Time Machines, Cold Fusion, and a Glucose Problem: A 2026 Report on § 101 Utility

Patent, Patentable Subject Matter, USPTO News

Utility rejections under 35 U.S.C. § 101 have become something of a relic at the USPTO. The Office mailed mailed over 650,000 office action rejections in 2025 - only 294 raised a utility ground. And, as you'll see below, utility rejections are typically an indication that the underlying disclosure is genuinely strange.

Utility-prong § 101 rejections as a share of all non-final and final office actions, 2008-2025

I pulled a small random sample of utility-bearing office actions mailed in early 2026 and want to walk through each:

  1. A pro se application for "curing leukemia and easy births" through time travel and "inspiration zones";
  2. Energy production by recreating black hole conditions in a heated steel enclosure;
  3. A cold-fusion-adjacent device, driven by "cycled electromagnetic radiation";
  4. A biochemistry case, now in its thirteenth year of prosecution, about whether melanin can synthesize glucose from carbon dioxide; and
  5. A room-temperature-superconductor application out of one of the most distinguished condensed-matter labs in the country.

This is a useful sample because each draws on a different strand of the utility doctrine, all tracing back through Brenner v. Manson, 383 U.S. 519 (1966), and the Federal Circuit's "implausible scientific principles" standard from In re Brana, 51 F.3d 1560 (Fed. Cir. 1995), that authorizes examiners to refuse claims premised on physics the applicant has not made credible.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Sixteen Years of §101: What Actually Moves Examiners

Patent, Patentable Subject Matter, USPTO News

by Dennis Crouch

In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), the Supreme Court set out its now familiar two step framework for determining eligibility under 35 U.S.C. § 101.  But the patent system did not really shift until two years later when the Court reiterated the same test. Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014).

Part of the story is that the legal framework only does some of the work.  In any system, we also have to look at how that law is administered.  For me, this means patent examination data. I have been pulling office action data going back to 2010 (several million rejections in total) and using a custom classifier to identify §101 rejections.

The headline finding is that ... (I know this is rude, but this data is so interesting that I decided keep it just for subscribers).

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Jurisdiction-If-We-Win: T-Mobile v. KAIFI and the Gunn Boundary Line

CAFC, Patent

by Dennis Crouch

The Federal Circuit heard oral argument this week in T-Mobile US, Inc. v. KAIFI LLC, No. 25-1006 (Fed. Cir. argued May 5, 2026), and most of the forty minutes were spent on the question: does the Federal Circuit even have jurisdiction over this appeal? (Listen on my ScotusGate site)

The underlying dispute is a Texas-law breach-of-contract case. T-Mobile and KAIFI settled patent infringement litigation on the eve of trial in the Eastern District of Texas. The settlement called for an upfront payment plus a contingent payment if any "Asserted Claim survives the [ex parte reexamination] EPR" then pending before the Patent Office. Although the USPTO confirmed several claims as patentable without amendment, T-Mobile refused to make the contingent payment, contending that KAIFI's positions before the examiner had narrowed the claims through prosecution disclaimer and that KAIFI's failure to disclose contradictory district-court filings rendered the patent unenforceable through inequitable conduct. Judge Gilstrap rejected those arguments and entered judgment for KAIFI for breach of contract.

The jurisdictional question matters because the case landed in the wrong court twice. T-Mobile's notice of appeal designated the Federal Circuit, but a "clerical error" sent the appeal to the Fifth Circuit, which transferred it to the Fed.Cir. on T-Mobile's unopposed motion. KAIFI then moved to transfer back, arguing that the contract claim does not arise under the patent laws. The motions panel deferred the question to the merits panel.  And then KAIFI changed its position. In its merits brief, KAIFI ultimately agreed that the Federal Circuit has jurisdiction, but only if the Court adopts KAIFI's preferred reading of the contract term "survives." T-Mobile's reply brief calls this a "jurisdiction-if-we-win-but-not-if-we-lose" argument. The oral arguments got into the "trying to have it both ways" argument and Judge Taranto pressed Philip Warwick (KAIFA's counsel) on the strangeness of conditioning jurisdiction on a particular merits resolution.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Pairing Down: Federal Circuit Affirms § 101 Dismissal of Vehicle-Mode Notification Patent

