By Trial Opinion entered by The Honorable Richard G. Andrews, following a bench trial, in Endo Pharmaceuticals Inc. et al. v. Amneal Pharmaceuticals, LLC et al., Civil Action No. 14-1382-RGA (consolidated) (D.Del. October 7, 2016), the Court ruled that defendants failed to prove their affirmative defenses of obviousness and implied license.

Plaintiffs, Endo Pharmaceuticals Inc. and Mallinckrodt LLC, filed these patent infringement actions against defendants Amneal Pharmaceuticals, LLC, Amneal Pharmaceuticals of New York, LLC (collectively, “Amneal”), Teva Pharmaceuticals USA, Inc. and Barr Laboratories, Inc. (collectively, “Teva”), in 2014 alleging that Abbreviated New Drug Applications (“ANDAs”) filed separately by Amneal and Teva infringe U.S. Patent No. 8,871,779 (“the ‘779 patent”). Id. at *3.  The Court conducted a bench trial on July 11-13, 2016.  Both Amneal and Teva conceded that their proposed products meet all the limitations of the ‘779 patent. Id. at *6.  However, both defendants contended in their defense that the ‘779 patent is invalid as obvious under 35 U.S.C. § 103. Id. Teva also contended in its defense that it obtained an implied license from Mallinckrodt and, thus, does not infringe. Id.

After considering the evidence presented, the Court concluded that both Amneal and Teva failed to prove by clear and convincing evidence that any of the asserted claims of the ‘779 patent are invalid. The Court also concluded that Teva failed to prove its affirmative defense of implied license by a preponderance of the evidence.

A copy of the Trial Opinion is attached.