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 Marval noted that “[i]n a significant policy shift,” the Argentine Executive Branch had repealed the guidelines, “marking a major turning point in the country’s patent landscape.”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).
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.
• 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.
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:
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.
The Parties – Senior Party Broad Institute, Harvard University, and MIT (collectively, “Broad”) and Junior Party Regents of the University of California, Berkeley; University of Vienna; and Emmanuelle Charpentier (collectively “CVC”) – each timely filed a paper on conception dates upon which they intend to rely in the Patent Trial and Appeal Board (PTAB) reconsideration on priority under remand from the Federal Circuit, who last year vacated and remanded the Board’s decision awarding priority in Interference No. 106,115 to Senior Party Broad.
CVC’s submission relied on the four dates contained in its earlier-filed Substantive Motion No. 2: “This motion first shows that the inventors had a complete conception by March 1, 2012 . . . . The motion provides additional evidence of conception, alternatively, by April 11, May 28, or June 28, 2012” (emphasis added in CVC’s Paper). Also mentioned in this Paper is that Broad acknowledged CVC’s assertion of these conception dates in its earlier-filed motions, which CVC also asserted in its Reply Brief for Substantive Motion No. 2, which addressed the putative absence asserted by Broad (in its Opposition to CVC Substantive Motion No. 2) of certain components (a U6 promoter) in CVC’s Reply Brief, which asserted that CVC was using this promoter by at least May 28, 2012.
The Broad in its Paper argued first for complete conception before CVC’s earliest conception date (March 1, 2012), specifically directed to Inventor Zhang’s “vector design” on August 7, 2011 and system disclosed in a January 12, 2012 NIH grant proposal. Broad also asserts independent conception of an embodiment on June 26, 2012 comprising a GAAA linker (characteristic of sgRNA).
These assertions will be argued in the Parties’ Opening Briefs filed on October 10, 2025 (limited to 25 pages); response/opposition to their opponents briefs filed on November 7, 2025 (limited to 25 pages); and a Reply by each party filed on December 5, 2025 (limited to 10 pages). It should be recognized with regard to Broad’s submission that the conception dates prior to CVC’s March 1, 2012 date are directed to so-called “dual guide” RNA species (wherein the CRISPR (crRNA) and tracer (tracrRNA) are present in the CRISPR complex with the Cas9 endonuclease as separate species), and CVC’s conception comprises so-called “single guide” RNA (sgRNA), illustrated by a laboratory notebook page submitted by CVC in this interference as evidence of conception:
The Count (that defines the interfering subject matter in the ‘115 Interference as declared) reads as follows:
Count 1: Claim 18 of Broad U.S. Patent No. 8,697,359
An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising a Cas9 protein and at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and the Cas9 protein cleaves the DNA molecules, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together, wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.
Thus, to establish priority each Party will need to show conception of this CRISPR using this sgRNA species.
Moreover, Broad’s assertion of conception of the sgRNA (which comprises the GAAA linker) is apparently contrary to (or perhaps inconsistent with) evidence of record in the interference regarding communication of CVC’s conception of sgRNA by Dr. Marrafini who attended a public scientific talk by Dr. Doudna after CVC’s earliest provisional applications disclosing CRISPR using these species had been filed (albeit dates not recognized as giving CVC priority in Substantive Motions CVC filed in an effort to be declared the Senior Party).
These issues will no doubt be argued extensively in the Parties’ briefs-on-remand discussed in forthcoming posts.
Among the many failings of the current U.S. patent eligibility framework under 35 U.S.C. § 101, perhaps none is more corrosive to the patent system’s basic function than the fact that the framework keeps changing. The judicial exceptions to patentability are, in theory, stable background principles. These exceptions limit the breadth and viability of inventions that encompass laws of nature, natural phenomena, and abstract ideas.
In practice, the Federal Circuit’s application of those principles to software patents over the twelve years since Alice v. CLS Bank has resembled less a coherent legal standard and more a series of freely-improvised opinions. Some of these opinions were briefly influential before being quietly diminished, and others have calcified into doctrine despite being logically indefensible. The result is a body of law that requires patentees and practitioners to track the current state of the doctrine on a monthly – if not weekly – basis.
In the immediate aftermath of Alice,the Federal Circuit went on something close to an invalidation streak. Ultramercial, LLC v. Hulu, buySAFE, Inc. v. Google, and Planet Bingo, LLC v. VKGS LLC all came down within months of the Supreme Court’s June 2014 decision, each finding ineligibility of the respective claims at dispute. Some in the patent community concluded, not unreasonably, that software patents as a class were effectively finished.
