Invalidating all relevant claims of the patent-in-suit, the Federal Patent Court of Germany handed down a decision for Ranbaxy Laboratories’ German subsidiary Basics GmbH in its case against Warner Lambert’s European Patent 0,409,281 (EP ’281) owned by Pfizer [Reference-No: 3 Ni 36/05 (EU)].

EP ’281 covered an enantiomer calcium salt which has a positive pharmaceutical effect in the treatment of hypercholesterolemia and hyperlipidemia. Pfizer marketed a cholesterol-lowering drug under the brand-name LIPITOR® (sold as “Sortis” in Germany) covered by EP ’281. The Court found that the subject matter of claims 1 through 3 is not novel due to prior art citations in U.S. Patent No. 4,681,893 (US ’893) as well as in WO 89/07 598 A2 (WO ’598). Further, the Court held that claim 4 does not amount to an inventive step in view of U.S. Patent No. 4,375,475 (US ’475) and US ’893, as well as a 1987 publication in a scientific journal.

The court based its decision on two prior art documents: WO ’598 and US ’893. Although the basic chemical composition of the enantiomer calcium salt is not mentioned verbatim in these documents, the court found the references sufficient to enable a person skilled in the art to recognize the chemical compound of the enantiomer calcium salt from the cited documents. The court concluded that claim 1 of EP ’281 lacks novelty. The court further nullified claim 2 of EP ’281 because this claim is directed to virtually the same chemical composition as claim 1.

The court also invalidated claim 3 of EP ’281 for lack of novelty. Claim 3 is directed to the use of the enantiomer calcium salt recited in claims 1 and 2 for the production of a pharmacokinetic potent composition for the treatment of hypercholesterolemia and hyperlipidemia. The Court held that this effect had been mentioned in prior art documents.

Finally, the court invalidated claim 4 of EP ’281 due to a lack of inventive step. Claim 4 is directed to two alternative production techniques for the pharmaceutical composition of claim 3. The court opined that the first alternative production technique had been utilized before and described in US ’475. According to the Court, a person skilled in the art would have been able to manufacture the pharmaceutical composition according to this method. The second alternative production technique was found not to constitute an inventive step because it results from the cited prior art documents.

Practice Note: This decision is a step of Ranbaxy’s worldwide legal efforts to destroy patent protection for Pfizer’s Lipitor. Therefore, it is not surprising that Pfizer has appealed this decision to the German Federal Court of Justice. It can be expected that a final decision of the German Federal Court of Justice will take up to three years.