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Same patent, same light: Director vacates IPR decision at odds with ITC decision

The director of the United States Patent & Trademark Office (USPTO) vacated a Patent Trial and Appeal Board final written decision finding challenged claims obvious where the US International Trade Commission, considering the same patent, parties, and obviousness theory, had reached the opposite conclusion. The director found that the Board had not adequately justified departing from the Commission’s analysis. Biofrontera Inc. v. Sun Pharmaceutical Industries Inc., IPR2024-01312 (USPTO Dir. July 29, 2026) (Squires, Dir.)

Biofrontera petitioned for inter partes review (IPR) of a Sun Pharmaceutical patent directed to a photodynamic dermatology device. The Board instituted review and ultimately found all challenged claims unpatentable as obvious.

The same patent was also at issue in a Section 337 investigation before the Commission. Sun Pharmaceutical had accused Biofrontera of importing certain photodynamic therapy systems that infringed two patents. An administrative law judge (ALJ) found infringement and recommended an exclusion order. The ALJ also found that Biofrontera had not shown the claims of the patent at issue in the IPR to be obvious.

Before the Board, Biofrontera argued that the ALJ’s determination did not warrant deference because it was not yet final, remained subject to Commission review, and was based on a different evidentiary record and burden of proof. The Board agreed and reached the opposite conclusion on obviousness.

On Director Review, the director rejected the Board’s explanations and vacated the final written decision. The director concluded that the Board had not identified a sufficient basis for reaching a patentability determination inconsistent with the Commission’s assessment of the same obviousness theory.

The director first rejected the Board’s reliance on the non-final status of the ALJ’s determination. By the time of Director Review, the full Commission had upheld the ALJ’s conclusion that Biofrontera had not shown the claims obvious, eliminating the finality concern on which the Board had relied. The director further explained that even a non-final ALJ determination may remain relevant when the Board considers whether parallel proceedings justify terminating or otherwise declining to continue an IPR.

The director also found that differences in the evidentiary records did not adequately explain the conflicting results. Although the IPR included expert testimony that had not been presented at the Commission, the Board did not sufficiently explain why that testimony warranted reaching a different conclusion on the same prior art combination.

Nor did the differing burdens of proof resolve the inconsistency. The director acknowledged that an IPR applies the preponderance-of-the-evidence standard, while a Commission respondent challenging patent validity faces a higher burden. But the difference in standards, standing alone, did not explain why the two tribunals reached conflicting factual conclusions regarding the same claim limitation and prior art combination.

Finding no adequate justification for the divergence, the director vacated the Board’s final written decision and dismissed the IPR petition rather than remanding for further proceedings.

Practice Note: Parties litigating patent validity in parallel Board and Commission proceedings should expect prior findings from one forum to receive meaningful consideration in the other, particularly where the same parties, prior [...]

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Patent disclosure erases trade secret protection

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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Virtually displayed: USPTO updates guidance for computer-generated interfaces and icons

To address evolving digital technologies, the United States Patent and Trademark Office (USPTO) issued supplemental guidance for examining design patent applications directed to computer-generated interfaces and icons. The guidance expands flexibility for applicants – particularly in projection, hologram, and virtual and augmented reality (PHVAR) contexts – while maintaining the statutory requirement that claimed designs be tied to an article of manufacture.

The USPTO first sought public input in 2020 on how the “article of manufacture” requirement under 35 U.S.C. § 171 should apply to emerging digital designs. Although many commenters urged recognition of PHVAR designs, subsequent guidance issued by the USPTO in 2023 did not fully address those technologies. The latest supplemental guidance responds to continued stakeholder feedback, particularly regarding the limitations imposed by prior drawing requirements.

Traditionally, applicants seeking protection for computer-generated icons or graphical user interfaces (GUIs) were required to depict a physical article of manufacture, such as a display screen, in solid or broken lines in the drawings. This requirement ensured that the claimed design was not merely a “transient or disembodied” image but was instead tied to a statutory article of manufacture.

