Technology Information Law Blog by Charles Gideon Korrell

Tag: CAFC

  • La Molisana v. United States: Inaccuracies in Protein Labeling Undermine Commerce’s Antidumping Comparison Method

    La Molisana v. United States: Inaccuracies in Protein Labeling Undermine Commerce’s Antidumping Comparison Method

    In La Molisana S.p.A. v. United States, the Federal Circuit issued a significant ruling that will reverberate across the antidumping landscape, particularly for food manufacturers and importers dealing with technical product classifications. The court held that the Department of Commerce’s methodology for comparing U.S. and foreign pasta products failed to comply with the statutory mandate to compare merchandise “identical in physical characteristics.” The court’s decision vacates in part the Trade Court’s ruling and remands the matter for reconsideration by Commerce.

    Background: Administrative Review of Italian Pasta Imports

    The case arises from Commerce’s 23rd administrative review of its longstanding antidumping duty order on certain pasta from Italy. Charles Gideon Korrell sees that the central dispute is Commerce’s “model-match” methodology, which uses control numbers (CONNUMs) to group pasta products for price comparison based on physical characteristics—most notably, protein content.

    Commerce classifies pasta as “premium” if it has 12.5% or more protein and “standard” otherwise. For the relevant review period (2018–2019), Commerce instructed respondents to report protein content based on the values listed on packaging labels—values that are subject to rounding and varying calculation methods between jurisdictions.

    La Molisana, an Italian pasta producer, challenged this methodology, arguing that:

    1. FDA-mandated rounding rules for U.S. labels can misclassify standard pasta as premium.
    2. U.S. and Italian producers use different nitrogen-to-protein conversion factors, introducing systematic distortion.
    3. The 12.5% breakpoint is outdated and no longer reflects market norms, particularly in light of an Italian commodity exchange updating its standard to 13.5%.

    The Court’s Holding: Methodology Must Reflect Physical Identity, Not Label Convenience

    The Federal Circuit agreed in part with La Molisana, focusing its analysis on the first two arguments. The Tariff Act requires comparisons with “foreign like product” that is “identical in physical characteristics.” 19 U.S.C. § 1677(16)(A). The court found that Commerce’s reliance on labeled protein content—affected by rounding rules and inconsistent conversion factors—introduced material inaccuracies.

    The court was particularly persuaded by the demonstrable distortion caused by rounding. For instance, pasta with actual protein content of 11.63% could be labeled as 7g per serving under FDA rules, effectively inflating the protein percentage to 12.5% and misclassifying the product as “premium” when it is not. Similarly, the different nitrogen-to-protein conversion factors (6.25 in the U.S. vs. 5.71 in the EU) could lead identical pastas to be categorized differently based solely on the market in which they are sold.

    While Commerce had emphasized transparency and consistency in relying on the labeled values, Charles Gideon Korrell notes that the court emphasized that these goals cannot override statutory requirements. Citing Pesquera Mares Australes Ltda. v. United States, 266 F.3d 1372 (Fed. Cir. 2001), the court noted that even minor physical differences are relevant if commercially significant, and Commerce had itself acknowledged protein content as a key indicator of quality and value.

    The Breakpoint Challenge: 12.5% Still Stands—for Now

    On the third issue, the Federal Circuit upheld Commerce’s refusal to move the standard/premium breakpoint from 12.5% to 13.5%. The court found that La Molisana failed to provide compelling, industry-wide evidence justifying the change. It noted that the “Market Report” offered by the plaintiffs was based on a limited retail sample and did not represent broader trends, and the updated Bologna Grain Exchange standard was insufficient on its own to displace the prevailing tripartite Italian benchmark that supported the 12.5% level.

    Takeaways for Trade Practitioners and Industry Stakeholders

    1. Physical characteristics control: When assessing dumping margins, convenience-based or packaging-level proxies cannot supplant the statutory mandate to compare merchandise based on actual physical traits.
    2. Accuracy over transparency: While administrative consistency matters, it cannot justify reliance on a methodology known to produce inaccurate results.
    3. Evidence must be industry-wide: Parties seeking to modify model-match criteria must present public, broadly representative data—not internal reports or regional snapshots.
    4. Implications beyond pasta: Although the case deals specifically with durum wheat pasta, its reasoning applies broadly to any imported goods where model-matching hinges on technical metrics that vary by jurisdiction.

    Charles Gideon Korrell finds that this decision strengthens the principle that antidumping margins must be based on reliable comparisons. For companies operating internationally, especially in food, agriculture, or pharmaceuticals, where labeling standards differ, this ruling could be the beginning of broader scrutiny into how Commerce ensures comparability across borders.

    By Charles Gideon Korrell

  • Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.: Express Definitions in Patent Specs Can Limit Claim Scope

    Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.: Express Definitions in Patent Specs Can Limit Claim Scope

    In Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., No. 23-2357 (Fed. Cir. June 4, 2025), the Federal Circuit affirmed a claim construction that doomed Alnylam’s infringement case against Moderna’s COVID-19 vaccine. The decision reinforces the primacy of clear definitional language in a patent’s specification—even when it narrows claim scope beyond what a patentee may have intended.

