Blog Big Molecule Watch August 14, 2022

Amgen Moves to Dismiss and to Stay Regeneron’s Antitrust Case

We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware.  Amgen recently filed a motion to dismiss Regeneron’s Complaint and a motion to stay the case.

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).”  In its motion to dismiss under Fed. R. Civ. 12(b)(6), Amgen argues that “antitrust law does not condemn—indeed, it embraces—competition and low prices,” and that Regeneron’s “allegations do not come close to meeting the standards required to state a claim” for an antitrust violation.  Specifically, Amgen argues that “Regeneron has failed to allege that Amgen’s price reductions violate the antitrust laws” because Regeneron “(1) fails to allege Amgen’s agreements with ESI Part D and Optum Commercial are exclusive or de facto exclusive; (2) alleges only 15.27% foreclosure—far short of the 40% to 50% courts generally require for “substantial foreclosure”; (3) does not plausibly allege the contracts are of sufficient duration to be exclusionary; (4) fails to allege coercion; and (5) itself employs exclusive dealing.”  Amgen also argues that Regeneron’s antitrust claim fails “because it does not allege that Amgen bundles Repatha® with rebates on a drug with monopoly or market power.”  Finally, Amgen argues that Regeneron’s remaining claims fail because they are derivative of the antitrust claims.

Amgen has also moved to stay the case “until resolution of a patent case between Amgen and Regeneron, which involves the same medicines at issue here” and is currently before the Supreme Court on Amgen’s petition for writ of certiorari.  Amgen argues that “[i]n this case, Regeneron alleges that Amgen engaged in anticompetitive conduct by selling its medicine, Repatha®, in a manner that foreclosed Praluent® from the market,” but “[m]any of Regeneron’s allegations refer to the patent litigation,” and as such, “Regeneron’s claims will be mooted if Amgen prevails in the patent case.”  Amgen states that it “makes this motion in order to avoid duplication of work, conserve judicial resources, and save costs and expenses of the parties and non-parties that may turn out to be unnecessary.”

We will continue to monitor developments in this case.

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