In a Hatch-Waxman ANDA infringement case, the court affirmed the grant of summary judgment of no invalidity and the denial of defendants’ motion to amend it invalidity contentions to add an on sale defense, but reversed the grant of summary judgment that the supplier of some of the ingredients to the defendants to obtain FDA approval was liable for inducing infringement.  As to obviousness, the court held that the reliance on a reference already considered by the patent examiner required that defendants have an added burden of overcoming the deference due to the examiner and held that defendants’ arguments were improperly based on hindsight.  As to the request to amend invalidity contentions, the court held that the district court did not abuse its discretion, because defendants learned of the on sale bar facts, yet delayed in bringing its motion, thereby demonstrating a lack of diligence.  As to the inducing infringement summary judgment, the court held that the acts of supplying ingredients for use to obtain FDA approval falls within the safe harbor provisions of §271(e)(1).

Shire LLC v. Amneal Pharmaceuticals, LLC, Case Nos. 2014-1736, -1737, -1738, -1739, -1740, -1741 (September 24, 2015); Opinion by: Linn, joined by Moore and Mayer; Appealed From: District Court for the District of New Jersey, Sheridan, J. and Chesler, J. Read the full opinion here.

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