by Dennis Crouch

The Supreme Court is currently considering whether to grant certiorari in Lynk Labs, Inc. v. Samsung Electronics Co., No. 25-308, a case that could reshape the evidentiary foundation of inter partes review (IPR) proceedings. The question presented asks whether patent applications that became publicly accessible only after the challenged patent's critical date qualify as "prior art consisting of . . . printed publications" within the meaning of 35 U.S.C. § 311(b). In its January 2025 decision, the Federal Circuit held that published patent applications may serve as prior art in IPR proceedings as of their filing date under § 102(a)(2), even if those applications were confidential at the time the challenged patent was filed. Lynk Labs, Inc. v. Samsung Electronics Co., 125 F.4th 1120 (Fed. Cir. 2025). The petition has attracted substantial amicus support. I had begun drafting my own amicus brief in support of the petition but did not complete that project. Instead, I offer some of my thoughts here.

At its core, the case concerns what I have called the "secret springing prior art" problem: a reference that was secretly on file at the USPTO at the time a patent application was filed, but which only becomes publicly accessible when it is later published. See Dennis Crouch, Secret Springing Prior Art and Inter Partes Review, Patently-O (Oct. 2024). The Martin reference at issue in Lynk Labs was filed in April 2003 but did not publish until October 2004, well after Lynk's February 2004 priority date. Under 35 U.S.C. § 102(a)(2), Martin qualifies as prior art because it was on file before Lynk's application, even though it was entirely non-public at that time. The question is whether such a reference can form the basis of an IPR challenge, given that § 311(b) limits IPR to challenges based "only on the basis of prior art consisting of patents or printed publications." The Federal Circuit held that it can, reasoning that "printed publication" is "temporally agnostic" and that the prior art status of a reference is determined separately from its status as a printed publication. I find that reading difficult see - particularly with our long tradition that a printed publication is defined by its date of publication.

The Federal Circuit's error lies in conflating two distinct inquiries: whether a reference qualifies as prior art under § 102(a)(2) and whether it qualifies as a printed publication under § 311(b). The result is that abandoned, unexamined applications are backdated to destroy issued patents, privileging the least-vetted references over genuine publications that were actually accessible to the public before the critical date.

by Dennis Crouch

The Solicitor General has recommended that the Supreme Court grant certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, to resolve whether a generic manufacturer's FDA-compliant carved-out labeling and basic commercial statements can constitute active inducement of patent infringement. The government's December 2025 brief argues that the Federal Circuit's decision threatens to undermine the Hatch-Waxman Amendments' balance between promoting generic competition and protecting patent rights. Although the statute does not create immunity per se, the brief argues that the appellate panel erred by treating communications integral to the section viii skinny label pathway as evidence of culpable inducement -- and thus created a substantial disincentive for generic manufacturers to invoke a mechanism that Congress explicitly designed to prevent method-of-use patents from creating de facto monopolies on entire drug compounds.

• Read the Gov't Brief Supporting Certiorari
• Dennis Crouch, Label-Plus Infringement: The Tinderbox Theory of Generic Inducement, Patently-O (July 7, 2025)
• Dennis Crouch, Supreme Court Preview: Will “Skinny Labels” Get a Weight Check?, Patently-O (Jan. 1, 2025)​
• Dennis Crouch, Generic Drugs, Skinny Labels, and Liability for Off Label (Infringing) Uses, Patently-O (Feb. 17, 2025)
• Dennis Crouch, Amarin v. Hikma: Federal Circuit reverses Inducement Dismissal in Skinny-Label Case, Patently-O (Sept. 6, 2024)
• Dennis Crouch, Hikma Challenges Federal Circuit’s Skinny Label Ruling, Patently-O (Aug. 26 2024)

The case involves Hikma's generic version of Amarin's Vascepa (icosapent ethyl).  The drug compound is no longer patented and the method-of-use patents covering severe hypertriglyceridemia treatment were held invalid in prior litigation between Amarin and Hikma.  But, using the drug to treat cardiovascular risk is still patented.  This is the exact situation for a "skinny label" carveout FDA approval - where a generic receives approval to market generic versions of a drug, but only for the unpatented purposes.  Hikma obtained FDA approval carving out Amarin's patented cardiovascular risk reduction indication while retaining only the non-patented severe hypertriglyceridemia indication.

