Giving deference on discovery issues and non-infringement findings, the US Court of Appeals for the Federal Circuit affirmed a non-infringement determination, finding the district court did not abuse its discretion by proceeding to trial notwithstanding the defendant’s violation of a discovery order regarding production of the alleged infringing product. Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC, Case No. 17-1560 (Fed. Cir., Feb. 9, 2018) (Stoll, J).

Amneal submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market a generic nasal spray with the active ingredient MFA. In response, Merck filed a patent infringement complaint alleging that the MFA in Amneal’s proposed product would convert to Merck’s patented MFM form over time. In violation of the district court’s standing discovery order, Amneal did not produce to Merck samples of all the batches it tested and submitted to the FDA. Merck file a motion to compel production of the samples, which the court denied. The case proceeded to trial, and the court ultimately found that Merck had failed to prove infringement. Merck appealed.

On appeal, the Federal Circuit acknowledged that the discovery question was “a close one” and that Amneal should have produced the samples it provided to the FDA, but held that the district court did not abuse its discretion in denying Merck’s motion to compel. The Court found that Merck had the opportunity to prove that the unproduced samples were substantively different from the produced samples, but failed to do so. At trial, Merck offered expert testimony to demonstrate that mixing promotes the conversion of MFA to MFM such that there were material differences between the samples it received and those it did not. The district court found, however, that Merck did not prove that actual testing of the non-produced samples was necessary to avoid prejudice.

The Federal Circuit further held that the district court did not err in relying on the produced samples of Amneal’s ANDA product as representative of its final commercial product. Merck argued that the samples produced by Amneal were only an intermediate product, and that the proper ANDA infringement inquiry should focus on what will be or is likely to be sold. The Federal Circuit rejected that argument, concluding that the evidence was sufficient to support a determination that the produced samples were representative of Amneal’s final commercial product and thus could be relied upon in deciding infringement.

Finally, the Federal Circuit held that the district court did not clearly err in finding non-infringement. While there was conflicting expert testimony regarding what was required to prove the presence of MFM (specifically, whether one or three “Raman peaks” on a spectrograph are necessary), Merck’s evidence showed only one Raman peak, and therefore the record sufficiently supported the district court’s non-infringement finding.