IP UPDATE
Exploring the latest in intellectual property law
IP UPDATE
Exploring the latest in intellectual property law
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Lost in the constellation: Result-oriented claims miss the mark under § 101

by | May 7, 2026 |

Addressing issues related to patent eligibility, infringement, and damages, the US Court of Appeals for the Federal Circuit vacated in part, affirmed in part, and remanded, finding that certain result-oriented claims were directed to an abstract idea, lacked an inventive concept, and were therefore not patent eligible. Constellation Designs, LLC v. LG Electronics Inc., et al., Case No. 24-1822 (Fed. Cir. Apr. 28, 2026) (Lourie, Stoll, Oetken, JJ.)

Constellation sued LG for infringing its patents directed to communication systems employing non-uniform constellations, which are signal configurations designed to improve data transmission capacity compared to conventional uniform constellations. The accused products were LG televisions compliant with the ATSC 3.0 broadcast standard.

Constellation successfully moved for summary judgment in its favor on patent eligibility under 35 U.S.C. § 101. At trial, Constellation asserted nine claims across four patents, which the parties grouped into two categories: “optimization claims,” which recited constellations optimized for capacity, and “constellation claims,” which recited specific non-uniform constellation configurations. A jury found willful infringement and awarded damages. The district court denied LG’s motions for judgment as a matter of law (JMOL) of noninfringement and no damages. LG appealed.

On the patent eligibility issue, the Federal Circuit applied the two-step Alice framework and vacated the district court’s ruling as to the optimization claims. At step one, the Court found those claims directed to the abstract idea of optimizing a constellation for parallel decoding capacity. The Court emphasized that the claims were written in a result-oriented manner, reciting a constellation “optimized” for capacity without specifying how that optimization was achieved. Although the claims did not cover every possible optimization technique, they were broad enough to encompass all ways of optimizing a constellation for parallel decoding capacity. The Court rejected Constellation’s reliance on technical details in the specification and reiterated that the § 101 inquiry focuses on the claim language, not unclaimed implementation details. At step two, the Court found no inventive concept, explaining that Constellation’s alleged innovation was the abstract idea itself and that arguments based on novelty or nonobviousness do not satisfy § 101.

In contrast, the Federal Circuit affirmed the district court’s eligibility determination for the constellation claims. The Court explained that representative claims recited specific, concrete configurations (such as unequally spaced constellation points, distinct labeling, and overlapping point locations) amounting to a particular technological solution to a defined problem. Because those claims were not directed to an abstract idea, the Court did not proceed to step two.

On infringement, the Federal Circuit affirmed the denial of JMOL. The Court clarified that a patentee may rely on industry standard compliance to prove some claim limitations while using product-specific evidence for others, as long as the standard is sufficiently specific and either mandatory or shown to be implemented in the accused products. Applying that framework, the Court found that substantial evidence supported the jury’s verdict.

As for damages, the Federal Circuit affirmed the denial of LG’s JMOL motion and its challenge to the admissibility of Constellation’s damages expert. The Court [...]

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Missed delivery: Institution decision statutorily unreviewable

by | May 7, 2026 | ,

Addressing the scope of appellate review under the America Invents Act, the US Court of Appeals for the Federal Circuit determined that challenges grounded in 35 U.S.C. § 312(a)(2)’s real-party-in-interest requirement are unreviewable where they are closely tied to the Patent Trial & Appeal Board’s institution decision. Fed. Express Corp. v. Qualcomm Inc., Case No. 24-1236 (Fed. Cir. Apr. 29, 2026) (Hughes, Cunningham, Stark, JJ.)

FedEx owns a patent related to sensor-based logistics systems that provide shipment information and allow customized access controls. After FedEx sued Roambee for infringement in district court, Qualcomm (although not a party to that litigation) filed inter partes review (IPR) petitions challenging the FedEx patent. Qualcomm identified the Roambee litigation as a related matter but did not list Roambee as a real party in interest.

