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Judge Castel Holds that Contemporaneous Documents Speak Louder than Words

On September 27, 2019, Judge P. Kevin Castel (S.D.N.Y) concluded that Serenity Pharmaceuticals Corporation (“Serenity”) and Reprise Biopharmaceutics, LLC (“Reprise”) had failed to prove by clear and convincing evidence that Dr. Seymour Fein, a former consultant for Ferring B.V., Ferring International Center S.A., and Ferring Pharmaceuticals Inc. (collectively, “Ferring”), was a co-inventor of Ferring’s U.S. Patent Nos. 7,560,429 (“the ’429 patent”) and 7,947,654 (“the ’654 patent”).  The inventorship issue originally arose in the underlying patent infringement suit— as we’ve previously covered here.

Correcting Inventorship After Issuance

The Patent Act requires that a patent accurately name the inventors of the claimed invention.  Failure to name all co-inventors renders the patent invalid, however, the Patent Act allows interested parties to have the inventorship of an issued patent changed to reflect the true inventors. An issued patent is presumed to be valid and requires clear and convincing evidence to amend the named inventors.

Judge Castel first restated the Federal Circuit’s opinion that the standard for determining joint inventorship is “one of the muddiest concepts in the muddy metaphysics of patent law.” In re Verhoef, 888 F.3d 1362, 1365 (Fed. Cir. 2018).  To add a joint inventor a party must establish that the putative inventor made a “not insignificant” contribution to the conception of the claimed invention and prove collaboration or joint behavior with the other inventors.   The party must also present corroborating evidence of a contemporaneous enabling disclosure.  Self-serving testimony by interested persons does not, standing alone, rise to the level of clear and convincing evidence.

Dr. Fein’s Consulting Work for Ferring

The co-inventorship claim centered around Dr. Fein’s consulting work for Ferring in August of 2001 on potential pharmaceutical formulations of the drug desmopressin.  Serenity and Reprise argued that Dr. Fein contributed the claimed features of low dosage (’429 patent) and sublingual administration (’654 patent).

Serenity and Reprise primarily relied upon testimony by Dr. Fein and Dr. Ronald Nardi, a former Corporate Vice President at Ferring responsible for research and development.  Dr. Fein and Dr. Nardi testified that they had several conversations regarding the alleged contributions and that they conveyed the ideas to the named inventors on the patent.  Serenity and Reprise also pointed to circumstantial evidence, such as Ferring’s clinical studies removing high doses and incorporating sublingual testing, and the inability of the named inventors to identify who conceived of the low dose and sublingual administration features.  Dr. Fein was also included as a named inventor on a related, previously-filed patent application by Ferring.

Absence of Proof is not Clear and Convincing

The court rejected Serenity and Reprise’s arguments and found they had not met their burden for any of the elements.  The court did not find Dr. Fein’s testimony credible because he had changed his date of invention from November 2001 to August 2001.  The court found that the testimony contradicted Dr Fein’s contemporaneous memo from May 2002 stating he and Dr. Nardi developed the alleged contributions in November 2001.  The court also discredited Dr. Nardi’s testimony as contradictory and self-serving due to Dr. Nardi’s ownership stake in Reprise, which has an ownership stake in Serenity.  Even considering other circumstantial evidence, the court concluded that Serenity and Reprise had failed to satisfy their burden to present corroborating evidence.

Regarding conception, the court found that employees at Ferring had independently considered sublingual “orodispersible” tablets as early as summer 1999 and that plans to test low dosages of desmopressin were already under consideration by summer 2001.  The court also determined that low dosages for desmopressin were already known in the prior art before to 2001.  In the alternative, the court pointed to Dr. Fein’s testimony admitting that his alleged contribution of sublingual “absorption” is not the same as the claimed feature of sublingual “administration.”  Accordingly, the court concluded that Serenity and Reprise had not proven by clear and convincing evidence that Dr. Fein contributed to the conception of the claimed subject matter in a not insignificant manner.

The case is Ferring B.V., et al. v. Allergan Inc., et al, No. 12-cv-2650 (PKC) (S.D.N.Y. September 27, 2017).