In Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC, [2017-1560] (February 9, 2018), the Federal Circuit affirmed the district court finding that it did not abuse its discretion in denying Merck’s request for additional samples and a new trial; that it did not err in finding that Merck failed to demonstrate that Amneal’s ANDA product, which formed the basis for the district court’s noninfringement finding, was not representative of Amneal’s final commercial product; and that district court did not clearly err in finding that three Raman peaks were required to prove infringement.

On the denial of additional discovery issue, the Federal Circuit reviews a district court’s denial of additional discovery under regional circuit law, and the Third Circuit will not disturb a denial of additional discovery absent an abuse of discretion and “a showing of actual and substantial prejudice.”  The Federal Circuit found the question “a close one.”

The Federal Circuit noted that Amneal’s failure to abide by the standing discovery order resulted in a trial situation that was “less than ideal.”  However, the Federal Circuit concluded that the district court did not abuse its discretion in denying the additional discovery, noting that the district court took adequate steps to ensure that proceeding with trial would not prejudice Merck.

The Federal Circuit said that the ultimate determination of infringement is a question of fact, which is reviewed for clear error.  The Federal Circuit rejected Merck’s argument that the district court improperly determined infringement of an intermediate product, rather than the final product, as imposing a heightened evidentiary standard in ANDA cases not supported by case law.  The Federal Circuit said that regardless of the type of sample (e.g., commercial or batch), the critical inquiry is whether it is representative of what is likely to be approved and marketed.

Finally, the Federal Circuit discerned no clear error in the district court’s fact-finding of noninfringement.  The district court found Amneal’s expert evidence “at least as consistent and credible” as Merck’s expert and concluded that Merck failed to prove infringement by preponderant evidence.

Amneal’s expert testified that although a single peak can be used at times, three Raman peaks are typically used to absolutely confirm the presence of molecules in complex mixtures like MFM.  Because the noninfringement finding was supported by this evidence in the record, the Federal Circuit concluded that the district court did not clearly err in its noninfringement finding.