by Dennis Crouch

At $3.2 million per dose, Elevidys is one of the most expensive drugs ever approved. The drug is used to treat Duchenne muscular dystrophy, a fatal genetic disease that progressively destroys muscle function and kills most patients in their twenties.  Elevidys represents both the remarkable promise and the profound access tension at the heart of gene therapy patents. The underlying technology was developed in the laboratory of Dr. James M. Wilson at the University of Pennsylvania, supported in substantial part by more than $105 million in NIH funding over Wilson’s career, and then exclusively licensed to REGENXBIO Inc., which sued Sarepta for using the platform technology without authorization.

On February 20, 2026, the Federal Circuit reversed a Delaware district court’s grant of summary judgment of ineligibility under 35 U.S.C. § 101, holding that the claimed genetically engineered host cells are not directed to a natural phenomenon. REGENXBIO Inc. v. Sarepta Therapeutics, Inc., No. 24-1408 (Fed. Cir. Feb. 20, 2026) (Stoll, J., joined by Dyk and Hughes).  The reversal applies settled doctrine that traces Diamond v. Chakrabarty through Myriad‘s cDNA holding and Diamond v. Diehr‘s prohibition on dissecting claims into old and new elements.  At the same time, the result here stands in sharp contrast to the § 101 struggles that have plagued software and diagnostic method claims over the past decade, where courts have routinely found “man made” items ineligible.

The patent at issue, US10526617, is owned by the University of Pennsylvania and exclusively licensed to REGENXBIO. The ‘617 patent expired in 2022, so this litigation was always about past damages, not injunctive relief. Representative claim 1 covers a cultured host cell containing a recombinant nucleic acid molecule encoding an AVV capsid protein having a sequence 95% identical to that listed.  The molecule also includes a heterologous non-AAV sequence.”

The key term “heterologous” means derived from a different species. “Recombinant” means the molecule is created by chemically splicing together nucleic acid sequences from two separate biological sources.  Thus, the claimed cells do not themselves occur in nature — but Judge Andrews still found the claims directed to a natural phenomenon.  REGENXBIO Inc. v. Sarepta Therapeutics, Inc., No. 20-cv-1226-RGA (D. Del. Jan. 5, 2024). (more…)

by Dennis Crouch

The very first provision of the Copyright Act is a curious definition:

An “anonymous work” is a work on the copies or phonorecords of which no natural person is identified as author.

17 U.S.C. § 101. If Congress assumed every author must be a natural person, why would it need to define a category of works where no natural person is identified? That textual puzzle sits at the heart of Stephen Thaler’s newly filed reply brief in Thaler v. Perlmutter, No. 25-449, which asks the Supreme Court to take up whether AI-generated works can receive copyright protection.  The case has been distributed for the Court’s February 27, 2026, conference.

SCOTUSGate: Supreme Court Petition Tracker

I have created a new website: SCOTUSGate (scotusgate.com), a tool for tracking petitions for certiorari at the Supreme Court. The site aggregates docket entries, briefing schedules, conference dates, and amicus filings for pending petitions. Cases can be browsed by topic, court of origin, or conference date. The Thaler case page is at scotusgate.com/case.php?number=25-449. 

The site also tracks cases flagged for response, relisted petitions, and CVSG orders, which are often early signals of the Court's interest in a case. SCOTUSGate is really at an Alpha stage - a work in progress - and I welcome feedback. -Dennis

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by Dennis Crouch

For the past year, the Federal Circuit has been systematically tightening the screws on patent damages and particularly pro-patentee expert testimony on the issue. Beginning with EcoFactor, Inc. v. Google LLC, 137 F.4th 1333 (Fed. Cir. 2025), the court vacated a $20 million reasonable royalty award for insufficient apportionment. Then came Jiaxing Super Lighting Electric Appliance Co. v. CH Lighting Technology Co., 146 F.4th 1098 (Fed. Cir. 2025), where the court vacated another award and suggested (in dicta) that experts must quantify their Georgia-Pacific adjustments. LabCorp v. Qiagen reversed a jury verdict on similar grounds. Coda Development v. Goodyear Tire “deflated” a $64 million award for inadequate apportionment. See Dennis Crouch, The Remedies Remedy is Almost Complete: EcoFactor v. Google, Patently-O (May 22, 2025); Dennis Crouch, Federal Circuit Extends EcoFactor Framework to Patent Damages Apportionment in Jiaxing Decision, Patently-O (Aug. 1, 2025); Dennis Crouch, Verdict Deflated: Fed Circuit Punctures Coda’s $64M Win Over Goodyear, Patently-O (Dec. 8, 2025). The cumulative message to patentees seemed pretty clear: jury verdicts on damages face appellate scrutiny, and experts who failed to satisfy the court’s increasing expectations would have their testimony excluded and the resulting awards overturned.

