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Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC

Deference to District Court’s Handling of Prejudice From Discovery Failure

Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC, 2018 WL 798668 (Fed. Cir. Feb. 9, 2018) (Taranto, Clevenger, STOLL) (D. Del.: Robinson) (3 of 5 stars)

Fed Cir affirms noninfringement judgment concerning Amneal’s proposed ANDA product, planned to compete with Merck’s Nasonex. Applying Third Circuit law, the district court did not abuse its discretion in denying Merck’s motion to compel production of certain samples, or to delay trial, where Amneal’s non-production contravened the district court’s standing discovery order. Although the issue is a “close one,” the district court did not abuse its discretion in proceeding to trial without said production because the court permitted Merck to present evidence and argument concerning the characteristics the non-produced samples would have in view of the available evidence. The opinion rejects Merck’s argument that actual testing of the non-produced samples was necessary to avoid prejudice.

Applying Fed Cir law, the district court did not clearly err in relying on produced samples as representative of the final Amneal ANDA product. The opinion discusses how the record demonstrates that Merck had the opportunity to prove that the samples analyzed at trial were non-representative of the final product, and failed to do so. Ferring, 764 F.3d 1401 (Fed. Cir. 2014), is not contradictory, as the samples at issue there were clearly non-representative of the ANDA product. Here, the evidence was sufficient to support a determination that the tested samples were representative.

The district court also did not clearly err in finding noninfringement. The opinion discusses how the record was sufficient to support the district court’s interpretation of what proof would be required to establish infringement (specifically, the presence of three “Raman peaks” in a certain spectrograph). As Merck’s evidence did not show three Raman peaks, the record supported the district court’s noninfringement finding.

KEYWORDS: HATCH-WAXMAN; DISCOVERY; INFRINGEMENT (NO); REPRESENTATIVE PRODUCTS