Ipsen Biopharm Ltd v. Galderma Laboratories LP

CourtDistrict Court, N.D. Texas
DecidedMarch 8, 2023
Docket4:22-cv-00662
StatusUnknown

This text of Ipsen Biopharm Ltd v. Galderma Laboratories LP (Ipsen Biopharm Ltd v. Galderma Laboratories LP) is published on Counsel Stack Legal Research, covering District Court, N.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ipsen Biopharm Ltd v. Galderma Laboratories LP, (N.D. Tex. 2023).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION

IPSEN BIOPHARM LTD., § § Plaintiff, § § v. § Civil Action No. 4:22-cv-00662-O § GALDERMA LABORATORIES, L.P., § and GALDERMA RESEARCH & § DEVELOPMENT, LLC, § § Defendants. §

MEMORANDUM OPINION & ORDER

Before the Court is Defendants’ Motion to Dismiss Complaint for Injunctive Relief (ECF No. 21), filed August 23, 2022. On October 20, 2022, Plaintiff filed its Response (ECF No. 29), and Defendants filed their Reply (ECF No. 34) on November 3, 2022. At the Court’s request, Defendants subsequently filed a Supplement to Motion to Dismiss (ECF No. 45) on November 14, 2022.1 Accordingly, the Motion to Dismiss is now ripe for review. Having considered the briefing and applicable law, the Court finds that the Motion to Dismiss Complaint for Injunctive Relief (ECF No. 21) should be GRANTED. I. FACTS In many respects, this case puts the “complex” in complex commercial litigation, given that it involves two multinational bio-pharmaceutical companies suing one another in courts and tribunals across the globe. Bolstered by talented legal teams, the parties have raised nuanced legal

1 On November 8, 2022, Plaintiff filed its Amended Complaint for Injunctive Relief, wherein it named Galderma Research & Development, LLC, as a defendant for the first time and added a new claim for injunctive relief. See Am. Compl., ECF No. 36. In their Supplement to Motion to Dismiss, Defendants argue that their Motion to Dismiss is not moot, since it is based on the jurisdictional issue of forum non conveniens which is not affected by Plaintiff’s addition of a new party and a new claim for injunctive relief. See Supp. to Mot. to Dismiss, ECF No. 45. The Court agrees with Defendants. arguments touching on topics such as civil procedure, international arbitration, contracts, and regulatory law. On a factual level, the parties’ briefing is equally thorough, replete with details on everything from bacterial neurotoxins to molecular chemistry to transnational business strategies.2 Yet despite this dispute’s byzantine trappings, the pertinent factual backdrop for Defendants’ Motion to Dismiss can be distilled to five main categories: the QM Agreement, the ICC

Arbitration, the Tribunal’s Interim Procedural Order No. 3, Galderma’s QM License Application to the FDA, and Galderma Affiliates Consent to Arbitration. A. QM Agreement Ipsen Biopharm Ltd. (“Ipsen”) is a bio-pharmaceutical company that has partnered with another bio-pharmaceutical company Galderma S.A. (“Galderma”) since 2007. Galderma is the parent company of Galderma Laboratories, L.P. (“Galderma Labs”) and Galderma Research & Development, LLC (“Galderma R&D”). Galderma Labs and Galderma R&D are now both parties to this litigation, but their parent company Galderma is not. Beginning almost a decade ago, Ipsen and Galderma partnered to develop QM-1114, a Botox®-like drug used primarily for cosmetic purposes. In 2014, this partnership was

memorialized through the QM Agreement. The QM Agreement applies to Ipsen and its Affiliates and Galderma and its Affiliates. The QM Agreement specifies, “For this Agreement, ‘Affiliates’ has the meaning given to it in the Europe DDA.”3 At present, the parties dispute whether Galderma Labs and Galderma R&D are “Affiliates” of Galderma, and thus subject to the terms of the QM Agreement.