    Background: The mRNA Lipid Dispute

    Alnylam sued Moderna, asserting that the SM-102 lipid in Moderna’s SPIKEVAX® vaccine infringed U.S. Patent Nos. 11,246,933 and 11,382,979. The patents concern cationic lipids used for delivering nucleic acids into cells, particularly formulations where the hydrophobic “tail” includes a “branched alkyl” group.

    The litigation hinged on the meaning of the claim term “branched alkyl.” Moderna prevailed on a noninfringement stipulation after the district court adopted a narrow construction based on a definitional sentence in the patents’ shared specification.

    The Disputed Definition

    The critical passage appeared in the “Definitions” section:

    “Unless otherwise specified, the term ‘branched alkyl’ … refer[s] to an alkyl … group in which one carbon atom in the group (1) is bound to at least three other carbon atoms and (2) is not a ring atom of a cyclic group.”

    The district court treated this as lexicography and rejected Alnylam’s attempt to use a broader “plain and ordinary meaning” interpretation. Because Moderna’s lipid did not include a carbon atom meeting the “bound to at least three other carbon atoms” requirement, the court granted judgment of noninfringement.

    Federal Circuit Analysis

    The Federal Circuit affirmed, holding that the passage was definitional under the standards set out in Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) and its progeny:

    • The term was in quotation marks, signaling definition.
    • It was introduced with “refer to,” which courts have consistently viewed as definitional (ParkerVision, Inc. v. Vidal, 88 F.4th 969 (Fed. Cir. 2023)).
    • It was placed in a section titled “Definitions,” supporting the lexicographic reading.
    • The specification used permissive phrasing elsewhere (“e.g.,” “include”), contrasting with the precise language used for “branched alkyl.”

    The panel also rejected Alnylam’s fallback argument that its claims fell under the “unless otherwise specified” exception. The court held that this clause required a clear, specific departure—and nothing in the claims, specification, or prosecution history met that bar. References to secondary carbon structures in dependent claims and the prosecution record did not rise to the level of an explicit override of the express definition.

    Key Cases Cited

    Takeaway

    This case is a strong reminder that express definitions in a patent’s specification—especially when found in a “Definitions” section and marked with formal language—will bind the claim scope unless there is a clear and unmistakable reason to depart. Practitioners should be cautious with language like “unless otherwise specified” unless they can point to explicit exceptions elsewhere in the specification or prosecution history. Ambiguities or broader examples won’t suffice to override precise definitions.

    By Charles Gideon Korrell

  • Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc.: Inherent Anticipation Requires Full Scope of the Claim

    Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc.: Inherent Anticipation Requires Full Scope of the Claim

    In a decision clarifying the boundaries between claim construction and factual findings of inherency, the Federal Circuit in Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc., No. 23-2211 (Fed. Cir. May 23, 2025), reversed the PTAB’s determination that certain claims of U.S. Patent No. 7,400,704 were not anticipated by the prior art. The court concluded that the Board had improperly narrowed the scope of the claims through implicit construction and that, under the correct claim scope, the prior art reference Jorgensen inherently disclosed the disputed limitation.

    Background

    Zeiss’s patent claims an X-ray imaging system incorporating “projection magnification,” with the key limitation being that the magnification of the projection stage is “between 1 and 10 times.” Sigray petitioned for inter partes review, arguing that a 1998 paper by Jorgensen disclosed all limitations of the claims, including this magnification range.

    The Board acknowledged that Jorgensen disclosed nearly all elements of the claims but found no anticipation because it concluded that the reference did not disclose “enough” beam divergence to result in the required projection magnification. Sigray appealed, arguing that this conclusion was based on an implicit and erroneous narrowing of the claim scope.

    Implicit Claim Construction

    The Federal Circuit found that the Board had implicitly construed the phrase “between 1 and 10 times” in a way that excluded very small—indeed undetectable—levels of magnification. The Board’s repeated focus on whether Jorgensen’s beam diverged “enough” and whether it created a “meaningful” amount of magnification revealed that it was assessing not just whether any magnification was present, but whether the magnification was perceptible or functionally significant.

    As the court explained, “[t]he Board’s use of the word ‘enough’ reflects that it considered a certain level of divergence as outside the claim. Narrowing the claim scope in this way is in fact claim construction.” The court emphasized that claim construction had occurred even though the Board disclaimed doing so—relying on its precedent in Google LLC v. EcoFactor, Inc., 92 F.4th 1049 (Fed. Cir. 2024), to look at the Board’s analysis and outcome rather than its labels.

    Inherent Disclosure and Physical Geometry

    After correcting the Board’s construction, the court held that Jorgensen inherently disclosed the disputed magnification limitation. Charles Gideon Korrell sees that the opinion stresses that under the geometric optics formula (M = (Ls + Ld)/Ls), any system with a diverging X-ray beam and a nonzero sample-to-detector distance (Ld > 0) necessarily results in magnification greater than 1.