Today’s decision in Willis Electric Co., Ltd. v. Polygroup Ltd., No. 2024-2118 (Fed. Cir. Feb. 17, 2026), suggests there is a limit. Writing for a unanimous panel, Chief Judge Moore affirmed a jury’s $40+ million reasonable royalty award on a single dependent claim covering coaxial barrel connectors used in pre-lit artificial Christmas trees. The opinion runs to 37 pages, with the bulk devoted to a comprehensive defense of the damages verdict under Rule 702 and Daubert. The court upheld every challenged aspect of the patentee’s expert testimony: her income-based apportionment, her market-based apportionment using comparable licenses, and her qualitative application of the Georgia-Pacific factors. Where EcoFactor drew a line against expert testimony predicated on inaccurate factual premises, Willis Electric draws a line in the other direction. It holds that methodological choices about how to model profitability, which licenses to consider comparable, and how to weigh qualitative factors are matters for cross-examination and jury deliberation, not judicial exclusion. The repeated refrain of the opinion is that reasonable royalty calculations “necessarily involve an element of approximation and uncertainty,” EcoFactor, 137 F.4th at 1340, and Rule 702 must accommodate that reality.

For many years, I have seen the reasonable royalty “calculation” as a form of speculative science fiction. It is filled with such uncertainty that attempts for mathematical precision simply mask what is fundamentally a rough estimation exercise. The hypothetical negotiation is a legal fiction built on counterfactual assumptions, and the Georgia-Pacific factors provide structure without providing answers. Courts and experts have long struggled with how much rigor to demand from an inherently imprecise inquiry.

In Willis Electric, Chief Judge Moore engages with that tension directly, and several passages seem destined for heavy citation in future damages disputes. The court’s core distinction is between (1) an expert who builds on erroneous factual premises — ones that are “contrary to a critical fact upon which the expert relied” (the EcoFactor problem, warranting exclusion) and (2) an expert whose methodological choices reflect a “fact [dispute] over which reasonable minds can differ” (the Willis Electric situation, left to the jury). The opinion also deploys EcoFactor‘s own language about “approximation and uncertainty” as a shield rather than a sword, embedding it within a historical survey of reasonable royalty doctrine stretching back to Dowagiac Manufacturing Co. v. Minnesota Moline Plow Co., 235 U.S. 641 (1915), and even a 1960 Columbia Law Review student note. Recovery in Patent Infringement Suits, 60 Colum. L. Rev. 840 (1960).

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by Dennis Crouch

Oral argument at the Federal Circuit typically lasts 30 minutes. But the judges on the panel do not divide that time equally among themselves.  I used a sample of 1000+ Federal Circuit oral arguments and found some big differences among the judges. 

Chief Judge Kimberly Moore leads the court with a median speaking time of 4.51 minutes per argument. Judge Taranto follows closely at 4.31. At the other end of the spectrum, Judge Lourie speaks for a median of just 0.86 minutes, and the newest member, Judge Cunningham for 0.92 minutes. That is a fivefold difference between the most and least talkative members of the court. (more…)

By Dennis Crouch

When a university scientist invents something valuable, a familiar sequence follows. The inventor assigns rights to the university as a condition of employment. The university licenses the patent to a corporate partner while the inventor retains a royalty interest. If infringement litigation erupts, the inventor watches from the sidelines while lawyers representing the university and its licensee make decisions that will determine the value of that royalty stream.  The inventor’s interests often align with the university – but certainly not always.

