On June 23, 2014, U.S. District Judge Stanley R. Chesler of the District of New Jersey issued a summary judgment decision, which granted FLH client Shire LLC’s motion for summary judgment that eighteen claims of four patents are valid and infringed. The patents-in-suit are listed in the FDA’s Orange Book as covering Shire’s drug Vyvanse® (lisdexamfetamine dimesylate), which is indicated as a treatment for attention deficit hyperactivity disorder (ADHD).

The defendants are generic pharmaceutical manufacturers who have filed Abbreviated New Drug Applications (“ANDAs”) seeking FDA approval to manufacture and sell generic versions of Vyvanse®, as well as their active pharmaceutical ingredient (“API”) supplier. The defendants in the case include Actavis LLC, Amneal Pharmaceuticals, LLC, Mylan Inc., Roxane Laboratories, Inc., and Sandoz Inc., and API supplier Johnson Matthey Inc. The Court’s ruling ensures that the defendants cannot launch generic versions of Vyvanse® until either the patents expire in 2023, or they appeal successfully to the U.S. Court of Appeals for the Federal Circuit.

The Court found that “[t]here is no real dispute about the ANDA Defendants’ direct infringement of the compound claims,” Johnson Matthey “is liable for inducing the ANDA Defendants’ direct infringement of the compound claims,” and “the ANDA Defendants have induced infringement” of a claimed method of treating ADHD. As to validity, the Court found that “Defendants have not shown that lisdexamfetamine was disclosed in the prior art” and “Defendants have failed to point to evidence sufficient to persuade a reasonable jury that [prior art reference] AU ’168 anticipates by disclosing lisdexamfetamine dimesylate,” and “have failed to defeat the motion for summary judgment regarding invalidity due to obviousness of the compound patents.” Additionally, the Court found that “Defendants have not offered evidence sufficient to prove [method of treating ADHD] claim 4 of the ’486 patent is invalid due to obviousness or anticipation.”

Shire is represented by Ed Haug, Porter F. Fleming, Sandy Kuzmich, Angus Chen, Andrew Roper, Richard F. Kurz, Stephanie Roberts, Leann Clymer, Michael W. Harkness, and Blaine M. Hackman of Frommer Lawrence & Haug LLP, and Michael R. Griffinger, Robert C. Brady, and Charles H. Chevalier of Gibbons P.C.

To read Judge Chesler’s Order, please click here.

To read Judge Chesler’s Opinion, please click here.

To read the relevant ip360 article, please click here.