Technology & Information Law Blog by Charles Gideon Korrell

Tag: patent law

  • Fraunhofer v. Sirius XM: CAFC Clarifies Limits of Equitable Estoppel in Patent Litigation

    Fraunhofer v. Sirius XM: CAFC Clarifies Limits of Equitable Estoppel in Patent Litigation

    The Federal Circuit reversed a district court’s grant of summary judgment in Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. v. Sirius XM Radio Inc., No. 23-2267, holding that disputed issues of fact precluded the application of equitable estoppel to bar Fraunhofer’s patent infringement claims. While the decision arises from a complex licensing history involving satellite radio technology, Charles Gideon Korrell believes that its precedential value lies in its clarifications regarding the elements of equitable estoppel, especially the requirements of reliance and prejudice.

    Background

    Fraunhofer, a German research institute, developed multicarrier modulation (MCM) technology and licensed it to WorldSpace in 1998, granting sublicense rights. XM Satellite Radio obtained such a sublicense and collaborated with Fraunhofer to implement the patented technology in its high-band satellite radio system. When XM later merged with Sirius in 2008 to form Sirius XM Radio Inc. (SXM), the combined entity continued to use the high-band system. Fraunhofer later asserted that WorldSpace’s 2010 bankruptcy terminated the license and that any rights in the patents had reverted to Fraunhofer.

    Despite its knowledge of SXM’s continued use of the technology, Fraunhofer waited until 2015 to notify SXM of alleged infringement and filed suit in 2017. The district court held that Fraunhofer’s delay and prior conduct gave rise to equitable estoppel and granted summary judgment in favor of SXM. The Federal Circuit reversed.

    Key Legal Issues and Holdings

    1. Misleading Conduct May Arise from Silence, But Context Matters

    The Federal Circuit affirmed that Fraunhofer’s five-year silence—despite knowledge of SXM’s continued use of the accused system—could constitute misleading conduct. Charles Gideon Korrell sees this as especially true where, as here, the patentee had participated in developing the allegedly infringing product. The decision reaffirms the rule from A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc), that silence can support estoppel where it conveys acquiescence.

    2. Reliance Requires More Than Inference—It Must Be Evidenced

    Charles Gideon Korrell sees the court’s most significant contribution to be its treatment of the reliance prong of equitable estoppel. It emphasized that the accused infringer must show actual reliance on the patentee’s silence or conduct—not just that the silence coincided with business decisions.

    SXM argued it relied on Fraunhofer’s silence when choosing to migrate car manufacturers to the high-band (allegedly infringing) system rather than to a non-infringing low-band alternative. But deposition testimony revealed that this decision was based on business pragmatism—migrating the smaller user base was easier—not on any perceived legal clearance.

    Charles Gideon Korrell notes that this distinction echoes prior holdings in SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC, 767 F.3d 1339 (Fed. Cir. 2014), and Hemstreet v. Computer Entry Systems Corp., 972 F.2d 1290 (Fed. Cir. 1992): independent commercial reasons cannot substitute for reliance on the patentee’s conduct.

    3. Prejudice Must Flow from Reliance, Not Merely From Delay

    The third requirement—material prejudice—must be causally connected to the reliance. Here, while SXM had clearly invested heavily in the high-band system, the Federal Circuit found that economic harm alone is not sufficient unless it was caused by reliance on misleading conduct. Without that link, the estoppel defense fails.

    Why This Case Is Precedential

    Charles Gideon Korrell believes that the Federal Circuit made this opinion precedential to:

    • Clarify that misleading conduct and economic prejudice do not by themselves establish estoppel—they must be joined by clear evidence of reliance;
    • Reinforce that estoppel is a fact-intensive defense and rarely suitable for summary judgment absent unequivocal evidence;
    • Provide guidance for licensing and collaboration disputes, particularly where technologies are co-developed or sublicensed under evolving corporate structures.

    These clarifications build upon a line of post-Aukerman cases and offer a refined framework for assessing estoppel in complex patent enforcement contexts.