2 Unless otherwise specified, the Court’s recitation of the facts is drawn from Defendants’ Motion to Dismiss, Plaintiff’s Response, Defendants’ Reply, and Defendants’ Supplement to Motion to Dismiss. See Mot. to Dismiss, ECF No. 21; Resp., ECF No. 29; Reply, ECF No. 34; and Supp. to Mot. to Dismiss, ECF No. 45. 3 QM Agreement 1, ECF No. 22-1 at 2. Among other sections outlining the terms of the partnership between Ipsen and Galderma, the QM Agreement included the following dispute resolution provision: This Agreement shall be governed by the laws of Belgium. All disputes arising out of or in connection with the present Agreement shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by three arbitrators appointed in accordance with the said Rules. The seat of arbitration shall be Brussels and the language of arbitration shall be English.4

Ultimately, while the parties tried to build a lasting relationship through the QM Agreement that was more than skin-deep, they could not prevent discord from breaking out. B. ICC Arbitration In the summer of 2021, the Ipsen-Galderma relationship hit a rough patch, as often occurs in long-term partnerships. The trouble first arose with a quarrel about the regulatory submission strategy for QM-1114. But as the situation developed, it became clear that the issues between them were more than merely cosmetic. To resolve these disagreements, the unhappy duo decided to settle their differences in court. More precisely, Galderma initiated an arbitration before the International Chamber of Commerce (“ICC”) in Brussels, Belgium pursuant to the dispute resolution provision of the QM Agreement. This ICC Arbitration is still ongoing. About a year after the initiation of the ICC Arbitration, Galderma and Galderma Labs informed Ipsen that they intended to move forward with submitting regulatory applications for QM-1114. Ipsen considered this proposed course of action to be a violation of the QM Agreement, subversive of the ICC Arbitration, and a threat to Ipsen’s trade secrets. In response, Ipsen filed a request for interim relief from the ICC Tribunal. Seeking similar relief, Ipsen also filed this lawsuit on August 2, 2023.

4 QM Agreement § 6.5, ECF No. 22-1 at 3. C. Tribunal’s Interim Procedural Order No. 3 As just mentioned, Ipsen requested that the ICC Tribunal impose an interim order barring Galderma and Galderma Labs from submitting regulatory applications for QM-1114 while the ICC Arbitration is pending. In response, Galderma also requested interim orders from the ICC Tribunal that would grant it permission to file QM-1114 regulatory applications and that would require

Ipsen to withdraw its Complaint before this Court. The ICC Tribunal issued Procedural Order No. 3 addressing these requests for interim relief on September 9, 2022. According to their briefing, both sides seem to think that Procedural Order No. 3 was decided in their favor. Moreover, the Court has struggled to determine which side is correct since neither submitted a complete version of Procedural Order No. 3 for the Court’s review. Instead, both sides have only submitted portions of Procedural Order No. 3, quite literally cherry-picking the sections that support their positions.5 Nevertheless, having reviewed the record, it is clear to the Court that the ICC Tribunal denied both Ipsen’s and Galderma’s requests for interim relief. This decision largely rests on the fact that ICC Tribunal’s jurisdiction over all Galderma Affiliates, including Galderma Labs,

remains uncertain. Referring to Galderma Labs as GLP, the Tribunal noted: GLP is indeed not a party to the present arbitration. Moreover, whether or not “Affiliates” of the Parties (as determined in the QM Agreement) are bound by the Agreement and its arbitration clause, is a question to be determined later in this arbitration. In these circumstances, ordering Ipsen Biopharm to withdraw its complaint against GLP would imply that the Tribunal has jurisdiction or some measure of control over GLP. However, this is not the case.6

Ipsen spins this finding as the Tribunal’s approval for this lawsuit to continue. Meanwhile, Galderma Labs insists that the instant lawsuit should be dismissed because the Tribunal plans to

5 Compare Plaintiff’s Procedural Order No. 3, ECF No. 30 at 15–22, with Defendants’ Procedural Order No. 3, ECF No. 35-2 at 1–6. 6 Defendants’ Procedural Order No. 3 ¶ 116, ECF No. 35-2 at 5.

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