The first exception to this narrative was DDR Holdings, LLC v. Hotels.com, decided in December of that year, in which the Federal Circuit managed to find eligibility by characterizing claims as “necessarily rooted in computer technology” and directed at solving a problem “specifically arising in the realm of computer networks.” For a time, DDR was considered a lifeline, as it stood for the principle that an invention could survive under § 101 if it addressed a problem that was native to the internet itself, rather than merely implementing a pre-existing human practice online.
The wave built in 2016. Enfish, LLC v. Microsoft Corp. held that claims directed to improvements in computer functionality itself (and not just the use of a computer to accomplish some other task) might survive at step one of the Alice framework. The self-referential database at issue in Enfish was patent eligible because the claims focused on the computer’s own performance rather than on a result to be achieved using a computer.
Shortly thereafter, McRO, Inc. v. Bandai Namco Games America found non-abstract a method for automating lip-sync animation using a specific, defined set of rules, on the theory that the claims were directed to a concrete improvement in a technical process rather than to the general concept of animation. BASCOM Global Internet Services v. AT&T Mobility added an Alice step-two variant; notably, even if a claim is directed to an abstract idea at step one, an unconventional arrangement of known components can supply the inventive concept needed to survive step two.
For a period of roughly two years, from mid-2016 through 2017, these three cases represented what felt like a durable framework for software patent eligibility. Improve the computer, use specific unconventional rules, or arrange known components in a non-routine way, and you had a fighting chance.
The problem was that these principles were never given stable content. Improving computer functionality turned out to mean whatever a particular panel thought it meant on a given day. Claims that looked very similar to the Enfish database (e.g., specific, technically detailed, directed at improving computer performance or functionality) were found ineligible by other panels on the grounds that the claimed improvement was to the result achieved by using the computer, not to the computer’s own operation.[1]McRO‘s specific rules proved similarly slippery. It was unclear how specific the rules needed to be, and how one was supposed to distinguish a specific technical rule from a specific abstract idea. By 2018 and 2019, the DDR / Enfish / McRO / BASCOM quartet was still nominally alive, but in practice courts were citing these cases mainly to distinguish over them on the way to finding claims ineligible.
The next significant development was procedural rather than substantive. In Berkheimer v. HP Inc. (Fed. Cir. 2018), and Aatrix Software v. Green Shades Software, the Federal Circuit held that whether claim elements are “well-understood, routine, and conventional” under step two involves underlying questions of fact that cannot always be resolved on a motion to dismiss or summary judgment without an evidentiary record. This was genuinely significant, at least on paper. It meant that a defendant could no longer simply assert in a brief that every element of a software claim was generic, without any supporting evidence, and walk out with an early dismissal.
What happened next was predictable in retrospect. Courts narrowed the reach of Berkheimer and Aatrix in practice by holding that only specific, well-pleaded factual allegations could defeat a § 101 invalidity motion at the pleading stage. In other words, the burden to establish an evidentiary record was transferred from the challenger to patentee. By the early 2020s, these decisions had lost much of their practical force. Courts routinely found that the factual questions supposedly raised by Berkheimer were not genuinely disputed, or that a complaint’s allegations of unconventionality were too conclusory to count.
Through the early 2020s, the Federal Circuit continued generating § 101 decisions at a volume and inconsistency that made the law difficult to summarize in any concise way. Different panels reached different conclusions on claims that practitioners regarded as substantively similar. The “improvement to computer functionality” rationale from Enfish was applied in some cases and given lip service in others with no discernible pattern. The “internet-centric problem” reasoning from DDR shrank in practical scope, with courts increasingly skeptical that framing a problem as internet-specific was enough to confer eligibility. The BASCOM “unconventional arrangement” principle was rarely the deciding factor in eligibility determinations.
