Dennis Crouch – Patently-O https://patentlyo.com America's leading patent law blog Mon, 22 Dec 2025 00:27:59 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.7 https://patentlyo.com/media/2025/11/cropped-patentlyo-favicon-square-no-border-4-32x32.png Dennis Crouch – Patently-O https://patentlyo.com 32 32 Dolby v. Unified: Informational Standing, RPIs, and the SharkNinja Twist https://patentlyo.com/patent/2025/12/informational-standing-sharkninja.html https://patentlyo.com/patent/2025/12/informational-standing-sharkninja.html#respond Mon, 22 Dec 2025 00:27:18 +0000 https://patentlyo.com/?p=47454 Dolby seeks SCOTUS review on revealing IPR real parties in interest (RPIs). A recent USPTO policy shift could revive their claim for full disclosure.

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by Dennis Crouch

Dolby Laboratories has filed an application for an extension of time to petition the Supreme Court for certiorari, seeking review of the Federal Circuit's June 2025 decision dismissing Dolby's appeal for lack of Article III standing. Dolby Laboratories Licensing Corporation v. Unified Patents, LLC, No. 2023-2110 (Fed. Cir. June 5, 2025). The case presents fundamental questions about whether the AIA creates informational rights for patent owners about the IPR real parties in interest (RPIs) and whether the Federal Circuit has improperly narrowed the Supreme Court's standing doctrine. If the petition is filed as planned by February 20, 2026, the Court would consider it during the current Term for potential argument next Term.

A critical development not mentioned in Dolby's extension application: On September 26, 2025, USPTO Director John Squires de-designated SharkNinja Operating LLC v. iRobot Corp. as precedential, eliminating the very framework that led the PTAB to refuse adjudication of Dolby's RPI claims. This development fundamentally changes the landscape and may provide Dolby with an alternative path to relief: remand for the Board to apply the restored pre-SharkNinja standard.  It will also be interesting to see whether the new Government opposes the petition.

Dolby Laboratories is a San Francisco-based technology company founded in 1965 that has evolved from its origins in analog noise reduction into a global IP licensing powerhouse with a market capitalization of approximately $6.3 billion. The company's business model relies heavily on patent licensing, which accounts for the vast majority of its approximately $1.3 billion in annual revenue. Dolby maintains a substantial patent portfolio of 10,000+ globally issued patents.  Unified Patents is a membership-based organization founded in 2012 that challenges patents its members view as problematic, primarily through IPR petitions. The company operates on a subscription model where technology companies pay annual fees in exchange for Unified's patent-challenge services, creating a structure where multiple member companies may have overlapping interests in any given proceeding. This business model sits at the heart of the RPI dispute. Dolby argues that Unified's members who would benefit from invalidation of its patents should have been named as real parties in interest, which would subject them to statutory estoppel if the challenge failed.


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Federal Circuit’s Top Precedents (2025): Claim Construction Classics and the Procedural Turn https://patentlyo.com/patent/2025/12/precedents-construction-procedural.html https://patentlyo.com/patent/2025/12/precedents-construction-procedural.html#comments Fri, 19 Dec 2025 20:38:01 +0000 https://patentlyo.com/?p=47452 In 2025, the Federal Circuit cites Phillips, KSR, and claim construction cases most—but procedural precedents on IPR review, waiver, and appellate standards also dominate practice.

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by Dennis Crouch

Which cases does the Federal Circuit cite most frequently? I recently compiled data on the top ten most-cited precedents appearing in Federal Circuit opinions during 2025 (so far). Some of the standards remain frequent: Phillips v. AWH Corp. leads, followed by KSR v. Teleflex. Markman v. Westview also makes the list.  What may surprise some readers is the prominence of procedural cases addressing threshold questions: whether arguments were preserved, what standard of review applies, and whether judicial review is even available.

