Section 271(e)(2) is the well known provision of the Patent Act that creates an artificial act of infringment by the filing of an ANDA with the FDA. This statute is the means by which a "case or controversy" arises so that the ANDA filer or a patentee can initiate suit regarding invalidity or infringement. But are the elements of Section 271 intended to be jurisdictional prerequisites?
Judge Farnan recently overruled defendants' objection and adopted a decision by Magistrate Judge Stark where Judge Stark applied Rule 12(b)(6) standards to a motion to dismiss an infringment action brought pursuant to 35 U.S.C. 271(e)(2). AstraZeneca Pharmaceuticals LP v. Aurobindo Pharma Ltd., C.A. No. 07-810-JJF-LPS, MDL No. 08-1949-JJF-LPS, Memo. Op. (D. Del. Feb. 25, 2009). The Court found that Judge Stark did not err in his application of Rule 12(b)(6) because the elements of Section 271(e)(2) are not jurisdictional but instead "subject matter jurisdiction over a Section 271(e)(2) claims still flows from 28 U.S.C. 1338(a)." Id. at 5.