The updated guidance removes the requirement that drawings depict a display panel or other physical article, provided that the title and claim clearly identify the relevant article of manufacture (e.g., a computer, computer display, or computer system). In such cases, the article need not appear in the drawings, so long as the application, taken as a whole, makes it clear that the claimed design is “for” an article of manufacture and not merely an abstract or disembodied image. For example, phrases such as “interface for a computer system” or “icon for a display panel” are sufficient to establish that the design is tied to a qualifying article.

The USPTO reiterated that the guidance “does not constitute substantive rulemaking and hence does not have the force and effect of law.” Examiners will continue to evaluate applications under all applicable patentability provisions, including §§ 102, 103, and 112.

Overall, the updated guidance provides applicants with greater flexibility in claiming and depicting computer-generated designs while reaffirming that such designs must remain tied to a qualifying article of manufacture.




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Too late to help: Inventorship fix fails to revive forfeited argument

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board, concluding that the retroactive effect of a correction of inventorship under 35 U.S.C. § 256 does not bar the application of forfeiture principles in inter partes review (IPR) proceedings, and that a patent owner that fails to timely raise an antedating theory during an IPR may forfeit reliance on a later corrected inventorship to resurrect that theory. Implicit, LLC v. Sonos, Inc., Case Nos. 20-1173; -1174 (Fed. Cir. Mar. 9, 2026) (Taranto, Stoll, Cunningham, JJ.)

Implicit owns patents directed to content rendering that originally named Edward Balassanian and Scott Bradley as co-inventors. Sonos filed IPR petitions against both patents, asserting unpatentability under 35 U.S.C. §§ 102 and 103, primarily based on Janevski, which had an effective prior art date of December 11, 2001.

To avoid Janevski as prior art, Implicit argued that the inventions were conceived and reduced to practice before December 11, 2001. It contended that Balassanian and Bradley conceived of the inventions and collaborated with another engineer, Guy Carpenter, to implement the invention prior to December 2001. Implicit argued that Carpenter’s work inured to the benefit of the named inventors, thereby antedating Janevski. The Board rejected Implicit’s argument and found the challenged claims unpatentable as anticipated or obvious over Janevski. The Board found Implicit’s evidence insufficient to establish conception and communication of the invention by Carpenter in a manner that would support an earlier reduction to practice.

Following the Federal Circuit’s and Supreme Court’s decisions in Arthrex v. Smith & Nephew addressing the Appointments Clause as applied to IPR proceedings, the case was remanded to permit Director review. While proceedings were ongoing, Implicit sought correction of inventorship under 35 U.S.C. § 256 to add Carpenter as a co-inventor. The United States Patent & Trademark Office (USPTO) granted the request and issued certificates of correction in August 2022. The Federal Circuit remanded the case to the Board to determine what impact, if any, the corrections had on the prior final written decisions. The Board concluded that equitable doctrines, including forfeiture, precluded Implicit from relying on the corrected inventorship to advance a new antedating theory. Implicit appealed.

The appeal presented two principal questions:

  • Whether the retroactive effect of a correction of inventorship under § 256 forecloses application of forfeiture principles in an IPR proceeding.
  • Whether the Board abused its discretion in finding that Implicit forfeited its right to assert a new antedating theory based on corrected inventorship.

Implicit argued that § 256 contains no temporal limitation and that corrections operate retroactively, requiring the Board to revisit its unpatentability determinations once Carpenter was added as an inventor. Sonos and the USPTO countered that Implicit had litigated the IPRs on a single inventorship theory and waited until after adverse final written decisions to change course.

The Federal Circuit affirmed on both grounds.

First, the Federal Circuit found that forfeiture principles may apply notwithstanding the retroactive effect of § 256. Although [...]

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IPR estoppel doesn’t extend to ongoing ex parte reexamination

The US Court of Appeals for the Federal Circuit affirmed a decision by the Patent Trial & Appeal Board, concluding that inter partes review (IPR) estoppel under 35 U.S.C. § 315(e)(1) does not apply to ongoing ex parte reexamination proceedings and that the Board may retain jurisdiction over a patent even after its expiration. In re Gesture Tech. Partners, LLC, Case No. 25-1075 (Fed. Cir. Dec. 1, 2025) (Lourie, Bryson, Chen, JJ.)

