Allergan Sales, LLC v. Sandoz, Inc

“Wherein” clauses in a method of treatment claim are claim limitations that should be given weight, resulting in the affirmance of a preliminary injunction.

August 29, 2019

GENERICally Speaking

Case Name: Allergan Sales, LLC v. Sandoz, Inc., No. 2018-2207, 2019 U.S. App. LEXIS 26200 (Fed. Cir. Aug. 29, 2019) (Circuit Judges Prost, Newman, and Wallach presiding; Opinion by Wallach, J.; Concurring Opinion by Prost, C.J.) (Appeal from D.N.J., Walls, J.)

Drug Product and Patent(s)-in-Suit: Combigan® (brimonidine tartrate / timolol maleate); U.S. Patents Nos. 9,770,453 (“the ’453 patent”), 9,907,801 (“the ’801 patent”), and 9,907,802 (“the ’802 patent”)

Nature of the Case and Issue(s) Presented to District Court: Combigan is a topical formulation for the treatment of glaucoma and ocular hypertension. The patents-in-suit shared a common specification and representative claim 1 of the 453 patent recites a method for the treatment of glaucoma or ocular hypertension that included “topically administering twice daily to an affected eye a single composition comprising 0.2% w/v brimonidine tartrate and 0.68% w/v timolol maleate.” The claim also included two “wherein” clauses providing that “the method is as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day” and that “the method reduces the incidence of one of more adverse events … when compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times daily.” The district court found the “wherein” clauses to be limiting and granted Allergan’s preliminary injunction.

Why Allergan Prevailed: Sandoz disputed that the “wherein” clauses were claim limitations, arguing instead that the clauses merely state the intended results of administering the drug product and that the recited results are not material to patentability. Stated another way, Sandoz argued that a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.

The Federal Circuit acknowledged that there was “some overlap between the language of the ‘wherein’ clauses and those results,” but nevertheless found that the “wherein” clauses constituted claim limitations. In particular, the Federal Circuit noted that the recited “benefits are described throughout the specification.” Further, “Allergan relied on the efficacy and safety of the claimed methods during prosecution … in responding to the examiner’s rejections.” The Federal Circuit concluded that the “wherein” clauses were material to the examiner’s patentability determination.  As a result, the “wherein” clauses were given patentable weight, and the preliminary injunction was upheld.

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