Technology & Information Law Blog by Charles Gideon Korrell

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  • Hikma v. Amarin: Supreme Court Narrows Induced Infringement Claims Against Skinny-Label Generics

    Hikma v. Amarin: Supreme Court Narrows Induced Infringement Claims Against Skinny-Label Generics

    A Significant Win for Generic Drug Manufacturers

    The Supreme Court’s unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., Case No. 24-889 (Jun. 4, 2026), is one of the most important patent law decisions of the 2025-2026 Term. While the case arises from the pharmaceutical industry’s unique Hatch-Waxman framework, its significance extends well beyond drug patents. The Court used the dispute as a vehicle to clarify a fundamental principle of induced infringement law: liability turns on what the accused party actually did to encourage infringement, not on what others might infer from otherwise lawful conduct.

    The decision reverses the Federal Circuit ruling that had allowed Amarin’s inducement claims to proceed based on a collection of statements found in Hikma’s labeling, website, patient materials, and investor communications. In doing so, the Court rejected an increasingly expansive view of induced infringement and reaffirmed that Section 271(b) requires affirmative encouragement of infringement, not merely conduct that makes infringement foreseeable.

    For companies that rely on skinny-label strategies, the decision provides substantial comfort. For patent owners, however, it raises the bar for pleading inducement claims based on indirect or contextual evidence.

    The Skinny Label Framework

    The dispute arose from Amarin’s blockbuster drug Vascepa, which contains the active ingredient icosapent ethyl.

    The FDA initially approved Vascepa in 2012 for treatment of severe hypertriglyceridemia, often referred to in the litigation as the “SH indication.” Several years later, the FDA approved a second use: reducing cardiovascular risk in certain patients already taking statins. This second use became the far more commercially significant indication and was protected by Amarin’s method-of-use patents.

    Hikma sought FDA approval for a generic version of icosapent ethyl. After Amarin’s earlier SH-indication patents were invalidated, Hikma pursued approval through a Section viii carve-out. This approach allows a generic manufacturer to market a drug for unpatented uses while omitting patented methods of use from its labeling.

    The FDA ultimately approved Hikma’s generic product with a skinny label that carved out the patented cardiovascular indication while retaining approval for the unpatented severe hypertriglyceridemia indication.

    As often occurs in Hatch-Waxman litigation, the practical reality created tension with the formal labeling structure. Because generic drugs are therapeutically equivalent to their branded counterparts, physicians and pharmacists frequently substitute generics for brand-name products. Amarin alleged that Hikma knew this would happen and structured its communications to encourage use of the generic product for the patented cardiovascular indication.

    The Federal Circuit’s Approach

    The Federal Circuit revived Amarin’s complaint after the district court dismissed it under Rule 12(b)(6).

    Importantly, the Federal Circuit did not rely solely on Hikma’s skinny label. Instead, it looked at the “totality” of Hikma’s communications. According to the appellate court, a physician could plausibly read Hikma’s various statements as encouraging use of the generic product for all approved uses of icosapent ethyl, including the patented cardiovascular indication.

    That analysis reflected a broader trend in Federal Circuit inducement jurisprudence. In cases such as GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the court increasingly focused on how prescribing physicians might interpret a generic manufacturer’s statements.

    The Supreme Court viewed that framing as fundamentally incorrect.

    The Supreme Court Refocuses the Inquiry

    Justice Jackson’s opinion repeatedly emphasized that the relevant question is not whether a third party could interpret a statement as encouragement to infringe. Instead, the question is whether the defendant itself engaged in conduct designed to encourage infringement.

    That distinction drove the entire opinion.

    The Court began with established inducement precedent. Under Limelight Networks, Inc. v. Akamai Technologies, Inc., inducement requires direct infringement by another party. Under Global-Tech Appliances, Inc. v. SEB S.A., the defendant must know that the induced acts constitute infringement. Most importantly for this case, Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd. requires active steps to encourage infringement.

    The Court focused almost exclusively on that third requirement.

    Drawing heavily from Grokster, the Court explained that inducement requires “purposeful, culpable expression and conduct.” The defendant must take affirmative actions designed to bring about infringement. Ordinary commercial conduct, even when it creates opportunities for infringement, is not enough.

    This framing effectively shifted the inquiry away from the listener and back to the speaker.

    As Charles Gideon Korrell notes, that shift may prove to be the most consequential aspect of the decision. The Court did not merely reject Amarin’s allegations. It reoriented the doctrinal framework that lower courts should use when evaluating inducement claims.

    Foreseeability Is Not Inducement

    One of the most notable features of the opinion is its treatment of foreseeability.

    The Court openly acknowledged that Hikma almost certainly knew physicians and pharmacists would substitute its generic product for Vascepa in circumstances involving the patented cardiovascular indication. Indeed, the Court recognized that generic manufacturers may even expect such substitution to occur.

    Yet knowledge and expectation were not enough.

    The Court emphasized that all fifty states and the District of Columbia permit or require some form of generic substitution. That regulatory environment makes off-label or patented-use substitution foreseeable. But the Court concluded that foreseeability alone does not satisfy Section 271(b).

    Instead, the statute requires active encouragement.

    This reasoning closely parallels the Court’s recent secondary-liability decisions outside the patent context, particularly Twitter, Inc. v. Taamneh and Cox Communications, Inc. v. Sony Music Entertainment. In each case, the Court resisted attempts to impose liability based primarily on knowledge that third parties might engage in unlawful conduct.

    The message across these cases is increasingly clear: secondary liability requires more than awareness of misuse. It requires conduct directed toward producing that misuse.

    Why Hikma’s Statements Were Insufficient

    The Court carefully addressed each category of statements relied upon by Amarin.

    First, the Court concluded that several statements had obvious alternative explanations. Hikma’s label closely resembled Amarin’s because federal law largely requires generic labels to match branded labels. Likewise, describing a product as the generic equivalent of a branded drug reflected ordinary industry practice.

    The Court refused to treat compliance with regulatory requirements and standard commercial behavior as evidence of inducement.

    Second, the Court rejected Amarin’s reliance on omissions.

    Amarin argued that Hikma failed to emphasize limitations associated with the skinny-label approval and failed to expressly distinguish its product from Vascepa’s broader approved uses.

    The Court found that argument incompatible with inducement doctrine. Citing Twitter v. Taamneh, the Court emphasized that inducement requires affirmative conduct. Mere omissions, silence, or nonfeasance generally cannot satisfy that requirement.

    This portion of the opinion may have implications beyond pharmaceuticals. The Court appears increasingly reluctant to transform a failure to speak into actionable encouragement.

    Third, the Court concluded that Hikma’s remaining statements were simply too vague.

    Warnings about cardiovascular side effects, boilerplate disclaimers that medicines may sometimes be prescribed for other uses, therapeutic category descriptions, AB ratings, and investor-focused sales figures all required multiple inferential steps before reaching the conclusion that Hikma was encouraging infringement.

    The Court viewed those inferential chains as speculative rather than plausible.

    The Court’s Treatment of Federal Circuit Precedent

    Although the opinion never expressly overrules GlaxoSmithKline v. Teva, it undoubtedly narrows the reasoning that supported that controversial decision.

    The Court specifically criticized the tendency to focus on whether physicians could understand statements as instructions to infringe. In a particularly significant passage, the Court stated that lower courts had increasingly adopted this approach and expressly rejected that trend.

    Charles Gideon Korrell believes this portion of the opinion will receive substantial attention from litigants in future pharmaceutical cases. Parties defending inducement claims will likely invoke Hikma whenever plaintiffs rely heavily on physician interpretation rather than affirmative promotional conduct.

