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Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire LLC, has settled all pending litigation with Actavis, Inc., Actavis LLC, and Actavis Elizabeth LLC (collectively “Actavis”) and Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and ANDA, Inc. (collectively “Watson”) in connection with Actavis’ and Watson’s Abbreviated New Drug Applications (“ANDAs”) for generic versions of Shire’s INTUNIV® ( guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder.
The settlement provides Actavis with a license to make and market Actavis’ generic versions of INTUNIV in the United States on December 1, 2014, or earlier in certain limited circumstances. Such sales will require the payment of a royalty of 25% of gross profits to Shire during the 180 day period of Actavis’ exclusivity. The settlement also provides Watson with a license to make and market Watson’s generic versions of INTUNIV in the United States 181 days after Actavis’ launch of generic INTUNIV, or earlier in certain limited circumstances. To date, the US Food and Drug Administration has granted final approval only to Actavis’ ANDA for generic versions of INTUNIV.
These litigations were patent infringement lawsuits relating to U.S. patents 6,287,599 (“the ‘599 Patent”), 6,811,794 (“the ‘794 Patent”), 5,854,290 (which was subsequently dedicated to the public). As part of the settlement, Actavis and Watson have agreed to a consent judgment confirming that their proposed generic products infringe Shire’s ’599 and ’794 Patents and that those two patents are valid and enforceable with respect to those proposed generic products and any other generic version of INTUNIV.
The lawsuit against Actavis proceeded to trial in the District Court of Delaware in September 2012 wherein Teva Pharmaceuticals, USA, Inc. was also a defendant. The Delaware court has not issued a decision. The lawsuit against Watson is scheduled for trial to begin on February 10, 2014 wherein Impax Laboratories, Inc. is also a defendant.
The agreements, which are effective immediately, will be submitted to the US Federal Trade Commission and Department of Justice for review as required by law.