Spotlight on Upcoming Oral Arguments – February 2025

The following arguments will be available live to the public, both in-person and through online audio streaming. Access information will be available by 9 AM ET each day of argument at: https://cafc.uscourts.gov/home/oral-argument/listen-to-oral-arguments/.

Wednesday, February 5, 2025, 10:00 A.M.

Global Health Solutions LLC v. Selner, No. 23-2009, Courtroom 203, Panel I

The Federal Circuit will hear argument in an appeal from a rare derivation proceeding. Appellant Global Health Solutions (“Global Health”) applied for U.S. Patent Application No. 15/672,197, and Appellee Marc Selner (“Selner”) applied for U.S. Patent Application No. 15/549,111, both of which are directed to a stable water-in-oil suspension with no added emulsifier for use as a wound treatment ointment. Global Health petitioned for a derivation proceeding against Selner at the Patent Trial & Appeal Board (“PTAB”), claiming that Global Health’s inventor conceived of and communicated the claimed invention to Selner by February 14, 2014. The PTAB initiated the derivation proceeding and ultimately found that none of Selner’s claims were derived from Global Health’s inventor. The PTAB found that Selner had established and corroborated that he independently conceived the invention mere hours before Global Health’s inventor. The PTAB based this finding primarily on two emails Selner sent to Global Health earlier in the day on February 14. It found that Selner had corroborated these emails based on the testimony of his lawyer’s clerk, who retrieved the emails from Selner’s computer, and the reliability of AOL as an email service provider.

On appeal, Global Health challenges the PTAB’s corroboration analysis and findings. Global Health argues that Selner’s testimony as to when he conceived of the invention was not corroborated. Global Health argues that the emails are insufficient corroboration because Selner himself authored and originated the content of the emails. Global Health also contends that the emails were unauthenticated hearsay and that the PTAB should not have taken judicial notice of the reliability of the email service provider. Global Health also takes issue with the clerk’s testimony, arguing that the clerk had no firsthand knowledge of the origination of the emails’ contents, and instead relied on Selner’s instructions to access the email account and retrieve the emails.

Selner, however, argues that the evidence, when viewed as a whole, corroborates his conception of the claimed invention. He contends that the clerk was independent because she had no interest in the outcome of the litigation. Selner also identifies circumstantial evidence that Global Health’s inventor received the email from Selner, that Global Health’s inventor acknowledged that Selner was the inventor of the claimed invention, and that the inventor copied a document sent by Selner containing information about the claimed invention. Further, Selner argues that Global Health does not offer any evidence as to the unreliability of the email or email service provider.

Thursday, February 6, 2025, 9:30 A.M.

Wilson v. Corning Incorporated, No. 24-1065, North Carolina Central University School of Law – Moot Courtroom, Panel C

Corning Incorporated (“Corning”) is the owner of several patents that relate to cell culture devices using gas-permeable membranes. In 2013, Wilson Wolf Manufacturing Corp. and its owner John Wilson (“Wilson”) sued Corning in the United States District Court for the District of Minnesota for misappropriation of trade secrets, breach of contract, and correction of inventorship. Wilson alleged that Corning developed its patented products based on Wilson’s own cell culture devices following a meeting between the parties. Corning countered that its products were distinct and that Wilson’s claims were time barred both by the statute of limitations and laches.

Throughout the parties’ ten-year dispute, two prominent issues arose. First, Corning requested to amend its answer multiple times to include its statute of limitations defense. Second, Wilson requested a jury trial, arguing that its damages claim was legal in nature. The district court denied both requests. After a bench trial, the court sided with Corning on all counts while also granting Corning leave to amend its answer to assert its statute of limitations defense. Now, Wilson appeals the district court’s decision.

Wilson first argues that it is entitled to a jury trial under the Seventh Amendment because its damages were legal in nature. Wilson argues that its damages theory, which rested on a reasonable royalty analysis supported by its expert, was legal in nature and entitled it to a jury trial. In Wilson’s view, a reasonable royalty was appropriate because if Corning had not misappropriated its trade secrets, the parties would have entered into an agreement for the products. Corning counters that there is no basis to order a retrial because Wilson’s damages are equitable in nature, and therefore, must be decided by a judge. Corning argues that Wilson’s damages theory, though labeled as a reasonable royalty analysis, was essentially a request for disgorgement, which is an equitable remedy that would allow Wilson to recover its lost profits and should be decided by a judge.

Wilson also contends that the district court erred by allowing Corning to amend its answer to include its statute of limitations defense. Wilson asserts that it was prejudiced by this decision because it detrimentally relied on the court’s previous holdings denying leave to amend to assert the defense. Because of those prior rulings, Wilson did not conduct discovery on facts related to fraudulent concealment, which would have tolled the statute of limitations and impacted the evidence presented at trial. Corning counters that the court properly allowed the motion to amend and that Wilson was on notice of this statute of limitations defense throughout the litigation. Alternatively, Corning argues that Wilson was not prejudiced by the district court’s decision because the same facts underlying Corning’s laches defense underlie its statute of limitations defense. Further, Corning maintains that Wilson slept on its rights by waiting years to bring suit, and is now time barred from asserting its claims.

Friday, February 7, 2025, 10:00 A.M.

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 24-2274, Courtroom 203, Panel M

Jazz Pharmaceuticals, Inc. (“Jazz”) and Avadel CNS Pharmaceuticals, LLC (“Avadel”) are competitors in the market for sodium oxybate products that treat narcolepsy and idiopathic hypersomnia (“IH”). Jazz sued Avadel for infringement of U.S. Patent No. 11,147,782, and Avadel stipulated prior to trial that its product, Lumryz, infringed claim 24. After a jury verdict of no invalidity, the district court granted-in-part Jazz’s Motion for a Permanent Injunction, enjoining Avadel from seeking FDA approval and marketing Lumryz for the treatment of IH.

On appeal, Avadel argues that the district court erred in issuing the injunction. Avadel argues that the injunction exceeds the scope of the district court’s authority, and that the district court erred in its assessment of the injunction factors. Specifically, Avadel contends that the district court enjoined conduct that was non-infringing under both Section 271(e)(1)’s safe harbor and under Section 271(a)(1). As to its safe harbor argument, Avadel maintains that the injunction’s prohibition on Avadel’s clinical trial contradicts the safe harbor for uses reasonably related to the development of information for FDA approval of a new drug product because Avadel’s use of the FDA-approved open-label safety extension portion of clinical trials is necessary to recruit clinical trial patients and to generate and track safety data. As to its Section 271(a)(1) argument, Avadel maintains that the Patent Act makes clear that mere submission of an FDA application and clinical trial results to the FDA does not constitute “use” of a patented invention and is, accordingly, non-infringing. Avadel also argues that its conduct falls within its First Amendment right to petition administrative agencies like the FDA. 

Meanwhile, Jazz contends that the district court did not abuse its discretion in issuing the injunction. Jazz argues that Avadel has waived, and thus cannot raise, its non-infringement defenses because: (1) it failed to raise them at the district court prior to issuance of the injunction (and Jazz argues that, regardless, there is no factual evidence that the new defenses protect the enjoined conduct); and (2) Avadel stipulated to infringement. In response, Avadel maintains that it had no basis to raise the safe harbor until Jazz proposed an injunction that would prohibit Avadel from seeking FDA approval of Lumryz for IH because Jazz affirmatively disclaimed infringement as to any safe harbor-protected acts in its complaint.