A new cert petition filed by Dr. Monib Zirvi highlights this structural problem. Zirvi v. Akin Gump Strauss Hauer & Feld, LLP, No. 25-940 (petition filed February 2026). Zirvi, a Cornell-trained scientist who co-invented “ZipCode” DNA sequencing technology, claims that the law firms controlling patent infringement litigation on behalf of Cornell University and its exclusive licensee Thermo Fisher Scientific told him that his interests were “aligned” with theirs and that they “represented his interests.” He spent hundreds of hours preparing confidential technical analysis at the lawyers’ request. But when the case settled, he had no seat at the negotiating table.

Zirvi later sued the lawyers for malpractice, but ultimately received a one-two civil procedure punch. (more…)

by Dennis Crouch

When Alexander Graham Bell filed his patent application on February 14, 1876, he titled it “Improvement in Telegraphy.” Not “Telephone.” Not “Apparatus for Transmitting Speech by Electricity.” Just a modest tweak to the existing telegraph art. The United States government later alleged this was no accident. In United States v. American Bell Telephone Co., 128 U.S. 315 (1888), the government’s bill of complaint charged that Bell “purposely framed his said application and claim in ambiguous and general terms” and “did not set forth or declare that his alleged invention had any relation to the art of transmitting articulate speech by means of electricity.” The strategy worked, at least initially: the Patent Office examiner “did not understand the application to lay claim to the art of transmitting speech” and so “did not make an inquiry as to the state of that art or the patents or the printed publications concerning it.” No search for the work of Reis, Meucci, or even the caveat filed that same day by Elisha Gray. Bell got his patent on March 7, 1876, three weeks after filing. The case raised serious fraud allegations that the Supreme Court addressed in a companion case, The Telephone Cases, 126 U.S. 1 (1888), but the patent survived.

Nearly 150 years later, patent attorneys are still doing the same thing, though the tools are better and the practice now has a name: targeted drafting. The basic idea is to frame an application so the USPTO routes it to a favorable art unit, where the examiner corps is more likely to allow claims. The mechanism is different from Bell’s era, but the impulse is identical. A good negotiator picks a willing counterpart. A good patent prosecutor picks an art unit where the odds favor allowance. Analytics vendors have for years been marketing tools to predict art unit assignment and suggesting language changes to steer applications toward friendlier examiners. (more…)

by Dennis Crouch

The War Industry (formerly Defense) heavily invests in new technology and patents. But, we see very few patent infringement lawsuits. A key reason is 28 U.S.C. § 1498. That statute channels patent infringement claims involving government-authorized work away from private defendants and into the U.S. Court of Federal Claims, with the United States as the sole defendant (and a reasonable royalty as the only remedy). For government contractors and subcontractors, § 1498 operates as a powerful shield: if the infringing activity was performed “for the Government” and “with the authorization or consent of the Government,” the patent holder’s only remedy is a compensation action against the United States. The contractor walks free. This design reflects a deliberate policy choice. The government pays heavily for technology development with taxpayer dollars and, in exchange, retains control as the key point person – and it allows the administration to resolve patent disputes as it sees fit.

In Arlton v. AeroVironment, Inc., No. 2021-2049 (Fed. Cir. Feb. 2026) (nonprecedential), the Federal Circuit affirmed summary judgment shielding AeroVironment from patent infringement liability under § 1498 for its work developing NASA’s Ingenuity Mars helicopter and a terrestrial copy called “Terry.” The Arltons — co-inventors and co-owners of U.S. Patent No. 8,042,763, covering a counter-rotating coaxial rotor UAV — had developed the underlying technology under Small Business Innovation Research (SBIR) contracts with the military. When the government declined to award them follow-on work and instead contracted with AeroVironment through JPL and NASA, the Arltons sued AeroVironment for infringement.

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by Dennis Crouch

In January 2026, USPTO Director John Squires issued his first decision targeting a Chinese state-linked entity’s inter partes review petition, and the result is both less dramatic and more revealing than the national-security framing might suggest. Yangtze Memory Technologies Co. v. Micron Technology, Inc., IPR2025-00098 & IPR2025-00099, Paper 38 (USPTO Jan. 15, 2026).  The Director vacated the PTAB’s decisions granting institution and denied YMTC’s petitions challenging two Micron NAND flash memory patents (U.S. Patent Nos. 8,945,996 and 10,872,903). The decision is designated informative.

