Ferring Pharmaceuticals Inc. v. Serenity Pharmaceuticals, LLC

Background

This opinion addresses motions in limine, which are pretrial requests to restrict evidence or argument at trial. The dispute concerns patents involving desmopressin. Counterclaimants filed three motions directed at Ferring’s proposed trial presentation, and Ferring filed one motion seeking to exclude testimony by Teresa Stanek Rea, a former Acting Under Secretary of Commerce for Intellectual Property and former Acting Director of the Patent and Trademark Office.

Indefiniteness theory

Ferring intended to argue that certain asserted patent claims were invalid because the word “about” made them indefinite under 35 U.S.C. § 112. Counterclaimants argued that Ferring had not disclosed this theory in its pleadings or initial and final invalidity contentions and that they therefore had no notice or opportunity to conduct discovery or obtain responsive expert testimony.

The court granted Counterclaimants’ motion to preclude the indefiniteness theory. It held that Ferring’s failure to disclose the theory in its initial and final invalidity contentions would unfairly prejudice Counterclaimants. The court rejected Ferring’s argument that Counterclaimants’ expert had effectively created the theory during a deposition. It explained that indefiniteness is an objective inquiry and that the expert’s subjective inability to determine the claims’ scope did not create a new indefiniteness defense.

Evidence about Ferring’s prior claim-construction positions

The court had previously construed “transmucosal” administration or delivery as delivering desmopressin through mucosal tissue, such as the sublingual mucosa. That construction did not require absorption through the mucosa. Counterclaimants sought to exclude testimony and argument based on Ferring’s rejected position that transmucosal administration required transmucosal absorption.

The court denied this motion. It found that Ferring was not trying to relitigate claim construction. Instead, Ferring sought to question Dr. Fein about his description of his invention, including his view that the invention involved sublingual absorption. The court held that this evidence could be relevant to Ferring’s challenges involving inventorship under 35 U.S.C. § 102(f) and written description under § 112, including whether Dr. Fein invented what the asserted claims cover.

Evidence from the European patent proceeding

Counterclaimants also sought to prevent Ferring from presenting evidence or argument about Dr. Fein’s response to a Notice of Opposition in a European Patent Office proceeding. They argued that the word “enabled” had different meanings under European and United States patent law, and that Ferring was taking the word out of its European context.

The court denied this motion. It found that Counterclaimants had not cited European authority showing that “enabled” had two entirely different meanings. Ferring planned to present expert testimony that European patent law, like United States law, asks whether a skilled person could practice the technical teaching disclosed in a prior-art document. The court also found potentially relevant Counterclaimants’ statement before the European Patent Office that the asserted patent’s disclosure was not enabled because it lacked examples showing that the suggested dose ranges achieved the claimed concentrations and therapeutic effects. The court said the issue appeared better suited for cross-examination of Ferring’s expert at the bench trial.

Ferring’s motion concerning Teresa Stanek Rea

Ferring moved to exclude Rea’s proposed testimony on grounds including that it repeated Patent and Trademark Office rules and legal principles, addressed matters unrelated to the claims or defenses, concerned Dr. Fein’s intent or state of mind, and exceeded her expertise.

The court found Ferring’s motion moot because it was granting Counterclaimants’ separate motion for judgment on the pleadings dismissing Ferring’s inequitable-conduct affirmative defense. The opinion states that Rea would no longer be called as a trial witness for that reason. The opinion does not explain the separate motion’s full reasoning.

Disposition

Chief Judge Colleen McMahon granted Counterclaimants’ motion to preclude Ferring’s indefiniteness theory. She denied Counterclaimants’ motion concerning Ferring’s failed claim-construction positions and denied Counterclaimants’ motion concerning Dr. Fein’s European Patent Office response. She found Ferring’s motion to exclude Rea’s testimony moot. The clerk was directed to remove Docket Nos. 642, 646, 649, and 651 from the list of open motions.