Pfizer announced today that the United Kingdom’s Court of Appeal has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in the company’s cholesterol lowering drug Lipitor. The appellate court ruling affirms a lower court decision in October 2005 which found that a proposed generic from Ranbaxy Laboratories Ltd., an India-based pharmaceutical company, would infringe the basic patent of Pfizer’s Lipitor. (see an earlier Barista post by Stephen and associated links). Ranbaxy had wanted to release a generic version of the drug in Britain. The patent covers atorvastatin, the active ingredient in Lipitor.
The appeals court backed the lower court by ruling invalid a second Pfizer patent covering the calcium salt of atorvastatin, which expires in July 2010.
The UK appellate court ruling affirms an October high court decision that found the basic patent on Lipitor, expiring in November 2011, was valid, but a more specific patent, running out in July 2010, was not. The ruling prohibits Ranbaxy from introducing a generic version of Lipitor in the United Kingdom before the expiration of the basic patent in November 2011, subject to a possible further appeal. Lipitor is known by the chemical name atorvastatin with annual sales of $12 billion.
In December, a U.S. federal court judge upheld the validity of two of Pfizer’s patents, dealing another setback to Ranbaxy, which had hoped introduce a cheaper copy as soon as 2008.
But let’s keep our eye on the ball – when looking at the patent landscape of the statins, this may have been only a small a victory for Pfizer that will play well in the press and for stockholders ever so briefly. Now that Zocor is off-patent in the US (which is also the major market), generic Zocor (which was approved by the FDA last Friday for Teva Pharmaceuticals) may actually represent a much bigger threat to the Lipitor market share and profitability in the US and worldwide.