CAFC, Patent, Patentable Subject Matter

The Federal Circuit's nonprecedential decision in TJTM Technologies, LLC v. Google LLC, No. 25-1218 (Fed. Cir. May 5, 2026), affirms a N.D.Cal. R.12(b)(6) dismissal of TJTM's infringement suit on § 101 grounds. The patent at issue, U.S. Patent No. 8,958,853, claims a mobile device that automatically enters an "inactive mode" upon pairing with a vehicle, suppressing call and text notifications and transmitting an automated away message to senders. TJTM accused certain Google Android distracted-driving features of infringement. Judge Trina Thompson granted Google's motion to dismiss after applying the two-step framework of Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), and a Federal Circuit panel of Judges Dyk, Chen, and Stark (with Judge Chen writing) affirmed in a brief opinion.

Representative claim 1 recites a generic mobile device with three structural components (a wireless communication module, a processor, and a memory) followed by a sequence of programmatic steps: providing a graphical user interface through which a user customizes inactive-mode functions, receiving a user selection to auto-initiate inactive mode upon vehicle pairing, receiving the away-message text, automatically initiating inactive mode in response to pairing, and upon an incoming communication transmitting the away message while suppressing the audible, visual, or vibration cues. The claim says nothing about how the Bluetooth pairing handshake works, how the OS-level interrupt suppression is accomplished, or how the away message is generated and routed. The Federal Circuit found this combination of generic components and conventional steps insufficient to clear either Alice prong.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Words of Approximation: Why “About” and “Substantially” Are Slipping Out of Patent Claims

CAFC, Claim Construction, Patent

by Dennis Crouch

In Enviro Tech Chemical Services, Inc. v. Safe Foods Corp., No. 2024-2160 (Fed. Cir. May 4, 2026), the Federal Circuit affirmed a district court judgment invalidating most claims of U.S. Patent No. 10,912,321 as indefinite under 35 U.S.C. § 112(b). The patent claims methods of treating poultry carcasses with peracetic acid to increase carcass weight (eww), and the asserted claims required adjusting the antimicrobial solution to a "pH of about 7.6 to about 10 by adding an alkaline source." Judge Lourie, writing for the panel, held that "about" failed to inform a person of ordinary skill in the art, with reasonable certainty, of the permissible deviation from the recited pH endpoints. Because that disposition invalidated all asserted claims, the panel did not reach the district court's alternative ground that "an antimicrobial amount" was also indefinite.

An interesting quirk: The patentee's problem might be that the specification said too much rather than too little. The specification included several experiments that treated a 0.3 pH deviation as the working tolerance. But, it also discussed a commercial-scale trial that permitted 0.35 to 0.5 deviations.  Either of these could be the "about" pH level, but the internal contradiction ended up doing more damage than silence.

As part of the problem, Enviro Tech amended the lower endpoint of its claimed range from "about 7.3" to "about 7.6" during prosecution to escape prior art teaching pH 7.0, but never explained on the record what "about" was supposed to mean.  The decision indicates that type of amendment to closely skirt the prior art  "necessitates much more clarity than using the vague term 'about.'"  The case concludes with the pithy statement: "The prior art is almost 'about' a pH of 7.6."

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Decimation: Ex Parte Reexamination Eclipses the IPR

IPR, Patent, USPTO News

For more than a decade, inter partes review has been the dominant mechanism for challenging issued U.S. patent claims. The data through May 2, 2026 show that position has collapsed. The past four weeks, we have only seen eleven (11) IPR petition filings -- the lowest 4-week period since the system began in September 2012.  Ex parte reexamination requests have climbed substantially and for the first time the once-marginalized process has overtaken IPR as the leading post-grant validity tool (at least at the initial petition stage).

