By Kevin E. Noonan –

The Federal Circuit reversed a District Court grant of judgment as a matter of law (JMOL) that overturned a jury verdict that defendant Eli Lilly had not satisfied the clear-and-convincing-evidence standard in challenging on Section 112(a) grounds claims asserted by Teva Pharmaceuticals in Teva Pharmaceuticals International v. Eli Lilly & Co.  In addition to providing a “man bites dog” aspect to the case, the opinion also sets forth circumstances where an insufficient disclosure in a patent specification relating to components of the claimed invention can be supplemented by the knowledge of one having ordinary skill in the art.

The case arose in patent infringement (not ANDA) litigation between the parties over claims in U.S. Patent Nos. 8,586,045; 9,884,907; and 9,884,908, relating to the use as a headache treatment (Teva’s Anjovy, Eli Lilly’s Emgality) comprising antibodies immunologically specific for calcitonin gene-related peptide (CGRP), wherein this protein can cause or exacerbate headache when binding to certain cell surface receptors and increasing blood flow thereby.  The antibodies prevent such binding and thus reduce or eliminate headache.  Claim 30 of the ‘045 patent is set forth as representative:

A method for reducing incidence of or treating headache in a human, comprising administering to the human an effective amount of an anti-CGRP antagonist antibody, wherein said anti-CGRP antagonist antibody is a . . . humanized monoclonal antibody.

The parties had been involved in several inter partes review (IPR) proceedings that had resulted in invalidation of Teva’s claims directed to the antibodies themselves (U.S. Patent Nos. 9,340,614; 9,266,951; 9,890,210; 9,346,881; 9,890,211; and 8,597,649).  The evidence from those IPRs according to the opinion was that murine anti-GCRP antibodies “were well known in the art” and that the art was “replete with exemplary disclosures of anti-CGRP antagonist antibodies,” as were methods for producing these antibodies (which were “extensively described”).  The antibodies recited in both the antibody and headache patents being humanized, Lilly had asserted evidence in the IPRs that humanization (modifying murine antibodies to be sufficiently human-like antibodies and thereby avoid immunological rejection) was “was a well-established and routine procedure” at the time these patents were filed.  On the other hand, Eli Lilly was unsuccessful in establishing for the Board that claims for methods of treating headache using these antibodies were invalid in view of the prior art.

In the face of a jury verdict that Eli Lilly had not satisfied the clear and convincing evidence standard to invalidate the asserted claims on § 112(a) grounds, the District Court granted JMOL on Eli Lilly’s § 112(a) defenses because, even though the jury could have reasonably found that murine anti-CGRP antibodies were known in the art and that the skilled artisan would have known how to make such antibodies, humanize such antibodies, and use such humanized antibodies to treat headache, as a matter of law the claims were invalid for failure to satisfy both the written description and enablement requirements of 35 U.S.C. § 112(a).

The Federal Circuit reversed and remanded, in an opinion by Judge Prost joined by Judge Cunningham and the Honorable Richard G. Andrews, District Judge, U.S. District Court for the District of Delaware, sitting by designation.  On de novo review under First Circuit law, the panel found that the District Court’s JMOL grant was not supported by evidence that “so strongly and overwhelmingly” was in Eli Lilly’s favor that “a reasonable jury could not have returned the verdict” that the claims were not invalid, under Acevedo-Diaz v. Aponte, 1 F.3d 62, 66 (1st Cir. 1993).  The opinion first addressed written description issues.  The opinion recites the now-established standard that for a genus claim the specification must disclose a representative number of species or structural features in common between the members of the genus; in this case, it was the “reasonable number of species” prong of the test that was at issue.  But the opinion also cautions that “there are no ‘bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention,’” citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), which many will recognize as the culmination of the development of written description jurisprudence beginning with Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997).  For their analysis of the issues supporting the jury’s decision (and that the District Court erred in granting JMOL), the panel turned to Ajinomoto Co. v. International Trade Commission (Fed. Cir. 2019), which stands for the proposition that when assessing the disclosure a specification is “read in light of the background knowledge in the art” that can establish that the representative number of species requirement was satisfied.  The Court then cited In re Herschler, 591 F.2d 693, 695 (C.C.P.A. 1979), for similar rubrics, where the invention was the use of dimethylsulfoxide (DMSO) to facilitate transfer of steroid drugs through the skin.  The written description requirement was satisfied in that case because, although only one species of steroid drug was disclosed, the skilled worker would have recognized that “while steroids ‘as drugs’ might vary broadly in their physiological activity, steroids ‘as a class of compounds carried through a layer of skin by DMSO’ appeared on the record to be ‘quite similar’” in the capacity to be more effectively transferred through the skin by DMSO.

Applying this precedent, the panel understood the invention to be a method using “anti-CGRP antagonist antibodies, or humanized versions thereof, to treat headache—not such antibodies themselves,” and that distinction is the basis for their opinion.  This shifts the focus away from the issues arising in Ariad and, more recently, Amgen v. Sanofi because the invention is this use, not the antibodies per se.  In a footnote, the opinion mentions Judge Bryson’s conclusion, sitting by designation in Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 276 F. Supp. 3d 629, 648 (E.D. Tex. 2017), that “when a genus is well understood in the art and not itself the invention but is instead a component of the claim, background knowledge may provide the necessary support for the claim” (emphasis in opinion).

The opinion states that the basis for reversing the District Court’s grant of JMOL is whether a reasonable jury could have come to its original conclusion (i.e., that Lilly had not established invalidity under the written description requirement by clear and convincing evidence), illustrating the changing criteria used by the Court.  What might have required express disclosure 20 years ago no longer does so, because of the development of additional knowledge in the art in the interim, wherein the inventor is entitled to include what the person of ordinary skill in the art would understand to supplement what is expressly disclosed.  This brings to mind the admonition that “a patent need not teach, and preferably omits, what is well known in the art,” in Hybritech Incorporated v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986), citing Lindemann Maschinenfabrik GmbH v. American Hoist and Derrick Co., 730 F.2d 1452, 1463 (Fed. Cir. 1984).

According to the panel, the prior art had disclosed several murine versions and prior-art methods of humanization against a backdrop of anti-CGRP antagonist antibodies (and methods of making them) being well known and humanization being routine.  This supplies what was not explicitly disclosed but does not have to be in view of what was known in the art.  “And, critically, a skilled artisan would have understood from the specification that all humanized anti-CGRP antagonist antibodies treat headache,” according to the opinion.  Treating headache was what was claimed (“[a] method for reducing incidence of or treating headache in a human”) and it is this claim against which the written description requirement was properly applied by the jury according to the Court.

The panel reviewed and dismissed as lacking Eli Lilly’s arguments to the contrary.  These include that humanized versions of the therapeutic antibodies (anti-CGRP antagonist antibodies) were not known in the art.  The panel rebutted this argument with the facts that murine versions of humanized versions of the therapeutic antibodies were known and the skilled artisan would understand methods for humanizing that were also known in the art.  This conclusion was supported by the Ariad decision, wherein a specification need not show an actual reduction to practice in order to satisfy the written-description requirement and that, at the time the application was filed amino acid sequencing of antibodies was routine.  Eli Lilly also cited Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004), for the principle that claims to methods of use require written description disclosure of what is used in the methods.  The Federal Circuit distinguished that opinion because in Rochester “the specification did not disclose any compounds usable in the claimed methods, nor was there any evidence that such compounds were known.”  The Court apparently recognized (without expressly stating so) that the Rochester claims were so-called “single means claims,” i.e., “methods of doing X using something that does X,” while in Ariad the claims were to “methods of doing X, and the claims ‘encompass[ed] the use of all substances’ that did X.”

