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Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC

Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, 881 F.3d 1376 (Fed. Cir. 2018) (Circuit Judges Taranto, Clevenger, and Stoll presiding; Opinion by Stoll, J.) (Appeal from D. Del., Robinson, J.)

Drug Product and Patent(s)-in-Suit: Nasonex® (mometasone furoate monohydrate); U.S. Patent No. 6,127,353 (“the ’353 patent”)

Nature of Case and Issue(s) Presented: The ΚΌ353 patent is directed to mometasone furoate monohydrate (“MFM”), the active ingredient in Merck’s Nasonex nasal product. Amneal filed an ANDA seeking approval to market a generic product comprising anhydrous mometasone furoate (“MFA”). At the district court, Merck alleged that Amneal’s ANDA product, which contained MFA, converted to the infringing MFM form over time. Following a bench trial, the district court found that Merck failed to prove infringement by a preponderance of the evidence. The Federal Circuit affirmed.

Why Amneal Prevailed: Merck first argued that the district court abused its discretion by not compelling Amneal to produce additional samples of its ANDA product prior to trial. The district court’s standing discovery order required Amneal to “immediately make available to Merck samples of any further representative commercial batches sent to the FDA.” Amneal, however, failed to produce two different samples that it sent to FDA. Merck argued that it was prejudiced because Amneal’s missing commercial batches were subjected to additional mixing prior to storage, which, according to Merck, causes MFA to convert to MFM. But based on the evidence of record, the Federal Circuit held that Merck presented little more than theoretical evidence to show that the missing samples would be more likely to undergo conversion than the produced sample batches. Specifically, the Federal Circuit held that the study conducted by Merck’s expert was not representative of Amneal’s ANDA product and did not measure the effect of mixing speed or time on the rate of conversion from MFA to MFM. The Federal Circuit stated that the question before it was “a close one,” but that the district court did not err in not requiring Amneal to produce the missing sample batches.

Merck next argued that the district court improperly based its noninfringement finding on Amneal’s intermediate product (i.e., the produced samples) rather than its final, commercial-sized product (i.e., the non-produced samples). As a threshold matter, the Federal Circuit explained that Merck was provided an opportunity during trial to prove that the non-produced samples would have materially differed from the produced samples, but was unable to do so.  Moreover, Amneal’s produced samples could not be considered an “intermediate product,” as it represented to FDA that the produced samples were demonstrative of its final ANDA product.

Finally, Merck argued that the district court erred in finding that three Raman peaks were required to confirm the presence of MFM in Amneal’s ANDA product. The Federal Circuit disagreed, stating that the district court did not err in crediting the testimony of Amneal’s expert who opined that three Raman peaks are typically used to confirm the presence in complex mixtures of molecules such as MFM.



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