The most recent chapter involves artificial intelligence, and it is not encouraging. Recentive Analytics, Inc. v. Fox Corp. held that claims applying established machine learning (ML) methods to new data environments without any improvement to the underlying ML model are ineligible. This was billed as a case of first impression, and in one narrow sense it was. The Federal Circuit had not previously addressed ML claims in precisely these terms. But the holding simply applied the existing Alice framework’s skepticism about computer implementation to the ML context. The new wrinkle, and the dangerous one, is the implication that ML-based claims must demonstrate innovation within the model architecture itself, not merely in the application of the model to a new domain. This effectively sets a floor of technical specificity for AI patents that the prior case law had not explicitly required for other categories of software.[2]
What is not debatable is the trajectory of the last twelve years taken as a whole. In 2014, the rule was (more or less) that software is presumptively suspect, with no clear path to eligibility yet established. By 2016, the rule was that software can be eligible if it improves computer functionality, uses specific unconventional rules, or arranges known components in a new way. By 2018, the rule added a procedural gloss in that eligibility questions may involve facts that need to be developed. By the early 2020s, the rule had effectively contracted again, with the pro-eligibility rationales of 2016 being cited mainly as foils. By 2025, the rule for AI appears to be that the model itself must be novel, not just its use.
Each of these iterations was announced as an application of the same two-step Alice framework. None of them was formally repudiated when the next one arrived. They coexist in the case law as nominally live authority, cited by courts and practitioners depending on which way the argument runs.
This is not how legal doctrine is supposed to work. A test is supposed to produce consistent outcomes when applied to similar facts. The § 101 test as applied to software produces outcomes that are consistent mainly in their inconsistency. An inventor filing a patent application drawn to machine learning today cannot know whether their claims will be evaluated under the Enfish improvement-to-computer-functionality rationale, under the Recentive ML-specific rule, or some weighted combination of these and other factors. What they can know is that the goalposts will likely have moved at least once more before any patent that grants from the application can be asserted.
[1] This distinction between improving what the computer does and improving the result the computer produces proved to be one of the more philosophically complex and practically useless dividing lines in the post-Alice doctrine. From an engineering standpoint, an improvement can be found in both a more efficient process to produce a result as well as a process that produces a better result. Why one is more likely to be eligible than the other remains mysterious but likely has little to do with real-world concerns.
[2] This is another distinction that makes no sense. One of the technical challenges in the ML space is determining which ML model to apply to what data. The differences between model output given the same data can be extreme. Requiring ML inventors to innovate at the model layer rather than the use case layer is the equivalent of telling the inventors of the spreadsheet that their software was patentable only if they disclosed a new transistor.
Neither the Parties nor the Patent Trial and Appeal Board (PTAB) have been resting in addressing the decision by the Federal Circuit that vacated and remanded the Board’s decision awarding priority in Interference No. 106,115 to Senior Party The Broad Institute, Harvard University, and MIT (collectively, “Broad”; Junior Party is the Regents of the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier, collectively designated “CVC”; while this reminder may not be necessary it has been a while). On August 15, 2025, the Parties and the Board participated in a conference call to determine the procedural bases for going forward.
First order of business was a change in the composition of the PTAB panel hearing the interference. According to Paper 2900, Administrative Patent Judges (APJs) Sally Gardner Lane and James T. Moore were replaced by APJs Rachel H. Townsend and David Cotta, joined by APJ Deborah Katz.
The Board then handed down an Order (Paper 2901; see below) regarding the further progress of the interference, which determined the order in which the Parties’ briefs are discussed. Both parties were given the opportunity to submit briefing supplementing their priority statements and arguments, to be submitted on the same day (October 10, 2025; limited to 25 pages). These briefs are then to be followed by a response/opposition to their opponents briefs (November 7, 2025; limited to 25 pages), followed by a Reply by each party (December 5, 2025; limited to 10 pages). Each Party was permitted to include argument regarding the issue of derivation, which the Board determined had been included in the remand order, specifically:
“On remand, the later party to reduce to practice will have the opportunity to show, under a conception date established by the correct standard . . . (2) it had ‘prior conception of the claimed subject matter and communication of the conception to the adverse claimant.’” (Regents, 136 F.4th at 1382 (quoting Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993) (awarding priority where there was “prior conception of the claimed subject matter and communication of the conception to the adverse claimant.”)).
The Parties are precluded from submitting new evidence without Board authorization.
In an Appendix to the Order is reproduced a jointly-filed e-mail to the Board regarding the Parties proposals.
The Parties each satisfied the deadlines imposed by the Board, and further posts will set forth each Parties arguments, Oppositions to their opponent’s arguments, and Replies. Also discussed in a future post will be the Parties’ renewed Priority Statements.
To date there has been no Order from the Board setting the date and time for Oral Hearing.
Update: Administrative Patent Judge Rae Lynn P. Guest replaces Administrative Patent Judge Rachel H. Townsend on the panel (Paper No. 2913; see below).
Hat tip to Mary Till of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP for bringing the panel change to our attention.
