Addressing for the first time the issue of whether §271(e)(2) applies to a patent that issued years after an abbreviated new drug application (ANDA) was approved, the US District Court for the District of New Jersey granted Defendants’ motion to dismiss pursuant to Rule 12(b)(6). Ferring B.V. v. Actavis, Inc., Case No. 15-4222 (D.N.J. May 26, 2016) (Chesler, J.)
Plaintiffs filed a complaint in June 2015 alleging that Defendants’ generic version of their Lysteda® product infringed a formulation patent that issued in January 2015. In addition to asserting infringement under §271(a) for the sale of Defendants’ product (the ANDA was approved in 2012), Plaintiffs also alleged that the filing of the ANDA in 2010 constituted infringement of the January 2015 patent under §271(e)(2). Defendants filed a motion to dismiss the §271(e)(2) claim under Rule 12(b)(1) for lack of subject matter jurisdiction or Rule 12(b)(6) for failure to state a claim. The court granted Defendants’ motion and dismissed the claim pursuant to Rule 12(b)(6).
The court rejected Defendants’ argument for lack of subject matter jurisdiction, finding that Plaintiffs satisfied the low threshold necessary to meet the requirement. As the court explained, the patentee need only allege that “another’s filing of an ANDA infringes its patent under § 271(e)(2).” Thus, the subject matter jurisdiction requirement was met by virtue of Plaintiffs’ allegation that Defendants’ ANDA infringed the asserted patent.
Next, the court turned to the question of whether Plaintiffs’ §271(e)(2) claim passed muster under Rule 12(b)(6), and concluded that it did not. The court found that Plaintiffs’ claim was inconsistent with the statutory text, which establishes that it “shall be an act of infringement to submit [an ANDA] for a drug claimed in a patent….” According to the court, the “inclusion of the phrase ‘claimed in a patent’ in the statute indicates that a § 271(e)(2)(A) claim must be based upon a patent that has already been issued at the time the infringing ANDA is filed.”
Furthermore, in view of the facts pled, allowing a claim under §271(e)(2) would contradict the purpose of the statute. Section 271(e)(2) “provides patentees with a defined act of infringement sufficient to create case or controversy jurisdiction to enable a court to promptly resolve any dispute concerning infringement and validity when the ANDA applicant was not making, using, or selling the patented product.” Plaintiffs “no longer need an artificial act of infringement claim under § 271(e)(2)(A) to enforce their patent rights.” Rather, Plaintiffs can (and did) “bring actual infringement claims against Defendants under §271(a), based on Defendants’ alleged marketing of a generic version of Lysted®.”