Federal Circuit Outcomes from the Past Four Years

Patent

by Dennis Crouch

[Update – I should have noted that these are limited to appeals from the USPTO – primarily IPR decisions focusing on the issue of obviousness]

The pie chart shown here depicts the distribution of Federal Circuit case outputs from 2000 to 2024 across three categories. The plurality of cases, 44%, resulted in a Non-Precedential Opinion, indicating a substantial volume of decisions with limited precedential impact. Following this, 38% of outcomes are categorized as “No Opinion (R.36).”  These are cases where the court issued a summary affirmance of a lower tribunal holding without any written explanation.  I want to note for a moment here that other federal appellate courts also have an approach known as “summary affirmance, but those courts always provide at least a brief explanation of the ruling and its justification. The Federal Circuit provides no opinion, just the judgment.

The final segment, 18% of dispositions, represent cases with Precedential Opinion.  This represents the smallest category and highlighting the court’s selection of cases deemed to warrant formal published opinions with binding effect on subsequent decisions.

 

 

Follow-up on Peterson v. Minerva: LIFT OUR VOICES Amicus Brief

Patent

by Dennis Crouch

In early January 2025, I wrote about Peterson v. Minerva Surgical, No. 24-712, a case involving a former Minerva sales director (Dan Peterson) seeking Supreme Court review of an arbitration award that went against his whistleblower claims. See Dennis Crouch, Patents as Product Liability Admissions: A Cert Petition Highlights Novel Use of Patent Filings in Whistleblower Case, Patently-O (Jan. 4, 2025).  As I explained in that post, Peterson's argument for review relies on Minerva's own patent filings as evidence that the company knew about safety issues with its endometrial ablation device —and that it fraudulently provided contradictory testimony during the arbitration proceedings.

The case has now drawn additional attention through an amicus brief filed by Lift Our Voices (LOV), filed by my University of Missouri Law School colleague Professor Michael Tripp.  LOV, led by former Fox News anchor Gretchen Carlson, advocates for workplace safety and equity -- and has particularly focused on how forced arbitration and non-disclosure agreements lead to a continuation of sexual harassment in the workforce. The brief presents the case as emblematic of broader concerns about the use of forced arbitration and non-disclosure agreements (NDAs) to shield corporate misconduct from public scrutiny.

Federal Appellate Judge: "I have No Power": LOV's brief emphasizes how the Tenth Circuit's extreme deference to arbitrators has effectively nullified any meaningful judicial review. The brief directly quotes the circuit court's striking admissions of powerlessness, including statements that federal courts "do not have discretion," "do not have power," and "cannot set aside an arbitration award based on legal error."  This language, LOV argues, represents a concerning abdication of Article III judicial authority that Congress never intended when enacting the Federal Arbitration Act (FAA) -- concluding that the Arbitrator was faced with a factual dispute about safety and decided that the device had not yet been proven unsafe.

The case provides stark language about the extremely limited scope of judicial review over arbitration awards. Specifically, the Tenth Circuit emphasizes in Peterson v. Minerva Surgical, Inc., No. 24-3003 (10th Cir. Aug. 15, 2024): "the standard of review of arbitral awards 'is among the narrowest known to the law.'" The court goes on to state directly that "federal courts do not have power to review an arbitrator's factual findings." And when it comes to legal errors, the court explains that it "cannot set aside an arbitration award based on legal error unless it amounts to 'a manifest disregard of the law, defined as willful inattentiveness to the governing law.'"

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Biologics Patent Enforcement: Regeneron Patents Block Biosimilar Entry for EYLEA

Patent

by Dennis Crouch

In a pair of significant decisions issued today, the Federal Circuit upheld preliminary injunctions blocking the launch of biosimilar versions of Regeneron's blockbuster drug EYLEA® (aflibercept). Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 2024-1965 (Fed. Cir. Jan. 29, 2025) (precedential); and Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 2024-2009 (Fed. Cir. Jan. 29, 2025) (nonprecedential). The cases pit Regeneron against foreign manufacturers, including Samsung Bioepis (SB) and Formycon AG, who had obtained FDA approval for their biosimilar products under the Biologics Price Competition and Innovation Act (BPCIA). Writing for a unanimous panel, Judge Taranto focused on three key issues: (1) personal jurisdiction over foreign biosimilar manufacturers; (2) obviousness-type double patenting in the biologics context; and  (3) standards for preliminary injunctive relief.  The decisions effectively maintain Regeneron's market exclusivity for EYLEA®, which generates approximately $6 billion in annual sales and serves as a primary treatment for several serious eye conditions including wet age-related macular degeneration. U.S. Patent No. 11,084,865.

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Is Google Simply Asking for More Efficient Infringement?

Patent

by Dennis Crouch

Three new amicus briefs were recently filed supporting EcoFactor in the pending en banc case against Google over patent damages methodology.

The briefs - one from Law Professor Michael Risch along with a group of patent trial attorneys and another from the Alliance of U.S. Startups and Inventors for Jobs (USIJ) argue that Google's position - further limiting expert damages testimony - threatens to undermine core aspects of patent damages law while potentially violating the Seventh Amendment's right to a jury trial.  The third brief, filed by Professor Gregory Dolin argues that Judge Newman - who the court "temporarily" suspended in 2023 - should be permitted to sit on the en banc panel.  (I put "temp" in scare quotes because it appears that this suspension is - in fact - permanent).

