Acorda Therapeutics, Inc. v. Alkermes Plc

CourtCourt of Appeals for the Federal Circuit
DecidedJuly 25, 2025
Docket23-2374
StatusPublished

This text of Acorda Therapeutics, Inc. v. Alkermes Plc (Acorda Therapeutics, Inc. v. Alkermes Plc) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Acorda Therapeutics, Inc. v. Alkermes Plc, (Fed. Cir. 2025).

Opinion

Case: 23-2374 Document: 77 Page: 1 Filed: 07/25/2025

United States Court of Appeals for the Federal Circuit ______________________

ACORDA THERAPEUTICS, INC., Petitioner-Appellant

v.

ALKERMES PLC, Respondent-Appellee ______________________

2023-2374 ______________________

Appeal from the United States District Court for the Southern District of New York in No. 1:23-cv-00223-NRB, Judge Naomi Reice Buchwald. ______________________

Decided: July 25, 2025 ______________________

GARRARD R. BEENEY, Sullivan & Cromwell LLP, New York, NY, argued for petitioner-appellant. Also repre- sented by STEPHEN J. ELLIOTT, MORGAN ROSE KNUDTSEN; BRITTANY BRUNS, Washington, DC.

BRIAN TIMOTHY BURGESS, Goodwin Procter LLP, Wash- ington, DC, argued for respondent-appellee. Also repre- sented by JORDAN BOCK, CHRISTOPHER T. HOLDING, Boston, MA. ______________________

Before TARANTO, HUGHES, and STARK, Circuit Judges. Case: 23-2374 Document: 77 Page: 2 Filed: 07/25/2025

TARANTO, Circuit Judge. Acorda is the developer of Ampyra®, a drug used to treat patients with multiple sclerosis. Until 2018, Alker- mes owned a patent covering Amprya’s active ingredient. Alkermes licensed the patent to Acorda in return for roy- alty payments and contracted to supply Acorda with the active ingredient in return for royalty payments. In July 2018, the licensed patent expired, but Acorda continued to make royalty payments—without protest until July 2020 and thereafter under protest. Acorda initiated an international arbitration, pursuant to the parties’ agreement, in July 2020. It sought (a) a judgment that, when the patent expired, the royalty provi- sions became unenforceable under federal law based on Brulotte v. Thys Co., 379 U.S. 29, 30–34 (1964); see also Kimble v. Marvel Entertainment, LLC, 576 U.S. 446, 449, 458–60 (2015) (declining to overrule Brulotte), and (b) re- coupment of royalties paid since July 2018. The arbitration tribunal (Tribunal) agreed that the provisions were unen- forceable but concluded that Acorda was entitled to recoup only payments made under formal protest. Amended Find- ings of Fact, Conclusions of Law, and Final Reasoned Award, Acorda Therapeutics, Inc. v. Alkermes PLC, Arbi- tration No. 01-20-0010-8421 (Am. Arb. Assoc. Int’l Ctr. Disp. Resol. Apr. 11, 2022) (Award); J.A. 33–55. Acorda filed the legal action now before us by petitioning the United States District Court for the Southern District of New York to confirm all the Tribunal’s rulings except for the denial of recoupment of the unprotested 2018–2020 payments, which Acorda sought to modify on the ground that the Tribunal acted in “manifest disregard” of federal patent law and a non-patent-law principle of law. Alker- mes disputed the modification request only. The district court rejected Acorda’s manifest-disregard arguments and confirmed the award in full. Acorda Therapeutics, Inc. v. Alkermes PLC, No. 23-cv-223, 2023 WL 5003767, at *1 (S.D.N.Y. Aug. 4, 2023) (Decision); J.A. 1–20. Case: 23-2374 Document: 77 Page: 3 Filed: 07/25/2025