FedEx opposed institution, arguing that Qualcomm’s failure to identify all real parties in interest violated § 312(a)(2), which requires that a petition identify all such parties before it may be considered. The Board instituted review and later denied FedEx’s motion to terminate, explaining that it would not decide the real-party-in-interest issue because doing so was unnecessary to resolve the proceeding absent a time-bar or estoppel concern. In its final written decision, the Board declined to revisit the issue and held the challenged claims unpatentable as obvious. FedEx appealed.

On appeal, the Federal Circuit declined to review FedEx’s real-party-in-interest challenges. Relying on Supreme Court precedent and its own case law, the Federal Circuit explained that § 312(a)(2) is a statutory prerequisite “closely tied” to institution because a petition may be considered only if it identifies all real parties in interest. Thus, challenges asserting that the Board failed to properly apply § 312(a)(2) necessarily attack the institution decision itself and fall within § 314(d)’s bar on appellate review.

The Federal Circuit rejected FedEx’s attempt to reframe its arguments as a challenge to the Board’s post-institution conduct, including the denial of FedEx’s motion to terminate. The Court explained that even when raised later in the proceeding, such arguments “boil down” to whether the Board should have instituted IPR in the first place. Because § 312(a)(2) operates as a prerequisite to institution, those challenges remain unreviewable.

Turning to the merits, the Federal Circuit vacated the Board’s obviousness determination as to several claims. The Board had found those claims obvious based on a combination of prior art because it believed FedEx had not contested that ground. Both parties agreed on appeal that this premise was incorrect: FedEx had in fact disputed the combination. Because the Board’s analysis rested on a mistaken understanding of the record and failed to address FedEx’s arguments or fully evaluate the prior art, the Court concluded that meaningful appellate review was not possible and vacated the Board’s obviousness determination.

The Federal Circuit declined FedEx’s request for outright reversal of the Board. The Court explained that reversal is appropriate only where the record supports a single outcome, but here unresolved factual issues remained, including whether the prior art satisfied the relevant claim [...]

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Expert rule: There are reviewable non-final agency actions

by | May 7, 2026 |

In a decision addressing the scope of constitutional challenges to agency action, the US Court of Appeals for the District of Columbia Circuit affirmed a district court’s injunction barring an investigation by the US International Trade Commission premised on a protective order issued by an unconstitutionally appointed administrative law judge (ALJ). Sidak v. ITC, Case No. 23-5149 (D.C. Cir. Apr. 24, 2026) (Katsas, Rao, Walker, JJ.)

Gregory Sidak served as an expert witness in a 2017 Commission proceeding. During that proceeding, the presiding ALJ issued a protective order governing confidential information. At the time, ALJs were appointed unilaterally by the Commission’s chairman – a practice later called into question by the Supreme Court’s decision in Lucia v. SEC, which held that ALJs are “inferior officers” who must be appointed by the president, courts, or the “head” of a department. The Commission subsequently ratified the appointments of its ALJs but did not ratify their prior actions, including the protective order at issue.

Years later, the ITC initiated an investigation into whether Sidak violated that protective order. In response, Sidak filed suit in district court seeking to enjoin the investigation, arguing that the order was unenforceable because it had been issued by an improperly appointed ALJ and never ratified. The district court granted a permanent injunction, and the Commission appealed.

The DC Circuit affirmed, first addressing several threshold procedural issues. The Court determined that the district court had subject matter jurisdiction under 28 U.S.C. § 1331 because Sidak’s claim arose directly under the US Constitution. The Court explained that no applicable statutory review scheme displaced that jurisdiction for this type of claim, and that litigants may pursue equitable relief to enjoin unconstitutional agency action.

The DC Circuit also rejected the Commission’s argument that Sidak’s claim was unripe. Because the case presented purely legal questions regarding the enforceability of the protective order and Sidak faced a credible threat of sanctions, the dispute was both constitutionally and prudentially ripe. The Court further explained that final agency action is not required where a plaintiff brings an implied constitutional claim rather than a claim under the Administrative Procedure Act.

Turning to timeliness, the DC Circuit determined that Sidak had not forfeited his Appointments Clause challenge. Unlike a party that invokes an agency adjudication and seeks a ruling on the merits, Sidak was a third-party witness who neither initiated the underlying proceeding nor sought relief from the ITC. The Court emphasized that forfeiture principles apply differently in that context and that Sidak had no earlier opportunity or obligation to raise his claim.