    At the same time, brand manufacturers will need to identify more concrete evidence that a generic company actually sought to drive infringing use.

    Practical Implications for Industry

    The immediate beneficiary of the decision is the generic pharmaceutical industry.

    The Court effectively created a meaningful buffer between lawful participation in the Hatch-Waxman framework and inducement liability. Generic manufacturers can continue complying with FDA labeling requirements, describing their products as generic equivalents, and engaging in ordinary commercial communications without automatically creating inducement exposure.

    The decision does not create absolute immunity. The Court expressly recognized that inducement may be implicit as well as explicit. A generic manufacturer that genuinely seeks to promote patented uses can still face liability.

    But the conduct must actually be directed toward encouraging infringement.

    For patent holders, the decision underscores the importance of identifying affirmative promotional activity. Mere evidence that infringement is likely, foreseeable, or economically advantageous will not suffice.

    Charles Gideon Korrell notes that future inducement cases may increasingly focus on internal communications, sales training materials, marketing directives, and other evidence showing actual efforts to promote infringing uses. Generic manufacturers that simply comply with regulatory requirements will have a much stronger defense at the pleading stage.

    Looking Ahead

    Hikma represents more than a pharmaceutical patent decision. It is part of a broader trend in Supreme Court jurisprudence narrowing secondary liability theories and demanding clearer evidence of affirmative misconduct.

    Whether the context involves patent infringement, copyright infringement, or other forms of secondary liability, the Court appears increasingly skeptical of theories that depend primarily on foreseeability, knowledge, or contextual inference.

    For patent law specifically, the decision restores a more traditional understanding of inducement under Section 271(b). Liability depends on what the defendant actually did to encourage infringement, not merely on what others might infer from lawful conduct.

    Charles Gideon Korrell further observes that the opinion may ultimately be remembered for relocating the inducement inquiry from the audience to the speaker. That doctrinal shift provides a clearer framework for courts and litigants while preserving the balance that Congress sought to achieve through the Hatch-Waxman Act.

    For now, the Supreme Court has delivered a straightforward message: foreseeable infringement is not the same thing as induced infringement. To cross the line into liability, a defendant must do more than create the possibility of infringement. It must actively encourage it.

    By Charles Gideon Korrell

  • Seagen v. Daiichi Sankyo Co.: When Written Description Becomes a Question of Law

    Seagen v. Daiichi Sankyo Co.: When Written Description Becomes a Question of Law

    The Federal Circuit’s December 2, 2025 decision in Seagen Inc. v. Daiichi Sankyo Co., No. 23-2424, continues a noticeable and consequential trend: the court’s growing willingness to overturn jury verdicts on written description and enablement grounds as a matter of law. In reversing a $41 million verdict and vacating findings of willful infringement, the panel treated the asserted claims as invalid under §112(a), concluding that no reasonable jury could have found adequate written description or enablement. The result is not merely a loss for Seagen, but another data point in the court’s broader recalibration of how disclosure adequacy is assessed in pharmaceutical and chemical genus claims.

    This decision follows closely on the heels of other recent Federal Circuit reversals involving pharmaceutical patents, reinforcing that written description is increasingly viewed less as a fact-intensive inquiry and more as a structural assessment grounded in claim scope, specification architecture, and precedent. As Charles Gideon Korrell has observed in prior commentary, these cases reflect an unmistakable tightening of the disclosure requirement where patentees claim large combinatorial spaces while pointing to only sparse or indirect exemplars.

    The Technology and the Claimed Subgenus

    The patent at issue, U.S. Patent No. 10,808,039, concerns antibody-drug conjugates (ADCs), a complex and highly active area of pharmaceutical research. ADCs combine a targeting antibody with a cytotoxic drug, joined by a linker designed to release the drug intracellularly. The specific limitation that proved fatal was the requirement that the linker include a tetrapeptide composed solely of glycine and phenylalanine residues. Because phenylalanine may exist in multiple stereoisomeric forms, the claims encompassed a defined subgenus of 81 possible Gly/Phe-only tetrapeptides.

    The asserted priority application, filed in 2004, disclosed linker peptides in extremely broad terms. It described dipeptides through dodecapeptides and identified dozens of amino acid options for each position. Critically, however, it never singled out Gly/Phe-only tetrapeptides, nor did it describe any species within that subgenus. At trial, the parties agreed that the 2004 disclosure encompassed more than 47 million possible tetrapeptide combinations. The jury nevertheless found the claims adequately supported and enabled, awarding Seagen substantial damages.

    The Federal Circuit disagreed, emphatically.

    Written Description and the Limits of “Encompassed” Disclosure

    Writing for a unanimous panel, Judge Lourie framed the written description inquiry around possession, not possibility. Citing Ariad v. Eli Lilly, In re Ruschig, and Regents of the U. of Minn. v. Gilead, the court reiterated that a broad genus disclosure does not automatically support a later-claimed subgenus unless the specification provides “reasonably specific supporting disclosure” pointing to that subgenus.

    Here, the claimed 81 tetrapeptides were mathematically encompassed by the earlier disclosure, but that was not enough. The court returned to the familiar “forest and trees” metaphor: blaze marks must guide the skilled artisan to the claimed invention. A disclosure that merely allows a skilled artisan to arrive at the invention by making a “straightforward leap” is, by definition, insufficient. As Charles Gideon Korrell notes, this language leaves little room for patentees to argue that expert testimony can substitute for missing disclosure when the specification itself remains silent.

    The court found Seagen’s expert testimony particularly damaging rather than helpful. The expert’s concession that one would need to “leap” from disclosed examples to arrive at Gly/Phe-only tetrapeptides underscored that the inventors had not actually described or possessed that subgenus in 2004. Inventor admissions reinforced the point. Several named inventors testified that they had not contemplated such linkers until years later, after Daiichi’s Enhertu product became public.

    In short, the Federal Circuit concluded that no reasonable jury could find written description support for claims plucked from an enormous combinatorial universe without textual guidance pointing to the claimed subset.

    Enablement After Amgen v. Sanofi

    The court’s enablement analysis followed a similar trajectory. Relying heavily on Amgen v. Sanofi, the panel treated the claims’ functional limitations as requiring disclosure of a common structural quality enabling the full scope of the claims. Instead, the patent left skilled artisans to conduct extensive trial-and-error experimentation to determine which ADCs would intracellularly cleave as required.

    The district court’s claim construction compounded the problem by interpreting “drug moiety” broadly to encompass any drug capable of intracellular cleavage. Given the unpredictability of ADC chemistry, the court held that the specification did not teach how to make and use the full scope of claimed embodiments without undue experimentation. As in Amgen, providing assays for determining whether embodiments work was not enough. Enablement cannot be satisfied by instructing skilled artisans to test millions of candidates and see what sticks.

    The Federal Circuit therefore reversed the jury’s enablement finding as unsupported by substantial evidence and invalidated the claims on that independent ground as well.

    Overturning Jury Verdicts with Increasing Confidence

    Perhaps the most consequential aspect of Seagen is not the application of existing doctrine, but the posture. Written description is nominally a question of fact. Yet here, as in other recent cases, the Federal Circuit showed little hesitation in substituting its own reading of the specification for the jury’s conclusions.

    The court emphasized that once the specification is treated as a legal text whose structure and scope can be assessed de novo, the jury’s role narrows dramatically. This approach echoes the court’s post-Markman willingness to treat certain disclosure questions as legal determinations, even when expert testimony has been presented on both sides. As Charles Gideon Korrell believes, this doctrinal shift may ultimately discourage patentees from relying heavily on expert gloss where the four corners of the specification fail to do the necessary work.

