We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware. The case concerns Regeneron’s allegation that Amgen has violated antitrust law by engaging “in a persistent exclusionary campaign to deny patients the life-saving benefits of [] Regeneron’s cholesterol-reducing medication, Praluent® (alirocumab).” According to Regeneron, the reason for Amgen’s campaign “is simple: for years, Praluent® has been the only direct competitor to Amgen’s own drug Repatha® (evolocumab) and Amgen is doing everything it can to avoid competing with Regeneron on the merits.” Praluent® and Repatha® are both PCSK9 inhibitors intended to help patients lower their low-density lipoprotein cholesterol.

On August 8, 2022, Amgen filed a motion to dismiss and to stay Regeneron’s antitrust complaint. Amgen moved to dismiss under Fed. R. Civ. 12(b)(6), arguing that Regeneron’s “allegations do not come close to meeting the standards required to state a claim” for an antitrust violation. Amgen also filed a motion to stay pending the resolution of related patent litigation before the Supreme Court, in which Amgen has appealed the Federal Circuit’s determination that two patents covering Amgen’s cholesterol medication Repatha® are invalid. On November 4, 2022, the Supreme Court agreed to review that case (No. 21-757) to decide “whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation.” Amgen argued that the Supreme Court’s decision will moot Regeneron’s antitrust claims.

Magistrate Judge Hall recently ruled on Amgen’s motions, recommending that Amgen’s motion to dismiss be denied, and ordering that the motion to stay be denied without prejudice. Regarding the motion to dismiss, Judge Hall noted that although she had “reservations about the basis for Regeneron’s claim for tortious interference with prospective business relations (Count Eleven),” Regeneron had properly pled antitrust violations and its pleadings were sufficient to survive at the motion to dismiss stage; Amgen’s arguments regarding Regeneron’s state law and federal antitrust claims “implicate[d] factual disputes that cannot be resolved at this stage of the case.”

In denying Amgen’s motion to stay, Judge Hall explained that “while it is possible that a Supreme Court ruling for Amgen will moot or simplify this case, there is more than a reasonable likelihood that a ruling for Amgen will actually complicate the case even more than it already is”; furthermore, “the potential prejudice to Regeneron by delaying the ultimate resolution of this case is significant.” Judge Hall noted that the motion to stay is denied without prejudice to renew after the Supreme Court issues its ruling in a few months.

We will continue to monitor developments in this case.