On the merits, the DC Circuit affirmed the district court’s decision to enjoin the Commission’s investigation. The Commission did not dispute that the ALJ who issued the protective order had been improperly appointed or that the order had not been ratified. The DC Circuit concluded that the district court did not abuse its discretion by granting injunctive relief to prevent enforcement of an order lacking constitutional authority.

Finally, the DC Circuit rejected the Commission’s challenge [...]

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Personal jurisdiction: Are cease-and-desist letters enough?

by | Apr 30, 2026 |

In a decision clarifying how certain pre litigation enforcement efforts can establish personal jurisdiction, the US Court of Appeals for the Eleventh Circuit reversed the dismissal of Lanham Act and tortious interference claims for lack of personal jurisdiction, concluding that cease and desist letters sent into the jurisdiction satisfied the minimum contacts requirement and did not offend due process. Frida Kahlo Corporation v. Mara Cristina Teresa Romeo Pinedo, Case No. 24-10293 (11th Cir. Apr. 17, 2026) (Luck, Lagoa, Abudu, JJ.)

Frida Kahlo and Frida Kahlo Investments (collectively, Kahlo) manage and license a portfolio of trademarks and publicity rights associated with the artist Frida Kahlo. Kahlo sued Familia Kahlo and Mara Cristina Teresa Romeo Pinedo (collectively, Pinedo) alleging tortious interference and Lanham Act violations arising from Pinedo’s efforts to halt a traveling Frida Kahlo exhibition and related merchandise.

Central to the dispute were cease and desist letters sent by Pinedo to Kahlo’s Florida based business partners. The letters asserted that Pinedo held superior rights to Frida Kahlo’s name, likeness, and trademarks and threatened legal action if the recipients continued their involvement with Kahlo. Kahlo alleged those claims were false and caused business partners to withdraw or hesitate, disrupting Kahlo’s licensing relationships.

Kahlo filed suit in Florida. Pinedo moved to dismiss for lack of personal jurisdiction. The district court granted the motion, concluding that Florida’s corporate shield doctrine protected Pinedo from jurisdiction and that, in any event, Pinedo lacked sufficient minimum contacts with Florida. Kahlo appealed.

The Eleventh Circuit reversed, concluding first that the corporate shield doctrine did not bar jurisdiction over Pinedo. The Court focused on the language of the cease and desist letters, which expressly identified Pinedo as the “heiress of the painter Frida Kahlo” and stated that the letters were sent “in our capacity as representatives of Mara Cristina Teresa Romeo Pinedo.” The Court found that those representations showed that Maria Pinedo was acting in her personal capacity, not merely as a corporate agent. As a result, the corporate shield doctrine, which can protect corporate officers from jurisdiction based solely on acts performed for a corporation, did not apply. Because the doctrine was inapplicable, Pinedo was subject to Florida’s long arm statute, which permits jurisdiction where a nonresident commits a tortious act outside the state that causes injury within Florida.

The Eleventh Circuit next addressed whether exercising specific personal jurisdiction would comport with due process. The Court answered in the affirmative, explaining that Pinedo intentionally directed conduct into Florida by sending cease and desist letters to Florida entities. The alleged tortious interference claims arose directly from those communications, satisfying the relatedness requirement for specific jurisdiction.

The Eleventh Circuit also found purposeful availment because Pinedo plausibly alleged an intentional tort, the letters were expressly sent to Florida entities, and it was reasonable for Pinedo to anticipate having to defend itself in Florida based on its actions.

Finally, the Eleventh Circuit concluded that Pinedo failed to make a compelling case that exercising jurisdiction would violate traditional notions of fair play and [...]

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Patent disclosure erases trade secret protection

by | Apr 30, 2026 | ,

Addressing the boundary between patent disclosures and trade secret protection, the US Court of Appeals for the Federal Circuit reversed a jury’s findings of trade secret misappropriation, breach of contract, and improper inventorship, concluding that the asserted “trade secrets” were generally known and therefore not protectable under California law. The Court affirmed, however, a $1 million statutory damages award for trademark counterfeiting. International Medical Devices, Inc. v. Cornell, Case Nos. 25 1580; 1605 (Fed. Cir. Apr. 17, 2026) (Dyk, Reyna, Taranto, JJ.)