    Since perfect collimation—i.e., zero divergence—is physically impossible in real-world systems, the court found that Jorgensen’s setup, which necessarily included some divergence, inherently satisfied the “between 1 and 10 times” magnification requirement. As stated in the opinion: “Here, it is undisputed that Jorgenson’s X-ray beams are not completely parallel and naturally must result in some magnification. That miniscule amount of magnification disclosed by the prior art definitionally achieves a magnification within the claimed range of 1 to 10.”

    Charles Gideon Korrell notes that the court relied heavily on SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005), in concluding that inherent anticipation does not require recognition or intention by the prior art. Rather, it is sufficient that the claimed feature necessarily results from practicing the prior art reference, regardless of whether it was appreciated at the time.

    Reversal and Remand

    • Claims 1, 3, and 4: Reversed. The court found that these claims were inherently anticipated by Jorgensen.
    • Claims 2, 5, and 6: Vacated and remanded. Sigray had argued these claims were obvious, not anticipated, so the Board must evaluate obviousness in light of the Federal Circuit’s clarified claim scope.

    Takeaway

    Charles Gideon Korrell thinks that this decision illustrates the Federal Circuit’s firm stance on the plain meaning of claim terms. The phrase “between 1 and 10 times” includes any magnification over 1, no matter how small, and the Board erred by requiring a “meaningful” or “detectable” amount. The ruling reinforces the principle from SmithKline that inherent disclosure encompasses all inevitable consequences of prior art, even if imperceptible.

    It also underscores how implicit claim construction—especially when it narrows the scope based on technical judgments about magnitude or significance—can fundamentally alter the outcome of IPR proceedings. Courts and the PTAB alike must be careful not to impose unstated thresholds that conflict with the express language of the claims.

    Finally, Charles Gideon Korrell believes that the opinion serves as a reminder that physical realities of system design (such as the impossibility of true parallel beams) can be decisive in proving inherent anticipation. The court’s analysis—rooted in the inevitability of divergence and magnification in Jorgensen’s geometry—shows that anticipation can rest not only on what’s disclosed, but also on what must unavoidably occur.

    By Charles Gideon Korrell

  • Curtin v. United Trademark Holdings, Inc.: No Standing for Consumers to Oppose Trademark Registrations Absent Commercial Interest

    Curtin v. United Trademark Holdings, Inc.: No Standing for Consumers to Oppose Trademark Registrations Absent Commercial Interest

    In Curtin v. United Trademark Holdings, Inc., No. 23-2140 (Fed. Cir. May 22, 2025), the Federal Circuit affirmed the dismissal of a consumer’s opposition to a trademark registration, holding that an individual lacking a commercial interest does not have statutory standing under 15 U.S.C. § 1063 to oppose trademark registration. Applying the Lexmark zone-of-interests and proximate cause framework—previously used in Lanham Act false advertising and cancellation contexts—the court clarified that opposition proceedings are reserved for parties asserting commercial harm.

    Background

    United Trademark Holdings (UTH) applied to register the mark RAPUNZEL for dolls and toy figures. Rebecca Curtin, a law professor and doll collector, filed a notice of opposition, asserting that the mark was generic, merely descriptive, and failed to function as a trademark. She claimed harm as a consumer who values access to a competitive marketplace for fairy tale-themed dolls.

    The TTAB dismissed her opposition, finding that she failed to demonstrate entitlement to bring the proceeding. Curtin appealed, arguing that the Board erred by applying the Lexmark framework instead of the Federal Circuit’s earlier test from Ritchie v. Simpson, 170 F.3d 1092 (Fed. Cir. 1999), which focused on whether the opposer had a “real interest” and a “reasonable basis” for believing they would be damaged.

    Federal Circuit’s Holding

    The Federal Circuit upheld the TTAB’s decision and confirmed that Lexmark International, Inc. v. Static Control Components, Inc., 572 U.S. 118 (2014), governs the analysis of who is entitled to bring opposition proceedings under § 1063. The court reasoned that Lexmark provides the correct interpretive framework for determining whether a party falls within the statutory cause of action. It also reiterated its earlier ruling in Corcamore, LLC v. SFM, LLC, 978 F.3d 1298 (Fed. Cir. 2020), which applied Lexmark to cancellation proceedings under § 1064.

    In Curtin, the court saw no reason to distinguish § 1063 from § 1064, especially given the parallel statutory language: both provisions authorize action by any person “who believes that he would be damaged” by a trademark registration. The court rejected Curtin’s argument that opposition proceedings are purely administrative and thus not subject to the same statutory cause-of-action analysis.

    Zone of Interests and Proximate Cause

    Applying the Lexmark test, the court held that Curtin’s interest—as a consumer—fell outside the zone of interests protected by the statutory provisions she invoked (genericness, descriptiveness, and failure to function as a mark). These provisions, the court explained, are designed to protect commercial interests and promote fair competition, not consumer choice or expression per se.

    The court also found Curtin’s alleged harms—such as reduced marketplace diversity, higher prices, and diminished access to “classic” Rapunzel dolls—to be too remote. These effects, it held, were speculative and derivative of any direct harm to commercial actors (e.g., doll manufacturers or sellers) and thus insufficient to establish proximate causation under Lexmark.