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Discovery, Injury, and Diligence: Reconciling Subjective and Objective Copyright Limitations Standards Post-Warner Chappell

Patent

by Dennis Crouch and Tim Knight

The Supreme Court is being asked to decide a case that could have a major impact on copyright law. The case involves photographs taken by Michael Grecco in 2017, but the lawsuit was not filed until 2021. The key question is whether the Copyright Act's three-year statute of limitations runs from when copyright infringement occurs or from when the copyright holder discovers it. The circuits are currently split on this issue, and the Supreme Court may finally settle the issue that has been brewing for years. (Note that the split overwhelmingly favors the discovery rule but there are differences in how it is applied). 

Although we don't delve into the issues of model-rights here -- it is interesting to note that Michael Grecco was the photographer; the model is a famous model Amber Rose (not involved in the lawsuit) and the shoes are designed by famed designer Ruthie Davis, who is also the accused infringer.

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USPTO’s Remote Work Program Faces Potential Rapid Dismantling Under New Federal Guidelines

Patent

by Dennis Crouch

Last week, I wrote about the twin challenges facing the USPTO: a return-to-office mandate and a hiring freeze that could significantly impact patent operations. Today’s joint memorandum from OMB and OPM provides a rapid timeline for implementing these changes, with agencies required to submit detailed implementation plans by February 7th, 2025. [OMB OPM Come Home Memo].

The USPTO must develop a comprehensive plan addressing not just space and staffing, but also the “risks, barriers, and resource constraints” that could prevent expeditious return to in-person work. While patent examiners await official word from agency leadership about their specific situations, the clock is ticking on what could be the most significant operational change at the USPTO in decades.

As someone who practiced 20 years ago — at a time when USPTO examiner morale was low and the agency had difficulty recruiting quality candidates — I recognize that things are so much better today. (Do you agree?).  For those of us outside the USPTO, now is the time to voice support both for the examiner community and uninterrupted USPTO operations — especially if you can provide Dir. Stewart with evidence that will aid efforts to water-down the negative effect of these orders.

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Two Mandamus Petitions: Transfer Granted, Improper Service Denied

Patent

by Dennis Crouch

A Federal Circuit panel recently released a pair of mandamus orders dealing with important civil procedure issues - one granting a petition to transfer venue under 28 USC 1404(a) , the other denying a petition challenging substitute service of process for a foreign defendant.

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Gogo Continues In-Flight Services as Federal Circuit Rejects SmartSky’s Preliminary Injunction Appeal

Patent

by Dennis Crouch

In SmartSky Networks, LLC v. Gogo Business Aviation, LLC, No. 2023-1058 (Fed. Cir. Jan. 31, 2024), the Federal Circuit has affirmed a lower court denial of a preliminary injunction sought by the patentee SmartSky against Gogo.  SmartSky sued Gogo in 2022 for patent infringement, alleging that Gogo’s 5G wireless network infringed several of SmartSky’s patents related to in-flight internet wireless connectivity.  See U.S. Patent Nos. 9,312,947, 11,223,417, 10,257,717, and 9,730,077.  Along with its complaint, SmartSky moved to preliminarily enjoin Gogo from providing its in-flight network.  SmartSky argued it had shown a likelihood of success on the merits and that it would suffer irreparable harm without an injunction, but the D.Del. district court Judge Gregory Williams disagreed.  A grant or denial of preliminary injunctive relief can be immediately appealed, but the patentee's appeal has also failed.

The preliminary injunction motion was associated with a new 5G network that Gogo had announced in 2019.  That network is, according to Gogo, "still in a pre-launch phase."  Although customers are not yet actively using the service, the network itself is actually complete and the final step is including the chipsets within the planes.  This aspect of the case was the most critical for the Federal Circuit who concluded that the current status of Gogo's operation was not definite enough to create irreparable harm.

 

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Race to the Finish: Timing Battles in Parallel IPR and District Court Litigation

Patent,

by Dennis Crouch

The new petition for certiorari filed by Liquidia raises some interesting questions about the ongoing race between inter partes review proceedings and district court litigation.  Liquidia Techs v. United Therapeutics Corp., 23-804 (US), on petition for writ of certiorari from United Therapeutics Corp. v. Liquidia Techs., Inc., 74 F.4th 1360 (Fed. Cir. 2023).

UTC won its infringement suit against Liquidia with a holding that its patent covering treprostinil administration by inhalation were valid and infringed. (US10716793).  While the appeal was pending, the PTAB sided against the patentee and found the claims unpatentable as obvious.  In the appeal, however, the Federal Circuit refused to give credence to the PTAB decision - finding that litigation was still "pending" and "non-final." The claims had not actually been cancelled yet - since the Director only issues the certificate confirming unpatentability after any appeal. Further, the Federal Circuit concluded that IPR decisions do not have issue-preclusive (collateral estoppel) effect until the decision is affirmed on appeal, or the parties waive their right to appeal. Citing XY, LLC v. Trans Ova Genetics, L.C., 890 F.3d 1282, 1294 (Fed. Cir. 2018).

Liquidia's petition argues that the PTAB's final-written decision should be given preclusive effect in parallel litigation even if an appeal is pending, just like would be done for a district court opinion.

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