The opinion then turns to Eli Lilly’s argument regarding the “structural or functional differences among the genus of humanized anti-CGRP antagonist antibodies” (there are three of them, although the anti-CGRP antagonist antibody disclosed in the specification bound only one of them).  In rejecting this argument, the opinion states that “a reasonable jury could have found that a skilled artisan reading the specification would have understood that ‘anti-CGRP antagonist antibodies could bind to different regions of CGRP and still accomplish the claimed function of treating headache,’” once again applying the written description standard to what was claimed, treating headache.  Lilly (also unsuccessfully) argued that, because its product differs structurally and functionally from the sole humanized anti-CGRP antagonist antibody disclosed in the specification, written description must be inadequate for a lack or “representativeness,” citing AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014).  The Court rejects this argument because written description provides no “bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention” and that:

[A] skilled artisan reading the specification would have understood that anti-CGRP antagonist antibodies were well known (and disclosed), that humanizing [antibodies] was routine (and disclosed), and that, insofar as treating headache is concerned, all humanized versions of such antibodies work [in the claimed method].

With regard to enablement, the panel asserted the standard that a disclosure must be “at least commensurate with the scope of the claims” under Amgen Inc. v. Sanofi, 987 F.3d 1080, 1084 (Fed. Cir. 2021), aff’d 598 U.S. 594 (2023).  Lilly makes the conventional breadth argument (unsuccessfully) regarding purportedly undue experimentation required to enable all anti-CGRP antagonist antibodies.  The Court concedes that if enablement required “screening and testing” the expected “very large number of candidate antibodies” to identify anti-CGRP antagonist antibodies, even if routine at the time the application was filed, it would constitute undue experimentation under Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1163 (Fed. Cir. 2019).  But the opinion distinguishes this required scope of enablement based on differences between composition claims and methods of using compositions not otherwise claimed, stating that “[t]he asserted claims here are unlike the claims in Amgen and Baxalta [Inc. v. Genentech, Inc., 81 F.4th 1362, 1366 (Fed. Cir. 2023)], however, because they do not claim humanized anti-CGRP antagonist antibodies themselves; instead, they claim only the use of such antibodies for the different, limited purpose of treating headache.”  Here, “[i]n light of the well-known status of anti-CGRP antagonist antibodies and the routine nature of humanization, the more relevant ‘research assignment’ in this case would have been determining which humanized anti-CGRP antagonist antibodies treat headache” according to the opinion.

Finally the Court distinguishes the situation in this case over that in Idenix because in that case there was no evidence that all the undisclosed species had the claimed structure, whereas in this case “it is undisputed that a reasonable jury could have found that all humanized anti-CGRP antagonist antibodies treat headache, thereby obviating any extensive screening to determine which ones do.”                                                                                      

As with all cases regarding sufficiency of disclosure, the outcome relied heavily on the facts.  To the extent that this decision provides any strategic recommendations it was the focus in the claims regarding methods for treating a specific ailment (headache) using known antibodies (anti-CGRP antagonist antibodies) to a known antigen (CGRP) or antibodies that could be produced using known methods (humanization), all in view of the understanding of the skilled artisan.  Also important was the capacity of all anti-CGRP antagonist antibodies to achieve the headache-relieving effect.  This case brings to mind opportunities for using (however counterintuitively) acknowledgment of what is known in the art (which Eli Lilly did not do in pursuit of claims to anti-CGRP antagonist antibodies lost in IPR) to provide sufficient support for what is not (using the anti-CGRP antagonist antibodies for treating headache).

* Eli Lilly was likely precluded by the provisions of 35 U.S.C. § 315(e)(2) from asserting these defenses at trial due to the PTAB and Federal Circuit’s determinations to the contrary in the IPRs.

Teva Pharmaceuticals International v. Eli Lilly & Co. (Fed. Cir. 2026)
Panel: Circuit Judges Prost and Cunningham and District Judge Andrews
Opinion by Circuit Judge Prost

By Michael Borella –

The U.S. Patent and Trademark Office has extended its Artificial Intelligence Search Automated Pilot Program (ASAP!) until June 1, 2026.  Originally slated to close to new petitions on April 20, 2026 (see “USPTO Announces That It Has Turned the Corner on Unexamined Application Backlog“), the Office has expanded both the duration and the scope of the program “in order to obtain more information to evaluate the effectiveness of the program.”  At the same time, the USPTO has waived the program’s fee. 

By way of background, ASAP! is a pilot program under which an original, noncontinuing, nonprovisional utility application filed under 35 U.S.C. § 111(a), and including Track One applications, is subjected to an automated, AI-driven prior art search prior to examination.  The results are delivered to the applicant as an Automated Search Results Notice (ASRN), which lists up to ten documents ranked by relevance, along with a search string that can be entered into the Patent Public Search tool to retrieve the cited U.S. patents and publications.  The ASRN does not require a reply.  Nonetheless, an applicant who receives an ASRN may elect to file a preliminary amendment, request deferral of examination, or expressly abandon the application to recover the applicant’s search fee and any excess claims fees.  The examiner eventually assigned to the application is free to use or disregard the ASRN when conducting their own search.

Three aspects of the extension are worth highlighting.  First, the USPTO has increased the program’s target from approximately 1,600 applications (200 per Technology Center) to at least 3,200 applications (400 per Technology Center).  Second, the USPTO will continue to accept petitions until the earlier of June 1, 2026 or the date on which each Technology Center has been docketed with at least 400 applications accepted into the program.  Third, and perhaps most consequentially for cost-sensitive applicants, the $450 petition fee has been waived for any petition filed on or after March 23, 2026.  As before, the petition must be filed electronically in Patent Center on the filing date of the application, and the application must be filed in DOCX format.

The fact that the USPTO is extending the program and eliminating the petition fee is telling.  It suggests that uptake until now was uneven across Technology Centers or otherwise insufficient to support any evaluation the USPTO would presumably like to perform on the program’s efficacy.  Indeed, as of the time of this writing, only 169 petitions have been filed across all the Technology Centers, and just 76 of these have been granted.

The fee, while modest in absolute terms, is a real deterrent for applicants who see only a questionable benefit in return.  Removing that fee is an acknowledgment that the initial cost-benefit balance was tilted in the wrong direction.  Further, the applicant would presumably want to review any references cited by ASAP! for relevance, which would incur its own administrative costs in terms of time and/or attorney’s fees.  Thus, even without the fee, the program is not truly “free.”

 On the balance, the fee waiver and the expanded intake should make ASAP! a more attractive proposition for applicants who were on the fence.  The upside is a free automated search that may (or may not) surface relevant prior art of which the applicant’s was unaware.  For applicants filing in technology areas where the USPTO’s AI search tool has access to a deep and well-classified corpus (e.g., software and electrical arts), the ASRN may prove genuinely useful. 

One further development is worth flagging.  At last week’s University of San Diego Patent Law Conference, it was reported that Director Squires announced a version 2 of the AI search tool that will be released in the near future.  The principal improvement, as described by Squires, is that the updated tool will actually search the claims of the submitted application.  Apparently, the version currently in use under the pilot has been searching based on the specification alone.  That is a surprising admission, and a meaningful one.

