Merck Sharp & Dohme fails to secure new nasal spray trial
The US Court of Appeals for the Federal Circuit denied Merck Sharp & Dohme’s (MSD) request for a new trial to determine whether Amneal infringed a patent related to a nasal spray on Friday, February 9.
MSD accused Amneal of infringing US patent number 6,127,353, which claims mometasone furoate monohydrate and is the active ingredient in MSD’s Nasonex nasal product, after Amneal submitted an Abbreviated New Drug Application (ANDA) to make a generic nasal spray in November 2014.
After a bench trial, the US District Court for the District of Delaware found that MSD had failed to prove that Amneal’s ANDA product will infringe the ‘353 patent.
MSD appealed to the Federal Circuit, arguing that the Delaware court had abused its discretion by not compelling Amneal to produce additional samples of its product for testing before trial. It also argued that the district court’s finding of non-infringement must be reversed because it wasn’t based on Amneal’s final commercial product, but instead on an intermediate product.
But the Federal Circuit backed the district court, finding that it didn’t abuse its discretion in denying MSD’s request for additional samples and a new trial.
The appeals court also found that the Delaware court didn’t err in finding that MSD had failed to demonstrate that Amneal’s ANDA product wasn’t representative of the final commercial product.
The district court required Amneal to “immediately make available to Merck samples of any further representative commercial batches sent to the Food and Drug Administration”.
However, Amneal didn’t produce samples of its ‘day four’ batch (samples drawn from a commercial batch on the fourth day) and the ‘A batch’ (the day four batch that had been mixed again), in violation of a discovery order from the Delaware court.
“The district court determined, however, that it did not have enough information at the time to determine whether the day four and A batch samples were materially different from the day one batch samples,” said the Federal Circuit.
Although the district court didn’t postpone the trial or order Amneal to produce samples, it did give MSD the opportunity to prove at trial that the samples were substantively different from the day one batch.
MSD argued that Amneal should have produced the batches because the additional mixing of the day four and A batches would have promoted conversion to the infringing mometasone furoate monohydrate form.
On the evidence, the Delaware court found that MSD hadn’t demonstrated that the additional samples would yield different results.
“The question before us is a close one. Amneal’s failure to abide by the standing discovery order resulted in a trial situation that was less than ideal,” said Circuit Judge Kara Stoll, on behalf of the court.
Stoll added that the district court hadn’t abused its discretion in choosing to continue the trial, as opposed to ordering additional discovery and delaying trial.
“The district court took adequate steps to ensure that proceeding with trial would not prejudice MSD,” she added.
The Federal Circuit also disagreed with MSD that Amneal’s day one batch samples were “merely an intermediate product” and not representative of Amneal’s final commercial product.
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