By Sherri Oslick --
Earlier this month by consent judgment, the Paragraph IV litigation between Eli Lilly and Glenmark Pharmaceuticals over Lilly's ADHD drug Strattera® was terminated. Per the parties' stipulation, Glenmark agreed that the patent-in-suit was neither invalid nor unenforceable, and further agreed to a permanent injunction enjoining it from manufacturing or selling its generic version of Strattera® during the lifetime of the patent-in-suit, absent a final judgment that the patent-in-suit is unenforceable or that its claims are invalid.
As we previously reported, the suit was originally filed in the District Court of New Jersey on August 9, 2007 against defendant Actavis Elizabeth LLC for infringement of U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/ Hyperactivity Disorder," issued August 19, 1997) following a paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Lilly's Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder). Shortly thereafter, Lilly amended its complaint to add nine additional ANDA filers: Glenmark Pharmaceuticals, Sun Pharmaceuticals , Sandoz, Mylan Pharmaceuticals, Apotex, Aurobindo Pharma, Teva Pharmaceuticals, Synthon Laboratories, and Zydus Pharmaceuticals (see "Eli Lilly Pursues Additional Strattera® ANDA Filers").
Glenmark is the third defendant to be dismissed from the case. In December, Lilly and Zydus reached an agreement comparable to the Glenmark agreement, and consent judgment was entered on December 12, 2007. On June 27, 2008, Lilly dismissed Synthon Laboratories by stipulation, the details of which remain confidential.