The Supreme Court recently rendered two important decisions for the biopharma industry. In the first decision, the Supreme Court ruled on enablement of genus claims for therapeutic antibodies, unanimously affirming the Federal Circuit decision in Amgen v. Sanofi.1 The decision rejected Amgen’s genus claims as invalid for lacking enablement to their full scope, which we summarized here. In the Amgen case, the Court opened the door for “follow-on” antibodies by delivering a final blow to antibody claims covering a genus of antibodies based on functional limitations of the genus. In contrast, the Court denied cert in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC 2, the “skinny label” case we discussed here, here, and here. By denying cert, the Court leaves standing the district court’s jury decision3 and the Federal Circuit’s decision in GSK’s favor.4 In so doing, the Supreme Court potentially reduces the opportunity for generic drug manufacturers to carve out non-infringing uses on their labels or, at a minimum, fails to clarify the legal limits of skinny labels as a means for generic drug manufacturers to avoid infringement.
In the GSK case, the Supreme Court denied cert despite Judge Prost’s dissent in the denial of Teva’s request for a rehearing en banc by the Federal Circuit in which she states, “[t]he issues in this case, at the intersection of patent law and pharmaceutical regulation, are unquestionably important—affecting millions of Americans.”5 Furthermore, Elizabeth Prelogar, U.S. Solicitor General, joined Teva in asking the Court to overturn the Federal Circuit’s decision ruling for GSK. The Solicitor General argued that GSK’s win could “seriously jeopardize” the carveout pathway for generic drug companies. Despite having requested guidance from the Biden Administration as to whether to consider the GSK case and despite Judge Prost’s strongly worded dissent imploring further consideration, the Supreme Court denied Teva’s petition.6 The denial of cert means that the case will be remanded for further consideration regarding Teva’s liability for willfully inducing infringement of GSK’s hypertension drug, carvedilol (COREG®), despite Teva’s use of a “skinny label” on its generic product. In particular, an issue on remand will be Teva’s affirmative defense of equitable estoppel based on representations GSK made to the FDA indicating its patented uses were limited to congestive heart failure.
The Supreme Court, as is customary, provides no analysis or rationale for its denial of cert in the GSK case. The order list states only that Justice Kavanaugh would have granted cert. There is a possibility this case will wind its way back up to the Court once fact-specific issues are resolved on remand. In the meantime, the Amgen case, along with Justice Kavanaugh’s signal in the GSK case, suggests that the Supreme Court will not avoid addressing laws critical to the biopharma industry and may well address the legal limits of “skinny labels” in the future – either after remand in the GSK case or in another pending “skinny label” case.