International Medical Devices, Menova International, and Dr. James Elist (collectively, the plaintiffs) manufacture and sell the Penuma® cosmetic penile implant. The plaintiffs sued Dr. Robert Cornell and associated individuals and entities after Cornell attended a Penuma® surgical training session under a nondisclosure agreement (NDA) and later helped develop a competing implant. The plaintiffs asserted claims for misappropriation of trade secrets, breach of the NDA, trademark counterfeiting based on unauthorized use of the Penuma® mark, and invalidity of two cosmetic implant patents for failure to name Elist as an inventor.

A jury found for the plaintiffs on all claims. After a bench trial on remedies, the district court awarded more than $17 million in trade secret and exemplary damages, entered a permanent injunction, and awarded $1 million in statutory damages for counterfeiting. Cornell appealed.

The Federal Circuit reversed the trade secret verdict in its entirety, concluding that none of the asserted trade secrets were protectable under California law. The Court concluded that the alleged technical trade secrets were disclosed in publicly available patents and thus were “generally known” as a matter of law.

In doing so, the Federal Circuit reaffirmed the long-standing principle that “that which is disclosed in a patent cannot be a trade secret.” Once information enters the public domain through patent disclosures, it cannot later be reclaimed as confidential business information through trade secret law.

The plaintiffs’ remaining alleged trade secret (a list of surgical instruments) fared no better. The Federal Circuit found that the list had been emailed to the defendants without any confidentiality designation or obligation, defeating any claim that reasonable measures were taken to maintain its secrecy.

Because the plaintiffs failed to identify any confidential information beyond the alleged trade secrets, the Federal Circuit also reversed the breach of contract verdict. The NDA expressly excluded information that was “generally available to the public,” and the Court found that an NDA cannot transform public domain information into protected confidential material.

The Federal Circuit reached a different conclusion on trademark counterfeiting, however, and affirmed the jury’s finding and the $1 million statutory damages award. The Court explained that the evidence showed that Cornell had advertised and offered Penuma® implants without authorization. Cornell argued that the Penuma® mark was registered only for goods, not services, and therefore could not support a counterfeiting claim tied to surgical procedures. The Court rejected that argument, concluding there was sufficient evidence that Cornell offered the Penuma® implant itself as a good, not merely a medical service.

Finally, the Federal Circuit [...]

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Article III standing: Claims of future injury must be sufficiently tied to the claim limitations at issue

by | Apr 16, 2026 |

The US Court of Appeals for the Federal Circuit dismissed an appeal of a post-grant review (PGR) for lack of Article III jurisdiction, finding that the appellant failed to meet its burden to prove it would likely suffer an injury in fact. ironSource Ltd. v. Digital Turbine, Inc., Case No. 2024-1831 (Fed. Cir. Apr. 7, 2026) (Moore, Lourie, Reyna J.J.)

Mobile advertising company Digital Turbine has a patent related to streamlined background processes for downloading and installing mobile applications. That patent is a continuation an earlier related patent which was invalidated during a prior PGR proceeding. Mobile advertising and app monetization platform ironSource once had a product on the market called Aura, which included “Click to Install” features. When faced with what it referred to as “veiled threats” of liability for infringement of the earlier patent, ironSource modified its Aura product – eventually removing it from the market – and petitioned the Patent Trial & Appeal Board for a PGR of the continuation patent’s claims 1 – 22.

During the PGR, the Board held that claims 1 – 22 were all unpatentable pursuant to its earlier decision in the earlier PGR but allowed Digital Turbine to amend the claims. In so doing, Digital Turbine included, among other changes, two narrowing limitations to the claims. The Board concluded that ironSource had not carried its burden of proving that the newly amended claims were unpatentable or ineligible for patent protection. ironSource appealed.

