UCB, Inc. v. Catalent Pharma Sols.

• Decision Date: 24 November 2021
• Docket Number: CIVIL 5:21-cv-00038-GFVT
• Parties: UCB, INC., et al., Plaintiffs, v. CATALENT PHARMA SOLUTIONS, INC., et al., Defendants.
• Court: U.S. District Court — Eastern District of Kentucky

UCB, INC., et al., Plaintiffs,
v.
CATALENT PHARMA SOLUTIONS, INC., et al., Defendants.

CIVIL No. 5:21-cv-00038-GFVT

United States District Court, E.D. Kentucky, Central Division, Lexington

November 24, 2021

MEMORANDUM OPINION & ORDER

Gregory F. Van Tatenhove United States District Judge

This matter is before the Court on the Defendants' (Catalent Pharma Solutions, Inc., Catalent Pharma Solutions, LLC, and Catalent, Inc. (collectively, “Catalent”)) Motion to Dismiss. [R. 48.] Plaintiffs UCB, Inc., UCB Biopharma SPRL, and Research Corporation Technologies, Inc. (collectively, “UCB”) allege that Catalent is infringing on their patent on the compound lacosamide. [See generally R. 30.] For the reasons that follow, the Defendants' Motion to Dismiss [R. 48] is DENIED.

I

Each of the Plaintiffs has an interest in United States Reissued Patent No. RE38, 551 (“the ‘551 Patent”), which claims the chemical compound lacosamide. [R. 30 at 6; R. 1-1.] The patent was first assigned to Research Corporation Technologies, Inc., which gave Harris FRC Corporation an exclusive right to use the compound.^[1] [R. 30 at 6.] Harris FRC then granted a

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sublicense in the ingredient to Schwarz Pharma AG, which was acquired by UCB and its affiliates. [Id.] UCB uses lacosamide as the primary ingredient in its anticonvulsant medication VIMPAT®. [Id. at 1.]

Defendant Catalent manufactures and sells pharmaceutical products, including generic drugs. Id. at 4. UCB alleges Catalent is infringing on the ‘551 patent by importing lacosamide into the United States. [Id. at 8-9.] They specify seven instances between April 2019 and September 2020 where Catalent “caused” another corporation, MSN Pharmachem, to import “over 550 kilograms” of lacosamide. [Id.] MSN is a separate pharmaceutical company that was involved in prior litigation over this patent with UCB. [Id. at 9-10.] UCB also requested injunctive relief [R. 1 at 12], but this Court denied the preliminary injunction, finding UCB was unlikely to succeed on the merits [R. 59]. UCB filed an amended complaint, making minor changes, during the adjudication of the preliminary injunction. [R. 30.] Catalent now moves to dismiss the amended complaint, claiming the complaint does not state facts establishing a plausible claim and that UCB was required and failed to address the statutory safe harbor in their complaint. [R. 48-1 at 9-10.]

II

Dismissal of this pharmaceutical patent infringement claim turns on a simple question of civil procedure: what a complaint must include to survive a motion to dismiss. UCB's amended complaint claims that Catalent is infringing the ‘551 Patent because it “has made, used, offered for sale, and/or sold” and “imported” lacosamide. [R. 30 at 10-12.] In response, Catalent argues the complaint should be dismissed under Rule 12(b)(6). [R. 48.] A motion to dismiss pursuant to Rule 12(b)(6) tests the sufficiency of a plaintiff's complaint. In reviewing a Rule 12(b)(6) motion, the Court “construe[s] the complaint in the light most favorable to the plaintiff, accept[s]

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its allegations as true, and draw[s] all inferences in favor of the plaintiff.” DirecTV, Inc. v. Treesh, 487 F.3d 471, 476 (6th Cir. 2007). The Court, however, “need not accept as true legal conclusions or unwarranted factual inference.” Id. (quoting Gregory v. Shelby County, 220 F.3d 433, 446 (6th Cir. 2000)).

The Supreme Court has explained that “[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, ‘to state a claim to relief that is plausible on its face.'” Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)); see also Courie v. Alcoa Wheel & Forged Products, 577 F.3d 625, 629 (6th Cir. 2009). Stated otherwise, it is not enough for a claim to be merely possible; it must also be “plausible.” See Courie, 577 F.3d at 630. According to the Court, “a claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. (citing Twombly, 550 U.S. at 556). Moreover, under limited circumstances, a claim may be rendered plausible if a plaintiff pleads its “information and belief' with supporting facts. See Modern Holdings v. Corning Incorporated, 2015 U.S. Dist. LEXIS 41134 at *12 (E.D. Ky. 2015) (“While pleading on information and belief cannot insulate a plaintiff at the 12(b)(6) stage, Iqbal did not render pleading on information entirely ineffectual.”) E.g., Arista Records, LLC v. Doe, 604 F.3d 110, 120 (2d Cir. 2010) (“The Twombly plausibility standard, which applies to all civil actions, does not prevent a plaintiff from pleading facts alleged upon information and belief where the facts are peculiarly within the possession and control of the defendant . . .”)).

The underlying legal principles are especially relevant in resolving this motion to dismiss. UCB alleges Catalent is infringing on its patent by importing lacosamide into the

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United States for commercial purposes. [R. 30 at 9-12.] Patent infringement is governed by 35 U.S.C. § 271, which states whoever “makes, uses, offers to sell, ” sells, or imports a patented invention without authority “infringes the...