AstraZeneca announced that it has entered into a settlement agreement in its US patent infringement litigation against Watson Laboratories, Inc., Actavis, Inc. (formerly known as Watson Pharmaceuticals, Inc.), and EGIS Pharmaceuticals regarding Watson’s proposed rosuvastatin zinc product.
Watson, a successor of Cobalt, also agreed not to further appeal a decision by the U.S. Court of Appeals for the Federal Circuit that upheld the validity and enforceability of the Crestor (rosuvastatin calcium) substance patent. Shionogi is also a party to the settlement agreement.
Under the agreement, Watson and EGIS concede that the CRESTOR substance patent is valid, enforceable and would be infringed by Watson’s rosuvastatin zinc product and its rosuvastatin calcium product.
The settlement agreement permits Watson to begin selling its generic version of Crestor and its rosuvastatin zinc product beginning May 2, 2016, at a fee to AstraZeneca of 39% of net sales of Watson’s products until the end of pediatric exclusivity on July 8, 2016. The entry date could be earlier and the fees eliminated in certain circumstances.
All claims and counterclaims will be dismissed in a consent judgment entered by the United States District Court for the District of Delaware. All other terms remain confidential.
The substance patent protecting CRESTOR expires on 8 January 2016, and the pediatric exclusivity period expires on 8 July 2016.
In compliance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, AstraZeneca will file the settlement agreement with the United States Federal Trade Commission and United States Department of Justice.
AstraZeneca brought suit against Watson and EGIS in the United States District Court for the District of Delaware, alleging that Watson’s rosuvastatin zinc NDA infringed AstraZeneca’s substance patent covering CRESTOR. Watson and EGIS filed counterclaims seeking declaratory judgment of non-infringement and invalidity of the substance patent. The trial took place between 12 and 19 December 2012.