    Looking Ahead

    The case now returns to the district court, where the parties’ remaining summary judgment motions remain unresolved. If SXM can prove at trial that it relied on Fraunhofer’s conduct in a legally meaningful way, the estoppel defense may still apply. But absent that showing, Fraunhofer’s infringement claims—despite their delay—remain viable.

    By Charles Gideon Korrell

  • Dolby Laboratories Licensing Corp. v. Unified Patents, LLC: No Standing to Appeal IPR RPI Dispute

    Dolby Laboratories Licensing Corp. v. Unified Patents, LLC: No Standing to Appeal IPR RPI Dispute

    In Dolby Laboratories Licensing Corp. v. Unified Patents, LLC, No. 23-2110 (Fed. Cir. June 5, 2025), the Federal Circuit dismissed Dolby’s appeal for lack of Article III standing. Although Dolby had prevailed before the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) initiated by Unified Patents, it sought to appeal the Board’s refusal to adjudicate a dispute over the petition’s Real Party in Interest (RPI) disclosure. The Federal Circuit held that none of Dolby’s asserted injuries established the “concrete and particularized” harm necessary to create a justiciable controversy.

    Background

    Unified Patents filed an IPR challenging claims 1, 7, and 8 of Dolby’s U.S. Patent No. 10,237,577. Dolby alleged that Unified improperly failed to disclose nine additional RPIs. The Board declined to resolve the RPI dispute, citing PTAB precedent (SharkNinja v. iRobot IPR proceeding, IPR2020-00734) and USPTO policy limiting such adjudications to when the outcome of the proceeding might be affected (e.g., due to time bar or estoppel).

    Charles Gideon Korrell notes that the PTAB ultimately found in favor of Dolby, upholding the challenged claims. Nonetheless, Dolby appealed, asserting that the Board’s refusal to decide the RPI issue caused it harm.

    No Standing Despite Statutory “Right to Appeal”

    Dolby first argued that it had standing based on 35 U.S.C. § 319, which provides a right of appeal to any “party dissatisfied” with a PTAB final written decision. The Federal Circuit rejected this argument, reiterating its longstanding view that statutory appeal rights under the America Invents Act (AIA) do not override the constitutional requirement of Article III standing (JTEKT Corp. v. GKN Automotive, 898 F.3d 1217 (Fed. Cir. 2018)).

    No Informational Injury Under § 312(a)(2)

    Dolby also contended that the failure to adjudicate the RPI issue violated its informational rights under 35 U.S.C. § 312(a)(2), which requires IPR petitions to identify all RPIs. The court disagreed, distinguishing this situation from the “public-disclosure” statutes found in Public Citizen v. DOJ, 491 U.S. 440 (1989) and FEC v. Akins, 524 U.S. 11 (1998). Unlike the statutes at issue in those cases, the AIA does not grant a general right of public access to RPI information, nor does it create a statutory cause of action to vindicate such a right. Furthermore, Charles Gideon Korrell notes, decisions regarding institution—including compliance with § 312(a)(2)—are explicitly made non-appealable under 35 U.S.C. § 314(d) (ESIP Series 2, LLC v. Puzhen Life USA, 958 F.3d 1378 (Fed. Cir. 2020)).

    Speculative Harms Do Not Establish Injury in Fact

    The remainder of Dolby’s arguments were similarly dismissed as speculative. The court found no credible evidence that:

    • Any of the alleged RPIs were violating Dolby license agreements (Apple Inc. v. Qualcomm Inc., 992 F.3d 1378 (Fed. Cir. 2021));
    • The administrative patent judges (APJs) had conflicts of interest;
    • Future estoppel rights would be compromised; or
    • Unified would alter its behavior if RPIs had to be disclosed.

    Without evidence of actual or imminent harm, the court held that Dolby failed to meet its burden under Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992), and Spokeo, Inc. v. Robins, 578 U.S. 330 (2016).