On appeal, the Federal Circuit explained that while Article III standing is not required before the Board, it is required to sustain an appeal of the Board’s decisions. The burden is on the appellant to prove it meets the requirements for standing under federal law at the time of filing. Federal law requires an appellant to prove it has “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the [appellee], and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo. Specific to patent cases, the appellant must show concrete evidence of its intended future actions that pose a substantial risk of infringement or an assertion of infringement.

To meet this obligation, ironSource submitted a declaration by one of its senior directors. The declarant discussed past changes and concessions to the Aura product that ironSource had made in light of Digital Turbine’s patent rights. It also stated that ironSource intended to reintroduce the Aura product to the market. Nevertheless, the Federal Circuit held that ironSource failed to meet its burden of tying that potential product’s features to the patent’s amended claims. Instead, ironSource focused on the claims of the original, alleging that they were “substantially identical” to the continuation patent’s claims, i.e., the claims Digital Turbine had previously “threatened” against the company. The Court emphasized, however, that ironSource failed to account for the narrowing limitations in the amended claims and thus failed to prove a likely injury in fact from infringement of the substituted claims.

Finally, the Federal Circuit distinguished [...]

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“X” marks the spot: A single DuPont factor may be dispositive

by | Apr 16, 2026 |

The US Court of Appeals for the Federal Circuit affirmed dismissal of a trademark opposition, concluding that a single DuPont factor may be sufficient on its own to support a finding of no likelihood of confusion. Fuente Mktg. Ltd. v. Vaporous Techs., LLC, Case No. 24-1460 (Fed. Cir. April 8, 2026) (Prost, Taranto, Hughes, JJ.)

Fuente Marketing and Vaporous Technologies both sell smoking related products. Fuente owns two standard character trademark registrations for the letter “X,” used in connection with cigars and related accessories. Vaporous sought to register a highly stylized design mark for use with its vaping products. The parties stipulated that Vaporous’ mark consisted of “an abstract stick figure consisting of two diagonal intersecting lines in the shape of a wide stylized letter ‘X’ with a shaded circle above.”

Fuente opposed the application at the Trademark Trial and Appeal Board (TTAB), arguing that Vaporous’ mark was likely to cause confusion with Fuente’s “X” marks. Applying the DuPont factors, the Trademark Trial & Appeal Board dismissed the opposition, concluding that there was no likelihood of confusion. Fuente appealed.

The Federal Circuit reviewed the Board’s factual findings for substantial evidence and its ultimate likelihood of confusion determination de novo. Fuente challenged the Board’s analysis of two DuPont factors and argued that the Board improperly weighed the factors as a whole.

The Federal Circuit focused on the first DuPont factor, which evaluates the similarity or dissimilarity of the marks in their entireties as to appearance, sound, connotation, and commercial impression. The court found that substantial evidence supported the Board’s finding that this factor weighed heavily against a likelihood of confusion. The Federal Circuit agreed that consumers were more likely to perceive Vaporous’ mark as a stylized stick figure rather than the letter “X.” Unlike Fuente’s standard character mark, Vaporous’ design mark did not sound like the letter “X” as it had no pronunciation, and it incorporated prominent visual features – including a shaded circle comprising roughly one fifth of the mark – that were “not a minor or unnoticeable feature.”

Although the Board found that the remaining DuPont factors were neutral or favored Fuente, the Federal Circuit explained that it could “discern the Board’s path to dismissal” and affirmed the conclusion that in a case like this one DuPont factor was sufficient to establish dissimilarity between the marks. The Court emphasized that a likelihood of confusion analysis is a balancing test, and no minimum number of factors must favor one party.

Practice note: This decision reinforces that a single DuPont factor, particularly the dissimilarity of the marks, may be dispositive of likelihood of confusion. Parties should not assume that favorable findings on other factors can overcome a clear lack of similarity in appearance, sound, connotation, or commercial impression.



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Settled means settled: Broad settlement release equates to res judicata

by | Apr 16, 2026 |

The US Court of Appeals for the Fourth Circuit affirmed a summary judgment decision, concluding that an intellectual property owner’s claims were barred by the scope of a settlement agreement resolving earlier state court litigation between the parties. Clear Touch Interactive, Inc. v. The Ockers Co. et al., Nos. 25-1304, 25-1374 (4th Cir. Apr. 1, 2026) (Wynn, Harris, JJ.) (Rushing, J. concurring in part and dissenting in part).