The list also reflects the court's post-AIA docket. Two cases addressing IPR judicial reviewability appear among the top ten: Cuozzo v. Lee and Thryv v. Click-To-Call.   The oldest on the list is Consolidated Edison Co. v. NLRB, a 1938 labor law decision that defines the boundary of appellate review.

* For this data, I parsed all of the CAFC's 2025 precedential patent decisions through December 15, 2025 to create a master table of authorities. 

1. Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) 

The Federal Circuit's en banc decision in Phillips remains the undisputed foundation of claim construction doctrine. Twenty years after its issuance, the case continues to lead citation counts because it establishes the framework courts apply in virtually every patent case. Phillips instructs that claim terms carry their ordinary and customary meaning as understood by a person of ordinary skill in the art at the time of invention, with that meaning informed primarily by the intrinsic record: i.e., the claims, the specification, and the prosecution history. The decision resolved a long-running tension about the relative weight of intrinsic versus extrinsic evidence with the result of subordinating dictionaries and expert testimony to the patent document itself.


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The Catch-22 of Court Transparency: Why Public Access Needs a Dedicated Intervention Rule https://patentlyo.com/patent/2025/12/transparency-dedicated-intervention.html https://patentlyo.com/patent/2025/12/transparency-dedicated-intervention.html#respond Fri, 19 Dec 2025 18:44:50 +0000 https://patentlyo.com/?p=47448 Federal Circuit dismisses EFF's bid to unseal patent case briefing as untimely, dodging substantive questions about court sealing practices.

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by Dennis Crouch

The Federal Circuit has dismissed an appeal by the Electronic Frontier Foundation  (EFF) seeking to unseal summary judgment briefing in a patent dispute involving standard-essential patents for cable modem technology. Entropic Communications, LLC v. Charter Communications, Inc., No. 24-1896 (Fed. Cir. Dec. 17, 2025) (nonprecedential). The CAFed held that the district court did not abuse its discretion in denying EFF’s motion for permissive intervention as untimely under Fifth Circuit law. Because EFF could not establish a right to intervene, the Federal Circuit concluded it lacked jurisdiction to address the substantive question that had drawn significant amicus attention: whether courts may seal judicial records based solely on the parties’ designation of materials as confidential under a stipulated protective order.

In the case, Charter raised a defense based on licensing commitments associated with the Data Over Cable Service Interface Specification (DOCSIS) standard, arguing that Entropic’s patents were standard-essential and therefore encumbered by FRAND licensing obligations. The parties filed extensive summary judgment briefing on this issue, with most materials filed under seal pursuant to a protective order the court had entered. According to EFF, more than 40% of Entropic’s opening summary judgment brief and 76% of Charter’s response were redacted in the public versions. The magistrate judge’s report and recommendation, which was filed publicly without redaction, recommended granting Charter’s license defense. The district court adopted that recommendation, and the parties promptly settled. EFF moved to intervene three months later, seeking to unseal the briefing so the public could understand how courts resolve disputes over standard-essential patent licensing.

Under Fifth Circuit law, permissive intervention under Federal Rule of Civil Procedure 24(b) is “wholly discretionary” — offering almost no chance on appeal. The would-be intervenor is effectively relegated to amicus status.

Judge Gilstrap found EFF’s motion untimely and denied intervention. The critical question was when EFF knew or should have known that its interest in public access would not be protected by the parties. The district court determined that EFF, given its expressed interest in the DOCSIS licensing issue, likely followed the case and would have known by October 11, 2023 (when summary judgment briefing was complete) that the sealed materials would remain sealed absent intervention, and found EFF’s March 2024 motion came too late.

I see this sort of public-access intervention as unique. EFF is intervening in order to ensure transparency of our court system.  Effectively FOIA for the courts.  Writing for the panel, Judge Bryson rejected this idea and instead concluded that public access intervenors receive more lenient treatment than other permissive intervenors.