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). Last week the latest, and likely last, Act of this sad drama was initiated by Judge Newman filing a petition for certiorari with the Supreme Court.
The Petition was filed on Judge Newman’s behalf by the New Civil Liberties Alliance and the Question Presented was crafted to Judge Newman’s positions taken before the D.C. District Court and the D.C. Court of Appeals in her lawsuit against the Judicial Council of the Federal Circuit:
1. Does 28 U.S.C. § 357(c)’s bar on judicial review of previously issued “orders” and “determinations” apply to ultra vires acts that exceed the scope of authority conferred by the Disability Act and the Constitution?
2. Does 28 U.S.C. § 357(c)’s bar on judicial review of previously issued “orders” and “determinations” deprive a court of jurisdiction to consider claims that seek forward-looking relief to enjoin future unlawful actions?
Counsel’s legal arguments are focused, as have Judge Newman’s arguments to inferior courts, on the ultra vires character of the Judicial Council’s suspensions, the incorrect interpretation of the statute under McBryde v. Committee to Review Circuit Council Conduct and Disability Orders of Judicial Conference of the United States, 264 F.3d 52, 58–68 (D.C. Cir. 2001), and the alleged unconstitutional actions by which the Judicial Council has accomplished a fait accompli of removing Judge Newman from the bench in contravention of the requirement that should she be removed, it can only be through impeachment by the House and conviction by the Senate.
The Petition then sets out the history of the Federal Circuit Judicial Council’s attempts to have Judge Newman permanently removed from the Court (and not without certain characterizations of these efforts). For example, the Petition asserts that the issues here are nothing less than “crucial constitutional and statutory aspects of lifetime tenure and judicial independence, especially the availability of judicial review for intra-branch infringements on judicial service” and “the very independence of Article III courts [that can] potentially affect every member of the federal judiciary.” And from the first paragraph, the Petition informs the Court that Judge Newman is known as “the Great Dissenter” as well as being the Federal Circuit’s “longest-serving and most storied jurist.” The undercurrent of a desire by the judges of the Federal Circuit to remove “this troublesome colleague” is a source of a greater issue than Judge Newman; rather, according to the Petition, the risk is that “[e]very judge who gets crosswise with her chief judge or her colleagues must now worry whether similar tactics could be used to remove them” if, as the D.C. Circuit held, “the Judicial Councils Reform and Judicial Conduct and Disability Act of 1980 (“the Disability Act”) bars review of the [unlawful, according to the Petition] actions taken against Judge Pauline Newman.” (The use of the qualifier “unlawful” is, reminiscent of Homeric qualifiers for its heroes, used in almost every instance where Judge Newman’s suspension is referenced in this Petition.)
The Petition argues that Judge Newman has continued to speak and write and yet the suspension has been maintained, despite ample evidence (see “Newman v. Moore – Down to a “Battle of the Experts”?“; “An American (and Entirely Unnecessary) Tragedy“) of the absence of evidence supporting Judge Newman’s suspension, including evidence that the Judge “voluntarily underwent and passed three expert evaluations of her mental fitness and was reported as having the mental ability of someone decades younger.” (Indeed, a review of the record shows that the basis for the suspension subtly changed from impairment in any inability to perform her duties to a charge of misconduct because the Judge would not comply with the Judicial Council’s demand that she be submitted to medical, neurological, and psychological testing by doctors of the Council’s choosing.)
As to the “unprecedented” nature of the situation underlying Judge Newman’s request for relief from the Court, the Petition notes that the Judge “has been suspended longer than any federal judge in history” and asserts “[t]he length of the suspension, the apparent intention to keep her off the bench permanently, the same judges acting as complainant, witnesses and judges, and the refusal to transfer the matter to another circuit for neutral investigation” as circumstances relevant to the Court’s consideration (specifically, and repetitively, mentioning that the remedy under the statute is that “on a temporary basis for a time certain, no further cases be assigned to” a Judge, in contrast to the serial suspensions unlimited in time imposed on Judge Newman.
The Petition addresses the statutory (and Constitutional) issues raised by the provision that, except for review by the Judicial Conference of the United States any decision (“orders and determinations”) by an appellate court’s Judicial Council “are ‘final and conclusive’ and ‘shall not be judicially reviewable on appeal or otherwise” under 28 U.S.C. § 357(c). The Petition also makes a distinction between review of past orders and attempts to “seek to enjoin the issuance of future orders or determinations,” which Judge Newman asserts should be subject to judicial review whether their challenge is based on the statute or the Constitution. And in an assertion that should be self-evident, the Judge argues that “the Disability Act does not authorize the judicial council (or anyone else) to act in violation of the Constitution.”
