LONDON--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.
MAIN FACTS:
-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.
-Write to Ian Walker at ian.walker@dowjones.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires