Court Confirms "Unique" Pleading Requirements In Hatch-Waxman Actions


In a March 31, 2019 opinion in Belcher Pharmaceuticals LLC v. International Mediation Systems, Limited, Judge Stark of the Delaware District Court held that complaints in Hatch-Waxman actions can satisfy the requirements imposed by Ashcroft v. Iqbal, 556 U.S. 662 (2009), and Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007), "as applied to the unique context of a Hatch-Waxman claim for patent infringement." C.A. No. 19-960-LPS-CJB, D.I. 30 at 9 (D. Del.) ("Mem. Op.").

There, the defendant filed an application under 21 U.S.C. § 355(b)(2), often called a "paper NDA," and sent a Paragraph IV Notice to plaintiff.[1] The parties subsequently negotiated an offer of confidential access, and the defendant provided its entire 4,000 page NDA to plaintiff about three weeks prior to the 45-day deadline for filing suit. In its complaint, plaintiff alleged that the defendant infringed claims 6 and 7 of the asserted patent under 35 U.S.C. §§ 271(a)-(c) and 271(e)(2) by filing its 505(b)(2) application. See C.A. No. 19-960-LPS-CJB, D.I. 1 at 6.

The defendant then moved to dismiss the Hatch-Waxman complaint under Rule 12(b)(6), arguing that the complaint was "fatally flawed" because it merely stated legal conclusions without alleging any particularized facts that could make a plausible case for patent infringement:

In essence, Defendant's position is that while the Hatch Waxman Act creates subject matter jurisdiction over the ‘artificial act of infringement' of filing a paper NDA ( or ANDA), actual infringement still must be pled with particularity to survive a Rule 12(b)(6) motion.

Mem. Op. at 5.

In denying the motion, the court emphasized that plaintiff's pre-complaint review of defendant's Paragraph IV Notice and, in particular, its entire NDA, showed that "Plaintiff has a non-frivolous, good faith basis for its allegation of infringement." Id. at 11. The court also noted that, given the "extremely limited time, just 45 days" for a plaintiff to decide whether to institute suit, "[i]t will not always be reasonable to expect a plaintiff in such a position to develop the level of specificity Defendant asks this Court to impose." Id. at 8. It therefore held that a Hatch-Waxman plaintiff can state a claim for infringement based on receipt of a paragraph IV certification, the filing of an ANDA or NDA, along with a contention that a defendant's proposed product will infringe:

In the Court's view, both the language and the purpose of the Hatch-Waxman Act establish that a plaintiff in receipt of a paragraph IV certification providing notice of the filing of an ANDA (or, as here, a paper NDA) relating to one of the plaintiff's Orange Book-listed patents may state a claim for infringement by alleging its interest in the patent, its receipt of the paragraph IV certification, the filing of the ANDA or NDA, and its contention that the defendant's proposed product will infringe.

Id. at 6-7 (citing 271(e)(2)(A)).

Lastly, the court noted that, because the defendant had applied for FDA approval for a drug listed in the Orange Book, it "already knows at least some of the reason" for plaintiff's suit. Id. at 8-9.

Although the underlying facts, such as the pre-complaint information exchange and the assertion of specific claims may be atypical, this decision appears to confirm the unique pleading standards for Hatch-Waxman complaints based on artificial acts of infringements under § 271(e)(2).

[1] Over defendant's objection, the court concluded the same pleading standard applies to both ANDA actions under § 505(j) and paper NDA actions under § 505(b)(2). Id. at 6 n.3.