15 months off the patent (`995) and Ranbaxy is working towards bringing the launch date forward, with a 180-day exclusivity in the US market, Mr Singh said. The latest decision on atorvastatin's main patent (`893) echoes the earlier ruling and hence did not change the status, he indicated. The main patent on atorvastatin expires in March 2010. He did not comment on whether Ranbaxy would seek a review of the appeals court's decision by the US Supreme Court. He also declined to comment on analysts' speculation of an out of court settlement between the two drug companies.

Technical Defect

Announcing the court's latest decision, Pfizer's Senior Vice-President and Associate General Counsel, Mr Peter Richardson, said in a communiqué on the company Web site: "... the lower court's decision was consistent with prior law, and it raised no matters of exceptional importance requiring that they be revisited again."

Pfizer plans to go back to the US Patent office to correct a technical defect in a second patent covering the calcium salt of atorvastatin (`995). The latest development does dent Ranbaxy's image, as though it is not a financial setback, as the product is not yet launched, said an analyst.

More Stories on : Pharmaceuticals | Courts/Legal Issues | IPR | Ranbaxy Laboratories Ltd

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