IPR Petitions vs. Ex Parte Reexamination Requests, 4-week trailing count, 2021-2026

The chart above traces the crossover. From early 2021 through mid-2025, IPR petitions cycled in a stable band of roughly 80 to 130 filings per 28-day window, and reexamination requests sat quietly between 20 and 40 (many of those were patentee-requested). Beginning in fall 2025, the lines collide. IPR collapses toward a single-digit floor; reexamination surges past 130 at its recent peak (with most of the addition being third-party requests). The director-tenure shading on the chart shows a gradual decline under Acting Director Coke Morgan Stewart, then free-fall under Director John Squires beginning in late 2025 and continuing through today. 

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Six on the Bench: The Federal Circuit’s Pending En Banc Patent Petitions

CAFC, Damages, Design Patent, Obviousness, Patent, Patentable Subject Matter

by Dennis Crouch

Six petitions for rehearing or rehearing en banc are currently pending before the Federal Circuit in patent cases.  I wanted to do a quick run through to highlight the unusual concentration of vehicles for doctrinal correction.  The court has been granting en banc petitions at a historically low rate of 0-1 per year, and several of the pending petitions explicitly ask whether the court will continue that trajectory.

Of the six petitions still pending, I see the post-EcoFactor Rule 702 petition in Barry v. DePuy and the Egyptian Goddess/Gorham challenge in Range of Motion v. Armaid as the most likely to attract en banc attention.

En Banc Rehearing at the Federal Circuit: Federal Rule of Appellate Procedure 35 and Federal Circuit Rule 35 govern en banc rehearing. A petition must demonstrate that the panel decision conflicts with a prior decision of the court or that the case presents a question of exceptional importance. The full court, including senior judges who participated in the panel, votes on whether to grant. A grant requires a majority of judges in regular active service. When the bench is full (12 judges), seven votes are needed. It is not clear to me whether the court is counting Judge Newman who has been "temporarily" removed from duty. If not, then only six votes would be needed.

Patent Eligibility Under § 101: Oasis Tooling

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

International Sanctions and the FRAND Framework

Damages, Patent

by Dennis Crouch

The English Patents Court has handed down its global FRAND determination in Samsung Electronics Co. v. ZTE Corp., [2026] EWHC 999 (Pat) (May 1, 2026), with Mr. Justice Meade setting a $392 million lump-sum balancing payment for a renewal cross-license between Samsung and ZTE (Samsung as the net payer because its mobile-phone sales dwarf ZTE's). The parties had already agreed that there should be a renewal of their 2021 portfolio license; what they could not agree on was the price. The court's task was therefore to determine the single global rate that would satisfy the FRAND obligation.

ZTE had asked for $731 million; and Samsung suggested substantially less.  The court eventually settled on $392 million.  The middle ground depended upon the court's application of "non-FRAND factors" -- particularly the impact of US export-control sanctions on ZTE's bargaining position. The court ultimately discounted the prior ZTE-Samsung 2021 and ZTE-Apple 2020 licenses because they were entered into in the shadow of the US sanctions imposed on ZTE beginning in 2018.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

The Thin Margin Between “Generic Vascepa” and Active Inducement

Patent, Supreme Court

by Dennis Crouch

The Supreme Court heard oral argument on April 29, 2026 in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, the term's only patent case focusing on patent inducement in the pharmaceutical "skinny label" context.  Justice Sotomayor pinned down all counsel to agree that no new doctrine is needed to decide this case. This led to several justices remarking that they should not even be hearing the case because it focused on factual error review rather than legal doctrine. Justice Barrett quoted Justice Alito's earlier-Term observation that "I'm not sure why this case is here except four of my colleagues wanted it to be."

Ultimately, a major § 271(b) pronouncement people braced for after January's cert grant looks somewhat unlikely.  If the generic Hikma wins reversal, I now expect it will be based upon the court's narrowing of the facts rather than rewriting the law.

