Lipitor patents upheld in Spain and South America

Published: 21-Dec-2005

The Court of First Instance in Madrid, Spain, has become the latest judicial body to upheld patents covering atorvastatin, the active ingredient in Lipitor, Pfizer's cholesterol-lowering medication.


The Court of First Instance in Madrid, Spain, has become the latest judicial body to upheld patents covering atorvastatin, the active ingredient in Lipitor, Pfizer's cholesterol-lowering medication.

The challenge to the patent (EP 409,281), which is subject to other pending challenges in Spain, was brought by Ratiopharm Espana, who can appeal the decision. Sold in Spain as Zarator and Cardyl, the ruling prevents sales of generic versions of Lipitor in the country until the patent's expiry in July 2010.

Lipitor has also recently gained protection in Peru, Ecuador and Venezuela, as The Andean Court of Justice in Quito, Ecuador, ruled that challenges to patents covering the crystalline form of atorvastatin and a process for making atorvastatin were without foundation and dismissed the case. Under Andean Pact law the decision is not open to appeal.

The news follows Pfizer's victory over Ranbaxy in the US, where two patents concerning atorvastatin (US Nos 4,681,893 and 5,273,995) were deemed to be both valid and, consequently, infringed upon by Ranbaxy's generic version. The decision, granted Pfizer a permanent injunction prohibiting Ranbaxy from obtaining approval for, or marketing its, generic version of atorvastatin until 2011.

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