The case sits at the intersection focal points. The first is geopolitical. YMTC is a Chinese semiconductor manufacturer founded in 2016 by the partially state-owned Tsinghua Unigroup with approximately $24 billion in initial state-backed investment. The company was placed on the Bureau of Industry and Security’s Entity List in December 2022 as an organization “reasonably believed to be involved, or to pose a significant risk of being or becoming involved, in activities contrary to the national security or foreign policy interests of the United States.” 15 C.F.R. § 744.11. The Department of Defense separately designated YMTC as a “Chinese Military Company Operating in the United States” in January 2024. Against this backdrop, YMTC filed IPR petitions challenging two Micron NAND flash memory patents. After Micron sought Director Review, Dir. Squires issued a Show Cause order on November 10, 2025, requiring YMTC to justify why adjudicating its petitions was an appropriate use of the Office’s limited resources given its Entity List designation. See Dennis Crouch, Shutting the Patent Office Door: YMTC and the Entity List, Patently-O (Nov. 16, 2025).

The second focal point is IPR process. Dir. Squires has been systematically tightening the IPR petition process, including the real-party-in-interest requirement. In September 2025, he de-designated SharkNinja Operating LLC v. iRobot Corp., IPR2020-00734, Paper 11 (PTAB Oct. 6, 2020), which had permitted PTAB judges to ignore RPI deficiencies in some instances. With SharkNinja gone, the statutory text of § 312(a)(2) returned to full force as an independent threshold requirement: a petition “may be considered” only if it identifies “all” real parties in interest.  Failure to disclose means the petition is simply not in condition for consideration. (more…)

by Dennis Crouch

The United States Patent and Trademark Office has filed two intent-to-use trademark applications for the mark BOARD OF PEACE, the name of the international body President Trump formally launched at the World Economic Forum in Davos on January 22, 2026. Trump described it as “the Greatest and Most Prestigious Board ever assembled at any time, any place.” The trademark applications, both signed and filed personally by USPTO Director John A. Squires, represent an unusual instance of a federal agency seeking trademark protection for a nascent governmental initiative.

The first application, Serial No. 76720938, was filed on December 30, 2025, for a standard character mark. The second application, Serial No. 76720939, filed January 21, 2026, covers a design mark featuring a globe superimposed on a shield flanked by laurel branches. The logo used at the Board of Peace’s inaugural meeting features a globe showing most of the United States along with portions of the Western Hemisphere, rendered in a gold color scheme. Both applications identify the USPTO itself as the applicant, described as an “Agency of the United States Government” holding rights in stewardship.

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by Dennis Crouch

The Federal Circuit’s decision in Range of Motion Products, LLC v. Armaid Company Inc., No. 2023-2427 (Fed. Cir. Feb. 2, 2026), affirms summary judgment of non-infringement in a design patent dispute involving body massaging devices.  The most important part of the case is Chief Judge Moore’s dissent, which offers an attack on how the Federal Circuit has been applying the “plainly dissimilar” standard for design patent infringement. Drawing on psychological research, empirical survey data from recent amicus briefs, and a children’s puzzle from Highlights magazine, Chief Judge Moore argues that the court’s post-Egyptian Goddess framing has fundamentally shifted the infringement analysis away from the Supreme Court’s “substantially similar” test in Gorham Co. v. White, 81 U.S. 511 (1871).

The majority opinion in this case, authored by Judge Cunningham and joined by Judge Hughes, dismisses these concerns in a footnote, setting up what may become a vehicle for Supreme Court review.  Note that in September 2025, the Federal Circuit denied en banc rehearing on a similar issue in North Star Technology v. Latham Pool Products, 23-02138 (Fed. Cir. 2025).

The oral arguments included lots of interesting statements including the following:

Judge Hughes: Well, first of all, the problem is you have failed to give a specific claim construction that would allow us to determine what’s ornamental and what’s not. You just say “the appearance.” Well, that’s just like your dumb patent …

Chief Judge Moore: You said that out loud. That was not just in your head.