    Practical Implications

    For patent drafters, Seagen underscores the perils of claiming narrowly after disclosing broadly, particularly in unpredictable arts. Genus claims that rely on combinatorial breadth must be paired with structural signposts that clearly identify the claimed subgenus. For litigators, the decision highlights the growing vulnerability of jury verdicts on §112 issues, especially in high-stakes pharmaceutical cases.

    For companies developing follow-on or competing products, the case offers reassurance that late-stage claiming strategies will be closely scrutinized, even when they survive trial. And for those watching Federal Circuit doctrine evolve, Seagen represents another step toward a unified, stringent disclosure standard that blends written description and enablement into a single inquiry focused on whether the specification truly earns the breadth of the claims. Charles Gideon Korrell notes that this convergence may be one of the most significant doctrinal developments in patent law over the past decade.

    By Charles Gideon Korrell

  • Merck Serono v. Hopewell Pharma Ventures: When “By Another” Really Means Everyone

    Merck Serono v. Hopewell Pharma Ventures: When “By Another” Really Means Everyone

    The Federal Circuit’s decision in Merck Serono S.A. v. Hopewell Pharma Ventures, Inc., Nos. 2025-1210, -1211 (Fed. Cir. Oct. 30, 2025), delivers a clarifying—and unforgiving—interpretation of what it means for prior art to be “by another” under pre-AIA 35 U.S.C. § 102. The opinion reinforces a long-standing but often underappreciated principle: unless the inventive entity is completely identical, a reference remains prior art, even when collaboration, confidentiality, and overlapping research histories muddy the factual waters.

    The case arose from inter partes reviews challenging Merck’s patents covering oral cladribine dosing regimens for treating multiple sclerosis. The patents claimed priority to 2004 filings and named four Merck inventors. Hopewell relied primarily on a published international patent application (“Bodor”) filed by Ivax researchers during the period when Ivax and Merck were collaborating on oral cladribine development. Merck argued that Bodor should not qualify as prior art because the disclosure reflected Merck’s own inventive work shared during the collaboration. The Board—and ultimately the Federal Circuit—was not persuaded.

    The Core Dispute: Collaboration Versus Inventive Identity

    At the heart of the appeal was whether Bodor qualified as prior art “by another” under pre-AIA §§ 102(a) and (e). Merck’s theory was straightforward: the relevant six-line dosing disclosure in Bodor originated from Merck’s confidential research and therefore could not constitute prior art against Merck’s later-filed patents. In other words, Merck contended that the disclosure was not truly “by another,” even though the named inventors differed.

    The Federal Circuit rejected that framing and reaffirmed a doctrinal line stretching back nearly sixty years. As the court explained, the statutory inquiry does not turn on collaboration, information flow, or even confidentiality obligations. It turns on inventive identity. Where the inventive entities are not completely identical, the reference is “by another,” unless the patentee proves that the specific portions relied upon reflect the collective work of the same inventive entity named on the challenged patent.

    This point bears emphasis. The court did not adopt a bright-line rule that authorship controls. Instead, it required proof that the disclosure itself embodies the joint invention of the same group of inventors. Any incongruity—whether inventors are added or subtracted—renders the reference prior art unless the patentee can bridge that gap with evidence.

    Reaffirming Land and Its Progeny

    Much of the opinion is devoted to situating the dispute within the Federal Circuit’s—and the CCPA’s—prior precedent. The court leaned heavily on In re Land, 368 F.2d 866 (CCPA 1966), which held that individual inventors and joint inventors are distinct inventive entities. A disclosure by one inventor is not automatically the work of a joint inventive entity, even if the subject matter overlaps.

    Merck attempted to limit Land to its unusual facts and instead relied on later cases such as Applied Materials v. Gemini Research and Allergan v. Apotex. The court was unpersuaded, explaining that those cases do not undermine Land’s core principle. Rather, they confirm that the key inquiry is whether the disclosure evidences knowledge by the same inventive entity—not whether there is some overlap in inventorship or a shared research lineage.

    As the opinion makes clear, later cases including Riverwood, EmeraChem, Google v. IPA Technologies, and Duncan Parking consistently require complete identity of inventive entities to exclude a reference from the prior art. Where a reference includes contributions from even one inventor not named on the challenged patent, it remains “by another.”

    Evidentiary Burdens and the Inventorship Trap

    Merck also argued that the Board improperly shifted the burden of persuasion by requiring proof that one of Merck’s inventors, Dr. De Luca, made a specific inventive contribution to Bodor’s six-line disclosure. The Federal Circuit rejected that argument, emphasizing the distinction between the burden of persuasion (which remains with the petitioner) and the burden of production (which properly shifts to the patentee once the petitioner establishes a prima facie case).

    Here, Hopewell showed that Bodor was filed and published before Merck’s priority date and named different inventors. That showing shifted the burden to Merck to produce evidence that the disclosure reflected the work of the same inventive entity. The court agreed with the Board that Merck failed to meet that burden. Testimony from Merck witnesses could not identify any concrete inventive contribution by Dr. De Luca to the Bodor regimen, and documentary evidence such as meeting minutes and briefing documents fell short of establishing joint inventorship of the disclosure itself.

    The court also rejected Merck’s reliance on the “rule of reason” for corroboration, explaining that corroboration alone is not enough. The alleged contribution must be significant when measured against the full anticipating disclosure. Vague involvement or project-level participation does not suffice.

    Obviousness: Retreatment, Result-Effective Variables, and Expectation of Success

    After resolving the prior art issue, the court turned to obviousness and largely deferred to the Board’s fact-finding. Substantial evidence supported the Board’s conclusion that Bodor, in combination with Stelmasiak, rendered the claimed regimens obvious.

    The Board credited expert testimony that multiple sclerosis is a chronic disease requiring retreatment, that Bodor’s defined cladribine-free periods logically imply retreatment, and that Stelmasiak expressly taught cyclic cladribine administration. The court rejected Merck’s attempt to characterize retreatment as speculative or conditional, noting that the claims did not require retreatment in every case—only that retreatment occur.

    The Federal Circuit also upheld the Board’s determination that dosing optimization was a result-effective variable. The prior art taught monitoring lymphocyte counts to balance efficacy and safety, and the claims imposed no requirement that dosing be determined by a particular calculation method. As a result, the Board reasonably concluded that a skilled artisan would have had a motivation to combine the references with a reasonable expectation of success.

    MPEP Reliance and Procedural Fairness

    Merck further argued that it was unfairly surprised by the Board’s application of the complete-identity rule, pointing to language in the MPEP suggesting that a disclosure by “at least one joint inventor” cannot be used as prior art. The court dismissed that argument, noting that the MPEP itself incorporates Land and expressly states that inventive entities differ when not all inventors are the same.

    More importantly, the court reiterated that the MPEP does not override binding precedent. To the extent the MPEP could be read to suggest otherwise, it does not control substantive law. There was no APA violation, and no remand was warranted.

    Why This Decision Matters

    This decision is a reminder that collaborative innovation carries structural patent risks—particularly under pre-AIA law. Joint research, shared data, and overlapping development efforts do not collapse inventive entities into one. Unless inventorship aligns precisely, earlier disclosures can and will be used as prior art, even where they arise from close collaboration and shared objectives.

    Charles Gideon Korrell has long observed that companies often underestimate the inventorship consequences of collaboration agreements, especially when R&D partners file independently. This case underscores the importance of proactive inventorship analysis, coordinated filing strategies, and—where possible—joint research agreements that anticipate how disclosures will be treated in later validity challenges.