The Petition then turns to the question before the Court, that the D.C. Circuit Court of Appeals has case law, McBryde, that precludes constitutionally based challenges of this statute unless that are facial and not “as-applied” challenges to a Judicial Council’s authority under the Constitution to impose a penalty (thereby blocking litigants from bringing the challenge at all). The Petition also sets forth the provisions of the statute and the protocol (“in practice”) that had been established in earlier cases (in contrast to the course of conduct in this case). This explication is followed by a review of that course of conduct against Judge Newman, which is replete with evidence of the differences that have occurred.* These include the response by Chief Judge Moore to one of her “characteristically excellent dissents” (in Rudisill v. McDonough), which response first “removed her from normal panel assignments,” followed by a Judicial Council Order that Judge Newman “not hear any more cases” and Chief Judge Moore telling the Judge that she “could either retire or ‘consider senior status’” (the Petition succinctly noting that “Judge Newman refused” those alternatives). The Petition makes a specific assertion that in response to Judge Newman’s refusal “Chief Judge Moore acted on her own initiative to ‘identify a complaint’ against Judge Newman under the Disability Act” and “alleged that ‘there is probable cause to believe that Judge Newman’s health has left her without the capacity to perform the work of an active judge.” The Petition states that an Order issued to establish a “special committee” to investigate these allegations that “rel[ied] on the personal knowledge of Judge Newman’s Federal Circuit colleagues,” despite “none of them [having] initiated a complaint,” and that Chief Judge Moore had “claimed that other ‘judges and staff” had brought” their concerns in this regard to her “based on their personal experience.” According to the Petition, the Chief Judge asserted that “half of the [Federal Circuit] judges” had expressed such concerns, albeit arising during deliberations (the Petition noting that “no one other than other Federal Circuit judges were in the room”). Also mentioned was that the Order “falsely asserted that two years earlier, in 2021, Judge Newman had ‘suffer[ed] a heart attack and undergo[ne] coronary stent surgery.’”
This litany was asserted as a basis for Judge Newman requesting that the Chief Judge and Special Committee transfer the investigation to another Circuit, to the extent that “members of the Special Committee would be serving as witnesses and noting the established routine practice of transferring complaints against circuit judges requiring more than minimal investigation to special committees outside the circuit of the judge under investigation.” Despite what the Petition characterizes as “blatant conflict of interest in [these Federal Circuit Judges] serving simultaneously as complainant, witnesses, and judges,” the transfer request was denied.
The Petition then notes as an impropriety under the Disability Act (88 U.S.C. § 354(a); Rules for Judicial-Conduct and Judicial-Disability Proceedings Rule 20(b)(1)(D)), Chief Judge Moore removed Judge Newman from normal panel assignments “[b]efore the investigation had even begun” (the Petition noting that in response, the Chief accused Judge Newman of “judicial misconduct” in inquiring about the basis for the removal and expanded the scope of the investigation thereby). And then the Petition further explained for the Court what the Special Committee demanded (that the Judge “submit to neurological and neuropsychological testing by doctors chosen by the committee” and supply “hospital records, medical, psychiatric or psychological, and other health-professional records”) and what Judge Newman provided (“expert reports from Dr. Ted L. Rothstein and Dr. Regina M. Carney, based on hours of testing and observation, attesting that her cognitive abilities are fully intact and that she remains capable of performing the functions of her office”**). This led to the Special Committee finding Judge Newman “guilty of misconduct for refusing to ‘cooperate’ with the committee”*** and recommending a one-year suspension (see “Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman“), which the Judicial Council entered (see “Judge Newman Suspended for One Year by Federal Circuit“).
Judge Newman appealed the suspension to the Judicial Conference of the United States, which denied her petition, and as the D.C. Circuit noted “neither the Judicial Council’s orders nor the JC&D Committee’s decision explicitly reflects genuine consideration of Judge Newman’s constitutional arguments,” and “[n]one of the orders appear to address any argument by Judge Newman that her suspension violates the Constitution by effectively removing her from office,” details certainly relevant to the Supreme Court’s decision whether to review.