  • Charles B. Klein (Winston & Strawn LLP) argued first as counsel for generic petitioner Hikma.
  • Malcolm L. Stewart (Deputy Solicitor General) argued second on behalf of the United States as amicus curiae, supporting petitioner.
  • Michael R. Huston (Perkins Coie LLP) came third, arguing for patentee respondent Amarin.

The U.S. Gov't amicus position - most often - the one to watch. I.e., it is the position that the Court is most likely to follow.  Here, although Stewart sided with the accused infringer on many points, he also did some work for the patentee.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

SCOTUS: IP Cases in the Pipeline

Patent, Supreme Court

by Dennis Crouch

The Supreme Court is hearing argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 on April 29, 2026 (as I write this). Hikma is the only granted patent case of the term.  But I wanted to step back and take stock of the IP pipeline at the Court. I identified twelve cases are now pending at various stages before the Supreme Court, including several pre-petition applications.

Patent Eligibility (§ 101): The most familiar question on the docket is whether the Court will revisit § 101.  And two cases are pending: (more…)

Range of Motion En Banc Petition: The Plainly Dissimilar Test and the Functionality Question

Patent

by Dennis Crouch

In Range of Motion Products, LLC v. Armaid Co., 166 F.4th 981 (Fed. Cir. 2026), Chief Judge Moore wrote a sharp dissent challenging the Federal Circuit’s “plainly dissimilar” rule.  Now, the losing patentee has petitioned for en banc rehearing and has support from three amici:

  • Robert Oake (lead counsel for Egyptian Goddess)
  • Perry Saidman (counsel for Avia Group in Avia Group International v. L.A. Gear, 853 F.2d 1557 (Fed. Cir. 1988)), and
  • The Industrial Designers Society of America, and the Institute for Design Science and Public Policy.

Armaid’s response is due May 20, 2026. [Range of Motion En Banc Briefs]

Three-way comparison of D'155 patent, Armaid2 accused product, and Armaid1 prior art

See my AI version of the accused “arm aid” device in action here.

(more…)

The Director’s Non-Statutory Statute of Limitations

CAFC, IPR, Patent, Supreme Court, USPTO News

by Dennis Crouch

In Thryv, Inc. v. Click-To-Call Technologies, LP, 590 U.S. 45 (2020), Justice Gorsuch in dissent warned that an expansive reading of 35 U.S.C. § 314(d) would leave the PTO Director free to “insulat[e] his favorite firms and industries from [IPR] entirely.” Now, Google’s petition for certiorari in Google LLC v. VirtaMove, Corp., No. ___ (U.S. filed Apr. 27, 2026), argues that the warning has been realized. The petition seeks review of the Federal Circuit’s denial of mandamus in In re Google LLC, No. 2026-111 (Fed. Cir. Jan. 27, 2026), and presents two intertwined questions about administrative power and judicial review under the AIA.

The first question asks whether the PTO has statutory authority to deny IPR based on a patentee’s “settled expectations” once a patent has been in force for six years. The second asks whether Article III courts retain power to review such denials when the petitioner contends they exceed statutory authority, particularly under Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024). (more…)

The Cox Shadow Over Hikma: Three Questions for Wednesday’s Argument

CAFC, Patent, Supreme Court

by Dennis Crouch

On Wednesday, April 29, 2026, the Supreme Court will hear argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889.  The Court has not heard a patent inducement case since 2015 (Commil v. Cisco) or a skinny-label case since 2012 (Caraco v. Nova Nordisk).  Here though the key case on point is the one that not briefed: Cox Communications, Inc. v. Sony Music Entertainment, 607 U.S. ___ (2026).

Cox was decided in late March 2026, with the Court narrowly construing contributory copyright infringement once again tying its analysis to the patent act’s statutory approach.  Justice Thomas, writing for the majority, held that secondary liability requires either inducement (active steps to encourage infringement) or tailoring (a service “not capable of substantial or commercially significant non-infringing uses”).  Although copyright does not have a statute on-point, the Court analogized these to the patent law’s 271(b) and (c) respectively.