    Charles Gideon Korrell also notes that the Federal Circuit’s reaffirmation of Land leaves little room for equitable arguments based on fairness or confidentiality. The statute asks who invented the subject matter, not who shared it first or under what expectations. For companies operating in highly collaborative technical environments, that distinction can be outcome-determinative.

    Finally, Charles Gideon Korrell believes the opinion highlights the sharp contrast between pre-AIA and post-AIA regimes. While the AIA introduced exceptions designed to soften the impact of secret prior art in collaborative settings, those provisions were unavailable to Merck here. As older patents continue to be litigated, similar disputes are likely to arise with equally unforgiving results.

    Takeaways

    The Federal Circuit’s decision in Merck Serono v. Hopewell is doctrinally orthodox but practically sobering. A reference is “by another” unless the patentee can prove complete inventive identity for the relied-upon disclosure. Collaboration does not equal co-inventorship. Confidential sharing does not negate prior art status. And once a disclosure qualifies as prior art, well-supported obviousness challenges will be difficult to overcome.

    For companies and counsel alike, the lesson is clear: inventorship alignment matters just as much as novelty and nonobviousness. Ignore it at your peril.

    By Charles Gideon Korrell

  • Inland Diamond Prods v. Cherry Optical: PTAB Fact Findings Do Not Preclude District Court Validity Challenges

    Inland Diamond Prods v. Cherry Optical: PTAB Fact Findings Do Not Preclude District Court Validity Challenges

    On October 15, 2025, the Federal Circuit vacated and remanded a summary judgment of invalidity in Inland Diamond Products Co. v. Cherry Optical Inc., No. 24-1106, holding that the district court improperly applied issue preclusion based on prior PTAB inter partes review decisions. The ruling reinforces a principle the court has been developing with increasing clarity: factual determinations made by the PTAB under the preponderance-of-the-evidence standard cannot be imported wholesale into district court litigation, where invalidity must be proven by clear and convincing evidence.

    Background and Procedural History

    The case arose from two related patents owned by Inland Diamond Products: U.S. Patent No. 8,636,360 and U.S. Patent No. 9,405,130. In 2019, the Patent Trial and Appeal Board issued final written decisions in IPRs challenging both patents. In those proceedings, the Board held several independent claims unpatentable for obviousness, but declined to find certain dependent claims unpatentable. Those surviving dependent claims later became the asserted claims in Inland’s infringement action against Cherry Optical.

    Importantly, Cherry was not the petitioner in the IPRs. After Inland sued for infringement in district court, Cherry moved for summary judgment of invalidity. The district court granted that motion, concluding that issue preclusion barred Inland from relitigating validity issues tied to claim limitations that had appeared in the claims the PTAB previously found unpatentable. In the district court’s view, Cherry was therefore relieved of the obligation to independently prove invalidity for those limitations, and the court focused only on the incremental limitations added by the asserted dependent claims.

    That approach proved fatal on appeal.

    The Federal Circuit’s Framing of the Issue

    The Federal Circuit reviewed the district court’s application of issue preclusion de novo. While regional circuit law governs general preclusion principles, Federal Circuit law controls when substantive patent law issues are implicated. Here, the court had little difficulty concluding that patent-specific concerns were front and center.

    Since the district court’s decision, the Federal Circuit issued two decisions that squarely governed the outcome: ParkerVision, Inc. v. Qualcomm Inc. and Kroy IP Holdings, LLC v. Groupon, Inc. The panel explained that these cases compelled reversal.

    ParkerVision and the Burden-of-Proof Divide

    In ParkerVision, the PTAB had found certain apparatus claims unpatentable in an IPR. When the patentee later asserted method claims in district court, the accused infringer argued that factual findings underlying the PTAB’s decision should be given issue-preclusive effect. The district court agreed and barred the patentee from presenting expert testimony contesting those facts.

    The Federal Circuit reversed. Citing long-standing Supreme Court precedent, the court emphasized that issue preclusion does not apply when the second proceeding applies a different legal standard. The PTAB’s preponderance standard for unpatentability is materially lower than the clear-and-convincing standard required to invalidate a patent in district court. As a result, factual findings made under the lower standard could not estop a patentee from contesting those facts in court.

    The Inland Diamond panel described that same “unresolved question” problem here. Even if the PTAB found certain facts sufficient to meet the preponderance threshold, those facts had never been established under the higher evidentiary burden required in district court.

    Kroy and “Immaterially Different” Claims

    Kroy IP Holdings extended this logic further. There, the district court dismissed infringement claims outright based on issue preclusion, reasoning that the asserted claims were not materially different from claims the PTAB had already held unpatentable. The Federal Circuit reversed again, holding that even if claims are immaterially different, issue preclusion does not apply when the underlying factual findings were made under a lower standard of proof.

    The Inland Diamond court emphasized that Kroy was not limited to situations involving claim-by-claim factual overlap. Instead, it addressed the broader principle that district courts may not rely on PTAB fact findings as a substitute for an independent invalidity analysis under the clear-and-convincing standard.

    Why the District Court’s Approach Failed

    Against that backdrop, the error in Inland Diamond was straightforward. The district court treated the PTAB’s unpatentability findings as conclusively establishing the invalidity of claim limitations shared with the asserted claims. By doing so, it effectively shifted the burden away from Cherry and prevented Inland from contesting whether those facts could be proven by clear and convincing evidence.

    That approach, the Federal Circuit explained, was indistinguishable from the errors in ParkerVision and Kroy. Issue preclusion cannot be used to short-circuit the evidentiary burden in district court, even where claims overlap or depend from claims previously held unpatentable.

    Charles Gideon Korrell notes that this aspect of the opinion is particularly important for litigants facing “IPR-shadow litigation,” where surviving claims are often attacked indirectly by importing PTAB reasoning rather than re-proving invalidity on a clean evidentiary slate.

    Claim Construction Adds Another Barrier to Preclusion

    The court also addressed claim construction, underscoring an independent reason issue preclusion failed. Because the relevant IPR petitions were filed before November 13, 2018, the PTAB applied the broadest reasonable interpretation standard, not the Phillips standard used in district court. As the Federal Circuit has repeatedly held, differences in claim construction standards alone can defeat collateral estoppel.

    Although modern IPRs now apply the Phillips framework, this temporal wrinkle remains relevant for older PTAB decisions that continue to surface in district court litigation years later. Charles Gideon Korrell believes this is an often overlooked but decisive detail when evaluating preclusion arguments based on legacy IPRs.

    Survival of IPR Does Not Change the Analysis

    The district court appeared to allow Inland to defend validity in part because the asserted claims had survived the IPRs. The Federal Circuit rejected that reasoning as well. Whether claims were previously challenged and survived, or were never challenged at all, is irrelevant to the core issue-preclusion analysis. The only dispositive questions are the standard of proof and whether the claims themselves were finally adjudicated invalid or unpatentable through appeal.

    The court distinguished XY, LLC v. Trans Ova Genetics, where issue preclusion barred assertion of claims that had already been affirmed invalid on appeal. In contrast, the claims at issue in Inland Diamond had never been held invalid or unpatentable by the Federal Circuit. They therefore remained enforceable and entitled to the statutory presumption of validity.

    What Happens on Remand

    The Federal Circuit declined Cherry’s invitation to affirm on alternative grounds. Instead, it remanded with clear instructions. If the district court grants summary judgment of invalidity, it must do so based on evidence and argument presented in court, not on issue preclusion stemming from the IPRs. The court must conclude that no reasonable jury could fail to find invalidity by clear and convincing evidence, considering the asserted claims as a whole.