I listened in on oral arguments, and Judge Bryson appeared particularly concerned about the substantive sealing practices even as he recognized the procedural obstacles. He pressed Charter’s counsel on whether protective order coverage could automatically justify sealing materials filed with the court. Charter conceded it could not. The two standards are different and sealing requires independent justification. Judge Bryson observed that many district judges use a process where parties file under seal initially and then submit redacted versions, with the court reviewing the redactions for propriety. But he distinguished this practice from treating protective order designations as dispositive of the sealing question. Charter’s counsel agreed with this distinction but argued the parties had followed local rules and should not be penalized for compliance.

This exchange highlights the substantive question the Federal Circuit refused to reach: whether Judge Gilstrap’s local rules permit an end-run around requirements for sealing judicial records. The district court interpreted entry of a blanket protective order as providing authorization to file documents under seal.  But, this conflates the “good cause” standard for protective orders governing discovery with the “compelling reasons” standard required to seal judicial records.  This is an error previously identified by courts. See, e.g., Binh Hoa Le v. Exeter Finance Corp., 990 F.3d 410 (5th Cir. 2021).

Sidebar: Protective Orders vs. Sealing Orders

Federal Rule 26(c) allows courts to enter protective orders limiting disclosure of discovery materials upon a showing of "good cause." This relatively lenient standard protects parties during litigation - but generally only applies to information being exchanged between the parties (or third parties). 

Sealing judicial records filed with the court requires a higher showing. Under the common law right of access, courts must find that "compelling reasons" justify secrecy. The First Amendment provides additional protection for certain judicial proceedings.

The distinction makes sense because discovery materials exchanged between parties are not public records, while documents filed with the court presumptively are.

The amicus briefing in this case documented the scope of the problem. Professor Mark Lemley and other legal scholars submitted a brief citing their empirical study, Secrecy by Stipulation, 74 Duke L.J. (forthcoming), which analyzed over 2.2 million federal docket entries. They found that judges grant 95-97% of stipulated protective orders, often without any explicit good cause finding. When courts then treat these protective orders as authorization to seal judicial records, the result is “circular justification” that allows private parties to override the public’s right of access. The Reporters Committee for Freedom of the Press, joined by nineteen media organizations including the New York Times and Washington Post, documented how post-judgment intervention has historically been essential to uncovering matters of public concern, from the Catholic Church abuse scandal to opioid litigation. They argued that “delays measured in years” should be acceptable when the public interest is at stake. See, San Jose Mercury News, Inc. v. U.S. District Court, 187 F.3d 1096 (9th Cir. 1999).

The disposition here creates a Catch-22 for public access advocates. The substantive question of whether the sealing practice is legal remains unresolved because EFF could not clear the procedural threshold of intervention. But, EFF did not learn of the sealed materials until after the case settled.

In my view, the openness of judicial proceedings is a foundational principle of our legal system. Public access promotes confidence in the judiciary, provides a check on judicial conduct, permits scrutiny of the litigation process, and ensures that legal rules developed through adjudication are available to guide future conduct. These values apply with particular force to standard-essential patent litigation.   But, the current procedural framework makes this process exceedingly difficult.

This case illustrates why Federal Rule of Civil Procedure 24 needs a dedicated pathway for public access intervention. The current framework forces organizations like EFF to satisfy requirements designed for parties seeking to protect private interests in litigation outcomes. That framework makes little sense when applied to intervenors whose sole purpose is vindicating the public’s constitutional and common law right of access to judicial proceedings. A new Rule 24(c) could establish intervention of right for persons seeking access to sealed judicial records, with timeliness measured not from when documents were filed but from when the would-be intervenor discovered the sealing or reasonably could have discovered it. The rule should toll timeliness during good-faith efforts to obtain voluntary unsealing, recognizing that meet-and-confer requirements serve judicial economy but should not create procedural traps. Many courts already grant what might be called “limited purpose intervention” for public access claims, permitting nonparties to challenge sealing without becoming full parties to the underlying litigation. Codifying this practice would ensure uniform treatment across districts and eliminate the current situation where access rights depend on which judge draws the case.