Judge Hughes: I’m perfectly content saying it out loud. I mean, you look at the front of your blue brief and you say the claim is this picture. Well, sure, that’s the way you do design patents, but when you’re doing claim construction, we use words and you have to give them words. And just saying “overall appearance” is not words.

Judge Hughes also authored the North Star Tech. opinion.  Listening to the North Star Tech oral arguments, I also note Judge Chen’s disregard of the patent in that case:

Judge Chen: I mean, we’ve had rectangular pools since there were pools. We’ve had rectangular tanning ledges ever since there were tanning ledges. We’ve had full-width steps from tanning ledges to the other part of the pool since forever. We’ve had deep-end benches since forever. And so I don’t understand what was the contribution. What’s the ornamentality here? Because other than what I just identified, this pool design doesn’t have anything. It’s so elemental. So basic.

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by Dennis Crouch

As January 2026 wraps up, I wanted to take a fresh look at the Supreme Court patent docket.  The centerpiece is Hikma v. Amarin after the Court granted certiorari on January 16, 2026. Hikma focuses on the doctrine of inducement – and particularly on how the patent doctrine fits with the Hatch-Waxman Act’s skinny label provisions. The Court previously looked at Skinny Label litigation almost fifteen years ago in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012). That earlier case addressed the Hatch-Waxman counterclaim provisions but did not resolve when a generic manufacturer’s marketing conduct crosses the line into inducement. Several other petitions have attracted Court attention through “Response Requested” orders, including cases challenging the Federal Circuit’s Section 101 jurisprudence and the scope of prior art available in inter partes review proceedings.

The docket’s composition reflects persistent tensions in patent law. Three petitions have received orders requesting responses from parties who initially waived their right to respond: United Services Automobile Association v. PNC Bank N.A., No. 25-853 (abstract idea eligibility); Agilent Technologies, Inc. v. Synthego Corp., No. 25-570 (prior art enablement); and Lynk Labs, Inc. v. Samsung Electronics Co., No. 25-308 (printed publications in IPR), which has attracted a number of amicus briefs. Two petitions are scheduled to be decided at the February 20, 2026 conference, and two others are on deck – having received extensions of time to file. Two interesting trademark cases pending before the court include RiseandShine Corp. v. PepsiCo, Inc., No. 24-1016, asking whether trademark strength is a question of fact; and Curtin v. United Trademark Holdings, Inc., No. 25-435, which focuses on standing to oppose trademark registrations. (more…)

by Dennis Crouch

The Solicitor General has filed a brief urging the Supreme Court to deny certiorari in Thaler v. Perlmutter, the case testing whether artificial intelligence can be recognized as an author under copyright law. The government’s opposition takes a notably restrained approach, relying entirely on statutory interpretation while avoiding the policy arguments about innovation incentives and economic impact that have dominated public discourse. The brief includes a strategic reframing of the question presented — attempting to narrow the case its unusual facts while leaving open the genuinely difficult questions about human-AI collaboration that will define copyright’s future in the near term. Brief for the Respondents in Opposition, Thaler v. Perlmutter, No. 25-449 (U.S. Jan. 2026).

The case arises from computer scientist Stephen Thaler’s application to register copyright in “A Recent Entrance to Paradise,” a visual artwork generated by his AI system called the “Creativity Machine.” Thaler’s application listed the Creativity Machine as the sole author and stated the work was “created autonomously by machine” without any human creative contribution.

The Trump Administration brief is notable for its restrained approach, relying entirely on statutory text and structure without invoking policy arguments about innovation or economic impact. At the same time, the government’s framing of the human authorship requirement appears more permissive than the Copyright Office’s recent registration decisions have suggested. The brief quotes the district court opinion for the proposition that that copyright protection remains available for AI-assisted works in very broad terms:

The rule requires only that the author of that work be a human being—the person who created, operated, or used artificial intelligence—and not the machine itself.

This language could be read to encompass a broader range of AI users than the Office has previously accepted.

In these situations, the US Gov’t brief will be signed by lawyers from both the DOJ and Copyright Office.  In this case, we only see DOJ attorneys, which suggests some disagreement in approach.  Of course, the Trump Administration (in control of the DOJ) is currently in litigation to remove the Copyright Registrar Shira Perlmutter, and so a lack of cooperation is not surprising.

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