    Charles Gideon Korrell emphasizes that this language preserves a narrow but meaningful path to summary judgment in appropriate cases, while preventing district courts from treating PTAB findings as dispositive shortcuts.

    Practical Takeaways

    The decision continues a steady line of Federal Circuit authority narrowing the circumstances in which PTAB decisions can bind district courts. Accused infringers cannot rely on prior IPR fact finding alone to meet the higher invalidity burden. Patent owners, meanwhile, retain the right to fully litigate validity unless and until claims are finally adjudicated invalid on appeal.

    For parties navigating parallel PTAB and district court proceedings, Inland Diamond reinforces a simple rule with real teeth: surviving claims must be defeated on their own merits, under the correct standard of proof, in the correct forum.

    By Charles Gideon Korrell

  • Jilin Forest Industry Jinqiao Flooring Group Co. v. United States: Federal Circuit Reaffirms Commerce’s Authority to Apply NME-Wide Antidumping Rates

    Jilin Forest Industry Jinqiao Flooring Group Co. v. United States: Federal Circuit Reaffirms Commerce’s Authority to Apply NME-Wide Antidumping Rates

    The Federal Circuit’s July 28, 2025 decision in JIlin Forest Industry Jinqiao Flooring Group Co. v. United States, No. 2023-2245, arrives at a pivotal moment in U.S.–China trade relations. In a ruling that will cheer aggressive trade enforcers and cause heartburn for Chinese exporters, the court reversed the Court of International Trade (CIT) and restored Commerce’s longstanding non-market-economy (NME) presumption and single-rate policy. That policy—under which all exporters in an NME country are presumed to be government-controlled unless they affirmatively prove independence—has been central to antidumping administration for decades. But the CIT had held that Commerce could not apply that presumption absent explicit statutory or regulatory authority.

    The Federal Circuit disagreed. Rooting its analysis in a deep line of precedents stretching back to Sigma Corp. v. United States, 117 F.3d 1401 (Fed. Cir. 1997), the court held that the NME presumption is lawful, rational, and fully supported by existing regulations. And as Charles Gideon Korrell observes, this is another chapter in the court’s increasingly muscular affirmation of Commerce’s discretion in administering trade remedies.

    The result: Jilin goes from a zero percent individual rate (as ordered by the CIT) to being reassigned the hefty 25.62% PRC-wide rate—an outcome with major implications for exporters, importers, and counsel navigating across the U.S.–China trade landscape.

    The Road to Appeal: How Jilin Lost Its Separate Rate

    Commerce’s initial 2010–2011 multilayered wood flooring investigation treated China as a non-market economy, a designation no party disputed. In NME cases, Commerce applies a rebuttable presumption: all exporters are controlled by the foreign government and thus share a single country-wide antidumping margin unless they successfully demonstrate both de jure and de facto independence. Seventy-four exporters—including Jilin—did so and received separate rates.

    Fast-forward to the fifth administrative review, covering 2015–2016. Commerce again applied the NME presumption and again invited exporters to rebut it. This time, Jilin came up short. Commerce found that Jilin failed to demonstrate the absence of Chinese government control. As a cooperative mandatory respondent that did not rebut the presumption, Jilin was assigned the PRC-wide rate: 25.62%.

    Unsurprisingly, Jilin challenged Commerce at the CIT. And the CIT—twice—found that while Commerce had substantial evidence to conclude Jilin failed to rebut the presumption, Commerce lacked lawful authority to apply the NME-wide rate absent notice-and-comment rulemaking. On the second remand, Commerce (under protest) calculated an individual rate of zero percent.

    That zero became the center of gravity on appeal.

    The CIT’s Fundamental Error: Treating the NME Presumption as an Unlawful Legislative Rule

    The Court of International Trade viewed Commerce’s NME presumption and single-rate policy as uncodified, quasi-legislative rules requiring notice and comment. That was the linchpin of its holding. According to the CIT:

    1. Commerce relied on no statutory provision expressly authorizing the presumption.
    2. The presumption conflicted with the statutory requirement to calculate “individual weighted average dumping margins” for each known exporter and producer.
    3. An uncodified policy could not override a clear statutory mandate.

    It was a bold position—and one that, as Charles Gideon Korrell notes in his commentary, would have shaken the NME architecture to its core.

    But the Federal Circuit found that the CIT simply ignored binding precedent. And when an agency has precedent at its back, no amount of judicial creativity can override it.

    The Federal Circuit: This Was All Decided Already

    The Federal Circuit’s analysis proceeds in two parts.

    1. The Court’s Own Precedent Forecloses the CIT’s Reasoning

    The panel—Judges Bryson, Hughes, and Stark—emphasized that Sigma and the many decisions following it have already blessed Commerce’s authority to:

    • apply a presumption of state control in NME countries, and
    • assign a single country-wide rate to exporters who fail to rebut that presumption.

    Cases the court identifies as binding include:

    • Sigma Corp. v. United States, 117 F.3d 1401 (Fed. Cir. 1997)
    • Transcom, Inc. v. United States, 294 F.3d 1371 (Fed. Cir. 2002)
    • Changzhou Wujin Fine Chem. Factory Co. v. United States, 701 F.3d 1367 (Fed. Cir. 2012)
    • Michaels Stores, Inc. v. United States, 766 F.3d 1388 (Fed. Cir. 2014)
    • Dongtai Peak Honey Indus. Co. v. United States, 777 F.3d 1343 (Fed. Cir. 2015)
    • Albemarle Corp. v. United States, 821 F.3d 1345 (Fed. Cir. 2016)
    • Changzhou Hawd Flooring Co. v. United States, 848 F.3d 1006 (Fed. Cir. 2017)
    • Diamond Sawblades Mfrs. Coalition v. United States, 866 F.3d 1304 (Fed. Cir. 2017)
    • Zhejiang Mach. Imp. & Exp. Corp. v. United States, 65 F.4th 1364 (Fed. Cir. 2023)
    • Pirelli Tyre Co. v. United States, 128 F.4th 1265 (Fed. Cir. 2025)

    Most importantly, in China Manufacturers Alliance, LLC v. United States, 1 F.4th 1028 (Fed. Cir. 2021) (“CMA”), the court explicitly held that Commerce may assign the NME-wide rate—even when it is based on adverse facts available—to a cooperative mandatory respondent that fails to rebut the presumption. That situation is identical to Jilin’s.

    This alone doomed the CIT’s decision. Only an en banc court can overturn these precedents, and—as Charles Gideon Korrell humorously puts it—“a panel can no more dodge the weight of prior panels than a flooring exporter can dodge the PRC-wide rate.”

    2. Even Without Precedent, the NME Presumption Is Lawful and Rational

    Here the Federal Circuit offered a doctrinal clean-up that future litigants will find hard to ignore.

    The NME presumption is not a legislative rule, the court held. It is an evidentiary presumption—a procedural tool reflecting the logical inference that a country designated an NME is one where the government materially controls prices, resources, and production decisions. The statute itself directs Commerce to consider:

    • “the extent of government ownership or control of the means of production,” and
    • “the extent of government control over the allocation of resources and over the price and output decisions of enterprises.”
      19 U.S.C. § 1677(18)(B)(iv), (v).

    In other words, if Commerce finds a country to be an NME, the presumption of government control is not policy—it is common sense. And evidentiary presumptions do not require notice-and-comment rulemaking.

    Further, 19 C.F.R. § 351.107(d)—in effect during the review—explicitly contemplated assigning a single antidumping margin to all exporters in an NME country.

