Pfizer Gains Favorable Ruling Barring Generic Lipitor

June 29, 2006
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Pfizer, Inc. (New York, NY) reports the United Kingdom's Court of Appeal has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in "Lipitor."

Pfizer, Inc. (New York, NY, www.pfizer.com) reports the United Kingdom's Courtof Appeal has upheld the exclusivity of the main patent coveringatorvastatin, the active ingredient in "Lipitor." Lipitor is Pfizer'stop-selling drug, with 2005 global sales of $12.2 billion.

The appellate court ruling affirms a lower court decision in October2005 that found a proposed generic by Ranbaxy Laboratories, Inc.(Gurgaon, Haryana, India, www.ranbaxy.com) would infringe Pfizer's basicLipitor patent (European Patent 247,633), said Pfizer in a companyrelease. The appellate court's decision prohibits Ranbaxy fromintroducing a generic version of atorvastatin in the United Kingdombefore the expiration of the basic patent in November 2011, subject toa possible further appeal to the House of Lords.

The appellate court also ruled invalid a second patent covering thecalcium salt of atorvastatin (European Patent 409,281), which expiresin July 2010 and therefore has no commercial relevance in the UK, saidPfizer.

Ranbaxy says it is evaluating the ruling and will decide on its courseof action shortly.