Any prior art search should include and focus on the claims, because the claims define what is actually being examined for novelty and non-obviousness.  A search drawn only to the specification will tend to surface prior art relevant to the disclosed embodiments as a whole, rather than art that maps to the specific limitations an applicant has chosen to claim.  Thus, the usefulness of the current program is questionable on its face.  But if version 2 delivers, the quality of the ASRN should improve materially.

By Donald Zuhn –

In a press release issued last week, the U.S. Patent and Trademark Office announced that for the first time in nearly a decade, the number of first Office actions that the USPTO has issued during the fiscal year is exceeding the number of new applications that are being filed.  The Office noted that as of April 6, the number of unexamined U.S. patent applications had dropped to 776,995 – the lowest level in two years – which is down from a high of 837,928 unexamined applications in January of 2025.  The Office also noted that in view of historical trends, the inventory of unexamined applications is expected to further decline through the third and fourth fiscal year quarters.  The Office stated that the reduction in unexamined patent applications has been achieved while also exceeding all fiscal year patent quality compliance targets.

Significantly, the Office noted that it is close to achieving its “aggressive fiscal year goal of virtually eliminating its inventory of unexamined applications that would otherwise exceed 36 months.”  USPTO Director John A. Squires pointed out that “[h]itting this subtle but important increment early bodes well because we are intent on slashing application examination wait time,” adding that “reduced wait time means money – our studies show even a one-week reduction in pendency increases a U.S. company’s value by approximately $35,000 on average.”  As for the reasons for the reduction, Director Squires stated that the Office has been “steadily releasing robust AI tools to assist our examiners, and we’re about halfway to our aggressive goal for new examiner hires.”

With respect to the “robust AI tools” mentioned by the Director, the USPTO announced last month that it was waiving the petition fee for the Artificial Intelligence Search Automated Pilot (ASAP!) program.  The Office noted that the petition fee set forth in 37 C.F.R. § 1.17(f) for petitions filed under 37 C.F.R. § 1.182 was being waived in order to alleviate any financial barriers to participation in the ASAP! program.  The Office also announced that it was increasing the number of applications to be accepted into the program to at least 3,200 applications (and at least 400 applications per Technology Center).  ASAP! program petitions will be accepted until the earlier of Monday, April 20, 2026, or the date that a Technology Center has docketed at least 400 applications accepted into the program.

The ASAP! program, which was announced last fall, is intended to test the efficiency of the USPTO’s internal AI tool for conducting pre-examination prior art searches.  In October, when the program was first announced, Director Squires noted that the ASAP! program “is the first of many planned AI pilots designed to help examiners and applicants alike ensure their patents are born strong.”  The program provides Applicants with an initial communication – an AI-Assisted Search Results Notice (ASRN) – identifying a list of potential prior art issues in need of attention, affording Applicants with an early opportunity to assess their claims against the prior art before substantive examination begins.  Automated searches are conducted using an internal AI system that derives contextual information from the classification of the application under the Cooperative Patent Classification (CPC) system, as well as from the specification, claims, and abstract of the application.  The ASAP! program will help the Office assess outcomes for pre-examination searches, evaluate the scalability of generating the ASRN, and collect data to inform next steps and companion pilots.  Additional information regarding the ASAP! program was provided in a Federal Register notice (90 Fed. Reg. 48161) issued last fall.

One AI “tool” that the USPTO will not be relying on to help reduce the unexamined application backlog, however, is the “first-of-its-kind” agentic AI tool, MATTHEW (McConaughey Agentic Tasking Technology Helping Examiner Workload), that the Office highlighted in a press release issued on April 1 (hint, hint).  The Office’s “explanation” can be found here.

By Kevin E. Noonan –

The alacrity with which the Patent Trial and Appeal Board (PTAB) came to the same conclusion in its latest priority determination in favor of the Senior Party in interference No. 106,115 that it had almost eleven months ago precluded an assessment of Broad’s Brief in Opposition to CVC’s Opening brief or both Parties’ Reply briefs,* but relevant portions of those submissions can be referenced for both Parties consistent with the arguments made throughout this interference and related Interference No. 106,048.

Broadly, the Broad’s position is consistent with its argument, expressed more directly in Interference No. 106,048, that the complexity of performing CRISPR in eukaryotic cells renders any conception incomplete unless and until there is a successful reduction to practice.  That argument faded in the ‘048 interference (when application of the “two-way obviousness test” sufficed for Broad to prevail; see “PTAB Decides CRISPR Interference in Favor of Broad Institute – Their Reasoning“), and Broad did not explicitly rely on that concept (which gained traction during the heyday of obtaining patents in isolated gene-encoding nucleic acids) in the current interference (at least not by name).  But it remains at the heart of Broad’s arguments, now couched in assertions that CVC’s conception was incomplete due to failure to reduce to practice prior to Broad’s success (the success of this misconception was at least part of the basis for the Federal Circuit to vacate and remand the PTAB’s earlier judgment in Broad’s favor).  This argument runs through their submissions in both interferences, which is not surprising in view of the timeline of actual reduction to practice for the parties.

The Board’s decisions show that another Broad argument resonated as well, wherein in addition to having reduced eukaryotic CRISPR to practice a few months earlier Broad argued that the several labs that used the sgRNA component of CRISPR undisputedly conceived by CVC:

were of greater than ordinary skill in the art, and thus these labs achieving actual reduction to practice did not show that the person ordinary skill in the art would have been able to do so by being informed of this species in conjunction with the capacity to express RNA (e.g., using the U6 promoter) and Cas9 protein (using recombinant expression known in the art for over a generation) in eukaryotic cells.  Broad was able to use the efforts by CVC and the time taken to achieve actual reduction to practice, as well as the litany of purported uncertainty by those CVC inventors gleaned by their improvident statements on the record, to convince the PTAB (once again) that Broad’s actual reduction to practice provided priority.  This argument, negating CVC’s conception, also was once again used to overcome CVC’s derivation arguments, because if several components other than sgRNA were required then Dr. Marraffini’s disclosure to the Broad inventors could not be sufficient to support their derivation argument.

CVC for its part argued that the critical conception was the sgRNA, using the historical fact that until that species was known (from its disclosure) the art did not evince the capacity to achieve CRISPR in eukaryotic cells.  The timing between Dr. Marraffini’s disclosure to Broad’s actual reduction to practice supported the conclusion that this species played some role in the achievement; this conclusion was also supported by labs other than Broad’s that used sgRNA acknowledging CVC’s contribution to their achievement.  The PTAB did not, on the other hand, seem to give the same type of credence to evidence that Broad’s inventors were themselves having difficulties achieving eukaryotic CRISPR until the sgRNA species was disclosed to them (including multiple instances of Zhang himself and his students evincing sentiments of failure prior to obtaining their invention from Dr. Marraffini (“the results were ‘nonspecific’” (Zhang); “wondering whether “‘other factors need to be identified’ for a working CRISPR system” (Lin); “Zhang’s experiments ‘all failed’; ‘d[id] not work in human cells; and had ‘fail[ed] to induce genome modification’”; “‘it was really a pity’ that Zhang’s lab ‘did not work it out before seeing [CVC’s] paper.’” (Lin)).  Also unavailing was the history (and Broad’s reliance on it, for example in its Supplemental Priority Statement filed under PTAB Order) that showed their construct for eukaryotic CRISPR:

(very different from CVC’s sgRNA) was not the species used to support actual reduction to practice more than six months after being submitted as part of an NIH grant proposal, where such actual reduction to practice using sgRNA took only a few weeks.