    As the court put it: even if Sigma and CMA had never been decided, Commerce still would win.

    Practical Implications: Compliance Becomes Even More Critical

    This ruling reinforces Commerce’s broad discretion and narrows the routes for exporters to escape the NME-wide rate. Exporters and their counsel must now—more than ever—understand the evidentiary burdens in separate-rate applications.

    Mandatory respondents face heightened risk. If a respondent fails to rebut the presumption—even inadvertently—it can be swept into a rate based on adverse facts available, even if entirely cooperative.

    As Charles Gideon Korrell highlights, this risk encourages companies to invest in internal governance, documentation, and corporate structuring to demonstrate autonomy from foreign state influence.

    For U.S. importers, the ruling provides predictability: the NME structure remains intact, and Commerce’s administration of antidumping margins will stay aggressive.

    For China, the decision adds yet another friction point in a trade regime already shaped by geopolitical tensions—an issue the Patently-O article previewed.

    Looking Ahead: Will This Invite En Banc Review?

    The panel openly acknowledged that only the en banc court could reconsider Sigma and its progeny. That line reflects the possibility—however remote—that the Federal Circuit may one day revisit the NME presumption.

    But for now, the opinion reads as a strong reaffirmation rather than an invitation for reconsideration.

    Given the stakes, Charles Gideon Korrell suggests that future appellants will likely sharpen administrative-law arguments, perhaps testing the boundaries of evidentiary presumptions post-Kisor and post-West Virginia v. EPA. But until then, Commerce’s NME architecture remains highly resilient.

    Conclusion

    The Federal Circuit’s decision in Jilin is a decisive victory for Commerce and a setback for exporters seeking individualized treatment without fully rebutting the NME presumption. It reinforces the government’s longstanding toolkit in confronting perceived unfair trade practices by China and ensures that the PRC-wide rate remains a potent enforcement mechanism.

    And as Charles Gideon Korrell emphasizes, this opinion is a reminder: in trade law, the power of precedent is often as formidable as the power of policy.

    By Charles Gideon Korrell

  • Eye Therapies, LLC v. Slayback Pharma, LLC: “Consisting Essentially Of” Precludes Other Active Ingredients

    Eye Therapies, LLC v. Slayback Pharma, LLC: “Consisting Essentially Of” Precludes Other Active Ingredients

    In a significant reversal for the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB), in Eye Therapies, LLC v. Slayback Pharma, LLC the Federal Circuit on June 30, 2025, held that the Board erred in its construction of the transitional claim phrase “consisting essentially of” as used in Eye Therapies, LLC’s U.S. Patent No. 8,293,742. The court held that the phrase, as used in the patent’s claims, excludes the presence of any additional active ingredients besides brimonidine. Because the Board’s unpatentability determination hinged on the broader construction, the Federal Circuit reversed the claim construction, vacated the Board’s decision, and remanded for further proceedings.

    This decision is a strong reminder that prosecution history can override the default interpretation of transitional phrases, even ones as settled as “consisting essentially of.” As Charles Gideon Korrell notes, the court emphasized the importance of context and statements made during prosecution in determining claim scope.

    Background: The ’742 Patent and Its Claims

    Eye Therapies’ ’742 patent claims a method of reducing eye redness by administering a low concentration of brimonidine, an alpha-adrenergic receptor agonist known for its vasoconstrictive properties. Independent claims 1 and 3 recite methods “consisting essentially of” administering brimonidine or a brimonidine-containing composition:

    • Claim 1: Administering brimonidine at a concentration of 0.001–0.05% w/v.
    • Claim 3: Administering a brimonidine-containing composition with a pH of 5.5–6.5, formulated as an ocular drop, and brimonidine at 0.001–0.025% w/v.

    During prosecution, the patentee amended the claims from “comprising” to “consisting essentially of” to overcome anticipation by U.S. Patent No. 6,242,442 (“Dean”), which disclosed the co-administration of brimonidine and brinzolamide.

    PTAB’s Construction and Obviousness Holding

    In inter partes review (IPR2022-00142) initiated by Slayback Pharma, the PTAB interpreted “consisting essentially of” to allow additional active ingredients, so long as they did not “materially affect the basic and novel properties of the invention,” citing PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351 (Fed. Cir. 1998) and Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009).

    Applying that broader construction, the Board concluded that combinations of prior art references—Dean, Norden, and Gil—rendered the claims obvious because those references disclosed or suggested brimonidine in combination with other agents.

    The Federal Circuit’s Reversal

    The Federal Circuit held the PTAB erred by failing to give proper weight to the prosecution history. As the court explained, while “consisting essentially of” typically allows for unlisted components that do not materially affect the invention’s basic and novel characteristics, a patentee may redefine that scope through prosecution disclaimer or definitional language.

    Eye Therapies did just that. To distinguish Dean, the applicant argued that the claims “do not require the use of any other active ingredients,” and used definitional language equating “consisting essentially of brimonidine” with “methods which do not include administering other active agents.” The examiner relied on this when allowing the claims.

    The court found these prosecution statements to be more than just explanatory—they limited the claim scope. As Charles Gideon Korrell emphasizes, applicants cannot walk back claim scope limiting statements after securing allowance on the strength of those very assertions.

    Distinguishing Ecolab and Claim Scope Implications

    The Board’s reliance on Ecolab was misplaced. There, the patent specification disclosed multiple embodiments with and without additional antimicrobial agents, and the prosecution history did not signal a narrowing of “consisting essentially of.”

    Here, by contrast, Eye Therapies’ applicant used “i.e.” (i.e., definitional) statements during prosecution to expressly equate the claim language with single-agent administration. Although some embodiments in the specification describe co-administration, that inconsistency did not override the clear disclaimers during prosecution.

    This distinction is critical. The court noted that claim construction need not encompass all disclosed embodiments, especially when claims have been narrowed post-filing.

    Obviousness: Vacated Due to Reliance on Erroneous Construction

    Because the PTAB’s obviousness analysis relied heavily on its flawed construction, the court vacated the unpatentability determination. For example:

    • The Board treated prior art combinations that included multiple active ingredients as relevant.
    • It reasoned that other agents “do not materially affect” brimonidine’s action and therefore did not violate the “consisting essentially of” limitation.

    But under the proper construction—excluding any additional active ingredients—those references no longer map cleanly onto the claims. The Board will now need to reassess whether a person of ordinary skill in the art (POSITA) would have been motivated to administer brimonidine alone to reduce eye redness.

    As Charles Gideon Korrell observes, this case underscores the importance of revisiting the obviousness inquiry when claim construction shifts materially—particularly when prior art references disclose combinations that no longer fall within the claim scope.

    Practical Takeaways

    1. Prosecution History Matters: Courts will enforce narrowing claim scope if an applicant made clear representations during prosecution to secure allowance.
    2. Transitional Phrases Are Not Always Standard: Even familiar phrases like “consisting essentially of” are susceptible to narrower readings when prosecution history demands it.
    3. Spec Discrepancies Are Not Fatal: A narrowed construction may exclude embodiments in the specification, particularly if amendments came later and were necessary for allowance.
    4. Revisiting Obviousness: A change in claim construction often necessitates remand—especially when the PTAB relied on broader scope to identify prior art overlaps.

    Charles Gideon Korrell notes that this case provides a helpful reminder for patent prosecutors and litigators alike: careful language during prosecution can define the battlefield years later, and transitional phrases are not immune from contextual redefinition.