    Notable Precedents

    Takeaway

    Curtin reinforces that only parties with a commercial interest may invoke § 1063 to oppose trademark registration on grounds such as genericness or descriptiveness. While consumers may be indirectly affected by trademark registrations, those harms do not suffice under the Lanham Act unless they directly relate to a commercial interest. The ruling narrows the scope of opposition proceedings and aligns § 1063 with the broader statutory cause-of-action framework developed in Lexmark and its progeny.

    By Charles Gideon Korrell

  • EcoFactor, Inc. v. Google LLC (En Banc): CAFC Clarifies Daubert Gatekeeping for Patent Damages Experts

    EcoFactor, Inc. v. Google LLC (En Banc): CAFC Clarifies Daubert Gatekeeping for Patent Damages Experts

    In a closely watched en banc decision issued on May 21, 2025, the Federal Circuit reversed the district court’s denial of a new trial on damages in EcoFactor, Inc. v. Google LLC, No. 2023-1101. The court held that the trial court abused its discretion by admitting expert damages testimony that was not based on sufficient facts or data, in violation of Federal Rule of Evidence 702 and Daubert. While the Federal Circuit reinstated the prior panel’s decision on non-damages issues, its en banc ruling significantly clarifies and tightens the standard for admissibility of expert testimony in patent damages cases.

    Background

    EcoFactor sued Google in the Western District of Texas, alleging that Google’s Nest thermostats infringed U.S. Patent No. 8,738,327. The jury found infringement and awarded a $20 million lump-sum damages award based on testimony from EcoFactor’s expert, David Kennedy. Kennedy opined that comparable licenses supported a reasonable royalty of $X per unit and that Google should pay damages on that basis.

    Google challenged the admissibility of Kennedy’s opinion under Daubert, arguing that his damages theory was not based on sufficient facts or reliable methodology. A panel of the Federal Circuit affirmed the district court (with Judge Prost dissenting in part), but the court subsequently granted rehearing en banc to consider whether the trial court complied with Rule 702 and Daubert in admitting Kennedy’s per-unit damages theory.

    The En Banc Holding

    Chief Judge Moore, writing for the majority, reversed the district court and ordered a new trial on damages. The court held that Kennedy’s opinion was inadmissible under Rule 702(b) because it relied on an unsupported factual premise: that three prior licensees (Daikin, Schneider, and Johnson Controls) agreed to a $X per-unit royalty in lump-sum settlements with EcoFactor.

    The court emphasized that Rule 702, especially after its 2023 amendment, requires trial courts to determine whether expert opinions rest on sufficient facts and whether those facts support the conclusions the expert seeks to offer. The court clarified that the judicial gatekeeping function under Daubert is not limited to methodology but extends to whether the factual basis itself is adequately supported by the record.

    Why Kennedy’s Testimony Was Excluded

    Kennedy relied on three license agreements to support his conclusion that a $X per-unit royalty had been accepted by other companies in the market. But the court found:

    • The license agreements expressly stated that the lump sums were not based on unit sales and did not reflect a royalty.
    • The “whereas” clauses recited only EcoFactor’s belief about the $X royalty and did not reflect any agreement or shared understanding with the licensees.
    • Kennedy’s testimony that prior licensees paid $X per unit was not supported by the contracts or any underlying sales data.

    Moreover, EcoFactor’s CEO, Shayan Habib, testified that he lacked access to sales data from the licensees and based his understanding of the lump sums on generalized knowledge of the industry and advice from undisclosed advisors. The court found this insufficient to support Kennedy’s expert conclusions.

    Because Kennedy’s opinion that others paid $X per unit was central to his damages analysis, and because the jury may have relied on that opinion in reaching its verdict, the error was not harmless.

    The Role of the 2023 Amendment to Rule 702

    A key part of the opinion is its reliance on the 2023 amendment to Rule 702, which clarified that courts must determine whether it is “more likely than not” that the proffered expert testimony meets the requirements of the rule. Importantly, the amendment emphasizes that questions of sufficiency of the facts or data are questions of admissibility, not weight. The court explicitly criticized the trend among some trial courts to defer these issues to cross-examination or jury consideration, reaffirming that trial judges must exclude opinions that extend beyond what the expert’s basis and methodology can reliably support.

    Interaction with Appellate Review Standards

    Although not the primary focus of the decision, the ruling has prompted commentary (including from Patently-O) about the Federal Circuit’s application of de novo review to what is ostensibly a discretionary evidentiary ruling. While the court couches its holding as a classic abuse-of-discretion review, its willingness to re-interpret the license agreements and witness testimony may suggest a more searching, fact-driven analysis than the deferential standard traditionally implies.

    Charles Gideon Korrell believes that this raises the question of whether the Federal Circuit is re-calibrating its approach to evidentiary rulings in damages cases, especially where expert conclusions turn on contract interpretation or disputed factual premises.

