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Chief Judge Sleet dismisses complaint, finds that plaintiff lacks standing to challenge defendant’s compliance with 21 U.S.C. § 355.

Chief Judge Sleet recently granted Mylan’s motion to dismiss for lack of standing a complaint filed by Endo alleging that Mylan “failed to comply with 21 U.S.C. § 355 by failing to provide notice of its Paragraph IV certification … to the patent’s purported assignee.” The Court agreed with Mylan’s contention that § 355(j)(2)(B) “does not create a private right of action and therefore … Endo does not have standing to assert this challenge.” Id. n.1 (relying on Minn. Mining and Mfg. Co. v. Barr Labs., Inc. 289 F.3d 775, 782 (Fed. Cir. 2012) (holding that parties cannot seek a judicial determination of whether a private party’s paragraph IV certification complies with § 355). Because Endo lacked standing to challenge Mylan’s compliance with § 355, the Court explained that it could not rule on Endo’s infringement allegations which were included in the complaint in case “the Court determines now or at a future date that Mylan has complied with its obligations under the Hatch Waxman Act to provide notice of a Paragraph IV Certification.” Id. n.2. As a result, the Court dismissed the complaint without prejudice.


Endo Pharmaceuticals Inc. v. Mylan Techs. Inc., et al., C.A. No. 11-220-GMS (D. Del. Mar. 30, 2012).

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