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Law360 (July 9, 2020, 10:38 PM EDT ) The remote bench trial between Ferring Pharmaceuticals and its rival Serenity took another turn into new territory Thursday when experts for Ferring testified from Europe before a New York federal judge, telling her that Serenity's patents are based on shoddy data and don't apply to Ferring's nighttime urination medication.
The trial before the Southern District of New York's Chief Judge Colleen McMahon, being held remotely because of the coronavirus pandemic, began with Ferring Pharmaceuticals' suit seeking to invalidate two Serenity Pharmaceuticals patents. Those patents relate to the use of the anti-diuretic compound desmopressin, the active ingredient in Ferring's medication Nocdurna. Serenity counterclaimed that Ferring's drug infringes its patents, kicking off the trial on these counterclaims.
On Thursday, Ferring began calling its witnesses to the stand, having two Dutch scientists videoconference in. Witnesses are offering their direct testimony via written affidavits.
First up was pharmacy doctorate Edwin Spaans, whose affidavit states that Serenity hasn't shown any examples of Nocdurna actually infringing the two claimed patents, which describe the use of desmopressin at specific blood plasma concentration levels in order to maintain the antidiuretic effect for "around" 4 to 6 hours.
"Counterclaimants have not pointed to a single instance of a patient actually taking Nocdurna at all, much less a patient taking Nocdurna and that patient having the claimed blood plasma concentrations," Spaans wrote.
Serenity attorney Jaime Olin of Skiermont Derby LLP pressed Spaans during cross-examination about this point, asking him whether it was customary for a company like Serenity to monitor individual patients of another company's drug in this manner.
Judge McMahon interceded, telling Olin to move off the subject because it is "not advancing the ball."
"Of course Serenity isn't in the business of monitoring individual Nocdurna patients, but that doesn't necessarily mean they didn't have to find a Nocdurna patient who infringed to prove infringement in this case," Judge McMahon said. "You're saying that they didn't but that's your argument to make … You're not going to get anywhere trying to get Dr. Spaans to agree that you didn't have to do it."
Next, Ferring called drug development expert Peter Vis, who was appearing from the Scottish Highlands. Vis testified in his affidavit that the key study cited in both patents, known as Example 8, contained faulty data and didn't actually back up the patents' claims about how long the drug lasts.
Vis testified that the way average urine concentration was measured in Example 8 skewed the data to make it appear that the drug was lasting longer than it actually is, and, calculated properly, it does not show the drug lasting about four to six hours.
Serenity attorney Paul Skiermont of Skiermont Derby LLP opened his cross-examination by getting Vis to concede that his expert report did not analyze or evaluate the claim language of the patents at issue. Skiermont also asked Vis to confirm that he did not review the file histories of the patents.
Serenity and its patent-holding company Reprise Pharmaceuticals LLC developed the use of desmopressin to treat nighttime urination and got a nasal spray called Noctiva approved by the U.S. Food and Drug Administration, Serenity witness Dr. Michael Mayersohn testified in an affidavit.
Noctiva hasn't been sold commercially since spring of 2019, according to the affidavit.
Ferring got FDA approval for Nocdurna — a desmopressin tablet administered under the tongue — in 2018, but it had already filed suit seeking to invalidate Serenity's patents in April 2017.
The two sides and the judge began developing the plan for the online trial in May after the coronavirus pandemic delayed the original trial plans.
Witnesses, including many overseas, were sent sealed physical binders for their cross-examinations, and digital exhibits were displayed to the entire "court" via Zoom's share screen functionality.
TrialGraphix is handling the trial through a Zoom-based application called TRIALanywhere and sent a special laptop to Judge McMahon. It has also provided a tech support person who will be in the courtroom throughout the trial.
Members of the public can "attend" the Zoom trial by joining the Zoom meeting or dialing in on the phone.
The patents-in-suit are U.S. Patent Nos. 7,405,203; and 7,579,321.
Ferring is represented by Mary Bourke, Daniel Attaway and Joshua Davis of Womble Bond Dickinson.
Serenity is represented by Paul Skiermont and Jaime Olin of Skiermont Derby LLP.
The case is Ferring Pharmaceuticals Inc. et al. v. Serenity Pharmaceuticals LLC et al., case number 1:17-cv-09922, in the U.S. District Court for the Southern District of New York.
--Additional reporting by Cara Salvatore. Editing by Steven Edelstone.
For a reprint of this article, please contact reprints@law360.com.