Unmentioned in all the briefing is the simple argument that, taking heed of Broad’s assertions in both the ‘048 and ‘115 interferences the complexities of eukaryotic cells made it just sufficiently less likely for a three component complex (Cas9, crRNA, and tracrRNA) to form in such cells than for a two component complex to do so (sgRNA and Cas9).  The oligonucleotide linker joining the crRNA and tracrRNA species in CVC’s sgRNA would have this advantage over the more complicated construct disclosed in their January 2012 NIH grant proposal by Broad, wherein when expressed the tracrRNA and crRNA would need to coalesce independently with Cas9 to form an active CRISPRR complex.

The question before the Federal Circuit will be whether the PTAB heeded the earlier panel’s appreciation that the Board had not properly considered the role of earliest conception followed by diligence towards reduction to practice, or be convinced that the complexities of achieving eukaryotic CRISPR were sufficient that only actual reduction to practice will suffice.  It might be fruitful for the Court to consider whether there is a “losing the forest for the trees” aspect of the PTAB’s analysis, unsurprising in view of the vigor with which Broad made its arguments asserting eukaryotic cell complexities, and whether the evidence is more consistent with sgRNA being the critical component of the CRISPR complex that permitted successful CRISPR cleavage in eukaryotic cells.

*Such analyses are forthcoming in perhaps more abbreviated form for completeness.

By Donald Zuhn –

Last week, Mexican law firm OLIVARES reported that Mexico had published amendments to the Federal Law for the Protection of Industrial Property (FLPIP) on April 3, 2026, that introduce changes that will impact patent filing and prosecution strategies in that country.  The report notes that the amendments incorporate mechanisms that are commonly used in other jurisdictions and introduce new procedural tools aimed at increasing flexibility, legal certainty, and efficiency in the Mexican patent system.

Among the changes that will affect patent practice in Mexico are:

• Restoration of priority rights – allows applicants to restore priority rights within a two-month period following the expiration of the original deadline (i.e., 12 months for patents and utility models, and 6 months for industrial designs).  The report notes that this change aligns Mexico with international practices that provide corrective measures for priority claims.  Significantly, OLIVARES noted in a separate alert that the amendments to the FLPIP did not address the time limits applicable to national phase entries of PCT applications – but suggested that the recent amendments may open the door for Mexico to review and potentially lift the restrictions currently in place with respect to national phase applications.

• Provisional patent applications – allows applicants to secure an early filing date with reduced formal requirements, with the applicant then filing a complete application within a non-extendable 12-month period.  Mexican provisional applications may not claim priority from any prior application, will not be published, and will not be subject to examination.

• Priority documentation – allows the Mexican Institute of Industrial Property (IMPI) to require the submission of a certified priority document and its Spanish translation within five (5) business days following the expiration of the current term (i.e., three months from the filing date).

• Restoration of procedural rights – allows applicants to request reinstatement of rights lost due to missed deadlines, including the failure to respond to office actions or pay grant fees.  Requests for reinstatement must be filed within fifteen (15) business days from the expiration of the missed deadline (counted from the business day following the expiration of the missed deadline), together with the previously omitted requirement and payment of the corresponding official fee.  If the request is accepted, the IMPI will allow the application to continue prosecution.  The report notes that this change represents a shift from the prior system, where abandonment was final and irreversible.

• Reduced prosecution timelines and number of office actions – in an attempt to accelerate prosecution at the IMPI, this change establishes a maximum period of one year for the issuance of a final decision in patent, utility model, and industrial design applications, once substantive examination begins.  If after the one year period there has been no resolution, the applicant may request the issuance of a mandatory resolution through a newly created specialized technical committee that is appointed by IMPI’s board of directors.  The one-year maximum prosecution period will apply for patent applications filed after the amendments were published.  However, applicants having applications that were filed and pending prior to publication of the amendments can still apply for a mandatory resolution once the specialized technical committee has been assembled.

Regarding the above change, OLIVARES suggested that:

While the effort to reduce prosecution timeframes is recognized, there is general uncertainty on the feasibility for the Mexican PTO to handle this significant increase in their workload and if this shortening of timeframes could provoke a massive filing of requests for mandatory resolutions by applicants.  There is also concern that there will be a decrease in the quality of the substantive office actions in view of the reduced timeframes.

In addition to the one-year maximum prosecution period, OLIVARES noted in a separate alert last month that an amendment to the administrative regulations that was published in the Mexican Official Gazette in March reduces the number of substantive office actions from four to two for patent and utility model applications.  A third office action that either allows or denies the application will follow the previous two.  The administrative amendment reducing the number of office actions took effect on March 12, 2026, but does not apply to applications that were filed prior to the effective date, which will continue to be examined under the rules in force at the time the application was filed.

• Third-party observations – allows for the submission of third-party observations for utility model and industrial design applications within a two-month period from publication.  Under the prior system, third-party submissions were limited to patent applications.

The report notes that the changes took effect on the day after their publication and that pending applications would continue to be prosecuted under the legal framework that was in force at the time those applications were filed.  One of the alerts also notes that further developments are anticipated, as the implementing regulations of the new IP law are still pending issuance and are expected to be published in the near term.

OLIVARES has provided additional information regarding the amendments to the FLPIP on its website:

• “Amendments to Mexico’s Intellectual Property Law: Principal aspects for patent practice.“
• “Mexico introduces new corrective mechanism for priority documentation.“
• “Reinstatement of rights following missed prosecution deadlines.“
• “Mexico introduces provisional patent applications.“
• “Mexico introduces restoration of priority rights for patent, utility model and industrial design applications.“
• “Mexico reduces prosecution timelines.“
• “New Technical Committee Mechanism.“

The Decision on Priority

By Kevin E. Noonan –

On March 26, the Patent Trial and Appeal Board, without holding an oral hearing and despite a rather sharply worded opinion by the Federal Circuit vacating and remanding its earlier priority decision (see “Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2025)“), granted priority in Interference No. 106, 115 to Senior Party The Broad Institute, Harvard University, and MIT (collectively, “Broad”) over Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”).  To the extent that the Federal Circuit held that the Board erred in the manner in which the evidence was considered and settled interference law applied, this Decision on Priority shows little evidence of any inclination by the Board to reconsider either aspect of its prior analysis, once more seemingly being content to focus on the trees at the expense of the forest.

Procedurally, the Decision properly imposes the burden on CVC to show earlier conception by a preponderance of the evidence.  The Decision delves deeply into the details of the methods for achieving eukaryotic CRISPR, assessing that evidence and finding the same indications in favor of Broad directed to their earlier reduction to practice swaddled in the language of conception (albeit avoiding the “incomplete conception” terminology found in their first priority decision).  The Board rejects as unsupported by the evidence that achieving eukaryotic CRISPR would be “straightforward,” as some evidence and testimony asserted, once the sgRNA species was disclosed, the Decision stating that:

[W]e find that one of ordinary skill in the art would have been a practicing Ph.D. research scientist who would have known about the routine techniques and methods available but would have been less capable than the Zhang, Church,  Kim, and Joung labs to reduce an embodiment of Count 1 to practice,

the Board apparently being convinced by Broad’s argument that the laboratories that quickly reduced eukaryotic CRISPR to practice (asserted by CVC as evidence that the methods used were “routine and well-known to the worker of ordinary skill) were not persons of ordinary skill but rather persons having sufficiently extraordinary skill to disqualify their efforts for the role attributed to them by CVC, despite the contemporaneous attribution to CVC of the methods for successfully performing CRISPR cleavage in eukaryotic cells.  Paradoxically the Board’s appreciation that the Broad inventors may have been of greater than ordinary skill did not provide an explanation for why they were able to achieve actual reduction to practice of eukaryotic CRISPR slightly more rapidly (only a matter of a few months) than the CVC inventors were able to achieve.