    Reinforcing Precedent on Licensing and Reasonable Royalties

    The decision is rooted in long-standing precedent regarding the use of license agreements in reasonable royalty calculations:

    EcoFactor builds on this line of cases by reinforcing that a reasonable royalty analysis must be grounded in actual, verifiable facts and that experts cannot rely on implied or asserted beliefs absent factual substantiation.

    Broader Implications: Is the Remedies Remedy Now Complete?

    Charles Gideon Korrell sees that the Federal Circuit’s en banc ruling sends a clear message: damages experts must tie their opinions to the factual record in a way that satisfies Rule 702’s admissibility standard—not just survive cross-examination. This decision may mark the culmination of a doctrinal tightening that began over a decade ago.

    If LaserDynamics began the process and Apple v. Motorola accelerated it, the en banc EcoFactor ruling may indeed represent the near-completion of the “remedies remedy”—a recalibration of how courts scrutinize damages theories in patent litigation.

    Experts must now be prepared not only to explain their methodologies but also to demonstrate a verifiable factual foundation for the inputs to their calculations. When the basis for a per-unit royalty is a prior license, courts will require clear evidence that the license actually reflects such a royalty—not just that a party believes it does.

    Final Thoughts

    While the decision is nominally about one expert’s flawed opinion, Charles Gideon Korrell believes that it carries broader implications for how trial courts are expected to apply Rule 702. The Federal Circuit has reinforced that trial judges must actively police the admissibility of expert testimony, particularly in patent damages cases where technical complexity and legal ambiguity often converge.

    Going forward, Charles Gideon Korrell believes that litigants should expect closer scrutiny of any damages theory that relies on settlement agreements or implied royalty rates—and should be ready to defend the factual integrity of those theories from the outset.

    By Charles Gideon Korrell

  • In re: Vetements Group AG — Generic Foreign Terms Cannot Serve as Trademarks

    In re: Vetements Group AG — Generic Foreign Terms Cannot Serve as Trademarks

    In In re: Vetements Group AG, Nos. 2023-2050, -2051 (Fed. Cir. May 21, 2025), the Federal Circuit affirmed the Trademark Trial and Appeal Board’s (TTAB) refusal to register “VETEMENTS” as a trademark for clothing and online retail clothing store services. Applying the doctrine of foreign equivalents, the court agreed that “vetements,” the French word for “clothing,” is generic or, at best, merely descriptive of the applicant’s goods and services and lacked acquired distinctiveness. The ruling underscores key limits on registering foreign-language marks that translate into generic English terms.

    Background

    Vetements Group AG sought registration of “VETEMENTS” in both standard and stylized forms for a variety of apparel items and related retail services. The USPTO refused registration under § 2(e)(1) of the Lanham Act, finding the term generic or merely descriptive without secondary meaning. The TTAB affirmed, concluding that consumers would likely translate “vetements” into “clothing,” and would perceive the term as referring to a genus of goods.

    Legal Standards and Application

    The court conducted a de novo review of the Board’s legal determinations and assessed factual findings under the substantial evidence standard. It framed its analysis around several well-established principles:

    1. Generic Terms Are Not Registrable: A generic term “is the ultimate in descriptiveness” and incapable of indicating source. (Bullshine Distillery LLC v. Sazerac Brands, LLC, 130 F.4th 1025, 1029 (Fed. Cir. 2025)).
    2. Doctrine of Foreign Equivalents: Foreign terms from modern languages are generally translated into English to assess descriptiveness or genericness. This doctrine applies where the “ordinary American purchaser” would likely “stop and translate” the term. (Palm Bay Imports v. Veuve Clicquot, 396 F.3d 1369, 1377 (Fed. Cir. 2005)).
    3. Ordinary American Purchaser: This includes U.S. consumers familiar with the foreign language. Even absent a majority, an “appreciable number” of speakers is sufficient. The Board found over 2 million U.S. residents speak French at home, and French is widely taught in U.S. schools—facts the court deemed substantial evidence.
    4. Context of Use: The court distinguished cases like Palm Bay and Tia Maria, where foreign terms had no logical connection to the goods and thus were unlikely to be translated. By contrast, “vetements” directly describes the goods at issue—clothing—and consumers encountering the term on apparel would likely understand and translate it.

    Notable Precedent

    The court’s decision reaffirmed and applied key precedents:

    Takeaway

    The Federal Circuit reaffirmed that marks comprised of foreign terms will not evade genericness or descriptiveness bars simply by virtue of being in another language. The doctrine of foreign equivalents is not discretionary in such cases; rather, it operates as a consistent threshold inquiry. Where a foreign term clearly describes or generically names the applicant’s goods and would be understood by an appreciable segment of U.S. consumers, registration is foreclosed.

    For brand owners, this decision reinforces the importance of assessing the English meaning and consumer perception of foreign-language marks, particularly in connection with goods or services closely tied to the translated term.