Ultimately, the Court held mere knowledge that downstream users will infringe, even combined with continued provision of a useful product, is not enough to justify an inducement finding. Justice Sotomayor concurred in the judgment, joined by Justice Jackson, urging preservation of a broader material contribution theory.

There are many parallels between Cox and Hikma, and the patentee (Amarin) will need to distinguish the two in order to win.  My own expectation is that Amarin will not be able to distinguish Cox. Although section viii’s interaction with state substitution laws and routine off-label prescribing produces what I have called the skinny-label tinderbox (a structural channel toward the patented indication that operates regardless of generic conduct), inevitability is not the same as encouragement, and Cox makes clear that secondary liability requires the latter.

See, Dennis Crouch, The Tinderbox: Market Structure, Skinny Labels, and Induced Patent Infringement, 73 UCLA L. Rev. Discourse ___ (Forthcoming 2026).

(more…)

Fun While It Lasted: Judge Albright to Leave the Bench

Patent

by Dennis Crouch

Judge Alan Albright confirmed Tuesday evening that he will resign from the Western District of Texas at the end of August, closing out the most unusual patent-venue experiment of the past decade.  Albright told Bloomberg Law that he misses being a trial lawyer and plans to return to private practice.

The announcement is less consequential than it would have been four years ago. Albright's patent gravity peaked in 2020-21, when roughly one in five U.S. patent cases landed in the Waco Division because he was the division's only district judge. Chief Judge Orlando Garcia ended that arrangement in July 2022 by ordering new Waco patent filings distributed randomly across twelve WDTX judges.  In 2024, Albright gave up Waco and transferred back to to Austin.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Recalibration: Seven Months of PTAB § 101 Data

Patent, Patentable Subject Matter, USPTO News

by Dennis Crouch

In a January 2, 2026 post I reported that the Patent Trial and Appeal Board’s rate of reversing § 101 rejections in ex parte appeals had roughly doubled during the first weeks of Director John Squires’s tenure. Dennis Crouch, PTAB Doubles Section 101 Reversal Rate Under Director Squires, Patently-O (Jan. 2, 2026). The natural concern with that finding was that it covered only about twelve weeks of post-Squires data and could still be a short-run fluctuation. Seven months of additional decisions now let me revisit the question. The shift has solidified with PTAB reversing examiners at about double the rate as prior to Squires swearing-in.

Although Dir. Squires has repeatedly discussed the issue and his push for weaking 101 threshold, I wanted to look a bit deeper into what is driving the shift. One additional obvious candidate was roster turnover. The 2025 Fork-in-the-Road (FORK) program and DOGE related resignation offerings reduced PTAB headcount materially, and a fresh panel draw could plausibly explain much of the movement. The data, however, rules out turnover as the primary driver. I looked at the data on particular PTAB judges, and found that individual judges have (statistically) shifted their behavior.  Mean reversal rate moved from 11.0% to 22.3%, a +11.3 point within-judge — a shift that is slightly larger than the aggregate +11.07 point shift. The conclusion is that the Board’s approach to § 101 has been recalibrated from the top, and that recalibration has operated primarily by changing how incumbent administrative patent judges vote rather than by replacing them.

(more…)

Still Climbing: PTA Hits 318 Days, Back to 2015 Levels

Patent, USPTO News

Six weeks ago I wrote about patent term adjustment climbing back to 296 days. The trend has continued. The six-week trailing average for newly issued utility patents now sits at 318 days as of mid-April 2026, back near the levels that prevailed in 2015 when the USPTO was still working through its early-2010s backlog. See Dennis Crouch, PTA Keeps Score: Patent Term Adjustment as a Measure of the USPTO Backlog, Patently-O (Mar. 10, 2026).

The post-2015 decline, from roughly 320 days down to a mid-2021 low of 120 days, took six years of steady effort. The reversal has been faster. PTA has nearly tripled since mid-2021, and the recent slope shows no sign of leveling. The average utility patent issuing today carries close to an additional year of term beyond the twenty-year baseline under 35 U.S.C. § 154(b), all of it paid for by USPTO delay.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

The DTSA’s Missing Preemption: Does § 1835(b) Bind State Courts?