Somewhat ironically, the Board once again focuses on statements by the CVC inventors regarding their difficulties in achieving CRISPR cleavage in eukaryotic cells, supported in this approach by their understanding that:

The court stated that “[t]he Board erred in its analysis by failing to consider routine methods or skill, and, instead, focusing almost entirely on Regents’ scientists’ statements about perceived experimental difficulties and doubts about success,” but the court did not say that the Board erred in considering the CVC inventors’ statements and the extent of their research or experimentation at all in the determination of the preponderance of the evidence of conception.

But the Board seemingly ignored similar references to the frustrations of failure emanating from the Broad lab prior to the disclosure of sgRNA species by Dr. Marraffini (see CVC Opposition to Broad Opening Brief, which recites multiple examples of similar frustrations that seemed to disappear after Dr. Marraffini’s disclosure, including multiple instances of Zhang himself and his students evincing sentiments of failure prior to obtaining their invention from Marraffini (“the results were ‘nonspecific’” (Zhang); “wondering whether “‘other factors need to be identified’ for a working CRISPR system” (Lin); “Zhang’s experiments ‘all failed’; ‘d[id] not work in human cells; and had ‘fail[ed] to induce genome modification’”; “‘it was really a pity’ that Zhang’s lab ‘did not work it out before seeing [CVC’s] paper.’” (Lin)).  The Board justifies its focus on any changes in the CRISPR methods during development by CVC as being evidence of incomplete conception (albeit avoiding that particular sobriquet) because:

Count 1 includes the ability of the CRISPR-Cas9 system to cleave or edit DNA in the eukaryotic cell to alter gene expression, we consider any additional requirements that affected the ability of the CRISPR-Cas9 system to cleave or edit DNA in the eukaryotic cell to alter gene expression to be a substantive aspect of the inventors’ conception of an embodiment within the scope of Count 1.

And there are other assertions in the Decision indicating a particular perspective when considering  the relationship between conception and reduction to practice that seem inconsistent with the Federal Circuit’s concerns with the Board’s prior assessment of priority, for example “[t]he need for seven months of diligent work is not consistent with the CVC inventors having  conceived of and described a complete system that would have required only ordinary skill, without extensive research or experimentation, to reduce to practice.”

In addition, CVC’s arguments suffered from the Federal Circuit’s decision not to overturn the Board’s determination that CVC’s earliest provisional applications (U.S. Provisional Application Nos. 61/652,086, P1, and 61/716,256, P2) did not provide a constructive reduction to practice of eukaryotic CRISPR (ironically because they did not disclose an actual reduction to practice of eukaryotic cell CRISPR), as illustrated in this graphical representation:

The Board’s decision is based on Broad’s earlier evidence of actual reduction to practice and the later filing date of CVC’s U.S. Provisional Application No. 61/757,640 (which was credited with constructive reduction to practice for containing experimental evidence of actual reduction to practice).  Underlying this analysis is a sub silentio acceptance of Broad’s long-standing argument that the complexity of performing CRISPR in eukaryotic cells raised a “simultaneous conception and reduction to practice” standard as applied but not enunciated in the Decision.

The Decision relies as well on certain structural differences in the sgRNA species developed by Broad, which could be relevant to their success in achieving actual reduction to practice according to Broad, as shown in these illustrations wherein the top illustration was used in vitro (CVC) and the bottom in vivo (Broad):

The Board apparently disregarded the history of the efforts to practice CRISPR cleavage in eukaryotic cells, which showed various variations and timelines of success, but that the one thing that all the labs had in common was using sgRNA to do so, a species unrecognized by any of these groups (including the Broad) prior to CVC’s disclosure of it.  As pointed out in CVC’s Opposition to Broad’s Opening Brief on Remand, prior to Dr. Marraffini’s disclosure on June 26, 2012, the RNA components of CRISPR used by Broad (as disclosed in the January 12, 2012 NIH grant relied upon for Broad’s additional priority claim; see Parties Supplemental Priority Statements on Remand) had the structure:

as compared with the sgRNA invented by CVC and disclosed by Dr. Marraffini and used substantially identically by Broad and the four other labs identified and relief upon by CVC:

Regarding derivation, as in its earlier Decision, the Board adopts the position that its determination regarding conception suffices to reject CVC’s arguments about derivation.  By determining that CVC did not have sufficiently complete conception to be entitled to priority it follows (for the Board) that CVC’s inventors could not have disclosed the invention sufficiently for the Broad inventors to have derived it.

This Decision, like the one before it, will no doubt be appealed and that will give the Federal Circuit the opportunity to inform the PTAB, and the rest of us, whether its earlier decision and the instructions contained therein were followed or disregarded by the Board in arriving at substantially the same decision arrived at four years ago (see “PTAB Grants Priority for Eukaryotic CRISPR to Broad in Interference No. 106,115“).  Ultimately, the question will be whether in the Board’s reconsideration of its determination of priority, the Federal Circuit believes that reconsideration of  the issue of conception was performed “under the proper application of the legal framework.”

There is likely to be some comfort the CVC inventors can take from this outcome:  whether the party who ultimately gets priority to the patents for this invention is remembered in the future, Jennifer Doudna and Emmanuelle Charpentier will be always remembered for winning the 2020 Nobel Prize for Chemistry for CRISPR.

By Donald Zuhn –

Earlier this year, Argentine intellectual property law firm Berken IP reported that Argentina had signed a Reciprocal Trade and Investment Agreement with the United States that included several commitments to harmonize its intellectual property system with international standards.  Among those commitments were “expeditiously” repealing the Guidelines for the Examination of Chemical-Pharmaceutical Patent Applications; submitting the Patent Cooperation Treatyto Congress for consideration and ratification vote by April 30, 2026; submitting the Budapest Treaty (Deposit of Microorganisms), Geneva Act of the Hague Agreement (Industrial Designs), Madrid Protocol (Trademarks), Patent Law Treaty, and UPOV 91 (Plant Varieties) for consideration and ratification vote before the end of 2027; and significantly reducing the patent backlog and pendency, including for pharmaceutical and biotechnological inventions, at the Instituto Nacional de la Propiedad Industrial (INPI).

Last month, Argentine law firm Marval O’Farrell Mairal reported that the 2012 patentability guidelines for pharmaceutical inventions had been abrogated.  Marval noted that “[i]n a significant policy shift,” the Argentine Executive Branch had repealed the guidelines, “marking a major turning point in the country’s patent landscape.”  According to the Marval report the 2012 pharmaceutical guidelines had introduced strict exclusions, denying patent protection to a wide range of subject matter, including crystalline forms, enantiomers, selection inventions, formulations, salts and esters, and Markush claims.  Marval noted that the new regulatory framework would apply to pending patent applications as well as to future patent applications.  However, Argentina’s new regulations will include a safe harbor provision, which will protect third parties that commercialized products during the validity of the former guidelines.  Thus, patents granted under the new regulations, which cover pharmaceutical products already marketed locally by third parties, cannot be used to prevent continued commercialization of such products or to pursue damages.

Reports regarding the March 18, 2026 repeal of the 2012 pharmaceutical guidelines were also issued by Berken IP (announcement), the LATAM team of European IP firm UNGRIA (announcement), and Latin American IP firm Daniel Law (announcement).

