Patent Office Challenges Highlight Federal Circuit’s 2026 Slate

December 22, 2025, 9:59 AM UTC

The Federal Circuit will kick-start 2026 continuing to grapple with a suite of challenges seeking to block significant changes to patent validity review procedures at the US Patent and Trademark Office.

Two varieties of appellate action are pending at the US Court of Appeals for the Federal Circuit, each targeting Trump administration efforts that have made it harder for infringement-suit defendants to challenge patents’ validity at the Patent Trial and Appeal Board. The court will have a chance to spell out the proper vehicle for challenging decisions by a PTO director and to either reign in or bless changes implemented in both Trump administrations.

Those challenges, along with appeals of massive district court verdicts and the continuing effort by Judge Pauline Newman to undo her suspension, are among the most significant issues facing the patent-centric appeals court in the new year.

Apple v. Squires

Apple Inc. is among the many Big Tech companies that frequently seek PTAB reviews of patents asserted against them in district court. Apple, joined by Google LLC, Intel Corp., and Cisco Systems Inc., sued the PTO in 2020 to challenge its move to create a six-factor “discretionary denial” framework for turning away patent challenges without reaching their merits.

The case has ping-ponged between the US District Court for the Northern District of California and the Federal Circuit for five years. A second appellate oral argument is scheduled for Jan. 5.

Apple is arguing the factors are a violation of the Administrative Procedures Act because they were put in place without a notice-and-comment rulemaking process. PTO Director John Squires, represented by the agency’s Solicitor’s Office, is arguing his instructions to the PTAB are a “general statement of policy” rather than “substantive rules” that would trigger the requirement of formal rulemaking.

Though Squires leads the agency today, the factors initially challenged by Apple were implemented by then-Director Andrei Iancu in 2020. Various directors have defended the authority of their position as the case has worked its way through the courts.

Mandamus Petitions

Other tech companies took a more direct approach to 2025 changes to the discretionary-denial process, filing petitions for writs of mandamus to undo inter partes review petition denials they said were illegitimate.

The court dismissed the first six of these challenges without oral argument. Those orders emphasized the high bar mandamus petitioners must clear generally, and the specific high bar in these cases to overcome a statutory provision in the America Invents Act blocking appeals of IPR institution decisions.

Oral argument hasn’t been scheduled in any of the pending petitions, but Tesla Inc. and Intel are among the more recent petitioners that have refined their arguments.

Tesla’s petition, for example, attacks the PTO’s “extra-statutory framework,” which it characterizes as a form of “shenanigans,” a category the US Supreme Court has said can still be reviewed by a federal court despite the AIA’s institution appeal bar.

Newman’s Suspension

The Federal Circuit has operated with only 11 of its 12 active judges taking case assignments since Judge Pauline Newman’s early-2023 suspension due to an investigation into her mental fitness. The fate of Newman, the nation’s oldest active judge at the time of her suspension, is now in the hands of another appeals court.

The suspension continued through 2025, with the court’s other active judges extending it another year and Newman continuing to refuse their request to sit for an independent psychological examination. A district court previously dismissed Newman’s lawsuit challenging the suspension, and a DC Circuit panel rejected arguments from Newman and her legal team at the New Civil Liberties Alliance that the suspension and the law that authorized it were unconstitutional.

Judge Bradley N. Garcia, who wrote the DC Circuit opinion rejecting Newman’s appeal, said the panel was bound to follow a 20-year-old precedent. But he also suggested the full court might consider the “important and serious questions” Newman raised about whether the investigative proceedings “comport with constitutional due process principles and whether her ongoing suspension comports with the structure of our Constitution.”

Newman’s petition for the court to hear the case en banc, which the other Federal Circuit judges have opposed, remains pending.

Big Patent Suit Award

Columbia University’s nine-figure verdict against Gen Digital Inc., which was enhanced to nearly half a billion dollars, will go under the Federal Circuit’s microscope in the new year.

Columbia won $185 million in a May 2022 verdict, which the district court judge later enhanced to $481 million. The court sanctioned Quinn Emanuel, the defendant’s initial law firm, for interactions with a witness who didn’t ultimately testify in the case.

Quinn Emanuel and Gen Digital both appealed the judgments, and the Federal Circuit scheduled a combined argument for Jan 5.

Quinn Emanuel is being represented by Supreme Court practitioner Paul Clement.

High Court Drought

For more than three years, the Supreme Court has declined to hear a patent appeal, despite more than 60 petitions for writs of certiorari.

That could change in 2026.

The US Solicitor General in December urged the high court to take up a petition from Hikma Pharmaceuticals USA Inc. challenging a Federal Circuit ruling that it induced doctors or pharmacists to prescribe its generic heart medicine for off-label, patent-infringing uses. Hikma marketed a generic version of Amarin Pharma Inc.'s Vascepa using a “skinny label” that directed it to be used to treat excessive levels of triglycerides in the blood, but not for a treatment of cardiovascular risk covered by Amarin patents.

The Federal Circuit said Hikma induced doctors or pharmacists to infringe the patents through its label, its description of its product as a “generic equivalent” of Vascepa, and other statements made to investors. But the solicitor general brief called those “anodyne statements with logical explanations having nothing to do with intentional encouragement of infringing uses.”

The cases are:

To contact the reporter on this story: Michael Shapiro in Washington at mshapiro@bloombergindustry.com

To contact the editors responsible for this story: James Arkin at jarkin@bloombergindustry.com; Adam M. Taylor at ataylor@bloombergindustry.com

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