ASTELLAS, PFIZER AT ODDS OVER LIPITOR AGREEMENT

Japanese drugmaker Astellas Pharma announced that it has sought a declaratory judgment to confirm that a development and marketing agreement for the cholesterol drug Lipitor, marketed by Astellas in Japan, will continue until 2016. The action was filed in the Tokyo District Court against Pfizer Overseas Pharmaceuticals, C.P. Pharmaceuticals International and Pfizer Japan, all subsidiaries of Pfizer.

Lipitor (atorvastatin calcium) was launched in Japan in 2000 by Astellas through a co-development agreement with Werner-Lambert, which subsequently merged with Pfizer.

The initial term of the agreement was decided as until the expiration of patents relating to Astellas' Lipitor or 10 years after the drug's launch. The Lipitor manufactured and marketed by Astellas is protected by various patents, including ones for drug substance and formulation, that are still valid, the company says. Therefore, Astellas believes that the agreement should be valid until 2016, the expiration date of the last patent. But Pfizer contends that the agreement will end in 2011 when the substance patent expires.

Since the objective of the declaratory judgment is solely to confirm the initial term of the agreement, Astellas believes it will have no adverse effect on its co-promotion agreement with Pfizer.