Regeneron Pharmaceuticals, Inc. v. Sanofi Biotechnology SAS, et al.

CourtDistrict Court, S.D. New York
DecidedMarch 17, 2026
Docket7:24-cv-08751
StatusUnknown

This text of Regeneron Pharmaceuticals, Inc. v. Sanofi Biotechnology SAS, et al. (Regeneron Pharmaceuticals, Inc. v. Sanofi Biotechnology SAS, et al.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Regeneron Pharmaceuticals, Inc. v. Sanofi Biotechnology SAS, et al., (S.D.N.Y. 2026).

Opinion

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK REGENERON PHARMACEUTICALS, INC., Plaintiff, OPINION & ORDER

-against- 24-CV-08751 (PMH) SANOFI BIOTECHNOLOGY SAS, et al.,

Defendants. Philip M. Halpern, United States District Judge: Regeneron Pharmaceuticals, Inc. (“Regeneron” or “Plaintiff”) presses a claim for breach of contract against Sanofi Biotechnology SAS, Sanofi, S.A., sanofi-aventis U.S. LLC, and Genzyme Corporation (collectively, “Sanofi” or “Defendants”). (Doc. 31, “Am. Compl.”).1 Defendants move to dismiss the Amended Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). (Doc. 49; Docs. 50 & 51, “Def. Br.”). Plaintiff filed an opposition (Docs. 53 & 54, “Pl. Br.”), and the motion was fully briefed with the filing of Defendants’ reply (Docs. 55 & 56, “Reply”).2 For the reasons stated below, Defendants’ motion to dismiss is DENIED.

1 Citations to specific pages of the Complaint and other filings on the docket correspond to the pagination generated by ECF. 2 The parties, in accordance with the Court’s Individual Practices, filed unredacted versions of their briefs under seal (Docs. 50, 53, 55) and redacted versions available for public viewing. (Docs. 51, 54, 56). Defendants also filed the contract at issue entirely under seal. (Doc. 50-1). Both Defendants’ and Plaintiff’s unopposed letter-motions to seal their respective briefs and the contract at issue (Docs. 48, 52) are granted. Because the parties’ briefs and the contract at issue are filed under seal, the Court’s Opinion and Order will be filed under seal and a redacted version will be filed publicly. BACKGROUND The Court, for purposes of deciding the pending motion, accepts as true the well-pled factual allegations in the Amended Complaint and draws all reasonable inferences in Plaintiff’s favor. See Lesser v. TD Bank, N.A., 463 F. Supp. 3d 438, 445 (S.D.N.Y. 2020). Plaintiff, in the Amended Complaint, alleges one claim for relief that Defendants breached

the Amended and Restated Collaboration Agreement (Doc. 50-1, “LCA”)3 entered into between Plaintiff, Aventis Pharmaceuticals Inc., and Sanofi-Aventis Amerique du Nord on November 10, 2009 by refusing to provide Plaintiff and its third-party auditors access to Defendants’ agreements with pharmacy benefits managers (“PBM Agreements”). (Am. Compl. ¶¶ 27, 74). Plaintiff seeks a variety of legal and equitable relief including money damages, specific performance, an injunction, and a declaratory judgment. (Id. at VI). Plaintiff, Aventis Pharmaceuticals Inc., and Sanofi-Aventis Amerique du Nord entered into a License and Collaboration Agreement on November 28, 2007, the scope of which was expanded in the LCA. (Am. Compl. ¶¶ 26-27). The LCA has since been amended five times and remains in effect. (Id. ¶¶ 1 n.1, 27). Defendants Sanofi

Biotechnology SAS and Sanofi S.A. are the successors-in-interest to Aventis Pharmaceuticals Inc. and Sanofi-Aventis Amerique du Nord, respectively. (Id. ¶¶ 11-12). Defendants sanofi-aventis U.S. LLC and Genzyme Corporation are both subsidiaries of Defendant Sanofi S.A. and allegedly perform certain obligations for Defendants Sanofi Biotechnology SAS and Sanofi S.A. under the LCA. (Id. ¶¶ 12-15). Defendant Sanofi Biotechnology SAS is also a subsidiary of Defendant Sanofi S.A. ((Id. ¶¶ 12, 15).

