On Tuesday, Judge Andrews issued what I believe is the first opinion in the district regarding "skinny labels" since the Federal Circuit issued its decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021).
As anyone immersed enough in patent law to read this blog will know, skinny labeling is the practice of excluding certain indications from the generic drug's label and associated inserts, so as to avoid inducing infringement of method of treatment patents listed in the orange book. In Amarin Pharma, Inc. et al v. Hikma Pharmaceuticals USA Inc., C.A. No. 20-1630-RGA, D.I. 97 (D. Del. Jan. 4, 2022), for instance, the branded drug was indicated for treatment of severe hypertriglyceridemia ("SH") and for cardiovascular risk reduction ("CV"). The plaintiff had patents directed to treating CV, but not SH, and so the defendant's generic label indicated only that it was approved to treat SH - thus, presumably, avoiding inducement. Accordingly, the defendant moved to dismiss the induced infringement claims.
The difficulty for the defendant was that it had (allegedly) advertised its products as the generic equivalent of the branded drug in the broad category of "hypertriglyceridemia" ("H") rather than merely SH. In ruling on the motion Judge Andrews accepted as true Plaintiff's allegations that H was a broad enough category to encompass infringing uses. Id. at 8.
The plaintiff argued that this placed the case on all fours with Glaxo, where the Federal Circuit found that the defendant's claims that the generic drug was "the AB rated generic equivalent of [the branded drug] and are indicated for treatment of [category that included both infringing and non-infringing uses]" supported a finding of inducement, despite its skinny label. Glaxosmithkline LLC v. Teva Pharm. USA, Inc. , Nos. 2018-1976, 2018-2023, 2021 U.S. App. LEXIS 23173, at *38 (Fed. Cir. Aug. 5, 2021) .
Judge Andrews disagreed, and granted the defendants motion to dismiss, noting that Glaxo was a "narrow, case-specific review." Amarin, C.A. No. 20-1630-RGA, D.I. 97 at 8 (quoting GlaxoSmithKline, 7 F.4th at 1326)). Specifically, Judge Andrews found the advertisements in Amarin distinguishable from those in Glaxo, because "unlike [the defendant's] press release in GSK, Hikma has not pointed to [the branded drug's] patented uses in describing itself as [the branded drug's] generic equivalent." Id. at 9.
This fairly narrow reading of the Glaxo holding should come as good news to all those with skinny labels. We'll keep you updated as the caselaw develops in this area.