By Dunstan Barnes, Catalina “Caty” Medrano, and Tristan Morgan –

On March 12, 2026, U.S. Patent and Trademark Office Director John A. Squires announced new supplemental guidance regarding examination of design patent applications related to computer-generated interfaces and icons.  Prior to this announcement, the U.S. was lagging behind three of the other four major design jurisdictions (the European Union, Japan, and the Republic of Korea) in protecting digital designs for augmented and virtual reality.  Until this announcement, apart from designs protecting typefaces and fonts, U.S. law required design patents to be tied to—and illustrated as being on or part of—a physical article of manufacture.  This limited potential protection for designs that are entirely virtual or projected.  This gap in protection created strategic challenges for businesses investing heavily in immersive technologies.  In light of the new guidance, applicants may now protect designs by identifying, but not necessarily depicting, the article of manufacture for the design.

Brief Background of Graphical User Interfaces (GUIs)

The earliest interactive display may date back to the 1950s, when Canadian Navy engineers integrated radar displays with trackball-operated cursors.  While this pioneered the concept of direct manipulation through use of a display, it preceded the modern desktop standard by decades.  During the 1960s and 1970s, computers remained specialized tools for professional environments.  Text-based interfaces where users typed commands to execute processes were the norm, with most system design focused on hardware optimization and backend computational logic.

The landscape shifted dramatically in the 1980s with the release of the Apple Macintosh.  As the first commercially successful mass-market computer featuring a GUI, the Macintosh became a catalyst for a new era of design centered on human interaction and user-friendliness.  By the 1990s, the rapid adoption of personal computers in homes and small businesses introduced a user base with diverse backgrounds and less technical training.  This shifted the market toward visually intuitive interfaces.  As graphics technology advanced, vibrant color schemes and smooth transitions became essential benchmarks of a successful system.

Today, this paradigm remains the gold standard for interface development.  Modern innovations, such as Apple’s pinch-to-zoom gestures and Google’s Material Design, are direct results of this evolution toward natural, high-fidelity interaction.

As we move forward into the future, designers have begun to develop GUIs that are not necessarily tied to a “display screen,” since they may be projected or virtual in nature.

Background of U.S. GUI Protection

The origin of U.S. design patent protection for graphical user interfaces is often traced back to Ex parte Strijland, 26 U.S.P.Q.2d (BNA) 1259 (B.P.A.I.), in which the applicant sought to protect the “ornamental design for an icon for information or the like, as shown and described.” (claimed icon shown below).

Despite affirming the rejection of the applicant’s design, the Board provided a roadmap as to how future applicants could seek to protect GUI designs, including showing an article of manufacture (such as a computer or display screen) in broken lines.  The Strijland holding indicated that computer-generated icons are patent eligible and afforded protection under 35 U.S.C. § 171 so long as the specification demonstrates, including specifically through drawings, the design applied to an article as required by 35 U.S.C. § 171 and by 37 CFR § 1.152.  By 1996, the USPTO had adopted the Strijland roadmap as its approach for assessing the subject matter eligibility of virtual designs.

Current Laws in the European Union

On May 1, 2025, the European Union—covering 27 member states—made significant changes to its design protection system.  While the different changes are set to take effect (or already have taken effect) on different dates, one aspect of the new regulation that is in force already has expanded the definition of “product” to include “digital and non-physical creations.”  Even though the existing EU design law allowed for protection of such designs as icons, GUIs, and fonts without reference to a display screen, the new changes more clearly allow applicants to protect wholly virtual components.

As such, as of the publication date of this article, each of the following categories of design are protectable by a Registered European Union Design:

• Graphic elements: logos, graphic symbols, icons, and graphic works

• Digital interfaces: GUIs, typefaces and fonts, application animations

• Virtual environments: objects in video games, metaverse products, and virtual spatial configurations

• Physical presentations: packaging, sets of articles, and interior arrangements (e.g., store designs)

Even before the new changes, many graphical designs were protectable without need for reference to a display screen or article of manufacture.  For example, Registered European Union Design No. 015019470-0001, filed in April 2023, is directed to a 3D or animated character without reference to a display screen or article of manufacture.

Current European Union design laws tend to provide more flexible protection for graphical designs than many other jurisdictions.

Current Laws in Japan

Prior to April 2020, Japanese design law limited protection for GUI designs to visual designs that were stored locally and shown on an electronic device, such as a PC or smartphone.

Starting on April 1, 2020, Japan’s Design Act allowed broader design protection for GUIs, including images that are not stored locally (e.g., images that are found on the internet and not saved to a computer) as well as GUIs that are projected onto roads or walls.  Note that Japan’s Design Act still requires a functional relationship between the GUI and the article of the design.

For example, six months after the new provisions took effect, the Japan Patent Office (JPO) granted Japanese Design Registration No. 1672383, which was filed on April 1, 2020, the date that the changes to Japan’s Design Act came into effect.  This Japanese design registration is directed to a vehicle information display image.  In particular, the design is directed to several images that may be projected onto a road surface from an image protection apparatus on a vehicle, such as a motorcycle.  The images have a functional relationship between the projected GUI and the article of the design—for example, the projected GUI may be used to indicate to nearby drivers that the vehicle intends to change direction.  The projected GUI may also help the driver to visually recognize the road surface condition around the vehicle, and may help other drivers to be aware of the presence of the vehicle due to the illuminated light on the road surface.

Prior to the changes to Japan’s Design Act, this GUI design would not have been protectable.

In March 2024, the JPO issued guidelines to further clarify how it would interpret the new regulations.  These guidelines, which were published in response to a design patent application for a GUI in virtual reality, specified the following:

• To be protected, a GUI must be used for operating a physical device or must be displayed as a result of performing a function of a physical device.

• A GUI merely displayed in virtual reality, such a cosmetic virtual item, is not a protectable image.

• A GUI displayed in virtual reality may be protectable, so long as it meets all the traditional requirements for image protection (e.g., the GUI must have a functional relationship to the article of the design).

The updated JPO guidelines from the JPO provide a pathway for applicants considering filing applications for projected or virtual reality GUI designs. 

Current Laws in the Republic of Korea (South Korea)

Prior to October 2021, designs that appeared outside of a physical article were not protectable in Korea.  In October 2021, Korea amended its Design Protection Act to allow for the protection of projected and augmented reality designs.  Similar to the current law in Japan, the new amendment allows for image designs not displayed on a screen to be protected, so long as design is used for “operation of a device that exhibits a function.”

The Korean Intellectual Property Office (KIPO), which was elevated to ministry status in October 2025 and renamed the Ministry of Intellectual Property (MOIP), has provided two examples of previously unprotectable projected designs in its Design Examination Guidelines (figures below) that are now protectable under the current Korean Design Protection Act.

Current Laws in the United States

With the March 12, 2026 guidance, the USPTO has now:

(1)  removed the requirement in MPEP § 1504.01(a) that the drawing depict the article of manufacture (e.g., a computer or a portion thereof) in either solid or broken lines for design patent applications drawn to computer-generated interfaces or icons where both the title and claim properly identify an article of manufacture;

(2)  clarified that a design of a computer-generated interface or icon for a computer, computer display, or computer system is more than a mere transient or disembodied picture or three-dimensional image and is patent-eligible subject matter when disclosed and claimed in accordance with the pertinent rules and statutory requirements;

(3)  clarified that claim and title language that indicates that an icon or interface is “for” a computer, computer system, or computer display panel adequately describes a design for an article of manufacture under 35 U.S.C. 171 and that examiners will no longer be instructed to object to such claims and titles under 37 CFR 1.153 or 37 CFR 1.1067;

(4)  highlighted additional types of patent-eligible designs based on the USPTO’s expanded understanding of design patent protection in light of new design formats resulting from the continued modernization of technology (see below); and

(5) provided guidance for examiners and applicants relating to these updates.