    Key Takeaways

    • Statutory appeal rights under the AIA do not eliminate the requirement of Article III standing.
    • The Federal Circuit continues to take a narrow view of informational injuries, especially in the context of administrative patent proceedings.
    • Speculative future harms and procedural disagreements—without more—are not enough to sustain federal appellate jurisdiction.

    Charles Gideon Korrell sees this case serving as a reminder that even victorious IPR patent owners must demonstrate a cognizable injury to pursue appeals based on procedural grievances.

    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

  • 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

  • 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

  • Ingenico Inc. v. IOENGINE, LLC: Public Availability of Prior Art Software Invalidates Patent Claims

    Ingenico Inc. v. IOENGINE, LLC: Public Availability of Prior Art Software Invalidates Patent Claims

    In a recent decision, Ingenico Inc. v. IOENGINE, LLC, the Federal Circuit upheld a jury’s finding that several claims of IOENGINE’s U.S. Patent Nos. 9,059,969 and 9,774,703 were invalid due to anticipation and obviousness by publicly available prior art. Specifically, the Court affirmed that a software application known as the “Firmware Upgrader,” part of M-Systems’ DiskOnKey System, constituted prior art under the “public use” provision of 35 U.S.C. § 102(b) (pre-AIA).

    Background

    IOENGINE’s patents relate to portable devices, such as USB thumb drives, that send communications to network servers upon user interaction. Ingenico challenged the validity of IOENGINE’s patents by demonstrating prior public use of M-Systems’ DiskOnKey System, including its Firmware Upgrader software.

    At trial, Ingenico presented significant circumstantial evidence of the Firmware Upgrader’s public accessibility before the critical date. Evidence included a July 2002 email to M-Systems employees encouraging dissemination of the Firmware Upgrader and associated documentation, a public press release, and archived web pages from which the software could be downloaded.

    Court Analysis and Key Precedents

    The Federal Circuit’s analysis emphasized two important precedents:

    1. Medtronic, Inc. v. Teleflex Innovations S.A.R.L. (2023) clarified that circumstantial evidence is equally persuasive and sufficient compared to direct evidence for proving public use.
    2. Minnesota Mining & Manufacturing Co. (3M) v. Chemque, Inc. (2002) was distinguished due to the lack of evidence in 3M demonstrating that samples provided were ever used in a manner fulfilling claim requirements.

    In contrast to 3M, Ingenico demonstrated clear evidence that the Firmware Upgrader software was publicly accessible and encouraged for use, meeting the claims’ criteria once downloaded. Thus, circumstantial evidence was adequate to satisfy the public use requirement.

    Clarification on IPR Estoppel and Jury Instructions

    IOENGINE argued for a new trial, asserting improper jury instructions regarding conception, diligence, public use, and sales offers. It also challenged the district court’s decision allowing Ingenico to rely on prior art under IPR estoppel provisions.

    The Federal Circuit rejected these arguments, holding that the jury was properly instructed on the clear and convincing evidence standard and other critical issues. Additionally, the court clarified the scope of IPR estoppel under 35 U.S.C. § 315(e)(2), holding that estoppel does not extend to grounds involving public use or on-sale bar evidence because these grounds cannot be raised in inter partes review, which is limited to printed publications and patents as prior art.

    Conclusion

    The decision underscores the importance of demonstrating prior art’s public accessibility through circumstantial evidence. Additionally, it offers crucial guidance on the limits of IPR estoppel, affirming that petitioners are free to assert public use and on-sale bars in district court actions despite participating in an IPR. Patent holders and challengers alike must carefully consider the implications of public availability and IPR proceedings in shaping their litigation strategies.

