MERCK SHARP & DOHME CORP. v. AMNEAL PHARMACEUTICALS LLC

Editor: Paul Stewart

Federal Circuit Summaries

Before Taranto, Clevenger, and Stoll. Appeal from the United States District Court for the District of Delaware. 

Summary: Proceeding to trial despite a party’s violation of a discovery order was not an abuse of discretion where the District Court took adequate steps to ensure the opposing party would not be prejudiced. 

This case arises out of a patent lawsuit between Merck and Amneal relating to Amneal’s generic version of Nasonex®.  Merck alleged that Amneal’s MFA form of the active agent would convert to the patented MFM form during storage and mixing.

Following a motion to compel, the District Court ordered Amneal to immediately produce samples of any “representative commercial batches” of its product that were sent to the FDA.  During expert discovery, Merck learned that Amneal had not produced samples of two batches.  Amneal argued that the two batches were cumulative of batches already produced.  In pre-trial hearings, the District Court acknowledged that Amneal should have produced the two batches, but was not convinced that the additional mixing that the two batches underwent would convert the MFA to MFM.  The District Court refused to compel production of samples and postpone trial, instead giving Merck the opportunity to prove that the unproduced samples were substantively different from the produced samples.  Following expert testimony, the District Court found that, on the evidence presented, Merck failed to demonstrate that additional mixing would cause the unproduced samples to convert to MFM.

The Federal Circuit affirmed the District Court’s rulings.  Though describing the case as a “close” one, the Federal Circuit held that the district court took adequate steps to ensure that proceeding with trial would not prejudice Merck. The Federal Circuit also rejected Merck’s arguments that the District Court erred by finding non-infringement based on Amneal’s produced samples, rather than the unproduced samples.     

This case is: MERCK SHARP & DOHME CORP. v. AMNEAL PHARMACEUTICALS LLC