These highlighted types of eligible designs include projections and holograms for computers, computer displays, and computer systems where the appearance of the interfaces and icons is separate from the claimed computer, computer display, or computer system that generates it.

Examples that would be newly compliant with the current USPTO guidance are shown below:

As a result of the new USPTO guidance, it is no longer necessary for applicants either to provide a dashed broken line perimeter to illustrate a display screen or to include a display screen in the title and claim.  That being said, applicants must ensure that a suitable article of manufacture is identified in both the title and claim.

The new USPTO guidance also corrects a bothersome legal fiction.  For decades, GUI design inventors have had to sign a declaration—under penalty of perjury—stating that they have invented a new design for a “display screen [or portion thereof] with graphical user interface” (implying on its face that they have invented a new display screen as part of their new GUI design) when, in reality, they have designed a new graphical user interface that may be displayed on a display screen.  In light of the new USPTO guidance, design patent titles and claims can better reflect inventors’ actual inventions to graphical user interfaces, projected interfaces, and virtual reality interfaces themselves.

By Kevin E. Noonan –

The course of the proceedings involving the attempts to remove Judge Pauline Newman from the Federal Circuit is long, and in many senses tragic (see links below).  Just when you might think the last Act has begun (see “Judge Newman Seeks Recourse from Supreme Court“), the Judicial Conduct and Disability Committee (JCDC; “Committee”) had its say. 

The decision (against Judge Newman, unsurprisingly) relates to the Judge’s petition for review of the Judicial Council for the Federal Circuit’s August 29, 2025 Order, extending the suspension that has now lingered for almost three years in the face of the language of the statute that such suspensions should be “temporary” (Judge Newman’s petition itself was filed on October 9, 2025, which may provide temporal context for the Committee’s decision).  The details of Judge Newman’s petition included that the suspension was contrary to the Judicial Conduct and Disability Act (“the Act”) and unconstitutional, and that the Federal Circuit Judicial Council’s denial of her request to transfer the complaint to another Circuit violated her Fifth Amendment right to procedural due process.

The Memorandum of Decision sets forth in detail the history of the Judicial Council’s suspensions and Judge Newman’s arguments and efforts to have them lifted, there being little new ground to survey in this latest recitation.  The Committee does make the effort to disclaim any review of the substance of the allegations against the Judge, including incapacity to accomplish her judicial duties; their remit is to determine the propriety of the consequences ensuing from the Judge’s refusal to submit to a neurophysiological examination by doctors of the Judicial Council’s choosing.  The decision also faults Judge Newman’s petition for not arguing that the Judge had been deprived of “a life, liberty, or property interest protected by the Fifth Amendment,” that was the subject of supplemental briefing that was submitted on November 3, 2025.

The Special Committee’s reasoning is affected by their deferring to the circuit judicial council’s consideration of the special committee’s review of the evidence, citing In re Memorandum of Decision of Judicial Conference Comm. on Judicial Conduct & Disability, 517 F.3d 563, 569 (U.S. Jud. Conf. 2008), in denying Judge Newman relief.  Judge Newman argued in her petition that “(1) the Committee should consider the merits of her as-applied constitutional arguments (in a footnote the Special Committee says they did); (2) the Federal Circuit Judicial Council’s renewal of her

suspension is contrary to the Act and is unconstitutional; and (3) the Federal Circuit Judicial Council’s denial of her request to transfer the complaint violates her Fifth Amendment right to procedural due process.  According to the Special Committee, the persistent renewal of the Judge’s suspension is not contrary to the Act.  Judge Newman’s petition, as in all other filings on the Judge’s behalf, argues that the serial imposition of one-year suspensions is contrary to the limits of the Judicial Council’s power to order, “on a temporary basis for a time certain, no further cases be assigned to the judge whose conduct is the subject of a complaint” (emphasis added), citing Section 354(a)(2)(A)(i) of the Act (also citing Rule 20(b)(1)(D)(ii) that the judicial council may order “that no new cases be assigned to the subject judge for a limited, fixed period”).  As Judge Newman has contended elsewhere, the petition argues that the Judicial Council, in the exercise of its power, has violated the “for a time certain” limitation and that in the practice of imposing suspensions under the Act, one year was the longest imposed hitherto.  Also included in this argument is that the suspension is “unprecedented” and has effectively been made permanent by circumvention of the “time certain” requirement under the Act.

The Special Committee disagrees that this is a unique situation, having found that while “[m]any suspensions have been for a one-year duration” that does not act to define the length of a “temporary” suspension, and there is one case (discussed in a footnote; In re: Complaint of Judicial Misconduct against United States District Judge G. Thomas Porteous, Jr. under the Judicial Conduct and Disability Act of 1980, No. 07-05-351-0085 (5th Cir. Jud. Council Dec. 20, 2007)) where the suspension was longer.  The decision notes that the Act provides no explicit definition of “temporary” but that a plain meaning definition would be “suspension for a limited time with a certain end date.”  The Special Committee states that having each term limited to one year, with review at the end of each term ensures that “the suspension is reviewed regularly to determine whether it is still appropriate under the circumstances.”  And the “lengthy consideration” given Judge Newman’s motion for reconsideration “demonstrates that the Judicial Council’s decision to renew the suspension is not simply a rubberstamp.”  The decision self-justifies on the basis that permitting Judge Newman to hear cases before the question of her competence is resolved “could have serious effects on litigants and prejudice the effective and expeditious administration of the business of the courts” (which is certainly the case for those litigants, such as the litigant in Rudisill v. McDonough, 601 U.S. 294 (2024), who saw Judge Newman’s dissent be persuasive before the Supreme Court).  The decision contains a long passage from the Special Committee’s July 28, 2025 Report, which speaks for itself:

Judge Newman’s conduct in refusing to undergo the medical examinations ordered by the Committee is a serious matter.  Her conduct prevents the Committee from completing the process established by Congress for determining whether a life-tenured judge suffers from a disability.  Litigants before this Court deserve to have confidence that the judges ruling on their matters do not suffer from a cognitive impairment that may affect the resolution of their cases.  They also deserve to have confidence that the mechanisms Congress established for addressing judicial disability function properly and that a judge with such an impairment cannot derail the process by refusing to cooperate.  The Committee and the Judicial Council have an overriding duty to ensure that the judges on this Court are able-minded and capable of performing their jobs.  We also have a responsibility to court employees to ensure that they have a workplace free from hostile and abusive behavior.  When serious concerns are raised about a judge’s fitness, they must be taken seriously and addressed expeditiously, and all judges must recognize their duty to facilitate that process.

The decision further justifies the extension of the suspension on the grounds that the Judicial Council “extensively considered additional expert reports and evidence that could have resolved the proceeding,” setting forth the possible outcomes in Judge Newman’s favor that are ephemeral under the actual circumstances.  The decision characterizes the Special Committee’s review as being “careful” and demonstrating that “the facts of the JC&D proceeding had meaningfully evolved” so that there was a possibility for resolution.  Under these possibilities, the Special Committee finds that the renewed suspension remains “temporary.”  The Special Committee interprets the Act as “envision[ing] that any suspension must be based on its own facts and circumstances to qualify as temporary under § 354(a)(2)(A)(i)” and that “[a] judicial council must approach each application of that power based on new facts and circumstances that emerge during its consideration of the remedy for ongoing complaints that are not yet resolved.”  The decision also posits that in a world where they had had an opportunity to review the circumstances of the first renewal, the outcome here might have been different.  But they did not, and here do not, provide a different outcome.