The problem with the skinny label approach is that everyone knows that its the same generic drug and so folks are bound to use the generic version for the patented purpose.  Doctors may prescribe generic drugs for any indication, and pharmacists often cannot determine why a particular drug is prescribed. Moreover, all fifty states and the District of Columbia either permit or mandate generic substitution when therapeutically equivalent generics are available, and this substitution occurs without regard to whether the generic is labeled for the specific use for which the brand-name drug is prescribed.  What this means is that we have a situation where Congress designed the Skinny Label system in a way that inevitably leads to off-label infringement.

by Dennis Crouch

The Federal Circuit has closed the courthouse doors on the second wave of challenges to the USPTO's restrictive new IPR institution policies. In four orders issued December 8-9, 2025, the same three-judge panel (Judges Prost, Chen, and Hughes) denied mandamus petitions from Cambridge Industries, SanDisk, Western Digital, HighLevel, and Inari Agriculture, each seeking to challenge discretionary denials of inter partes review institution. The decisions follow the court's November ruling in In re Motorola Solutions, Inc., No. 2025-134, 159 F.4th 30 (Fed. Cir. Nov. 6, 2025), and collectively establish that the "final and nonappealable" language of 35 U.S.C. § 314(d) bars virtually all judicial oversight of institution decisions, whether framed as constitutional due process claims, statutory ultra vires arguments, or Administrative Procedure Act challenges. The practical effect is stark: accused infringers now have no meaningful avenue to contest the USPTO's decision to deny IPR, even when those denials rest on criteria found nowhere in the America Invents Act.

The lead case, In re Cambridge Industries USA Inc., No. 2026-101 (Fed. Cir. Dec. 9, 2025), squarely addressed the "settled expectations" doctrine that has become the USPTO's primary tool for denying institution. The agency denied institution on two patents that had been in force for seven and nine years, finding the patent owner had "settled expectations" in those rights. The Federal Circuit refused to disturb that decision, rejecting Cambridge's arguments that the settled expectations factor exceeds statutory authority, was imposed without notice-and-comment rulemaking, and violates due process. The court emphasized that it was not deciding whether the USPTO's actions were correct or permitted by statute, but only that Cambridge had not shown a "clear and indisputable right" to mandamus relief given the limits on judicial review.

by Dennis Crouch

A jury awarded $64 million to a Czech inventor who claimed Goodyear stole his self-inflating tire technology. The district court threw out the verdict. The Federal Circuit has now affirmed that decision, holding that no reasonable jury could have found trade secret misappropriation on any of the five asserted trade secrets. Coda Development s.r.o. v. Goodyear Tire & Rubber Co., No. 2023-1880 (Fed. Cir. Dec. 8, 2025). The decision offers a thorough examination of what it means to define a trade secret with "sufficient particularity" under state uniform trade secret acts (UTSAs), distinguishing between those that describe functional outcomes versus those that identify actual protectable knowledge.

The case also continues an observable pattern at the Federal Circuit: juries finding for IP holders, only to have courts conclude that no reasonable jury could have reached that verdict. The following is an incomplete list of some of these anti-jury pro-JMOL cases from 2024 and 2025 that I've been tracking in the patent context:

by Dennis Crouch

The USPTO has issued new guidance on using Rule 132 declarations to address subject matter eligibility rejections. The two memoranda, signed by Director John A. Squires on December 4, 2025, provide a new roadmap for how applicants can submit evidentiary declarations to overcome § 101 rejections. One memorandum is directed to the Patent Examining Corps, explaining how examiners should evaluate these submissions. The other is directed to applicants and practitioners, outlining best practices for preparing what the USPTO now calls "Subject Matter Eligibility Declarations" or SMEDs. The guidance does not create new procedures but instead highlights an existing and underutilized path under 37 C.F.R. § 1.132 for submitting evidence that may help establish patent eligibility.

• USPTO News Alert
• USPTO Examiner Memo on 132 Decs
• USPTO Public Memo on 132 Decs

The SMED guidance arrives as part of Director Squires's broader effort to address what he has characterized as "conflicting (and confusing) questions about patent subject matter eligibility." In his view, Examination and Eligibility are two distinct issues that should be separated. On his first day in office, Squires signed two patents in technical fields that have frequently faced eligibility challenges: distributed ledger/crypto technologies and medical diagnostics. Three days later, he issued the In re Desjardins Appeals Review Panel decision, Appeal No. 2024-000567 (PTAB Sept. 26, 2025), vacating a PTAB sua sponte § 101 rejection of claims directed to training machine learning models while preserving prior tasks. That decision, which Squires designated as precedential on November 4, 2025, warned against overbroad eligibility rejections and emphasized that improvements in "computational performance, learning, storage, data sets and structures" can constitute patent-eligible technological advancements under the Alice framework. The SMED memoranda represent the next step in this initiative, providing applicants with tools to build an evidentiary record supporting eligibility.

