In Allergan Sales, LLC v. Sandoz, Inc., No. 2018-2207 (Fed. Cir. Aug. 29, 2019), the Federal Circuit held that the “wherein” clauses in Allergan’s method-of-treatment claims are limiting. Claim 1 of the patent-at-issue recited topically administering a composition comprising 0.2% w/v brimonidine tartrate and 0.68% w/v timolol maleate, “wherein” the method is as effective as a 0.2% w/v brimonidine tartrate monotherapy, and “wherein” the method reduces the incidence of one or more specified adverse effects compared to the 0.2% w/v brimonidine tartrate monotherapy.
The court found that the specification demonstrated that the claimed invention was ultimately a formulation (and methods of using that formulation) that allowed for increased efficacy and safety. The Federal Circuit reasoned that those benefits, instead of merely being intended purposes, were believed by Allergan to be material to patentability.
The Federal Circuit also noted that Allergan relied on the efficacy and safety of the claimed methods during prosecution in response to the examiner’s rejections and that the Examiner explicitly relied on the “wherein” clauses in explaining why the claims were “novel and non-obvious over the prior art” in the Notice of Allowance. Accordingly, the Federal Circuit concluded that the intrinsic evidence supported that the “wherein” clauses were material to patentability and thus limiting.