Patent, Supreme Court

by Dennis Crouch

Ten years ago, when the Defend Trade Secrets Act was still awaiting President Obama's signature, I flagged a provision that I predicted would become "the most cited aspect of the new law." Dennis Crouch, Rights of Trade Secret Owners in Federal Cases, Patently-O (May 3, 2016). The provision was 18 U.S.C. § 1835(b), titled "Rights of Trade Secret Owners," which prohibits courts from authorizing or directing the disclosure of information a party asserts to be a trade secret without first giving the owner the opportunity to file a submission under seal explaining why confidentiality should be maintained. I noted at the time that unlike other provisions of the EEA/DTSA, this "right" was not expressly limited to actions arising under the federal statute and could be read broadly as providing procedural rights in all federal cases.

The DTSA's Confidentiality Framework: When enacted in 1996 as part of the Economic Espionage Act, 18 U.S.C. § 1835 consisted of a single undivided paragraph requiring federal courts to enter confidentiality orders in Chapter 90 prosecutions. The DTSA restructured the provision in 2016, retaining the original text as subsection (a) "In General" and adding subsection (b) "Rights of Trade Secret Owners." Subsection (b) contains three sentences: a sealed-submission opportunity before compelled disclosure, a limit on the use of sealed submissions in Chapter 90 prosecutions, and a non-waiver rule for disclosures made in connection with such prosecutions. The key textual question is whether subsection (b)'s opening mandate extends beyond proceedings brought under the EEA/DTSA.

A new certiorari petition filed February 2, 2026, pushes that observation even further. In Chaturvedi v. Bridge Over Corporation, a pro se petitioner asks the Supreme Court to decide whether § 1835(b)'s confidentiality protections bind state courts exercising concurrent jurisdiction over disputes involving federally defined trade secrets. The petition arises from Massachusetts state court proceedings in which the trial judge reportedly declared on the record: "There is no confidentiality. . . . I don't care about 18 U.S.C. We are in state court."

The petition frames this as a structural conflict between a mandatory federal procedural safeguard and state court discovery practices, raising questions about the DTSA's preemptive scope that Congress left unresolved in 2016 and that no appellate court has squarely addressed. The case also implicates the "inverse Erie" doctrine, under which state courts adjudicating federal claims must apply federal substantive law. Because the DTSA grants state courts concurrent jurisdiction, the question of whether § 1835(b) is a substantive component of the federal cause of action or merely a procedural rule has real consequences for how trade secrets are protected in state court litigation.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Barry v. DePuy Returns: En Banc Petition Tests EcoFactor’s Reach on Rule 702 Gatekeeping

CAFC, Patent

by Dennis Crouch

In January, I covered the Federal Circuit's divided panel decision in Barry v. DePuy Synthes Cos., 164 F.4th 896 (Fed. Cir. 2026), which reversed a district court's mid-trial exclusion of two expert witnesses and ordered a new trial.  Judge Stark's majority treated the challenged testimony as a permissible application of the court's claim construction and treated the survey expert's methodological problems as questions of weight for the jury. Judge Prost dissented, warning that the majority "contravenes the principles embraced in EcoFactor and the 2023 amendments" to Federal Rule of Evidence 702.

DePuy (a JNJ Subsidiary) has now petitioned for en banc rehearing, and the petition has drawn amicus support from the Chamber of Commerce and National Association of Manufacturers, the Washington Legal Foundation, Lawyers for Civil Justice, and a coalition of the High Tech Inventors Alliance and Software & Information Industry Association. These parties are all interested providing large operating companies with additional tools to limit expert testimony. Barry's response is due May 15, 2026.