The substantive standard for public access intervention should incorporate a balancing test that accounts for the public importance of the sealed information. Matters involving government conduct, public health and safety, industry-wide practices, and the interpretation of legal standards affecting large populations warrant greater solicitude for access claims. Standard-essential patent disputes, which shape the balance between intellectual property rights and technological interoperability, fall squarely within this category. The DOCSIS licensing materials sealed in this case involve technology deployed in millions of homes; the public has a legitimate interest in understanding how courts resolve such disputes. A reformed intervention rule should also address the “prejudice” question that defeated EFF’s motion here. The burden of responding to an unsealing motion is simply the cost of having sought secrecy in the first place, not cognizable prejudice that can defeat intervention. Congressional action may be necessary to achieve this reform, as the Rules Enabling Act process can be slow and the Judicial Conference has historically been cautious about expanding access rights. But the alternative, a system where sealing practices effectively escape appellate review because intervenors cannot clear procedural thresholds is simply not working.

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Idaho’s Anti-Troll Law Takes Aim at Federal Court Complaints: Federal Circuit Punts on Preemption https://patentlyo.com/patent/2025/12/federal-complaints-preemption.html https://patentlyo.com/patent/2025/12/federal-complaints-preemption.html#respond Thu, 18 Dec 2025 19:26:15 +0000 https://patentlyo.com/?p=47443 Federal Circuit dismisses appeal of $8M bond under Idaho's anti-troll law, deferring preemption question of whether states can regulate complaints.

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by Dennis Crouch

The Federal Circuit dismissed an interlocutory appeal in Micron Technology, Inc. v. Longhorn IP LLC, No. 2023-2007 (Fed. Cir. Dec. 18, 2025), finding no appellate jurisdiction over a district court order imposing an $8 million bond under the Idaho Bad Faith Assertions of Patent Infringement Act. This jurisdictional ruling delays what promises to be a consequential showdown over federal preemption.

Roughly thirty states have anti-patent-troll legislation -- mostly targeting bad faith demand letters.  But, Idaho's is one of the more aggressive because it identifies filing a complaint (i.e., filing the lawsuit) as a potentially unlawful communication. That choice puts Idaho on direct collision course with federal patent law in ways that other state statutes have more carefully avoided.  The problem is that patent law (supported by the U.S. Constitution) gives patentees the right to sue infringers for infringement.  Under Federal Circuit precedent, state laws that impose liability based on patent enforcement activity are generally preempted unless the patent holder's assertions were objectively baseless and made in subjective bad faith.

The appellants in this case, Longhorn IP and Katana Silicon Techs, argued that Idaho's attempt to regulate federal court pleadings is facially preempted because such filings are governed by federal patent law.  Micron and the State of Idaho responded that the state has the right and power to regulate bad-faith patent assertions, regardless of whether the assertion appears in a demand letter or a complaint. I listened in on the oral arguments and noted that the panel spent considerable time probing these questions.  But, the court ultimately concluded it lacked appellate jurisdiction. So, we'll have to wait until final judgment we receive a clear appellate answer.  And, it means that the patentee will need to pay the $8 million bond if it wants the infringement litigation to move forward.

More background:

Federalism on Trial: Idaho’s Attempt to Regulate Patent Litigation


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Element-by-Element: Federal Circuit Rejects Functional Equivalence in Car Seat War https://patentlyo.com/patent/2025/12/element-functional-equivalence.html https://patentlyo.com/patent/2025/12/element-functional-equivalence.html#respond Thu, 18 Dec 2025 03:09:28 +0000 https://patentlyo.com/?p=47440 Fed Cir reverses DOE verdict and injunctions in Wonderland v. Evenflo, but orders new willfulness trial over excluded "Dracula" emails.

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by Dennis Crouch

Wonderland Switzerland AG v. Evenflo Company, Inc., No. 2023-2043 (Fed. Cir. Dec. 17, 2025) (Moore, C.J.)