ACORDA THERAPEUTICS, INC. v. ALKERMES PLC 3

Acorda appealed, asserting that this circuit has appel- late jurisdiction over the appeal and should reverse the dis- trict court’s denial of the 2018–2020 recoupment it sought. We conclude that Acorda’s petition to modify the arbitral award on the ground that the arbitration panel manifestly disregarded the law is not within our jurisdiction under 28 U.S.C. § 1295(a)(1). We therefore transfer the case to the United States Court of Appeals for the Second Circuit. I A Acorda is the developer of Ampyra®, a drug used to im- prove the walking ability of patients with multiple sclero- sis. Decision, at *1; J.A. 357. Alkermes owned now-expired U.S. Patent No. 5,540,938, which claimed a sustained-re- lease formulation of the active ingredient in Ampyra, dal- fampridine. Decision, at *1. In 1998, Acorda and Alkermes entered into a joint-venture agreement, under which Alk- ermes licensed the ’938 patent to Acorda, and supplied the active ingredient, for an ongoing royalty of 18% of the net sales price of drugs sold as part of the joint venture, among other conditions. Award, at 6–7; J.A. 320. In 2003, Acorda and Alkermes dissolved the joint venture due to regulatory concerns and entered into a new agreement with two con- tracts. Award, at 7; J.A. 329–30. Under those two con- tracts, Acorda, as seller of Ampyra, would pay a 18% royalty to Alkermes, structured as a 10% royalty under a License Agreement plus an 8% royalty under a Supply Agreement. J.A. 154; J.A. 214–15; J.A. 329–30. In 2010, upon FDA approval of the relevant new drug application, Acorda began to market Ampyra. J.A. 357. On July 30, 2018, the ’938 patent expired and generic versions of Ampyra soon entered the market. J.A. 365, 388. In December 2019, Acorda contacted Alkermes and re- quested an adjustment to the royalties in light of the expi- ration, but Alkermes refused. J.A. 265; J.A. 391, 394. Acorda continued to make payments, without (as the Case: 23-2374 Document: 77 Page: 4 Filed: 07/25/2025

parties accept before us) stating a formal protest. Acorda Opening Br. at 11–12; Alkermes Response Br. at 9; J.A. 265; J.A. 628 n.5. In April 2020, Acorda again asserted to Alkermes that the royalty provision of the License Agree- ment was unenforceable due to the expiration of the ’938 patent, citing Brulotte, 379 U.S. at 32, but Acorda contin- ued to make payments without a protest. J.A. 390, 394. In July 2020, two years after the ’938 patent expired, Acorda began to include a protest with each payment made under the License Agreement, while not doing so for payments made under the Supply Agreement. J.A. 265; J.A. 446. B On July 28, 2020, Acorda filed with the American Ar- bitration Association’s International Centre for Dispute Resolution a Demand for Arbitration with Alkermes, pur- suant to arbitration terms of the License and Supply Agreements. Award, at 1–2; J.A. 83. Among other claims, Acorda sought a declaration that the licensing royalty pro- vision was unenforceable after the expiration of the ’938 patent in July 2018, and a return of royalties Acorda had paid after July 2018, invoking unjust enrichment as a basis for such recoupment. Award, at 2–3. As the parties agree, New York law governed the arbitration. Id. at 18 n.10. On November 7, 2022, after discovery, summary-judg- ment, and other proceedings, the Tribunal issued an arbi- tral award. See generally Award. It agreed with Acorda that, under Brulotte, the License Agreement’s royalty pro- vision was unenforceable upon the expiration of the ’938 patent. Id. at 8–16; see Brulotte, 379 U.S. at 32 (“[A] pa- tentee’s use of a royalty agreement that projects beyond the expiration date of the patent is unlawful per se.”). It then determined that “the License and Supply Agreements are, for all intents and purposes, one agreement” and thus that the Supply Agreement’s royalty provision was also unen- forceable. Award, at 16–17. Case: 23-2374 Document: 77 Page: 5 Filed: 07/25/2025

ACORDA THERAPEUTICS, INC. v. ALKERMES PLC 5

The Tribunal then turned to the question of monetary remedies—specifically, whether Acorda was entitled to re- cover any payments made after patent expiration under a theory of “unjust enrichment/restitution.” Id. at 17. Re- garding the License Agreement, the Tribunal applied the New York Voluntary Pay Doctrine (NYVPD)—under which “payments that are ‘made with full knowledge of the facts, even if made under mistake of law,’ are not recoverable”— to bar recovery of the payments that Acorda had made without protest. Id. at 18 (quoting Dillon v. U-A Columbia Cablevision of Westchester, Inc., 740 N.Y.S.2d 396, 397 (App. Div.

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