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Judge McMahon’s Motions in Limine Rulings Clear Way for Ferring v. Serenity Trial

The years-long dispute may finally be headed for trial between Ferring Pharmaceuticals, Inc. and its affiliates, Serenity Pharmaceuticals, LLC, and Reprise Biopharmaceutics, LLC over patents claiming a sublingual application of desmopressin, a drug used to treat symptoms of diabetes insipidus, including frequent nighttime urination (“nocturia”).  On March 11, 2020, U.S. District Judge Colleen McMahon (S.D.N.Y.) ruled on three motions in limine filed by defendants and counterclaimants Serenity and Reprise.

Reprise owns patents covering applications of desmopressin—U.S. Patent Nos. 7,405,203, 7,579,321, and 7,799,761—which it had exclusively licensed to Serenity to market Noctiva, a drug that treats nocturia.  Ferring, which developed a rival product, Nocdurna, first filed this suit in April 2017 against Serenity and Reprise, seeking a declaratory judgment that Reprise’s patents were invalid and unenforceable, and were not infringed by Ferring’s Nocdurna product, which also treats nocturia.  Serenity and Reprise asserted counterclaims against Ferring, alleging infringement of the ’203 and ’321 Patents by Ferring’s Nocdurna.  

First, Judge McMahon granted Serenity and Reprise’s motion to exclude Ferring’s theory of indefiniteness of the term “about” in the patents’ claims.  Ferring had not included the theory in either its initial or final invalidity contentions, and only disclosed it after Serenity and Reprise’s expert testified regarding the “about” limitations.  Judge McMahon rejected Ferring’s argument that expert testimony “created” a new indefiniteness argument, holding that because indefiniteness is an objective standard, Ferring could have, but did not, raise the argument earlier.

Next, Judge McMahon denied Serenity and Reprise’s motion to exclude testimony and argument regarding Ferring’s failed claim construction positions.  In January 2019, the court construed the patents’ terms “transmucosal delivery” and “transmucosal administration” of desmopressin to not require transmucosal absorption of desmopressin.  Serenity and Reprise sought to exclude argument relating to the patents’ inventor’s direct testimony about whether the inventions, but not the patents’ claims, require sublingual absorption of desmopressin.  Judge McMahon rejected Serenity and Reprise’s argument that Ferring sought to relitigate claim construction.  She explained that, instead, the inventor’s “purported contribution of sublingual absorption is relevant to the determination of whether [the inventor] invented what is claimed” in the patents, and is thus relevant to Ferring’s invalidity defenses under § 102(f) for inventorship and § 112 for lack of written description.

Finally, Judge McMahon denied Serenity and Reprise’s motion to exclude the patents’ inventor’s statements in proceedings before the European Patent Office (“EPO”).  Ferring seeks to argue at trial that, before the EPO, Serenity argued that the ’203 Patent was not “enabled” because its disclosure provides no examples of the suggested dose ranges to provide therapeutic efficiency.  Judge McMahon rejected Serenity and Reprise’s argument that “enable” has two distinct meanings under U.S. and European law holding that, if true, Serenity’s argument before the EPO would be an admission against interest and relevant to Ferring’s invalidity arguments and defenses.

A bench trial is currently scheduled to begin on May 26, 2020.

Case:  Ferring B.V., et al. v. Serenity Pharms., LLC, et al., No. 17-CV-9922 (S.D.N.Y.).