In the past, many patent attorneys have avoided filing Rule 132 declarations except as a last resort. The reasons are familiar: expense, the difficulty of establishing a sufficient nexus between the evidence and the claims, and concern about seeding the prosecution record with testimonial statements that could later be used against the patent owner in litigation. But I believe the SMED memoranda represent a new opportunity. Here, the Director is affirmatively inviting these submissions and signaling that they will be given meaningful weight in the eligibility analysis. For applications of potential value, practitioners should consider whether a SMED might strengthen their response to a § 101 rejection, ideally after vetting the approach with experienced patent litigation counsel who can help navigate the prosecution history implications.

by Dennis Crouch

We have another mandamus petition at the Federal Circuit challenging the USPTO's IPR institution denials. In re Tesla, Inc., No. 26-116 (Fed. Cir. filed Dec. 2, 2025). The case involves patents asserted by Granite Vehicle Ventures LLC against Tesla's Self-Driving technology. But the petition's significance extends well beyond this particular dispute. Tesla advances a statutory interpretation argument that, if accepted, would fundamentally constrain the USPTO's claimed authority to deny IPR institution based on factors Congress never authorized.

The core legal question is simple: Does 35 U.S.C. § 314(a) grant the Director unfettered discretion to invent new reasons to deny IPR institution? The USPTO has increasingly claimed discretionary power to justify denials based on a variety of novel explanations including "time-to-trial" concerns, "settled expectations," and other criteria that do not appear in AIA or its legislative history.  In its petition, Tesla argues the USPTO's approach transforms a provision limiting the Director's authority into an unlimited grant of power to nullify IPR entirely.

by Dennis Crouch

In consecutive weeks, the Federal Circuit has reversed two jury verdicts totaling over $80 million in pharmaceutical patent disputes, holding in both cases that the specifications failed (as a matter of law) to satisfy §112(a)'s disclosure requirements. Seagen Inc. v. Daiichi Sankyo Company, Ltd., Nos. 2023-2424 (Fed. Cir. Dec. 2, 2025); Duke University v. Sandoz Inc., No. 2024-1078 (Fed. Cir. Nov. 18, 2025).

In my view, these cases represent a significant doctrinal development. I see these as revealing three interconnected trends:

1. The Federal Circuit's increasing willingness to treat patent specifications as legal texts subject to judicial interpretation of the text rather than factual determinations of its meaning;
2. The practical (re)convergence of written description and enablement into a unified adequacy inquiry; and
3. The court's growing confidence in overturning jury verdicts on §112(a) grounds as a matter of law.

by Dennis Crouch

The Federal Circuit has affirmed a judgment invalidating patent claims for indefiniteness where the claims used "optimal" and "best" language without providing objective boundaries for those terms of degree. Akamai Technologies, Inc. v. MediaPointe, Inc., No. 2024-1571 (Fed. Cir. Nov. 25, 2025).

by Dennis Crouch

The Federal Circuit's 2022 decision in Thaler v. Vidal seemed to settle a fundamental question: only natural persons can be inventors under U.S. patent law.  But, the bigger near-term question has always been about human-AI collaboration - and what level of human contribution is sufficient to qualify as inventive.  Director Kathi Vidal implemented a team-based framework that allowed patenting if the human made a "more than insignificant contribution" to the invention.  This approach basically asked whether the human had done enough to be considered a joint joint inventor (alongside the AI). While that approach had some conceptual problems (permitting patenting without complete human inventorship), it - at least - set a standard for the agency to consider.

