Lipitor Split Decision Keeps Pfizer Fighting

By William Murphy

Published on August 04, 2006

Pfizer sued Indian drug maker Ranbaxy Laboratories Ltd. over Ranbaxy's atorvastatin-containing product, which amounted to a generic version of Lipitor. In December a Delaware federal court ruled that Ranbaxy had infringed on two Pfizer patents, essentially guaranteeing Pfizer's exclusivity over atorvastatin, Lipitor's active ingredient, until 2011.

The recent U.S. Court of Appeals ruling upheld the Delaware court's decision covering Pfizer's atorvastatin patent, but reversed a second ruling that protected the Pfizer patent for the calcium salts of atorvastatin. Invalidation of that patent could shorten Lipitor's June 2011 expiration date by 15 months, opening the door to generic atorvastatin products in March 2010.

Pfizer said that the court invalidated the calcium salts patent because of a "technical defect" and that a course of action for correcting the defect is available in the U.S. Patent and Trademark Office. Pfizer said that it plans to pursue that option.

Lipitor has revenues of more than $12 billion annually, making it the world's top-selling drug.

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