3 Defendants argue, and Plaintiff does not dispute, that the Court can and should consider the LCA in deciding the pending motion. (Def. Br. at 5 n.2; see also Pl. Br.). The Court considers the LCA, in addition to the Amended Complaint, in deciding Defendants’ motion to dismiss because the LCA is integral to the Amended Complaint and incorporated by reference. See Heckman v. Town of Hempstead, 568 F. App’x 41, 43 (2d Cir. 2014). The parties to the LCA agreed to “cooperate in good faith to Develop, Manufacture and Commercialize Licensed Products . . . to optimize the commercial potential of each Licensed Product.” (Id. ¶ 30; LCA § 2.1).4 The LCA makes Sanofi “the lead Party with respect to the Commercialization of Licensed Products in the Field.” (LCA § 6.1). One such product that the parties agreed to develop and commercialize under the terms of the LCA is Dupixent, “an

injectable biologic” used to treat a host of conditions, including atopic dermatitis. (Am. Compl. ¶ 28). Dupixent has been a widely successful pharmaceutical, reaching $8.8 billion in sales in 2023 and, as of August 2024, approximately one million users worldwide. (Id. ¶ 29). Sanofi, as part of its commercialization efforts, enters into PBM Agreements “to establish pricing terms, coverage, formulary positioning, access, and other terms for Dupixent.” (Id.). Pharmacy benefit managers “serve as intermediaries between manufacturers, pharmacies, and insurance companies to negotiate rebates and discounts on coverage terms and formulary placement, among other things.” (Id. ¶ 39). Plaintiff alleges that “the discounts and rebates provided under the PBM Agreements for Dupixent are estimated to be a significant fraction of

total Dupixent sales in recent years.” (Id. ¶ 43). According to Plaintiff, “[t]he PBM Agreements may reveal additional reimbursements and profit-sharing adjustments in Regeneron’s favor” and, thus, access to the PBM Agreements is necessary “to verify Defendants’ and their Affiliates’ compliance with other material provisions of the LCA.” (Id. ¶¶ 50, 52).

4 Plaintiff, Aventis Pharmaceuticals Inc., and Sanofi-Aventis Amerique du Nord, also entered into the Amended and Restated Discovery and Preclinical Development Agreement, under which Plaintiff was tasked with developing products and offering them to Sanofi to jointly develop and commercialize. (Am. Compl. ¶¶ 26-27). If Sanofi exercised its right to co-develop and commercialize a product with Plaintiff, the product became a “Licensed Product” under the LCA and would be governed by the LCA’s terms. (Id.). The Amended and Restated Discovery and Preclinical Development Agreement is no longer in effect. (Id. ¶ 27). Plaintiff alleges that it and its auditors must review Defendants’ PBM Agreements to ensure Defendants are not “bundling” Dupixent with other pharmaceuticals, which is prohibited under the LCA. (Id. ¶ 53).5 Plaintiff also alleges that it is entitled to access “[c]ommunications between Defendants and PBMs . . . whether oral or in writing” to determine if Defendants are bundling Dupixent with other products. (Am. Compl. ¶ 53 n.6). Plaintiff contends that LCA Section 6.4(b)

grants it “full access to material information directly relating to the Commercialization of [Dupixent],” and that this “material information” includes the PBM Agreements and “[a]ny side agreements between Defendants and the PBMs . . . .” (Id. ¶¶ 66, 74 (first alteration in original)). The LCA, according to Plaintiff, also grants its auditors access to the PBM Agreements through Sections 14.1 and 14.2(a), which allow each party to the agreement to hire third-party auditors to verify the “accuracy of all financial, accounting and numerical information and calculations provided, and payments made, under th[e LCA].” (Id. ¶¶ 74-75 (alteration in original)). Defendants offered Regeneron’s auditors, but not Regeneron, access to “discrete portions of the PBM Agreements” selected by Defendants, accessible only through “screen-sharing technology

controlled by Defendants’ representatives,” and provided that the auditors “refrain from capturing any image of the screen-shared Agreements.” (Id. ¶ 45). Plaintiff contends that it and its auditors are entitled to full access to the PBM Agreements. (Id. ¶¶ 41, 46). STANDARD OF REVIEW A Rule 12(b)(6) motion enables a court to dismiss a complaint for “failure to state a claim upon which relief can be granted.” Fed. R. Civ. P.

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Regeneron Pharmaceuticals, Inc. v. Sanofi Biotechnology SAS, et al., Counsel Stack Legal Research, https://law.counselstack.com/opinion/regeneron-pharmaceuticals-inc-v-sanofi-biotechnology-sas-et-al-nysd-2026.