On Vacation; Just Quoting The Opinion -- Analysis Next Week: Nasonex® Wasn't Infringed Via Amneal's Mometasone Furoate Monohydrate...

I am out to a Friday evening dinner, but here it is -- the appellate level Federal Circuit panel has ruled against Merck's patent defense -- to Amneal's pending introduction of a generic mometasone furoate monohydrate, the active ingredient in a nasal product (which Merck sells as Nasonex^®).

Here is the full 18 page PDF of the opinion -- but this likely means Kenilworth won't seek the Supremes' review, as Nasonex is already being sold as a generic, by others -- if my unaided memory serves.

. . . .Following a bench trial, the district court found that Merck failed to prove by preponderant evidence that Amneal’s ANDA product will infringe the ’353 patent. On appeal, Merck argues that the district court abused its discretion by not compelling Amneal to produce additional samples of its ANDA product for testing before trial.

Merck also argues that the district court’s noninfringement finding must be reversed because it was not based on Amneal’s final commercial product. Merck also challenges the district court’s fact-finding that a Raman spectroscopy three-peak analysis was required to confirm the infringing form of mometasone furoate in Amneal’s product.

For the reasons explained below, we conclude that the district court did not abuse its discretion in denying Merck’s request for additional samples and a new trial. Further, we hold that the district court did not err in finding that Merck failed to demonstrate that Amneal’s ANDA product, which formed the basis for the district court’s noninfringement finding, was not representative of Amneal’s final commercial product. Finally, we conclude that the district court did not clearly err in finding that three Raman peaks were required to prove infringement. Accordingly, we affirm. . . .

Now you know -- stay warm and stay snuggly, as we all watch the opening ceremonies, on demand (and on a slight delay, tomorrow night). Smiling here -- as ever, as I enjoy a 75 degree evening outdoors. . . .

नमस्ते