Gesture Technology owns a patent covering methods and apparatus for rapid TV camera and computer-based sensing of objects and human input for applications such as handheld devices, automotive systems, and video games. Samsung requested ex parte reexamination, which the United States Patent & Trademark Office (USPTO) granted.

While the ex parte reexamination was pending, Unified Patents, an organization that includes Samsung as a member, filed two IPR petitions. After the Board issued a final written decisions on the IPRs, Gesture Technology petitioned to terminate the ex parte reexamination, asserting that Samsung was estopped under 35 U.S.C. §315(e)(1) from “maintain[ing] a proceeding” at the USPTO challenging the patent on grounds it could have raised in the IPRs. The USPTO denied the petition, concluding that the estoppel provision does not apply to continuing ex parte reexamination proceedings.

Gesture Technology appealed both IPR final written decisions where the Board invalidated all but two claims. In the ex parte reexamination, the examiner rejected the two remaining claims as anticipated by Liebermann, a patent directed to an electronic communication system designed for deaf individuals that enables real-time interaction using sign language and speech translation. The Board affirmed. Gesture Technology appealed.

Gesture Technology argued that:

  • Estoppel under 35 U.S.C. §315(e)(1) should bar the reexamination because Samsung had previously participated in an IPR.
  • The Board had no jurisdiction because the patent expired.
  • The Board erred in finding anticipation based on Liebermann.

The Federal Circuit rejected Gesture Technology’s estoppel argument, explaining that § 315(e)(1) applies to an IPR “petitioner” maintaining a proceeding before the USPTO. In contrast, under 35 U.S.C. § 305, the USPTO – not the requester – maintains an ex parte reexamination. Thus, estoppel does not bar ongoing ex parte reexamination proceedings.

Gesture Technology argued that Liebermann did not correlate information with a function of the apparatus because its sending function was always selected. The Federal Circuit disagreed, finding substantial evidence that Liebermann disclosed a transmitter/receiver device with a camera performing initial image processing and transmitting processed data. Liebermann’s description of reducing images to pertinent data and sending that data to a processing center supported the conclusion that its device correlated image information with a transmission function, satisfying the claim limitations.

Finally, the Federal Circuit concluded that the Board retains jurisdiction over ex parte reexaminations even after patent expiration. Patent owners maintain rights such as the ability to sue for past damages, creating a live case or controversy that an ex parte reexamination can resolve.

Practice note: Ex parte reexamination remains a viable tool for challengers even after an IPR concludes because estoppel [...]

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Pick a lane: USPTO Director nixes IPR for inconsistent claim construction positions

The Director of the United States Patent and Trademark Office (USPTO) vacated a Patent Trial & Appeal Board decision instituting an inter partes review (IPR) proceeding after finding that the petitioner advanced inconsistent claim construction positions before the Board and in parallel district court litigation without adequate justification. Tesla, Inc. v. Intellectual Ventures II LLC, IPR2025-00340 (PTAB Nov. 5, 2025) (Stewart, USPTO Dir.)

Intellectual Ventures II LLC (IV), the patent owner, requested director review of the Board’s decision granting institution, arguing that the decision should be reversed because Tesla, Inc., the petitioner, failed to adequately explain why it advanced inconsistent claim construction positions before the district court and the Board.

In the district court, Tesla opposed IV’s plain and ordinary meaning construction of the claim limitation “generating said target feature information from said data statistics” in independent claim 1. Tesla argued that the limitation was indefinite because a person of ordinary skill in the art could not determine its meaning and scope with reasonable certainty. In contrast, before the Board, Tesla asserted that “no claim term requires express construction” and that the challenged claims should be given their plain and ordinary meaning.

IV contended that Tesla’s justification (that it was statutorily prohibited from raising indefiniteness challenges in an IPR) was insufficient to explain the divergent positions. While the Board’s rules do not categorically prohibit petitioners from taking inconsistent claim construction positions across forums, petitioners must explain why those differences are warranted.

The Director agreed with IV, finding Tesla’s rationale inadequate. The Director explained that simply asserting that indefiniteness cannot be raised in an IPR does not explain why a petitioner should be permitted to raise inconsistent invalidity challenges in two forums. In vacating the institution decision, the Director emphasized that permitting such inconsistencies without proper justification would undermine the USPTO’s goal of “providing greater predictability and certainty in the patent system.”