    By Charles Gideon Korrell

  • Fintiv, Inc. v. PayPal Holdings, Inc.: No Structure, No Claim — Payment Handler Terms Held Indefinite Under § 112 ¶ 6

    Fintiv, Inc. v. PayPal Holdings, Inc.: No Structure, No Claim — Payment Handler Terms Held Indefinite Under § 112 ¶ 6

    In Fintiv, Inc. v. PayPal Holdings, Inc., No. 23-2312 (Fed. Cir. Apr. 30, 2025), the Federal Circuit affirmed the Western District of Texas’s ruling that the asserted patent claims were invalid as indefinite. The decision underscores the court’s continued enforcement of 35 U.S.C. § 112 ¶ 6 for software-related terms that fail to recite sufficient structure, extending the line of cases exemplified by Williamson v. Citrix Online, LLC, 792 F.3d 1339 (Fed. Cir. 2015).

    Background

    Fintiv asserted four patents—U.S. Patent Nos. 9,892,386, 11,120,413, 9,208,488, and 10,438,196—relating to a cloud-based mobile transaction system. At issue were various claims referring to a “payment handler” or “payment handler service” that either (1) used APIs of various payment processors or (2) exposed a common API for interacting with them.

    The district court, applying § 112 ¶ 6, found the payment-handler terms to be means-plus-function limitations and held the claims indefinite for failure to disclose corresponding structure. Fintiv appealed.

    Key Holdings

    1. The Payment Handler Terms Invoke § 112 ¶ 6

    The Federal Circuit agreed with the district court that the “payment handler” and “payment handler service” terms were functional, lacked sufficient structural meaning, and thus invoked § 112 ¶ 6. Although these terms did not use the word “means,” the court found that the presumption against § 112 ¶ 6 was rebutted under Williamson, which allows application of § 112 ¶ 6 when a term “recites function without reciting sufficient structure for performing that function.”

    The panel emphasized that:

    • “Handler” is akin to “module,” a term previously found by the court to lack structural significance.
    • Appending the term “payment” did not supply structure but merely described a function.
    • Expert testimony indicated that a person of ordinary skill would not understand how to implement the recited functions based on the claim language alone.

    Fintiv’s reliance on Dyfan, LLC v. Target Corp., 28 F.4th 1360 (Fed. Cir. 2022), was unpersuasive. Unlike Dyfan, where unrebutted expert testimony supported structure, here neither party’s expert testified that “payment handler” connoted a definite structure.

    2. Lack of Corresponding Structure in the Specification

    Once § 112 ¶ 6 was triggered, the court found that the patents failed to disclose any algorithm or adequate structure for the “payment handler” functionality. Merely restating the claimed function—“wrap[ping] APIs” and “expos[ing] a common API”—did not meet the requirement.

    Citing Aristocrat Technologies Australia Pty Ltd. v. International Game Technology, 521 F.3d 1328 (Fed. Cir. 2008), and Rain Computing, Inc. v. Samsung Electronics America, Inc., 989 F.3d 1002 (Fed. Cir. 2021), the court reiterated that describing only a general-purpose computer without a specific algorithm is insufficient.

    Fintiv’s attempt to point to a supposed two-step algorithm was rejected as merely a restatement of the claim language. The court also dismissed the idea that the figures in the patents showed a structural implementation of the payment handler, noting a lack of clarity on how the functions were performed or how different APIs were integrated.

    Implications

    This decision adds to the growing body of Federal Circuit case law demanding structural specificity in software patent claims. Key takeaways include:

    • Terms that combine a generic function descriptor with a purpose (e.g., “payment handler”) are increasingly likely to be swept into § 112 ¶ 6 territory if not clearly supported by structural description.
    • Boilerplate specification language that simply mirrors claim terms without detailing implementation will not rescue functional claims.
    • Practitioners should be cautious in relying on software terms like “service,” “module,” or “handler” without anchoring them to known, sufficiently detailed structures or algorithms in the specification.

    Conclusion

    Fintiv v. PayPal reiterates that when it comes to software patents, claiming a function is not enough—patentees must disclose how the function is performed with sufficient specificity. This decision reinforces the Federal Circuit’s post-Williamson trajectory and continues the tightening of indefiniteness doctrine in the software space.

    By Charles Gideon Korrell