CoraMed USA LLC v. Alexion Pharmaceuticals, Inc.

CourtDistrict Court, E.D. New York
DecidedSeptember 27, 2023
Docket1:20-cv-02052
StatusUnknown

This text of CoraMed USA LLC v. Alexion Pharmaceuticals, Inc. (CoraMed USA LLC v. Alexion Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
CoraMed USA LLC v. Alexion Pharmaceuticals, Inc., (E.D.N.Y. 2023).

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK ----------------------------------------------------------------X CORAMED USA, LLC, d/b/a CORAMED SOLUTIONS,

Plaintiff, MEMORANDUM & ORDER -against- 20-CV-2052-SJB

ALEXION PHARMACEUTICALS, INC.,

Defendant. ----------------------------------------------------------------X BULSARA, United States Magistrate Judge:

Alexion Pharmaceuticals, Inc. (“Alexion”) is a global pharmaceutical company that manufactures Soliris, the sole drug approved by the U.S. Food and Drug Administration to treat life-threatening “complement cascade” disorders. This action arises from an alleged agreement between Alexion and CoraMed USA, LLC (“CoraMed”), under which CoraMed would exclusively sell Soliris to Alexion’s competitors for use in clinical trials for novel therapies. CoraMed alleges that it entered into and performed its agreement with Alexion, which failed to honor its side of the purported contract. CoraMed asserts a variety of state law claims, four of which Alexion now seeks to dismiss—breach of contract, breach of the implied covenant of good faith and fair dealing, tortious interference with contract, and tortious interference with prospective economic advantage. (Mot. to Dismiss dated Oct. 14, 2020, Dkt. No. 27). For the reasons described below, the motion is granted in part and denied in part. FACTUAL BACKGROUND AND PROCEDURAL HISTORY For the purposes of this motion, the Court is “required to treat” the Complaint’s “factual allegations as true, drawing all reasonable inferences in favor of [CoraMed] to the extent that the inferences are plausibly supported by allegations of fact.” In re Hain Celestial Grp., Inc. Sec. Litig., 20 F.4th 131, 133 (2d Cir. 2021). The Court “therefore recite[s] the substance of the allegations as if they represented true facts, with the understanding that these are not findings of the court, as we have no way of knowing at this stage what are the true facts.” Id. Alexion is an international pharmaceutical company that produces drug

therapies used to treat rare autoimmune and blood diseases termed “Complement Cascade Disorders.” (Compl. dated May 5, 2020 (“Compl.”), Dkt. No. 1 ¶¶ 2, 24). Its leading drugs by sales are eculizumab, sold under the brand name Soliris, and ravulizumab, sold under the brand name Ultomiris. (Id. ¶¶ 27–28). These two drugs are the only therapies approved by the U.S. Food and Drug Administration (“FDA”) to treat Paroxysmal Nocturnal Hemoglobinuria, Atypical Hemolytic Uremic Syndrome, and Generalized Myasthenia Gravis. (Id. ¶¶ 29–35). Alexion is the producer and patent owner for the only FDA-approved therapies for Complement Cascade Disorders. (Id. ¶ 26). Alexion reported $4.99 billion in net product sales for 2019, $3.95 billion of which is attributable to sales of Soliris. (Id. ¶ 37). Some of Alexion’s competitors have sought to acquire these drugs for use in

clinical trials for new therapies, as an investigational product to measure or test the efficiency of a proposed new or alternative drug. (Id. ¶¶ 2, 36). This process— “Comparator Use”—is a necessary precondition for other pharmaceutical companies to obtain FDA approval for their potential competing therapies. (Compl. ¶¶ 4, 36). Facing increasing demand and pressure to sell its drugs for Comparator Use, Alexion published a “Request for Proposal” (“RFP”) on July 12, 2019, seeking a partner to manage the sale of Soliris to sponsors of clinical trials—in effect, to act as an intermediary third party in the distribution process.1 (Id. ¶ 51). The third party’s role was to evaluate the suitability of sponsors seeking to source Soliris for clinical trial use and then assist with brokering such sale transactions. (Id.). CoraMed provides third-party management of sales for Comparator Use for pharmaceutical companies. (Id. ¶ 2). During a July 18, 2019 conference call, Alexion