This split decisions hits on three separate issues:

  1. When the doctrine of equivalents can overcome structural differences between claimed and accused elements;
  2. What evidence suffices to establish irreparable harm for injunctive relief; and
  3. How trial courts should balance probative value against prejudice when excluding evidence relevant to willful infringement.

Writing for the majority, Chief Judge Moore reversed a jury's infringement finding under the doctrine of equivalents for certain accused products, reversed permanent injunctions covering both asserted patents, and ordered a new trial on willfulness based on excluded email evidence. Judge Reyna dissented regarding the willfulness ruling, arguing the majority improperly substituted its judgment for the district court's evidentiary determinations under Federal Rule of Evidence 403.


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How the Printed Matter Doctrine Sees Through X-Ray Markers https://patentlyo.com/patent/2025/12/printed-doctrine-through.html https://patentlyo.com/patent/2025/12/printed-doctrine-through.html#respond Tue, 16 Dec 2025 20:49:19 +0000 https://patentlyo.com/?p=47425 New Fed Cir ruling: Radiographic markers lack patent weight as "printed matter," leading to anticipation in C.R. Bard v. AngioDynamics.

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by Dennis Crouch

Five years ago, I posed this question: How does the printed matter doctrine apply to letters that can only be read using an X-ray? Dennis Crouch, Patent Eligibility of Claims Directed to Printed Matter, Patently-O (Nov. 11, 2020). The Federal Circuit's first decision in the long-running C.R. Bard v. AngioDynamics litigation had held that the informational content conveyed by radiographic markers on vascular access ports constitutes printed matter not entitled to patentable weight, but that the structural requirement of a radiographically discernible marker could still distinguish the claims from prior art. C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372 (Fed. Cir. 2020). The case went back for retrial, the jury again sided with the patentee on validity, and the district court again granted judgment as a matter of law rejecting the jury verdict. Now the Federal Circuit has affirmed, but on anticipation rather than eligibility grounds, and in doing so has clarified just how little remains of these claims once the printed matter is stripped away. C.R. Bard, Inc. v. AngioDynamics, Inc., No. 2023-2056 (Fed. Cir. Dec. 15, 2025) (per curiam, nonprecedential).

The patents at issue claim assemblies and methods for identifying "power injectable" vascular access ports. These are devices implanted beneath a patient's skin that allow medical providers to inject fluids directly into the veins. Power injection involves high-pressure, high-flow-rate delivery of contrast agents during CT imaging. Following a 2005 FDA warning about port failures during power injection, Bard developed ports with radiographic markers (the letters "CT" etched in titanium foil) that would appear on x-ray scout scans, allowing clinicians to confirm the port was rated for power injection before use. Representative claim 1 of US8475417 recites an assembly with "a first identifiable feature ... identifying the access port as suitable for flowing fluid at a [high] fluid flow rate" and "a second identifiable feature ... identifying the access port as suitable for accommodating a [high] pressure" where "one of the first and second features is a radiographic marker perceivable via x-ray." Dependent claim 5 further requires that "the radiographic marker is one or more radiographic letters."

The printed matter doctrine has become one of patent law's more complex areas, operating at the intersection of subject matter eligibility under Section 101 and the novelty and nonobviousness inquiries under Sections 102 and 103. The doctrine's core principle is that claim limitations directed to the content of information are not entitled to patentable weight unless that information has a "functional relationship" to its substrate. As the Federal Circuit explained in In re Gulack, 703 F.2d 1381 (Fed. Cir. 1983), the question is "whether there exists any new and unobvious functional relationship between the printed matter and the substrate." In Gulack, the court found such a relationship where digits printed on an endless wristband embodied a mathematical sequence; the physical structure of the band placed the numbers in specific spatial relationships that satisfied the claimed algorithm. But where information merely labels or describes the substrate without altering how the substrate functions, it receives no patentable weight.