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Double trouble: Proposed IPR institution changes would limit duplicative proceedings

The United States Patent and Trademark Office (USPTO) proposed changes to the rules governing inter partes reviews (IPRs) before the Patent Trial & Appeal Board, including setting limits on use of IPR proceedings for patent claims that have already been challenged in a prior proceeding. According to the USPTO, the proposal is aimed at preventing duplicative litigation against patent holders and promoting fairness, efficiency, and predictability in patent disputes.

The Notice of Proposed Rulemaking introduces changes to 37 C.F.R. § 42.108 that would bar the institution of IPRs in cases where:

  • A petitioner refuses to stipulate that it won’t pursue invalidity challenges under §§ 102 or 103 in other venues, such as a district court or the US International Trade Commission (ITC).
  • The challenged claims were found not invalid or not unpatentable in a prior district court, ITC, Board reexamination, or Federal Circuit proceeding.
  • Parallel litigation involving the patent will likely reach a decision before the final IPR written decision.

The proposed rule would provide an exception to the proposed IPR limitations in “extraordinary circumstances,” such as a bad faith institution of a previous IPR or a substantial change in law that renders a prior challenge irrelevant.

The USPTO explained that the proposed changes will offer greater certainty for patent owners by reducing serial validity challenges, improving judicial efficiency by minimizing duplicative proceedings, and facilitating lower litigation costs and stronger investment incentives. The USPTO noted that the changes would benefit smaller technology companies, which often lack the litigation resources of larger companies and are more vulnerable to the effects of weaker patent rights.

The proposed changes would represent a significant shift in the availability of IPR for petitioners and would alter the timing and strategy of decisions about whether to pursue an IPR. Comments on the proposed rule changes are due by November 17, 2025, and can be submitted via the federal eRulemaking portal.




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Use of general knowledge in IPR petitions will no longer work

On July 31, 2025, the US Patent & Trademark Office (PTO) issued a memo clarifying the requirements under 37 C.F.R. § 42.104(b)(4) for inter partes review (IPR) petitions. The memo emphasizes that petitioners must clearly identify where each element of the challenged claims is found in the prior art patents or printed publications relied upon.

Historically, the Patent Trial & Appeal Board permitted petitioners to rely on applicant admitted prior art (AAPA), expert testimony, common sense, and other forms of general knowledge to fill in missing claim limitations. However, the new guidance states that such general knowledge, including AAPA, can no longer be used to supply missing claim elements. If an IPR petition relies on general knowledge to bridge gaps in the prior art, the Board will now deny institution.

The memo clarifies that § 104(b)(4) does not limit the use of general knowledge to support a motivation to combine or to demonstrate the knowledge of a person of ordinary skill in the art. However, § 104(b)(4) may be narrower than 35 U.S.C. § 311(b). Just weeks before the memo was issued, the US Court of Appeals for the Federal Circuit’s decision in Shockwave Medical. v. Cardiovascular Systems held that AAPA can be used to supply missing claim limitations without violating § 311(b), highlighting a potential tension between the rule and judicial interpretation.

The PTO’s new requirements will apply to all IPR petitions filed on or after September 1, 2025.

Practice note: To meet the threshold for institution, IPR petitioners should ensure that each claim element is explicitly mapped to prior art patents or printed publications. Reliance on general knowledge to fill in missing elements will no longer be sufficient.




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Take That Conception Out of the Oven – It’s CRISPR Even If the Cook Doesn’t Know

Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception of an invention does not require that the inventor appreciated the invention at the time of conception. Knowledge that an invention is successful is only part of the case for reduction to practice. Regents of the Univ. of Cal. et al. v. Broad Inst. et al., Case No. 22-1594 (Fed. Cir. May 12, 2025) (Reyna, Hughes, Cunningham, JJ.)

The Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, Regents) and the Broad Institute, Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively, Broad) were each separately involved in research concerning CRISPR systems that “are immune defense systems in prokaryotic cells that naturally edit DNA.” At issue was the invention of the use of CRISPR systems to modify the DNA in eukaryotic cells. Regents and Broad filed competing patent applications resulting in an interference proceeding under pre-AIA law at the US Patent & Trademark Office Board of Patent Appeals & Interferences to determine which applicant had priority to the invention.