Clear Touch, a designer and manufacturer of interactive technology products, entered into exclusive reseller agreements with information and communications technology reseller Ockers in 2014. After Clear Touch revoked Ockers’ exclusivity in 2017, Ockers began developing a competing product called TouchView. Clear Touch terminated Ockers as a reseller in 2019. The following year, Ockers filed suit in South Carolina state court alleging breach of contract and asserting various tort, trade secret, defamation, and civil conspiracy claims.

In June 2021, the parties resolved the state court action through a settlement agreement that dismissed the case with prejudice and included a broad mutual release of all claims and counterclaims – known or unknown – that were brought or could have been brought and that arose out of or related to the subject matter of the lawsuit.

Despite that settlement, Clear Touch filed a federal action one month later against Ockers, two of its officers (John J. Houser and Jason Houser), and TouchView Interactive, asserting claims for trademark infringement, trade secret misappropriation, and unfair competition based on the TouchView product. The defendants moved for judgment on the pleadings, arguing that the settlement agreement and the state court’s dismissal with prejudice barred Clear Touch’s claims.

The district court initially allowed some claims to proceed, including certain Lanham Act claims and claims against TouchView Interactive, but dismissed the remainder. After discovery, however, the court revisited the preclusion issue and granted summary judgment to Ockers and its officers, concluding that all of Clear Touch’s remaining claims were barred by res judicata. The district court also granted summary judgment to TouchView Interactive, finding it to be a shell entity with no commercial activity. Following a jury verdict in favor of Ockers, Clear Touch appealed.

Clear Touch challenged the district court’s res judicata determination, arguing both substantive error and procedural error under Rule 54(b). The Fourth Circuit rejected both arguments. Substantively, the Fourth Circuit held that Clear Touch failed to create a genuine dispute regarding the settlement agreement’s plain language or the parties’ mutual intent to release all claims, including those that could have been brought, arising from the same operative facts. Even when viewed in the light most favorable to Clear Touch, the federal claims were precluded because they could have been asserted as counterclaims in the prior state court action, which had been dismissed with prejudice.

Procedurally, the Fourth Circuit found no abuse of discretion in the district court’s decision to revisit its earlier rulings. Rule 54(b) permits revision of nonfinal orders when new evidence emerges or a legal error becomes apparent. Here, supplemental evidence showed that Clear Touch [...]

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Where’s Waldo? Inventorship error fatal when omitted coinventor cannot be found

by | Apr 16, 2026 |

Addressing the limits of correcting inventorship, the US Court of Appeals for the Federal Circuit affirmed an invalidity determination where an omitted coinventor could not be added because statutory notice requirements could not be satisfied. Fortress Iron, LP v. Digger Specialties, Inc., Case No. 24-2313 (Fed. Cir. Apr. 2, 2026) (Lourie, Hughes, Kleeh, JJ.)

Building products manufacturer Fortress Iron sued competitor Digger Specialties for infringement of two patents directed to pre assembled vertical cable railing panels. The inventions resulted from collaboration among Fortress’ owner and an employee, as well as two employees of its quality control liaison, Hua Ping Huang and Alfonso Lin, who proposed design changes to address cable tensioning issues. The issued patents, however, named only Fortress personnel and omitted Lin and Huang as coinventors.

During the litigation, Fortress acknowledged that Lin and Huang were coinventors. Fortress successfully added Lin under 35 U.S.C. § 256(a) but was unable to locate Huang, who had left the liaison company years earlier without providing contact information. The parties filed cross motions for summary judgment, with Fortress seeking correction of inventorship and Digger seeking invalidity. The district court denied Fortress’ motion and held the patents invalid for incorrect inventorship. Fortress appealed.