The petition frames the panel disagreement as a structural conflict with the en banc decision in EcoFactor, Inc. v. Google LLC, 137 F.4th 1333 (Fed. Cir. 2025), and argues that the panel has quietly reintroduced the "weight-not-admissibility" framework that EcoFactor and the 2023 Rule 702 amendments were designed to eliminate. The alignment of players underscores the stakes: Judge Stark authored the Barry majority after being one of two EcoFactor en banc dissenters, and Judge Prost's Barry dissent echoes the panel dissent she wrote in EcoFactor that triggered en banc rehearing there.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Same Problem, Same Solution: Reading Trade Secrets Across Fields

CAFC, Patent

by Dennis Crouch

International Medical Devices, Inc. v. Cornell, No. 2025-1580 (Fed. Cir. Apr. 17, 2026)

The Federal Circuit reversed a substantial jury verdict and bench-trial damages award against a group of Texas urologists and their affiliates who were found to have misappropriated four trade secrets embodied in the Penuma cosmetic penile implant. Writing for a unanimous panel, Judge Dyk held that three of the asserted trade secrets (internal pockets to soften silicone, distal mesh tabs to promote tissue ingrowth, and absorbable sutures paired with mesh tabs) were generally known under California law because each had been disclosed in prior patents; that the fourth (the Penuma instrument list) had lost any secrecy when it was emailed to third parties without confidentiality restrictions; and that the same ideas that failed to qualify as trade secrets also failed to sustain a claim that plaintiff Dr. James Elist was a co-inventor of the defendants’ two patents. The court vacated roughly $17 million in reasonable-royalty and exemplary damages and a five-year permanent injunction, while affirming a $1 million statutory counterfeiting judgment tied to Dr. Cornell’s unauthorized use of the Penuma trademark.

The opinion is a useful teaching vehicle on the patent/trade-secret interface. It reinforces the familiar rule that ideas placed in the public domain through a patent disclosure cannot be reclaimed as trade secrets. It also articulates something of an obviousness rule for trade secrets: “no protectable trade secret results from translating a generally known concept from one environment to another environment where both environments present the same problem that is solved by the same solution.”

In most jurisdictions, the trade secrecy definition is limited to information “not being generally known to, and not being readily ascertainable through proper means by, another person …” 18 U.S.C. § 1839(3). But, California law – the law of this case – omits the “readily ascertainable” language its statutory definition of a trade secret.  Here, though the court found that the “generally known” standard absorbs much of the functional load.

The inventorship holding, grounded in Board of Education ex rel. Board of Trustees of Florida State University v. American Bioscience, Inc., 333 F.3d 1330 (Fed. Cir. 2003), illustrates how a finding that information is in the public domain for trade-secret purposes can ripple into patent validity by defeating a claim of inventive contribution.

(more…)

Extra Credit Not Required: Teva v. Lilly and the Limits of Amgen’s Reach

CAFC, Enablement, Patent

by Dennis Crouch

Since the Supreme Court's 2023 decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), pharmaceutical patentees have been grappling with the heightened disclosure demands for genus claims, particularly in the biologics space where many similar compounds can have similar treatment uses. The Federal Circuit's subsequent application of Amgen in Baxalta Inc. v. Genentech, Inc., 81 F.4th 1362 (Fed. Cir. 2023), reinforced the issues -- and left many wondering whether broad antibody claims could survive at all.

Today's decision in Teva Pharmaceuticals International GmbH v. Eli Lilly & Co., No. 2024-1094 (Fed. Cir. Apr. 16, 2026), provides an important limiting principle. Writing for a unanimous panel, Judge Prost holds that when a patent claims a method of using a well-known genus of compounds rather than claiming the compounds themselves, both the written description and enablement requirements of 35 U.S.C. § 112 are evaluated differently. The court reversed a district court's grant of judgment as a matter of law (JMOL) that had overturned a jury verdict of willful infringement and $177 million in damages, reinstating Teva's win in this battle between two migraine drugs: Teva's Ajovy and Lilly's Emgality.

The case has been closely watched on Patently-O since the district court's 2023 JMOL decision. The appeal presented a good vehicle for testing the boundaries of post-Amgen disclosure doctrine because the asserted claims are method-of-treatment claims rather than composition claims. That distinction turns out to be dispositive.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.