The main issue before the Board was a priority dispute over who first conceived of the invention and sufficiently reduced it to practice under pre-AIA patent law. Regents submitted three provisional patent applications dated May 2012, October 2012, and January 2013 and moved to be accorded the benefit of the earliest filing date, May 2012, for the purpose of determining priority. Alternatively, Reagents sought to be accorded either October 2012 or January 2013 as its priority date. The Board found that Regents’ first and second provisional applications (filed in May and October 2012, respectively) were not a constructive reduction to practice because neither satisfied the written description requirement of 35 U.S.C. § 112. The third provisional application, filed in January 2013, was the first to amount to a constructive reduction to practice of the counts in interference. The Board then ruled that Broad was the senior party for the purposes of priority in the interference proceeding because Broad reduced the invention to practice by October 5, 2012, when a scientist submitted a manuscript to a journal publisher. The Board ruled that Regents failed to prove conception of the invention prior to Broad’s actual reduction to practice. Regents appealed.

Regents argued that in assessing conception, the Board “legally erred by requiring Regents’ scientist to know that their invention would work.” The Federal Circuit agreed and vacated the Board’s decision. As the Court explained, there are three stages to the inventive process: conception, reasonable diligence, and reduction to practice. At the conception stage, “an inventor need not know that his invention will work for conception to be complete.” Rather, knowledge that the invention will work, “necessarily, can rest only on an actual reduction to practice.” The Board therefore legally erred by requiring Regents to know its invention would work to prove [...]

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New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical landscape, including pharmaceutical benefit manager (PBM) pricing practices, next-generation drug releases, patent portfolio assertions, and use of US Food and Drug Administration (FDA) regulatory mechanisms. Many of the bills’ proposals have been proposed before, but it is significant that the six bills were moved to the full Senate with bipartisan support.

The Affordable Prescriptions for Patients Act, if passed, would limit how many patents a reference product sponsor can assert in a Biologics Price Competition and Innovation Act (BPCIA) litigation against a biosimilar applicant, although such limits could be surpassed with court approval. A biologics license holder could assert up to 20 patents in a BPCIA case. Certain patents, such as method of treatment patents, would fall outside the limitation.

Against the backdrop of the Supreme Court’s 2013 holding in FTC v. Watson that certain “pay for delay” agreements are prohibited as anticompetitive, the Preserve Access to Affordable Generics and Biosimilars Act would add precision to the boundaries of permissible settlements in the pharmaceutical industry. The Federal Trade Commission (FTC) would have specific authority to institute a civil action to recover penalties, and certain presumptions would apply. For example, any agreement providing a generic or biosimilar applicant with “anything of value, including an exclusive license,” would be presumptively anticompetitive, with certain exceptions and exclusions. Terms that would remain permissible include a pre-expiration launch date, reasonable litigation expenses, and covenants not to sue for patent infringement.

Targeting the concern that branded small molecule and biologics drug manufacturers release new products with patent protection and withdraw or unfairly disincentivize older products to avoid generic competition, the Drug Competition Enhancement Act would deem the alleged practice of “product hopping” unfair competition subject to enforcement actions. The bill would define a hard switch as when a branded or biologics manufacturer discontinues or withdraws an application and introduces a follow-on product within a certain period relative to generic or biosimilar approval. It would define a soft switch as when the brand manufacturer took actions that “that unfairly disadvantage the listed drug or reference product relative to [a] follow-on product.” The bill would provide specific exclusions and justifications for branded manufacturer actions that would otherwise constitute a hard or soft switch.

Seeking to curb perceived abuses of the FDA citizen petition process, the Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would grant the FTC the authority to bring a civil action against those filing “sham petitions” with the FDA, with penalties up to $50,000 per calendar day of review or the revenue earned by the seller of the branded product, whichever is greater. A petition could be classified as a sham based on its own objective unreasonableness, an intention to delay approval of a generic or biosimilar product, or as part of a series of covered petitions.

Based on [...]

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