United States: Pleading Direct Patent Infringement In ANDA Cases Upon Information And Belief

December 5, 2015, saw the abrogation of Federal Rule of Civil Procedure 84 and Form 18, the sample complaint for direct patent infringement. Since that date, courts have uniformly applied the pleading standard set forth in two less recent Supreme Court cases to complaints alleging direct patent infringement. Under this standard, the complaint must provide sufficient factual allegations "to state a claim for relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). A claim is plausible when "the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678(2009). "Determining whether a complaint states a plausible claim for relief will . . . be a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id., 556 U.S. at 679.

In cases brought pursuant to the Hatch Waxman Act, the submission to the FDA of an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification of patent invalidity or non-infringement is the "artificial" act of infringement giving rise to a cause of action. 35 U.S.C. § 271(e)(2). The ANDA filer is required to give notice of the Paragraph IV certification filing to the patentee, who then has 45 days in which to bring suit in order to receive a 30-month stay of ANDA approval pending the litigation outcome. 21 U.S.C. § 355(j)(5)(B)(iii). Prior to the receipt of a Paragraph IV notice, a patentee is generally in the dark as to the existence, composition, and properties of the ANDA filer's proposed drug product. Furthermore, the Paragraph IV certification notice letter does not always provide all of the details of the ANDA product, particularly if it does not provide any substantive non-infringement position. During the 45-day period, the patentee can obtain additional information regarding the ANDA product, usually under the terms of an Offer of Confidential Access (OCA) that restrict access of the confidential ANDA information and may forbid any mention of such information in any publicly available pleading. In this post-Rule 84 era, and under the Twombly and Iqbal standards, the patentee must then balance the need to allege sufficient facts to support a plausible claim for patent infringement with its lack of access to information or its potential obligation to keep certain details regarding the ANDA product confidential.

Fortunately for the Hatch Waxman Act plaintiff, the Federal Circuit has acknowledged, albeit with respect to Form 18, that "[a] defendant cannot shield itself from a complaint . . . by operating in such secrecy that the filing of a complaint itself is impossible." K-Tech Telecommunications, Inc. v. Time Warner Cable, Inc., 714 F.3d 1277, 1286 (Fed. Cir. 2013). Furthermore, the plausibility standard is a flexible one. Iqbal, 556 U.S. at 679; see also DermaFocus LLC v. Ulthera, Inc., No. 15-654-SLR, 2016 BL 261077 (D. Del. Aug. 11, 2016) (finding that the plaintiff had given the defendant reasonable notice of a plausible claim for direct infringement using certain, more limited information where "it is not apparent to the court whether the information demanded by the defendant is in the public domain and, therefore, reasonably available to plaintiff").

Where the information needed to eventually prove infringement either rests solely in the hands of the accused infringer or is subject to an obligation of confidentiality, courts generally allow plaintiffs to allege facts "upon information and belief." See Fed. R. Civ. P. 11(b)(3). For example, in Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., the second amended complaint presented a claim of induced infringement based on defendant Hikma's "active encouragement of third-party infringement, including Mitigare sales representatives' statements telling healthcare providers to prescribe Mitigare for the unapproved indications covered by Takeda's patents . . . and its distribution of a sales aid which explicitly references [guidelines] that recommend Takeda's patented methods." No. 14-1268-SLR, 2016 BL 414733 (D. Del. Dec. 14, 2016). Hikma argued that Takeda provided no details as to the identity of the persons involved in the conversations or when such conversations took place, and thus dismissal would be appropriate given the Twombly and Iqbal standards. However, "given that Hikma would be the actual source of the requisite factual information, the court conclude[d] that the proposed second complaint contain[ed] sufficiently detailed allegations (1) to plausibly give rise to a claim for inducement of patent infringement, and (2) to give Hikma fair notice of such claim." Id.

Similarly, the court in Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc. held that the allegation that "[o]n information and belief, Teva has or will have knowledge [sic] that if it were to [make and sell its proposed ANDA product] during the proposed shelf life of the product, such activities would result in the sale and/or use of an infringing article" was sufficient to withstand a motion to dismiss. No. 14-874-SLR, 2015 BL 210448 (D. Del. Jul. 1, 2015). Merck grounded its claim of infringement on the theory that the substance present in Teva's ANDA product would convert, during the shelf life of the product, to the claimed substance. Although Merck did not expressly identify and provide details of its conversion theory in its complaint, the court found Merck's allegation plausible, noting that "to rule in favor of Teva on this issue, the court would have to credit Teva's interpretation of Merck's theory over the language of the complaint itself." Id. (also declining "to engage in a fact finding analysis regarding the merits of Merck's theory of liability at the pleadings stage"). Beware, however, that conclusory allegations "upon information and belief" may not suffice in some circumstances. E.g., McDermott v. Clondalkin Grp., Inc., 649 F. App'x 263, 267-268 (3d Cir. 2016) (boilerplate and conclusory allegations unaccompanied by factual allegations that make the claim plausible will not suffice); TeleSign Corp. v. Twilio, Inc., No. 16-2106, 2016 BL 297262 (C.D. Cal. Aug. 3, 2016) (allegation that "[o]n information and belief, Twilio is making, using, selling, offering to sell and/or importing technology similar to the above-mentioned products and services but not known to Telesign" and such related technology "is also within the scope of the 'Accused Technologies'" is "clearly deficient").

In an ANDA case, the plaintiff can generally begin by alleging public facts that can be gleaned from the Paragraph IV notice letter (which is not confidential), the portions of its own product labeling that the ANDA filer must copy, and the fact that ANDA products are generally touted by the ANDA filer as pharmaceutically equivalent, bioequivalent, and therefore therapeutically equivalent to the branded product. For Orange Book-listed patents that have relatively straight-forward claims directed to the active pharmaceutical ingredient or methods of treatment, those factual allegations may well suffice for direct infringement. For other patents, such as for example those directed to particular formulations or polymorphs, the plaintiff should be able to allege confidential or missing information that is likely to have evidentiary support after the discovery process "upon information and belief" and withstand a motion to dismiss.

Originally printed in  BNA's Pharmaceutical Law & Industry Report on April 14, 2017.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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