The decision next turns to Judge Newman’s assertion that these serial suspensions “usurp Congress’s exclusive control over impeachment and removal” and, accordingly, the Judicial Council is required to refer her to the House of Representatives for impeachment if “her misconduct is so serious it requires an unprecedented three-year suspension.”  The Special Committee declines to consider the bases for Judge Newman’s suspension to amount to “Treason, Bribery, or other high Crimes and Misdemeanors” under U.S. Const. art. II § 4 that would qualify the Judge for impeachment (and reasons that no judicial council has ever done so as the result of a disability complaint).  The decision further notes that Congress does not need a “certificate of impeachment” from a judicial council to impeach, and is not compelled to impeach should it receive one.  According to this logic, Judge Newman’s continued suspension does not usurp Congress’s right to impeach (which seems to create a procedural limbo for the Judge, or misses her point).

The Special Committee’s rationale on the constitutionality of renewable suspensions is that “the ‘judicial power’ referenced in Article III belongs to the judiciary, not individual judges,” citing N. Pipeline Constr. Co. v. Marathon Pipe Line Co., 458 US 50, 59–60 (1982), and finds no authority for the (reasonable) proposition that judicial power is exercised (and to some extent only exists) by individual judges (or at least a panel of them).  This conclusion is supported by citations that don’t seem to be quite on point.  The decision also makes distinctions between being removed from office and being prohibited from hearing cases, but to the extent the distinction involves a judge “continu[ing] to receive salary and would continue to hold office” it is unclear how such a judge could be “eligible to exercise judicial authority” as the decision contends.  And the further distinction that the Chief Judge did not reassign any of Judge Newman’s cases at the time of her first suspension (having been prohibited from taking any other cases for six months before) seems unavailing for the Special Committee’s argument.  This portion of the decision returns again to the calculus that because Judge Newman refused to comply with the Judicial Council’s demands to neurophysiological examination which was required in order for them to make a “fully informed determination as to whether Judge Newman is suffering from a disability that prevents her from discharging the duties of office,” the “temporary” suspension(s) under 28 U.S.C. § 354(a)(2)(A)(i) “[did] not amount to removal from office” (if only because the Judge kept her salary and title).

Finally, the Special Committee’s decision holds that refusal of Judge Newman’s request to transfer her case to the Judicial Council of another Circuit Court did not violate the Judge’s Fifth Amendment right to due process.  The basis for this decision is that Judge Newman has no protected property interest from which she was deprived.  One reason for this outcome is that the property interest Judge Newman asserted was the exercise in “judicial power,” which the Special Committee decided was not a personal interest but “belongs to the courts, not individual judges” under N. Pipeline Constr. Co.  The decision also uses the distinction that Judge Newman was permitted to continue working on the cases she had heard before the Chief Judge prohibited her from sitting on any additional cases three years ago.  Thus, according to the decision, Canon 3(A)(2) (“a judge ‘should hear and decide matters assigned, unless disqualified’”) did not support her claim to a property right to her judgeship.  And the decision enumerates a list of the perquisites of her position (including an office, a law clerk salary, and benefits) and concludes that “Judge Newman cannot have been deprived of a property interest in an office she still holds,” citing Abcarian v. McDonald, 617 F.3d 931, 941-42 (7th Cir. 2010).

The Special Committee is willing to acknowledge that Judge Newman has alleged a protected liberty interest in her “personal medical records and in avoiding compelled neuropsychological examinations” but that is not enough to convince the Committee that the Judge has been deprived procedural due process.  The Special Committee recognizes Judge Newman’s argument that “due process requires the disqualification of a decision maker when the circumstances present a risk of actual bias or create the appearance of bias so substantial that it would tempt the average adjudicator” but rejects application to this case of the legal citations the Judge relied upon in making her claims.  The basis for the decision is that the actions of the Judicial Council are administrative rather than judicial, and that “[t]he Supreme Court has rejected the argument that the combination of investigative and adjudicative functions creates an unconstitutional risk of bias in an administrative proceeding,” citing Withrow v. Larkin, 421 U.S. 35, 47 (1975):

The contention that the combination of investigative and adjudicative functions necessarily creates an unconstitutional risk of bias in administrative adjudication has a much more difficult burden of persuasion to carry.  It must overcome a presumption of honesty and integrity in those serving as adjudicators; and it must convince that, under a realistic appraisal of psychological tendencies and human weakness, conferring investigative and adjudicative powers on the same individuals poses such a risk of actual bias or prejudgment that the practice must be forbidden if the guarantee of due process is to be adequately implemented [emphasis in brief].

Specifically, the Special Committee rejects Judge Newman’s allegations, inter alia, that the Judicial Council’s rejection of the reports of her experts was evidence of bias, because the basis for this conclusion was that her evidence was insufficient.  And the Special Committee in setting forth the circumstances suggests that the request for transfer was premature:

When the Committee considered Judge Newman’s petition for review of her initial suspension, it noted that if the Judicial Council were to reach the ultimate issue of whether Judge Newman suffers from a disability, she might seek testimony from her colleagues on the Judicial Council if a Rule 14 hearing were held.  We explained that under those circumstances, the Chief Circuit Judge and Judicial Council should give due consideration as to whether a request for transfer would be warranted.  . . .  If at a later stage in the proceedings, members of the Judicial Council will be called upon to provide testimony on the ultimate issue – whether Judge Newman suffers from a disability – then due process concerns would counsel in favor of a request to transfer the complaint.

Whereas here the narrow question before the Judicial Council did not implicate these situations that might support transfer.

Finally, the Special Committee’s decision contains a possibility of a favorable decision to transfer, saying that “throughout the proceedings, Judge Newman has consistently represented that she would agree to cooperate with the investigation and undergo a medical examination if the complaint were transferred to a different circuit.  In that event, the Committee expects Judge Newman to honor her representation to undergo further medical evaluation.”  Not an explicit quid pro quo, perhaps, but more than a suggestion that there may be a path forward (other than retirement) should the Supreme Court deny the Judge’s certiorari petition.

For additional information regarding this topic, please see:

• “Judge Newman Seeks Recourse from Supreme Court,” March 15. 2026
• “Judge Newman’s Petition for Rehearing En Banc Denied,” December 30, 2025
• “Judge Newman’s Challenge Fails at D.C. Circuit,” August 22, 2025
• “Federal Circuit Special Committee Recommends Continued Suspension for Judge Newman,” July 28, 2025
• “Newman v. Moore – Down to a “Battle of the Experts”?” March 25, 2025
• “Judge Newman Files Appeal with D.C. Circuit,” December 22, 2024
• “An American (and Entirely Unnecessary) Tragedy,” December 9, 2024
• “Judge Newman Suspension Renewed,” July 25, 2024
• “Judge Newman’s Suit Comes to an End,” July 9, 2024
• “Judge Newman Suspended for One Year by Federal Circuit,” September 20, 2023
• “Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman,” August 6, 2023
• “Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit,” May 21, 2023

Despite a pointed decision by the Federal Circuit vacating and remanding the matter to the Patent Trial and Appeal Board, yesterday the Board once again granted priority for CRISPR technology to the Broad Institute. A more detailed discussion of the basis for this judgment will follow.