    By Charles Gideon Korrell

  • Regents of the University of California v. Broad Institute: Federal Circuit Faults PTAB for Conflating Conception and Reduction to Practice Standards in CRISPR Interference

    Regents of the University of California v. Broad Institute: Federal Circuit Faults PTAB for Conflating Conception and Reduction to Practice Standards in CRISPR Interference

    In a closely watched battle over the origins of one of the most transformative technologies in modern biology, the Federal Circuit has partially reversed a PTAB ruling in Regents of the University of California v. Broad Institute, Inc., No. 22-1653 (Fed. Cir. May 12, 2025). The dispute centers on who first invented the use of CRISPR-Cas9 systems with single-guide RNA (sgRNA) to edit DNA in eukaryotic cells—a breakthrough that has revolutionized gene editing and spurred enormous commercial and scientific interest.

    The Federal Circuit vacated the PTAB’s finding that the Broad Institute had priority over the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, the “Regents”), holding that the Board applied the wrong legal standard for conception. While affirming the PTAB’s determination that the Regents’ provisional applications lacked adequate written description, the Court remanded for further proceedings on conception.

    Background: A Decade-Long Dispute Over CRISPR Dominance

    This interference proceeding is the latest chapter in a long and contentious legal saga between two groups of academic researchers. The Regents’ team, scientists, directed by Emmanuelle Charpentier, Jennifer Doudna, and Martin Jinek, published a seminal 2012 paper demonstrating that a CRISPR-Cas9 system could be programmed using a chimeric sgRNA to cut DNA in a test tube. The Broad team, led by Feng Zhang at MIT and the Broad Institute, was the first to obtain patents for using CRISPR-Cas9 in eukaryotic cells, including human cells, after submitting expedited applications to the USPTO.

    The potential commercial implications of these patents are immense. CRISPR technologies are foundational in developing gene therapies, agricultural tools, and synthetic biology applications. The 2020 Nobel Prize in Chemistry was awarded to Doudna and Charpentier for their discovery, but the patent rights remained under dispute. This case, involving Interference No. 106,115, marks the second interference declared between the parties and focuses specifically on claims involving the use of a single-guide CRISPR-Cas9 system in eukaryotic cells.

    Federal Circuit: PTAB Misapplied the Legal Standard for Conception

    The Federal Circuit found that the PTAB improperly required the Regents’ scientists to know their invention would work in eukaryotic cells in order to establish conception. This, the Court held, conflated the distinct legal standards for conception and reduction to practice.

    Citing Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223 (Fed. Cir. 1994), the panel emphasized that an inventor need only have a “definite and permanent idea” of the complete invention. Certainty of success or experimental proof is not required at the conception stage.

    The Court also held that:

    • The PTAB placed undue weight on contemporaneous expressions of doubt by the Regents’ scientists, without analyzing whether these doubts led to substantive changes in their design;
    • The Board erred by failing to consider whether others—using the Regents’ published design and routine methods—were able to achieve successful editing in eukaryotic cells, which would support the argument that the invention required only ordinary skill to reduce to practice;
    • The PTAB wrongly disregarded the use of “routine techniques” in the field as a key factor in assessing whether conception had been achieved.

    The Court remanded the case for further findings under the proper legal framework, which will allow the Regents to reargue their priority claim based on their early 2012 planning and public disclosures.

    Written Description: Affirmed Due to Unpredictability in the Field

    The Court affirmed the PTAB’s determination that the Regents’ first (P1) and second (P2) provisional applications lacked adequate written description under 35 U.S.C. § 112. The claims at issue involved an sgRNA-guided CRISPR-Cas9 system functioning in a eukaryotic cell.

    Given the acknowledged unpredictability in adapting prokaryotic systems to eukaryotes, the Court agreed with the PTAB that the P1 application did not sufficiently convey possession of an operative embodiment. The Board reasonably found that the application lacked specific instructions or empirical evidence demonstrating success or feasibility, particularly in light of the complexity of the technology.

    Although the Court reaffirmed that a working example is not required, it found the Regents’ disclosure wanting because it failed to bridge the gap between concept and implementation in eukaryotic systems.

    Broad’s Cross-Appeal: Dismissed as Moot

    Broad’s cross-appeal challenged the PTAB’s construction of “guide RNA” as being limited to a single-molecule configuration. However, the Court dismissed the appeal as moot because the Board had denied Broad’s related motions on independent procedural grounds that Broad did not challenge on appeal. Thus, even if the claim construction were reversed, it would not alter the outcome of those rulings.

    Takeaways

    This decision breathes new life into the Regents’ claims of priority in the eukaryotic CRISPR space and signals the Federal Circuit’s continued insistence on correctly distinguishing between conception and reduction to practice. Some key takeaways:

    • The Court reaffirmed that certainty of success is not required for conception. Inventors need only have a definite and permanent idea of the invention that a person of ordinary skill can reduce to practice.
    • In unpredictable arts like biotechnology, written description demands more. Disclosure must demonstrate possession, not just hypothesis, particularly when transitioning between biological systems.
    • Experimental success by third parties using routine methods is relevant to whether an invention was complete at the time of conception.
    • Procedural missteps can be fatal. Broad’s failure to adequately support its claim construction-based motions before the PTAB rendered its cross-appeal ineffectual.