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Lynk Labs: How the Least-Vetted Documents Destroy Issued Patents https://patentlyo.com/patent/2025/12/documents-destroy-patents.html https://patentlyo.com/patent/2025/12/documents-destroy-patents.html#comments Mon, 15 Dec 2025 16:32:53 +0000 https://patentlyo.com/?p=47421 Supreme Court considers whether abandoned, unexamined patent applications can be backdated as "printed publications" to invalidate issued patents in IPR.

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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.


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Grounds for Reversal: Federal Circuit Finds KAHWA Registrable for Coffee Shops https://patentlyo.com/patent/2025/12/grounds-reversal-registrable.html https://patentlyo.com/patent/2025/12/grounds-reversal-registrable.html#respond Wed, 10 Dec 2025 20:53:11 +0000 https://patentlyo.com/?p=47404 The KAHWA decision explores limits of the foreign equivalents doctrine and evidentiary standards for genericness in trademark registration.

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by Dennis Crouch

Note, I've updated this post.  I had previously stated that Kahwa meant Coffee in Arabic, but that conclusion is not of record in the appeal.  And, the English-Arabic transliteration is typically Qahwa rather than Kahwa. 

In November 2025, I wrote about the still-pending cert petition in the trademark case of Vetements Grp. AG v. Stewart.  That case focuses on the doctrine of foreign equivalents and argues that the Federal Circuit applies its translation-based framework too rigidly and in tension with the Lanham Act's consumer-perception principles.  This week though the court released a new decision that complicates the narrative somewhat by reversing a TTAB refusal to register KAHWA for café and coffee shop services, holding that the doctrine of foreign equivalents did not apply because the term has a well-established alternative English meaning. In re Bayou Grande Coffee Roasting Co., No. 2024-1118 (Fed. Cir. Dec. 9, 2025).  The decision also imposed rigorous evidentiary requirements for genericness and descriptiveness findings, demanding actual marketplace evidence rather than speculation about what cafés might theoretically sell.

Bayou Grande has operated coffee shops in the Tampa Bay area under the KAHWA name since 2008. But, when the company sought federal registration of its name, the examining attorney refused under the doctrine of foreign equivalents, asserting that KAHWA means "coffee" (قهوة) in Arabic. The examiner also added alternative "grounds" based on KAHWA's meaning as a type of Kashmiri green tea. After Bayou Grande appealed, the Board declined to address the Arabic translation issue entirely, instead affirming the refusal based solely on the tea meaning. The Board reasoned that because KAHWA refers to a type of green tea, and because cafés serve tea, the mark was generic or merely descriptive of café services.

On appeal, the Federal Circuit disagreed on every point, finding the Board's genericness and descriptiveness determinations unsupported by substantial evidence and holding that the doctrine of foreign equivalents cannot apply when a foreign term has an established alternative English meaning.


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Label-Plus Liability: The Government Warns the Federal Circuit Misread Hatch-Waxman https://patentlyo.com/patent/2025/12/liability-government-federal.html https://patentlyo.com/patent/2025/12/liability-government-federal.html#comments Wed, 10 Dec 2025 17:27:10 +0000 https://patentlyo.com/?p=47398 Trump DOJ urges Supreme Court review of Hikma v. Amarin, arguing the Federal Circuit’s inducement ruling threatens Congress’s skinny-label framework.

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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.

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.


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The Unreviewable Director: How § 314(d) Shields the USPTO’s IPR Denial Regime from Judicial Oversight https://patentlyo.com/patent/2025/12/unreviewable-director-oversight.html https://patentlyo.com/patent/2025/12/unreviewable-director-oversight.html#comments Wed, 10 Dec 2025 04:23:21 +0000 https://patentlyo.com/?p=47400 Director Squires' near-zero institution rate stands unreviewable as Federal Circuit closes courthouse doors to IPR petitioners in four new rulings

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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.


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