Fortress argued that Huang was not a “party concerned” under § 256(b) and therefore was not entitled to notice and a hearing. The Federal Circuit rejected that argument, explaining that an omitted inventor qualifies as a “party concerned” regardless of whether the inventor has a demonstrated economic interest in the patent. The Court explained that inventorship carries legal, financial, and ownership consequences that an inventor has a right to contest, and § 256(b)’s notice and hearing requirements cannot be bypassed. The Court further clarified that standing and “party concerned” status under § 256(b) are distinct legal concepts with different requirements.

The Federal Circuit also rejected Fortress’ characterization of § 256(b) as a broadly permissive “savings provision,” explaining that the statute only operates to save patents once its procedural prerequisites of notice and an opportunity to be heard are satisfied.

Turning to Fortress’ second argument, the Federal Circuit concluded that a patent that incorrectly lists its inventors and cannot be corrected under § 256 has a clear statutory basis for invalidity. Reading § 256(b) together with §§ 101 and 100(f), the Court concluded that when an invention has multiple inventors, all must be named. Allowing a patent to survive with only some inventors listed would render § 256’s corrective framework meaningless.

Practice note: The decision underscores the importance of accurate inventorship determinations and the practical risk that patents may be rendered invalid if an omitted inventor cannot be located and statutory correction requirements cannot be met.



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Game over: No self-help clock reset for mandatory stay request

by | Apr 9, 2026 |

The US Court of Appeals for the Federal Circuit held that a respondent in a US International Trade Commission proceeding may not seek a mandatory stay of a companion federal district court case under 28 U.S.C. § 1659(a)(2) by refiling a declaratory judgment action involving the same parties when it missed the mandatory 30-day deadline for seeking a stay in the originally filed action. Ascendis Pharma A/S v. BioMarin Pharmaceutical Inc., Case No. 26-1026 (Fed. Cir. Mar. 26, 2026) (Lourie, Chen, Stoll, JJ.)

Ascendis Pharma and BioMarin Pharmaceutical are both drug manufacturers. Ascendis filed a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for its drug TransCon CNP. The next day, BioMarin filed a complaint at the Commission, alleging that TransCon CNP infringed a BioMarin patent. To avoid the Commission’s importation safe harbor, BioMarin alleged that TransCon CNP was being imported in a quantity that exceeded “any quantity that would be solely for uses reasonably related to the development and submission of information to the FDA.”

Ascendis filed a declaratory judgment action in federal district court, asserting that its “manufacture, use, and importation” was “exempt from patent infringement liability by the statutory safe harbor.” After BioMarin moved to dismiss or stay the declaratory judgment action, Ascendis reversed course and filed a notice of voluntary dismissal, stating its intention to refile its declaratory judgment action and seek a mandatory stay under § 1659(a)(2). Ascendis refiled and two weeks later filed a § 1659(a)(2) motion for a mandatory stay. The district court granted BioMarin’s discretionary stay and denied Ascendis’s motion as moot. Ascendis appealed.

First addressing appellate jurisdiction, the Federal Circuit held that Ascendis had standing for its appeal. At the district court, BioMarin had argued that the district court should retain authority to lift any stay and stated that if the FDA approved TransCon CNP and the Ascendis NDA, BioMarin intended to seek preliminary injunctive relief from the district court. The Federal Circuit explained that those circumstances created a sufficiently real and immediate controversy for appellate jurisdiction.

The Federal Circuit then assessed whether it had jurisdiction under the collateral order doctrine. Under that doctrine, an order must meet three requirements to permit an interlocutory appeal. It must “(1) ‘conclusively determine the disputed question’; (2) ‘resolve an important issue completely separate from the merits of the action’; and (3) ‘be effectively unreviewable on appeal from a final judgment.’” Because denial of Ascendis’s stay motion conclusively determined that issue, and because the intent of § 1659(a)(2) is to prevent overlapping litigation, the Court found that the requirements for collateral order jurisdiction were met.

The Federal Circuit concluded that Ascendis’s arguments failed on the merits, however. After entering a discretionary stay, the district court had denied Ascendis’s motion as moot. The Federal Circuit found that a temporary stay does not necessarily render a stay under § 1659(a)(2) moot, and that a discretionary stay that can be lifted is not the same as (and thus does not moot) a request for [...]

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