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25 August 2020AmericasRory O'Neill

Ferring wins Nocdurna patent suit with ex-employee

Swiss-based Ferring Pharmaceuticals has prevailed in a patent dispute with rivals Serenity Pharmaceuticals and Reprise Biopharmaceuticals over a nighttime urination, or nocturia, treatment.

The dispute concerns inventorship of Nocdurna (desmopressin acetate), Ferring’s nocturia tablet that was approved by the US Food and Drug Administration (FDA) in 2018.

Following a bench trial, Colleen McMahon, chief judge of the US District Court for the Southern District of New York, ruled that Serenity’s co-founder and chief medical officer Seymour Fein was not the sole inventor of Nocdurna.

Fein, a former scientist at Ferring, is named as the sole inventor on Serenity patents covering the use of desmopressin acetate to treat nocturia.

But in her judgment, issued on August 21, McMahon found that Fein’s contribution was limited to the finding that the drug could be absorbed under the patient’s tongue.

McMahon said there was “clear and convincing evidence that Dr Fein was not the sole inventor of everything he now claims to have invented all by himself.”

“He is, at best, one of many fathers of the concepts that underlie the patents-in-suit—and far from the most significant,” McMahon continued.

The decision means the Serenity patents, which are licensed from sister company Reprise, are now invalid.

McMahon also ruled that the Serenity patents were invalid for lack of enablement, as they failed to teach a person of ordinary skill in the art how to practice the claimed invention.

“There is simply no way that the disclosures in this case demonstrate that Dr Fein had invented anything that remotely like the invention claimed in the patents-in-suit,” the decision said.

McMahon added: “Indeed, the data disclosed in the specification does not include a single example that actually achieved the functional limitations of the asserted claims.”

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