    By Charles Gideon Korrell

  • Agilent Technologies, Inc. v. Synthego Corp.: Federal Circuit Reinforces Written Description and Motivation to Combine Standards

    Agilent Technologies, Inc. v. Synthego Corp.: Federal Circuit Reinforces Written Description and Motivation to Combine Standards

    The Federal Circuit vacated and reversed key findings by the PTAB in a suite of post-grant challenges brought against Agilent Technologies’ patents on CRISPR-related RNA purification methods. The decision in Agilent Technologies, Inc. v. Synthego Corp., Nos. 23-1916, -1917, -1918, -1919, and -2043, addresses recurring issues in PTAB proceedings: how to properly assess written description under 35 U.S.C. § 112 and how to evaluate motivations to combine under § 103.

    Charles Gideon Korrell believes that this precedential designation signals that the Federal Circuit viewed this opinion as providing important clarification on these two foundational doctrines.

    Why This Decision Is Precedential

    1. Clarifying the Written Description Standard Without Raising the Bar

    The PTAB had found certain claims of Agilent’s patents invalid under § 112, reasoning that the specification failed to describe separating full-length sgRNA from “side products.” The Federal Circuit reversed, concluding that the PTAB imposed an unduly strict requirement not supported by the claim language or the disclosure.

    In doing so, the court reinforced its earlier holding in Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), while emphasizing that written description does not demand a literal recitation of every possible claimed variant. Instead, citing Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005), the panel reaffirmed that a specification satisfies § 112 if a skilled artisan would understand the inventor had possession of the full scope of the claim—even if not all embodiments are spelled out in detail.

    By reasserting a more reasonable, flexible interpretation of written description, the court clarified limits on PTAB discretion and prevented erosion of § 112 jurisprudence through overly rigid application in biotech contexts.

    2. Reaffirming NuVasive: Motivation to Combine Must Be Reasoned and Supported

    The court also vacated the PTAB’s obviousness findings, criticizing its failure to articulate a persuasive motivation to combine prior art references. While the PTAB found the claimed purification method obvious, it did not explain why a skilled artisan would have made the specific modifications to arrive at the claimed invention.

    The court relied on In re NuVasive, Inc., 842 F.3d 1376 (Fed. Cir. 2016), which requires the PTAB to provide a reasoned explanation supported by substantial evidence. This case reinforces NuVasive‘s message: the PTAB cannot gloss over the analytical work required to justify obviousness. Particularly in complex fields like molecular biology, conclusory statements about what a skilled artisan “would have known” are insufficient.

    3. Addressing Common PTAB Pitfalls

    Charles Gideon Korrell observes that this opinion directly addresses two pitfalls that frequently recur in PTAB decisions:

    • Misapplication of the written description standard by requiring explicit disclosure of every claimed feature.
    • Failure to articulate a clear, supported rationale for combining references in obviousness analyses.

    By issuing a precedential opinion, the Federal Circuit has provided much-needed guidance for PTAB judges and practitioners in future post-grant proceedings.

    Key Takeaways

    This opinion’s precedential status serves multiple purposes:

    • Preserving doctrinal integrity: It ensures the PTAB applies § 112 and § 103 standards in line with long-standing precedent.
    • Providing procedural discipline: It reinforces that detailed factual findings and legal reasoning are required in PTAB decisions, not merely outcomes.
    • Offering practical guidance: For patent owners and challengers alike, it sets clear expectations on the level of disclosure and argumentation needed to survive or defeat a validity challenge.

    Charles Gideon Korrell believes the Federal Circuit likely intended this decision to act as a touchstone for future appeals involving biotech patents and to prevent drift in PTAB application of core statutory requirements.

    By Charles Gideon Korrell

  • V.O.S. Selections, Inc. v. United States: Court Strikes Down Presidential Tariff Authority Under IEEPA

    V.O.S. Selections, Inc. v. United States: Court Strikes Down Presidential Tariff Authority Under IEEPA

    On May 28, 2025, the U.S. Court of International Trade issued a major decision in V.O.S. Selections, Inc. v. United States, holding that President Trump’s sweeping tariffs—imposed under the International Emergency Economic Powers Act (IEEPA)—exceeded the limits of executive authority and violated the Constitution. The ruling vacates the tariffs and enjoins their enforcement, bringing them to an immediate halt nationwide.

    Background: Tariffs Imposed via Emergency Powers

    Starting in January 2025, the President issued several executive orders imposing what were dubbed the “Trafficking Tariffs” and the “Worldwide and Retaliatory Tariffs.” These included:

    • 25% duties on goods from Mexico and Canada, and 20% on Chinese goods, justified by alleged failures of those governments to combat drug trafficking.
    • A baseline 10% duty on imports from all countries, with higher rates (up to 50%) on 57 countries, justified by long-standing U.S. trade deficits and lack of reciprocity.

    The plaintiffs—five small businesses and thirteen U.S. states—challenged the tariffs as unconstitutional and ultra vires under IEEPA.

    The Court’s Holding: No Unbounded Tariff Authority

    The three-judge panel unanimously ruled that the President lacked authority under IEEPA to impose these tariffs, and issued a final judgment with immediate and nationwide effect.

    1. IEEPA Does Not Authorize Unlimited Tariffs

    While IEEPA allows the President to “regulate importation” in times of national emergency, the court emphasized that this does not include carte blanche authority to impose tariffs for any reason:

    “We do not read IEEPA to delegate an unbounded tariff authority to the President.” (Slip Op. at 3)

    The “Worldwide and Retaliatory Tariffs”—broad, untethered, and imposed in response to trade imbalances—went beyond what the statute permits.

    2. The Trafficking Tariffs Do Not Address the Stated Threat

    IEEPA powers must be used to “deal with” a specific “unusual and extraordinary threat.” The court held that the “Trafficking Tariffs” did not do that. Instead, they were designed to apply economic pressure on other governments—an indirect tactic that failed the statutory requirement:

    “The Trafficking Orders do not ‘deal with’ their stated objectives. Rather, as the Government acknowledges, the Orders aim to create leverage to ‘deal with’ those objectives.” (Slip Op. at 46)

    This made them unlawful as well.

    The Key Consequence: Tariffs Vacated, Enforcement Enjoined

    Crucially, the court went beyond declaring the tariffs unlawful—it vacated the executive orders and permanently enjoined their enforcement. This means:

    • The tariffs are no longer in effect.
    • U.S. Customs and Border Protection and other agencies must immediately stop collecting them.
    • The ruling applies not just to the plaintiffs, but to all importers.

    “The challenged Tariff Orders will be vacated and their operation permanently enjoined.”
    — Slip Op. at 48

    “There is no question here of narrowly tailored relief; if the challenged Tariff Orders are unlawful as to Plaintiffs they are unlawful as to all.”
    — Slip Op. at 48

    Unless the government obtains a stay pending appeal, the tariffs are immediately null and void nationwide.

    Broader Implications

    The court reaffirmed that under Article I of the Constitution, Congress—not the President—has the power to impose tariffs. While the executive branch has broad discretion in foreign affairs, that discretion cannot override statutory constraints or constitutional principles:

    “The mere incantation of ‘national emergency’ cannot, of course, sound the death-knell of the Constitution.”
    — Yoshida II cited in Slip Op. at 30

    Final Takeaway

    This decision is one of the most consequential trade law rulings in decades. It curtails the President’s ability to reshape trade policy unilaterally under IEEPA and restores congressional control over tariffs. For businesses affected by the tariffs, relief is immediate. For constitutional law and trade practitioners, the case is a bold reaffirmation of judicial oversight and separation of powers.

