Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC, No. 17-1560 (Fed. Cir. 2018)Annotate this Case
Merck’s 353 patent claims mometasone furoate monohydrate, the active ingredient in Merck’s Nasonex® nasal product. Amneal submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food & Drug Administration (FDA) seeking approval to market a generic mometasone furoate nasal spray. In Merck’s infringement suit, the district court found that Merck failed to prove that Amneal’s ANDA product will infringe. The Federal Circuit affirmed, upholding the district court’s refusal to require Amneal to produce additional samples of its ANDA product for testing before trial. The court rejected a claim that the noninfringement finding must be reversed because it was not based on Amneal’s final commercial product. The district court did not clearly err in finding that a Raman spectroscopy three-peak analysis was required to confirm the infringing form of mometasone furoate in Amneal’s product. Raman spectroscopy is a vibrational spectroscopy technique. A laser is used to generate a Raman spectrum, which indicates the vibrational modes of molecules and can be used to differentiate crystalline forms.