confirmed CoraMed would sell Soliris for Comparator Use. (Id. ¶ 53). CoraMed subsequently responded to the RFP on July 29, 2019. (Id. ¶ 54). During another telephone conference between Alexion’s procurement team and CoraMed’s President on August 15, 2019, Alexion confirmed it would sell Soliris to CoraMed, and CoraMed would resell it to sponsors. (Compl. ¶ 56). Alexion “advised” CoraMed had been awarded the project the following day. (Id. ¶ 58). On a September 5, 2019 telephone call, Alexion’s representative re-confirmed this arrangement. (Id. ¶ 63). CoraMed was designated as the “exclusive source” for distribution of Alexion’s products for Comparator Use. (Id. ¶ 7). CoraMed was not paid

1 Alexion sought

a strategic third partner to act as an intermediate third party who will 1) evaluate the suitability of sponsors seeking to source Alexion commercial product for clinical trial use, 2) if determined suitable, on-board sponsors in order to process and provide sponsor with Alexion commercial product for clinical use, 3) assure that sponsors seeking to source Alexion commercial product for clinical use meet the safety and reporting requirements for each Alexion product, 4) aggregate the total demand from potential sponsors of Alexion commercial product for clinical trial use, and 5) assist with brokering transactions between a sponsor and Alexion to purchase Alexion commercial product for clinical trial use.

(Compl. ¶ 51; Request for Proposal (RFP)—Management of Alexion Commercial Product Sourcing Request for 3rd Party Clinical Use dated July 12, 2019 (“RFP”), attached as Ex. 2 to Compl., § 2.1). directly by Alexion; it was to earn its fee through a markup paid by purchasers. (Id. ¶¶ 7, 11). On August 20, 2019, Alexion advised CoraMed that it should start work immediately. (Id. ¶ 59). Three days later, Alexion provided CoraMed with 18 months’ worth of backorders and put CoraMed in touch with prospective purchasers. (Compl.

¶ 60). On September 13, 2019, CoraMed presented its first round of order requests for Alexion’s internal consideration, and Alexion subsequently approved the sale to three sponsors. (Id. ¶¶ 64–65). From August 2019 through January 2020, CoraMed managed Alexion’s Comparator Sales and continued to screen requests to purchase Soliris for Comparator Use. (Id. ¶ 71). It also provided “grey market product security risk analyses” and analyzed the impact of proposed legislation on Alexion’s business. (Id. ¶ 70). And Alexion “repeatedly” advised potential purchasers that CoraMed was the exclusive manager of Comparator Sales for Soliris. (Id. ¶ 62). Unbeknownst to CoraMed, Alexion began dealing directly with purchasers in November or December 2019, collecting payment for the first orders of Soliris for

Comparator Use. (Id. ¶¶ 73, 75). Without prior warning or notification, Alexion terminated the parties’ arrangement on January 14, 2020. (Compl. ¶ 76). Alexion claimed the reason for the termination was that an Alexion employee held an ownership interest in CoraMed. (Id. ¶ 80). But that employee’s ownership interest was, in fact, disclosed to three of Alexion’s senior officers—before CoraMed even submitted its initial bid proposal—all of whom confirmed in writing their knowledge of the employee’s ownership interest. (Id. ¶¶ 80–81). The employee was walled off from the RFP process. (Id. ¶ 82). Alexion failed to pay CoraMed for the services it rendered. (Id. ¶ 84). CoraMed sets forth six claims in the Complaint: (1) breach of contract (Count I); (2) breach of the implied covenant of good faith and fair dealing (Count II); (3) unjust enrichment (Count III); (4) quantum meruit (Count IV); (5) tortious interference with contract (Count V); and (6) tortious interference with prospective economic advantage (Count VI).2 (Id. ¶¶ 90–144). Alexion moved to dismiss Counts I, II, V, and VI.

DISCUSSION “The purpose of a motion to dismiss for failure to state a claim under Rule 12(b)(6) is to test the legal sufficiency of . . .

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CoraMed USA LLC v. Alexion Pharmaceuticals, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/coramed-usa-llc-v-alexion-pharmaceuticals-inc-nyed-2023.