District Court Finds that a Defective Complaint Still Triggers a 30-Month Stay

A district court found that a defective complaint still a triggers 30-month stay. The District of Delaware recently issued an opinion holding that a defective complaint in which the plaintiff did not have standing could still trigger a thirty-month stay.

The case arose out of Mylan’s ANDA seeking approval to manufacture a generic version of Endo’s Lidoderm® patch. After filing its ANDA, Mylan sent a Paragraph IV notice letter to Endo, who Mylan believed to be the owner of the Orange Book patent (the “’510 patent”). Endo claims that the ’510 patent was actually owned by another entity, LecTec. Endo filed suit against Mylan, asserting two counts: (1) that Mylan failed to comply with statutory requirements when it failed to give proper notice to the LecTec, the actual patent owner; and (2) a claim in the alternative that, if the Court were to find that Mylan in fact did provide proper notice under the Hatch-Waxman act, that the submission of Mylan’s ANDA infringed the ’510 patent.

In March of last year, the Court dismissed Endo’s complaint without prejudice, finding that Endo did not have standing to raise a challenge to Mylan’s notice. The Court cited to the Federal Circuit’s 3M v. Barr Labs case, which held that parties “cannot seek a judicial determination of whether a private party’s paragraph IV certification complies with 21 U.S.C. § 355(j)(2)(B).” Minn. Mining and Mfg. Co. v. Barr Labs., Inc., 289 F.3d 775, 782 (Fed. Cir. 2002). The Court further held that, because Endo’s second count for infringement was conditioned on a determination of the first count—which the Court had no jurisdiction to decide—that the second count also had to be dismissed.

In response, Endo sought leave to amend its complaint to correct the “defect” of having conditioned its infringement count upon the notice count. The Court granted leave, finding that Mylan would not be prejudiced where it was clearly put on notice of Endo’s infringement claim.

The Court further rejected Mylan’s argument that the amended complaint could not relate back under Federal Rule of Civil Procedure 15(c) and that Endo had thus missed its 45-day window for filing suit. Mylan’s argument was premised on the idea that a complaint that is dismissed without prejudice is to be treated “as if it never existed.” While the Court recognized that the argument has some appeal, it ultimately concluded that, despite the defects, Endo’s complaint was “an action… brought for infringement of the patent that is the subject of certification” as required by U.S.C. § 355(j)(5)(B)(iii). In light of that determination, the Court noted that it “does not view its dismissal order or its decision on the present motion as having any immediate effect on the thirty month stay.”