The FINANCIAL — AstraZeneca PLC (AZN), a global, innovation-driven biopharmaceutical business, said Monday it has entered into a settlement agreement in its U.S. patent infringement litigation against Watson Laboratories, Inc., Actavis, Inc. (ACT), and EGIS Pharmaceuticals (PLC (EGIS.BU) 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(R) (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.
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.
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.
Substance patent protecting CRESTOR expires on Jan. 8, 2016, and the pediatric exclusivity period expires on July 8, 2016.
AstraZeneca will file the settlement agreement with the United States Federal Trade Commission and United States Department of Justice.
AstraZeneca shares closed Friday at 3236 pence valuing the company at 40.39 billion pounds, according to Borsa Italiana Spa.
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