Despite Discovery Violations, Amneal Prevails on against Merck in Nasonex Patent Dispute

Merck Sharp & Dohme Corp. v. Amneal Pharm. LLC, No. 2017-1560, (Fed. Cir. Feb. 9, 2018) (Before Taranto, Clevenger, and Stoll, J.) (Opinion for the court, Stoll, J.)

Merck appealed the lower court’s finding of non-infringement of U.S. Patent No. 6,127,353 (“the ‘353 patent”), which is directed toward mometasone furoate monohydrate (“MFM”), commercially used in Merck’s Nasonex. Amneal submitted an Abbreviated New Drug Application (“ANDA”) to the FDA disclosing a composition of anhydrous mometasone (“MFA”) as opposed to MFM. Merck alleged that although Amneal’s ANDA product contained MFA, it would convert to an infringing MFM over its two-year shelf-life. Merck argued that the court abused its discretion by not compelling Amneal to produce additional samples of its ANDA product, by not basing its non-infringement decision on Amneal’s final product, and an improper chemical analysis of Amneal’s product.

In violation of a discovery order, Amenal only produced the “Day 1 Batches,” but failed to submit the “A Batches” and “Day 4 Batches.” Merck argued that the court abused its discretion by not compelling Amneal to produce the “A Batches” and “Day 4 Batches.” Merck contended that as a result of mixing, the “A Batches” and “Day 4 Batches” might contain infringing MFM. The Federal Circuit held that the lower court’s decision to deny compelling discovery did not prejudice Merck because it allowed Merck to prove at trial that the “Day 4 Batches” and the “A Batches” were different than the “Day 1 Batches” for purposes of infringement.

Merck further contended that the district court erred by basing its non-infringement ruling on the “Day 1 Batches” rather than the “A Batches” because the focus must be on what will be the final commercial product. However, the Federal Circuit rejected this argument by pointing out Merck’s failure to prove a material difference between the “Day 1 Batches” and the “Day 4 Batches” and “A Batches.”

Finally, on the issue of infringement, Merck argued that the court clearly erred by finding three Raman peaks were required to confirm the presence of MFM in the “Day 1 Batches.” Amneal’s expert rebutted evidence of a single Raman peak characteristic of MFM in the “Day 1 Batches” by stating that at least three Raman peaks were necessary to confirm the presence of MFM. Additionally, the court considered Schering’s three Raman peak requirement. Because the court’s finding was supported by Amneal’s expert testimony and precedence, it did not clearly err.

Take Away

A failure to produce a discoverable sample may be insufficient to compel discovery if the party produces another sample that is not materially different. The standard for evaluating chemical properties of a product may be found through expert testimony and/or precedence.




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