AstraZeneca UK Limited made peace with two leading generic drug manufacturers on Monday, settling long-running patent litigation over its patent for the blockbuster anticholesterol drug Crestor.
In a statement, AstraZeneca announced that it was ending its suit against Watson Laboratories Inc. (now doing business as Actavis Inc.) and Egis Pharmaceuticals plc after the generics admitted they had infringed AstraZeneca’s patent. AstraZeneca had originally filed suit in October 2010 in U.S. district court in Delaware, one month after Watson filed an application with the U.S. Food and Drug Administration seeking approval for a drug containing rosuvastatin, the active ingredient in Crestor. Egis was added to the suit in November 2011 after it also requested FDA approval of its rosuvastatin drug.
AstraZeneca was represented in the litigation by Finnegan, Henderson, Farabow, Garrett & Dunner and Womble Carlyle Sandridge & Rice. Watson and Egis had Potter Anderson & Corroon and Knobbe, Martin, Olson & Bear.
The deal came four months after a December bench trial before U.S. District Judge Leonard Stark of Wilmington. Stark had yet to issue a ruling before the parties agreed to settle. According to Monday’s press release, the generics have agreed not to contest a December ruling by the U.S. Court of Appeals for the Federal Circuit that affirmed the validity of AstraZeneca’s Crestor patent. AstraZeneca, for its part, will permit the generics to start producing their versions of the drug two months before AstraZeneca’s exclusivity period ends in July 2016. The generics have promised not to market their rosuvastatin products before then.
"This agreement ensures that consumers will benefit from an earlier launch of a rosuvastatin calcium product and eliminates ongoing litigation and uncertainty of marketplace acceptance of a non-generically substitutable product if Actavis had proceeded to launch the alternate product," said Actavis CEO Paul Bisaro in a statement. AstraZeneca counsel Charles Lipsey of Finnegan declined to comment. Watson’s and Egis’s lawyers, Richard Horwitz of Potter Anderson and Steve Maddox of Knobbe Martin, did not respond to requests for comment.