    As this high-stakes dispute continues to unfold, the next round at the PTAB may prove decisive in determining who truly owns the foundational CRISPR patent rights in eukaryotic systems.

    By Charles Gideon Korrell

  • Incyte Corp. v. Sun Pharmaceutical Industries: Federal Circuit Reverses Preliminary Injunction for Lack of Irreparable Harm

    Incyte Corp. v. Sun Pharmaceutical Industries: Federal Circuit Reverses Preliminary Injunction for Lack of Irreparable Harm

    In a follow-on decision reinforcing its earlier order, the Federal Circuit in Incyte Corp. v. Sun Pharmaceutical Industries, Ltd., reversed a preliminary injunction granted by the U.S. District Court for the District of New Jersey. The district court had enjoined Sun from launching its FDA-approved drug Leqselvi, a deuterated version of ruxolitinib for treating alopecia areata (AA), based on Incyte’s assertion of U.S. Patent No. 9,662,335. The Federal Circuit found that Incyte failed to establish irreparable harm—a required element for injunctive relief under Winter v. Natural Resources Defense Council, 555 U.S. 7 (2008)—rendering the injunction improper.

    Background

    Incyte’s ’335 patent covers deuterated ruxolitinib compounds, and the dispute arose after Sun secured FDA approval in July 2024 to market Leqselvi for AA. Incyte, which is still in early development stages for a topical version of the drug, moved to preliminarily enjoin Sun. The district court granted the motion, primarily crediting Incyte’s argument that Sun’s launch would grant it a “head start” and erode Incyte’s competitive position before its own product could reach the market.

    The Federal Circuit’s Analysis

    Writing for the panel, Chief Judge Moore found the district court’s irreparable harm analysis clearly erroneous. The court underscored that preliminary injunctions require a showing that harm is likely absent an injunction, not merely speculative or inevitable.

    While the Federal Circuit recognized that in some cases a first-mover advantage and loss of “sticky” customer relationships may constitute irreparable harm (Bio-Rad Labs., Inc. v. 10X Genomics Inc., 967 F.3d 1353 (Fed. Cir. 2020); Natera, Inc. v. NeoGenomics Labs., Inc., 106 F.4th 1369 (Fed. Cir. 2024)), the facts here were materially different. Unlike Natera, where the injunction prevented immediate entry and preserved the patentee’s imminent market position, Incyte’s product is still years away from launch—even under its most optimistic development timeline—and certainly after the ’335 patent’s expiration in December 2026.

    This distinction proved fatal to Incyte’s argument. As the court explained, “[b]ecause Incyte cannot enjoin Sun from launching after its ’335 patent expires, Sun’s multi-year head start is inevitable regardless of any injunction.” Thus, any advantage Sun might gain from launching before Incyte was not attributable to the absence of an injunction, but to the natural expiration of the patent.

    Comparison to Earlier Decision

    This ruling builds on the court’s prior order on April 9, 2025, vacating the injunction without a full opinion. Both decisions underscore a consistent message: patent holders must offer concrete, non-speculative proof of irreparable harm that an injunction can actually prevent. A delay in entry that would happen regardless of judicial intervention—because of patent expiration or the plaintiff’s own development delays—does not suffice.

    Key Takeaways

    1. Inevitable Market Entry Is Not Irreparable Harm: When a competitor’s entry into the market is inevitable post-patent expiration, courts will be reluctant to find that harm from early entry is “irreparable.”
    2. Development Timelines Matter: A patent holder that is years away from commercial launch faces a high hurdle in arguing that it will suffer imminent harm absent an injunction.
    3. First-Mover Advantage Is Contextual: While first-mover advantage can support injunctive relief, it must be tethered to a plausible timeline and preventable disruption.

    This decision reflects the Federal Circuit’s increasing scrutiny of the evidentiary basis for irreparable harm, particularly in the pharmaceutical and biotech space. Litigants seeking preliminary injunctions would be wise to present a realistic commercial timeline and show how the injunction meaningfully alters competitive dynamics within the remaining life of the patent.

    By Charles Gideon Korrell

  • Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals: Clarifying the Limits of Injunctive Relief Under the Hatch-Waxman Safe Harbor

    Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals: Clarifying the Limits of Injunctive Relief Under the Hatch-Waxman Safe Harbor

    In the recent Federal Circuit decision Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, the court provided critical guidance on the limits of injunctive relief relating to FDA submissions and clinical trials under the Hatch-Waxman Act.

    Background and Procedural History

    Jazz Pharmaceuticals manufactures Xywav®, currently the only FDA-approved drug for treating idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals sought approval of its competing product, Lumryz, for narcolepsy and IH through a paper New Drug Application (NDA) relying partly on data associated with Jazz’s Xyrem®.

    Jazz’s patent infringement lawsuit initially relied on 35 U.S.C. § 271(e)(2), claiming Avadel’s FDA submission infringed its later-issued patent, the ’782 patent. The district court permanently enjoined Avadel from applying for FDA approval or marketing Lumryz for IH, initiating new clinical trials, and offering open-label extensions (OLE) in clinical studies.