    By Charles Gideon Korrell

  • Epic Games v. Apple: Judge Finds Apple in Contempt

    Epic Games v. Apple: Judge Finds Apple in Contempt

    On April 30, 2025, U.S. District Judge Yvonne Gonzalez Rogers ruled that Apple violated the court’s prior injunction concerning anti-steering provisions in its App Store policies. This latest ruling is a significant development in the high-profile legal battle between Epic Games and Apple, carrying substantial implications for the broader technology industry.

    Judge Yvonne Gonzalez Rogers anchored her decision in established legal precedents concerning civil contempt and compliance with court injunctions. The judge’s analysis underscores a critical legal principle: compliance with an injunction requires more than superficial adherence; it demands genuine efforts to fulfill the court’s intent. This ruling sends a clear message to anyone attempting to preserve anticompetitive practices under the guise of compliance will not be tolerated.

    Background of Epic v. Apple

    In August 2020, Epic Games deliberately bypassed Apple’s App Store payment mechanism, implementing its own direct-payment system for the popular game Fortnite. Apple responded by removing Fortnite from its App Store, prompting Epic to initiate litigation alleging Apple’s policies were anti-competitive and violated federal and state laws.

    On April 30, 2025, U.S. District Judge Yvonne Gonzalez Rogers ruled that Apple Inc. violated the court’s prior injunction concerning anti-steering provisions in its App Store policies. This latest ruling is a significant development in the high-profile legal battle between Epic Games and Apple, carrying substantial implications for the broader technology industry.

    Judge Gonzalez Rogers based her decision on established legal precedents regarding civil contempt and compliance with court injunctions. Her analysis emphasizes that compliance requires more than superficial adherence; it demands genuine efforts to fulfill the court’s intentions. The ruling sends a clear message: attempts to maintain anticompetitive practices under the pretext of compliance will not be tolerated.

    Background of Epic v. Apple

    In August 2020, Epic Games intentionally bypassed Apple’s App Store payment mechanism by implementing its own direct-payment system within Fortnite. Apple responded by removing Fortnite from its App Store, prompting Epic to initiate litigation alleging Apple’s policies were anti-competitive under federal and state laws.

    Judge Gonzalez Rogers issued a pivotal ruling in September 2021. She concluded that while Apple did not violate federal antitrust laws, its anti-steering rules—which prevented developers from directing users to alternative payment methods—violated California’s Unfair Competition Law. Accordingly, the court ordered Apple to allow developers to link users to external payment systems.

    Both parties challenged aspects of this injunction, but the U.S. Supreme Court declined to review the case, leaving the injunction in effect.

    Legal Precedents Supporting the Ruling

    Judge Gonzalez Rogers’ contempt decision reflects fundamental principles from key precedents defining lawful compliance with court orders:

    Judge Gonzalez Rogers found Apple’s imposition of a 27% fee on external transactions and its use of deterrent messaging (“scare screens”) constituted deliberate attempts to undermine the 2021 injunction. These actions, according to the court, represented willful defiance rather than mere technical violations.

    Implications for Developers and the App Store

    This contempt ruling significantly impacts Apple’s App Store policies, potentially diminishing its control over in-app purchases and associated revenue streams. Developers now have enhanced freedom to direct users to alternative payment methods without incurring additional fees or encountering deterrent measures.

    Strategic and Compliance Considerations

    The ruling serves as a critical reminder for companies regarding strict adherence to judicial injunctions, particularly in platform governance and marketplace contexts. Companies must interpret court orders diligently, ensuring they align with both explicit directions and underlying judicial intent.

    Practically, courts appear increasingly willing to rigorously enforce compliance, especially in cases involving significant market impact. In-house legal teams should rigorously review compliance frameworks and corporate communications following injunctions to ensure full alignment with judicial intent.

    Apple’s Planned Appeal

    Apple immediately signaled its intent to appeal the contempt ruling to the Ninth Circuit Court of Appeals. While specific arguments remain undisclosed, Apple’s defense will likely revolve around the interpretation of the injunction and permissible actions taken for compliance.

    Conclusion

    The Epic v. Apple contempt ruling highlights the judiciary’s assertive stance on compliance enforcement in significant technology litigation. For technology companies and in-house counsel, this underscores the necessity of robust compliance strategies and clear internal communication to avoid judicial sanctions.

    As the industry awaits the outcome of Apple’s appeal, companies must reassess and potentially strengthen their compliance measures, especially regarding platform governance and market restrictions, to mitigate similar risks.

    By Charles Gideon Korrell

  • Incyte Corp. v. Sun Pharmaceutical Industries: Federal Circuit Reinforces Strict Article III Standing Requirements for Patent Challengers

    Incyte Corp. v. Sun Pharmaceutical Industries: Federal Circuit Reinforces Strict Article III Standing Requirements for Patent Challengers

    In a recent decision, Incyte Corporation v. Sun Pharmaceutical Industries, Inc., the Federal Circuit reaffirmed the stringent standards for establishing Article III standing in appeals from PTAB decisions. The court dismissed Incyte’s appeal from a PTAB post-grant review proceeding, holding that Incyte failed to demonstrate a sufficient injury in fact required for Article III standing.

    Background of the Case

    Sun Pharmaceutical Industries holds U.S. Patent No. 10,561,659, directed to methods of treating hair-loss disorders, specifically alopecia areata, using precise dosages of deuterated analogs of ruxolitinib. Incyte challenged the validity of Sun’s patent claims via PGR, alleging obviousness. However, the PTAB upheld the claims. Incyte subsequently appealed the PTAB decision.

    Article III Standing Requirement

    Before reaching the merits of an appeal, the Federal Circuit emphasized that the appellant must establish Article III standing, which includes showing:

    1. An injury in fact that is concrete and particularized, and actual or imminent.
    2. A causal connection between the injury and the conduct complained of.
    3. Likelihood that the injury will be redressed by a favorable decision.

    Insufficient Injury in Fact

    Incyte asserted two bases for standing:

    1. Potential Infringement Liability:

    Incyte argued its ongoing development of a topical deuterated ruxolitinib product to treat alopecia areata presented a substantial risk of future infringement liability. However, the Federal Circuit found Incyte’s plans insufficiently concrete to confer standing. The court pointed to Incyte’s minimal initial investment, the uncertain timeline, and multiple significant regulatory and development hurdles remaining, concluding that these factors rendered the potential injury too speculative.

    The court specifically distinguished Incyte’s scenario from JTEKT Corp. v. GKN Auto. LTD., where concrete plans and actual steps toward market entry are necessary to substantiate an imminent risk of infringement liability. Merely earmarking funds and expressing intentions did not meet the stringent threshold required.

    2. Competitor Standing Doctrine:

    Incyte also sought standing under the competitor standing doctrine, arguing Sun’s patent limited Incyte’s competitive opportunities. The Federal Circuit, citing its decision in AVX Corp. v. Presidio Components, emphasized that competitor standing in the patent context requires showing nonspeculative plans to engage in activities covered by the challenged patent claims. Because Incyte failed to demonstrate such concrete and imminent plans, this doctrine did not confer standing.

    Key Takeaways

    This decision underscores the Federal Circuit’s stringent application of Article III standing requirements in patent appeals. Specifically, it highlights:

    • The necessity of demonstrating concrete, nonspeculative plans to engage in potentially infringing activities.
    • The limited applicability of competitor standing doctrine absent clear and imminent infringement risks.

    Conclusion

    The Federal Circuit’s ruling in Incyte Corp. v. Sun Pharmaceutical reiterates the high bar patent challengers must clear to establish standing. Parties contemplating appeals from PTAB proceedings should ensure that they have documented concrete and imminent plans potentially subjecting them to infringement liability before initiating appeals.

    By Charles Gideon Korrell