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Allergan Sales, LLC v. Sandoz, Inc.

“Wherein” Clauses Material to Patentability May Be Limiting

Allergan Sales, LLC v. Sandoz, Inc., __ F.3d __, 2019 WL 4063570 (Fed. Cir. Aug. 29, 2019) (Prost (concurring), Newman, WALLACH) (D.N.J.: Walls) (3 of 5 stars)

Fed Cir affirms entry of a preliminary injunction against Sandoz’s introduction of a generic version of Allergan’s ophthalmic drug Combigan. The district court correctly construed the claim as limited by various “wherein” clauses that recited various aspects of the claimed formulation’s effectiveness. The opinion rejects Sandoz’s contention that these clauses merely stated intended results. Taking the entire specification into account, the opinion reasons that the clauses are material to patentability, and thus limiting, because Allergan relied in part on evidence of unexpected results, as well as increased efficacy and safety, during prosecution. Bristol-Myers, 906 F.3d 1013 (Fed. Cir. 2018), is not contradictory because this is not a case where the clauses were added after the examiner had indicated allowability. Georgetown Rail, 867 F.3d 1229 (Fed. Cir. 2017), is not contradictory because in that case the applicant had not relied on the claim terms during prosecution.

Concurrence: Chief Judge Prost notes prior authority in which “wherein” clauses reciting intended results were not treated as limiting. In her view, the “wherein” clauses here “give meaning and purpose to the other manipulative steps” of the claim, which is important to overcoming that authority. Concur. at 3. She also expresses skepticism about Sandoz’s contention that clauses comprising “over half the claim language in claim 1” could be considered a mere “intended result.” Id. at 9.

KEYWORDS: PRELIMINARY INJUNCTION; CLAIM CONSTRUCTION; INTENDED RESULT