Chief Judge Sleet grants motion for leave to amend complaint to cure defective claim and finds that 30 month stay is not terminated by a dismissal without prejudice.

Chief Judge Gregory M. Sleet issued a memorandum order this week granting a plaintiff’s motion for leave to amend its complaint, which the Court previously dismissed without prejudice. Endo Pharmaceuticals Inc. v. Mylan Technologies Inc., et al., C.A. No. 11-220-GMS (D. Del. Mar. 11, 2013). The first claim of the plaintiff’s original complaint alleged that the defendant failed to comply with the notice requirements of the Hatch-Waxman Act, because the plaintiff (which was the recipient of the defendant’s Paragraph IV Notice) was not actually the owner of the patent at issue at the time notice was provided. Id. at 1. The second claim in the original complaint alleged that in the event the Court were to “determine[] now or at a future date that [the defendant] has complied with its obligations under the Hatch-Waxman Act . . . [the defendant] has infringed the ’510 Patent by submitting an ANDA . . . containing a Paragraph IV certification with respect to that patent”. Id. at 2. The Court dismissed the complaint, finding that because the plaintiff acknowledged that it was not the owner of the ’510 patent, it lacked standing to bring its first claim. Id. In turn, the Court was unable to reach the second claim because, “as pled, [it] was conditioned on a determination of” the first claim. Id.

Shortly after the dismissal, the plaintiff moved to amend its complaint to restate its second claim to correct a “technical defect in pleading.” Id. The defendant countered that the “technical defect” was not an “inadvertent error,” but instead was an intentional “strategy to extend the statutory 30 month stay . . . instead of bringing a claim for infringement.” Id. at 4 (quoting D.I. 21 at 1, 3). The defendant argued further that the plaintiff had ample time to amend its complaint in response to the motion to dismiss but chose not to do so until the complaint was dismissed. In the defendant’s view, the plaintiff’s failure to promptly amend its complaint was “the result of undue delay and dilatory conduct.” Id. (quoting D.I. 21 at 3).

The Court disagreed with the defendant. Because the plaintiff had a good faith basis to believe that its original complaint would not be dismissed, and because the plaintiff filed its motion for leave to amend within fourteen days of the complaint’s dismissal, the Court was “unable to discern any dilatory motive and concludes that the delay was not so excessive as to be unreasonable.” Id. at 5-6. The Court also rejected the defendant’s argument that it would be unduly prejudiced if an amended complaint were permitted to be filed, explaining that the defendant “was clearly put on notice of [the plaintiff’s] infringement claim” by the original complaint, “and the amendment does not substantially change the underlying theory of the case.” Id. at 6.

The Court also rejected the defendant’s argument that the plaintiff’s amended infringement claim should not relate back to the date of the original complaint (which was filed within 45 days of the Paragraph IV Notice). The Court explained that although the original infringement claim was defective, there was no dispute that it was “brought” within 45 days of the Paragraph IV Notice, which was all that the statute required to trigger a 30 month stay. Id. at 9. The Court further found that its dismissal of the complaint had not terminated the 30 month stay once it was triggered, because “if Congress had wished the thirty month stay to be extinguished upon a dismissal without prejudice, it would have said as much.” Id. at 10.

Endo Pharmaceuticals Inc. v. Mylan Technologies Inc., et al., C.A. No. 11-220-GMS (D. Del. Mar. 11, 2013).

%d bloggers like this: