Digest of Shire LLC v. Amneal Pharm., LLC, Nos. 2014-1736, 2014-1737, 2014-1738, 2014-1739, 2014-1740, 2014-1741 (Fed. Cir. Sep. 24, 2015) (precedential). On appeal from D.N.J. Before Moore, Mayer, and Linn.

Procedural Posture: Defendants/accused infringers appealed summary judgment of no invalidity, and decision affirming magistrate judge’s denial of motion to amend invalidity contentions. CAFC affirmed these decisions. A single defendant separately appealed judgment of induced infringement, and CAFC reversed this judgment and remanded to the district court.

  • Obviousness: The accused infringers did not raise a genuine issue of material fact as to obviousness of the claimed compound. The defendants’ primary reference was listed on the face of the patent, and so defendants faced an added burden of overcoming the deference owed to the examiner, who was presumed to have considered the reference. No reference relied upon by the defendants specifically suggested the combination relied upon by the defendants, and the formula disclosure relied upon was not sufficiently definite or limited. Further, the defendants showed no motivation to modify the prior art.
  • Discovery: The accused infringers did not show that the district court abused its discretion in denying their motion to amend their invalidity contentions to include an on-sale bar contention. The documents that prompted accused infringers to raise an on-sale bar argument had been produced by the plaintiffs more than a year before the motion to amend was filed. Accused infringers have not addressed the magistrate’s finding that they should have discovered this documentation earlier.
  • Indirect Infringement—Inducement: The district court improperly rejected one defendant’s argument that it could not be liable for induced infringement based on the “safe harbor” provision of 35 U.S.C. § 271(e)(1) for those engaged in certain activities in support of filing an Abbreviated New Drug Application (ANDA) before the FDA. This defendant supplied other defendants with the allegedly infringing compound in order for them to file an ANDA and filed a drug master file on that compound, but did not submit an ANDA itself. These activities are protected by the safe harbor provision, thus the district court erred in ruling that this defendant induced infringement of the claims covering the compound.