    Federal Circuit’s Analysis and Key Holdings

    The Federal Circuit addressed each aspect of the district court’s injunction separately:

    1. Initiating New Clinical Trials: The court unequivocally reversed this portion of the injunction, emphasizing that the Hatch-Waxman safe harbor (§ 271(e)(1)) expressly protects activities solely related to FDA submissions. The court noted that such experimental activities do not constitute infringement and that § 271(e)(3) explicitly bars injunctive relief against these safe-harbor activities. The panel emphasized that no factual development was required here, given the purely legal nature of Avadel’s challenge to this aspect of the injunction.
    2. Offering Open-Label Extensions (OLE): Similarly, the injunction prohibiting Avadel from offering OLE periods to clinical trial participants was reversed. The Federal Circuit clarified that this activity had not been adjudicated to fall outside the protection of the safe harbor, and thus, prematurely enjoining it exceeded statutory limits.
    3. Applying for FDA Approval for New Indications: The court vacated and remanded the injunction barring FDA submissions for new Lumryz indications. While acknowledging FDA submissions themselves do not infringe under § 271(a), the court explored the nuance of artificial infringement under § 271(e)(2). The decision identified unresolved legal questions about whether submitting a paper NDA for a non-Orange Book listed patent constitutes artificial infringement, directing the district court to examine this issue on remand. The Federal Circuit underscored that even if not infringement, an injunction against submitting FDA applications could only stand if clearly necessary to prevent actual infringement—an analysis the lower court had not sufficiently articulated.

    Implications for Patent Litigation and FDA Regulatory Submissions

    This ruling highlights the judicial restraint required in granting injunctions in pharmaceutical patent cases, especially concerning activities explicitly shielded under Hatch-Waxman’s safe harbor provisions. Companies engaged in FDA-related drug development activities can rely on clearer boundaries protecting their clinical research endeavors. Furthermore, the decision signals to district courts that injunctive relief must directly correspond to actual or likely infringing activities and be clearly supported by detailed factual and legal analysis.

    The remand provides further opportunity for nuanced interpretation and application of the Hatch-Waxman Act, particularly regarding the interplay between FDA regulatory submissions and patent infringement litigation, setting important precedent for future cases.

    By Charles Gideon Korrell

  • In re Thomas D. Foster, APC: Trademark Refusal Reinforces Timing and False Connection Analysis Under the Lanham Act

    In re Thomas D. Foster, APC: Trademark Refusal Reinforces Timing and False Connection Analysis Under the Lanham Act

    In a recent decision, the Federal Circuit affirmed the TTAB’s refusal to register the trademark “US SPACE FORCE,” emphasizing critical considerations under § 2(a) of the Lanham Act related to false suggestions of a connection. This ruling highlights the significance of timing in trademark analysis and clarifies the factors influencing determinations of false associations with government entities.

    The appeal arose from Thomas D. Foster, APC’s attempt to register “US SPACE FORCE” (Nos. 87839062 and 87981611) following President Trump’s public announcement in March 2018 about creating a new military branch under this name. Shortly thereafter, Foster filed an intent-to-use trademark application. The examining attorney refused registration under § 2(a), alleging the mark falsely suggested a connection with the United States government, a decision subsequently upheld by the TTAB.

    Addressing the critical timing aspect, the Federal Circuit cited Piano Factory Group, Inc. v. Schiedmayer Celesta GmbH, where the court had previously determined that the relevant period for evaluating false connection claims is generally the time of registration. Here, because the matter concerned an application rather than an existing registration, the court clarified that for refusals, the relevant period extends up to the completion of the examination process. Thus, evidence arising during the examination period could properly be considered.

    Applying the four-part test articulated in Univ. of Notre Dame Du Lac v. J.C. Gourmet Food Imports Co., the court analyzed:

    1. Whether the mark closely approximates the identity previously used by another entity;
    2. Whether it uniquely and unmistakably points to that entity;
    3. Whether the applicant is connected to the named entity; and
    4. Whether the entity’s fame or reputation would cause a presumed connection.

    Foster disputed the TTAB’s findings on the first two prongs, arguing primarily against the consideration of evidence developed after his filing date. However, substantial evidence—including extensive media coverage and official government announcements—demonstrated the public association between the “US SPACE FORCE” mark and the United States government, particularly as the name of an official military branch.

    In affirming the Board’s refusal, the Federal Circuit underscored that Foster’s arguments lacked substance against the compelling evidence that the mark unequivocally pointed to the United States government. This decision aligns with earlier precedent such as In re Geller and Bridgestone/Firestone Research, Inc., reinforcing robust protections under § 2(a) against trademarks that falsely suggest governmental connections.

    This ruling emphasizes two critical takeaways for practitioners:

    • Timing for evaluating false connection claims in application refusals is comprehensive, extending throughout the examination period.
    • Establishing a false suggestion of a connection involves assessing not only similarity but the public’s recognition and association of the mark with an existing entity.

    Practitioners should remain mindful of these considerations when advising on trademark strategies involving names potentially associated with prominent governmental entities or widely publicized initiatives.

    By Charles Gideon Korrell