In a November 2025 guidance, new USPTO Director John Squires has rejected the Vidal approach and instead established a "don't ask, don't tell" policy for AI-assisted inventions creates a presumption of human inventorship so long as any natural person is willing to sign the oath.  For all practical purposes, this approach is also a repudiation of Thaler, so long as the patent applicant is able to find a human close to the invention willing to self-identify as the inventor. The system now effectively rewards an old habit in invention culture: when attribution becomes optional and unverifiable, someone will always be willing to step forward and claim the mantle of inventor.  In a chapter I wrote a few years ago examining corporate invention, I observed: "It is easy to identify a human with some relation to the product or innovation and prop-up that human as the inventor." Dennis Crouch, Legal Fictions and the Corporation as an Inventive Artificial Intelligence in R. Abbott ed., Research Handbook on Intellectual Property and Artificial Intelligence (Edward Elgar Publ’g 2022).

by Dennis Crouch

Three new mandamus petitions recently arrived at the Federal Circuit, each attempting to navigate around the court's November 6 decisions that rejected challenges to the USPTO's expanded use of discretionary denials.

• In re Google LLC (No. 26-111),
• In re Intel Corporation and Lenovo (No. 26-113), and
• In re Kangxi Communication Technologies (No. 26-115)

The new petitions raise arguments their counsel contend are distinct from those already rejected in In re Motorola Solutions, Inc., No. 2025-134 (Fed. Cir. Nov. 6, 2025) (precedential). The petitions challenge both the "settled expectations" rule and parallel proceeding denials, while advancing novel theories designed to overcome the § 314(d) bar that has proved insurmountable for prior petitioners. Whether these distinctions carry legal weight remains to be seen, but the filings reflect a coordinated effort to keep pressure on the Federal Circuit as Director John Squires continues to deny IPR institution at a 0% rate.

Since assuming personal control of all IPR institution decisions in October 2025, Director Squires has denied every petition reaching his desk, now totaling 91 consecutive denials. These summary notices contain no reasoning or analysis, listing only IPR numbers alongside the statement institution "is denied." The practice stands in stark contrast to the PTAB's historic institution rate of approximately 67%. Meanwhile, the USPTO's proposed rulemaking (comments due December 2, 2025) would codify categorical bars to IPR institution without addressing the "settled expectations" doctrine or the practice of no-explanation denials. (Note that these  new petitions are all based upon actions by Acting Dir. Stewart, the Squires-prompted petitioners are coming next month).

by Dennis Crouch

Director John Squires has released a new set of IPR institution decisions. The third grouping since taking personal charge of the institution decision making process in October 2025. Once again, the institution rate remains 0%, but the newest batch include some ray of hope for petitioners.

Let me explain. By mid-November, Dir Squires had decided 34 institution decisions - denying each and resulting in my 0% institution rate post.  The newest batch includes three groupings:

• 56 new cases discretionarily denied;
• 31 new cases that were not denied, but that still need to "be reviewed for merits and non-discretionary considerations;"
• 1 new case denied on the merits; and
• 0 new cases instituted.

by Dennis Crouch

Micron v. Longhorn IP, Appeal No. 2023-2007 (Fed. Cir. 2025)

This interesting pending case focuses on an Idaho state law  regulating patent trolls. Idaho Code § 48-1703(1).

"It is unlawful for a person to make a bad faith assertion of patent infringement in a demand letter, a complaint or any other communication."

Back in 2022, Katana, an affiliate Longhorn, sued Micron for patent infringement in the W.D.Tex. Micron responded in two ways: it asserted a counterclaim under Idaho's statute in the Texas case and, one month later, filed a separate Idaho action against Longhorn under the same theory. The cases were later consolidated in Idaho, and Judge David Nye ordered Longhorn or Katana to post an $8 million bond under the Idaho law before the case could move forward.  In the process, Judge Nye upheld the Idaho law against preemption and First Amendment (petition the government) challenges and also found a "reasonable likelihood" of bad faith assertion by Katana. The case is now on appeal before the Federal Circuit with oral arguments held recently before Judges Lourie, Schall, and Stoll.

Idaho is the only state whose anti-troll statute expressly regulates complaints filed in federal court. Most states, including Vermont, explicitly exclude litigation conduct from their statutes. Vt. Stat. Ann. tit. 9, § 4197(a). Idaho's statute also authorizes an uncapped bond when a target shows "reasonable likelihood" of bad faith, without requiring findings equivalent to either the Federal Circuit's established standard for bad faith assertion liability which requires objective baselessness plus subjective bad faith.  See also, Professional Real Estate Investors, Inc. v. Columbia Pictures Industries, 508 U.S. 49 (1993) (sham litigation test).