UCB, Inc. v. Catalent Pharma Sols.

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 patent.” However, the Hatch-Waxman Act adopted an important exception, known as the safe harbor, codified at § 271(e)(1):

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products

35 U.S.C. § 271(e). Catalent does not argue that they are not importing lacosamide but claims their importation is protected under this safe harbor provision. [R. 48-1 at 15-19.] They move for dismissal, arguing the complaint fails to state a claim because it does not allege facts showing Catalent's use “infringes outside the scope of the safe harbor.” [Id. at 15.] They claim this precludes UCB from being able to “state a plausible claim for patent infringement.” [Id.] They also argue the complaint fails to state a claim for patent infringement without considering application of the safe harbor because its allegations are not plausible. [Id. at 15-17.] In response, UCB states its complaint is sufficient to notify Catalent of the claim against it and that a plaintiff is not required to preemptively respond to an affirmative defense. [R. 57 at 8-14.]

A

To determine whether UCB's amended complaint states a claim for patent infringement, the Court must first determine which of the complaint's allegations are proper to consider. Much has been made in the pleadings about the effect that prior hearings and briefings in this Court, particularly those related to the preliminary injunction, have on dismissal of the complaint. [See R. 48-1 at 15-19; R. 57 at 9-10.] Catalent bases some of its argument on the notion that UCB should have addressed the safe harbor in its amended complaint because UCB participated in the

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preliminary injunction process and was aware that Catalent intended to claim that defense. [R. 48-1 at 15.] Further, they point out alleged inconsistencies between the amended complaint and testimony submitted in relation to the preliminary injunction. [Id. at 16-17.]

Catalent points to Bassett as support for its assertion that the Court can consider these filings. [R. 48-1 at 18.] But that case, specifically the portion quoted in Catalent's motion, contradicts this assertion. This Court can consider portions of the record “so long as they are referred to in the complaint.” Bassett v. Nat'l College Athletic Ass'n, 528 F.3d 426, 430 (6th Cir. 2008). The preliminary injunction filings and related testimony were not referred to in the amended complaint [see R. 30], so the Court cannot consider them in resolving the motion to dismiss. For the same reasons, the Court will not consider the “admissions” Catalent made in the adjudication of the preliminary injunction, which UCB points to in its Response. [R. 57 at 9-20.]

In contrast, the Court will consider the information contained in the “four corners of the complaint, ” except for its “threadbare recitals” of the elements of a patent infringement claim. Berry v. United States Dep't of Labor, 832 F.3d 627, 637-38 (6th Cir. 2016). Catalent portrays the complaint as “a mishmash of bare allegations and rote recitations of claim elements.” [R. 481 at 15.] It is true that some of the allegations in the complaint are merely conclusory or restatements of elements, which the Court does not have to accept as true. On multiple occasions, the complaint states some formulation of: “Catalent has used, manufactured, sold, and/or offered to sell lacosamide, and/or drug products comprising lacosdamide in the United States.” [R. 30 at 9; see also id. at 5, 10-11.] These “allegations” are merely restating the patent infringement statute itself: “whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented

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invention during the term of the patent therefor, infringes the patent.” 35 U.S.C. § 271(a). The Court will not construe these conclusory statements as true.

However, the complaint does contain other allegations that are sufficiently plead to state a claim for patent infringement. UCB outlines seven instances where Catalent “caused” another corporation to import lacosamide. [R. 30 at 8-9.] These allegations include when, where and in what amount the compound was imported. [Id.] Though they are on “information and belief, ” these statements are far from conclusory...