“The upshot” of these proceedings, according to Judge Newman, is that she:
[H]as, for all practical effect, been removed from office despite Article III’s guarantee of tenure during good behavior— and despite the Disability Act’s strict admonition that “[u]nder no circumstances may the judicial council order removal from office”—and without the impeachment and conviction needed to remove Senate-confirmed judges from office against their will.
The Judge’s final statements regarding her lawsuit before the D.C. district court and appeal before the Circuit Court of Appeals is focused on her statutory and constitutional claims and the bases for both courts to reject these claims. Those bases rested almost entirely on the McBryde decision, wherein 28 U.S.C. § 357 as thus construed barred her complaint on anything other than facial challenges (dismissing other counts in her complaint on lack of subject matter jurisdiction; see “Judge Newman’s Suit Comes to an End” and “Judge Newman’s Challenge Fails at D.C. Circuit“). The Judge takes the opportunity to inform the Court of the D.C. Circuit’s recognition of “the constitutional issues raised by Judge Newman being important and serious” and that its decision that “its hand were tied by McBryde” raised “constitutional concerns” that could only be resolved by en banc review (Judge Newman’s petition for which was denied; see “Judge Newman’s Petition for Rehearing En Banc Denied“).Having set forth the predicate factual and procedural underpinnings of the case, the Petition turned to the reasons the Court should grant certiorari. The first of these set forth in the Petition is that the Court needed to clarify the scope of Section 357(c) of the Disability Act such that it does not shield ultra vires acts (like the actions taken by the Judicial Council of the Federal Circuit) from judicial review. The basis for the argument is that this section of the statute is limited to authority conferred by the Act and does not extend to actions without any statutory or constitutional authority. The Petition cites Johnson v. Robison, 415 U.S. 361 (1974) (regarding decisions by the Administer of Veterans’ Affairs), supported by Norton v. Shelby County, 118 U.S. 425, 442 (1886)(“[A]n unconstitutional act is not a law; it confers no rights; it imposes no duties; it affords no protection; it creates no office; it is, in legal contemplation, as inoperative as though it had never been passed”) and Ex parte Siebold, 100 U.S. 371, 376 (1879); and Webster v. Doe, 486 U.S. 592 (1988) (regarding the Director of Central Intelligence). Again, somewhat self-evidently, the Petition asserts “[t]he Disability Act . . . , cannot authorize the judicial council (or anyone else) to act in violation of the Constitution” and accordingly the construction of the Act below exceeded its scope. Thus, the Petition argues that Judge Newman is entitled to judicial review of “a host of constitutional challenges to her suspension orders, and [her] claims that the judicial council has exceeded the scope of its statutory powers and violated the Constitution (and the Act) by effectively removing her from office despite the life tenure promised by Article III.”
The second basis for the Court to grant certiorari advocated by the Petition is that the lower courts erred in upholding under McBryde the scope of § 357(c) to preclude claims seeking prospective relief. Here the Petition argues that “at most” the Disability Act bars judicial review of past orders, and the consequence of the decisions of the lower courts would permit the one-year suspensions to be imposed “indefinitely” if there can be no challenge before they are imposed. Should the Court so rule, Judge Newman expects (as set forth in a footnote) the possibility of the prospect that her authority to hear cases would be “immediately restored.” Judge Newman argues that the express language of § 357(c) states that judicial review is only blocked for existing (i.e., past) “orders and determinations.” The Petition states that, at a minimum the Court could vacate and remand for reconsideration under their intervening decision in Bowe v. United States, 146 S. Ct. 447 (2026) (having to do with subsequent habeus corpus motions), which the Judge argues “forecloses any construction of section 357(c) that would close the doors on Judge Newman’s claims for purely prospective relief” because under Bowe the statute would be construed narrowly to apply to only prior orders and determinations under a “clear indication” rule of statutory construction.
The Petition also argues that the absence of a circuit split and the longevity of McBryde (25 years) should not inhibit the Court from granting certiorari because there is no prospect of a circuit split arising given the “thankfully rare” nature of litigation over judicial-suspension orders. The Petition puts the issue in the context of “recent attacks on the independence of Article III judges” and the constitutional protections necessarily enjoyed by judges that permit them to “apply the law without fear of retaliation from those who dislike their decisions.” The Petition directly asserts Chief Judge Moore’s role in “using the Disability Act to circumvent these constitutional protections, in an attempt to implement a constructive discharge of a judicial colleague with whom she no longer wishes to serve,” calling them “heavy-handed tactics [that] cannot be tolerated if the independence of Article III judges is to be preserved.” The Petition sets forth additional negative consequences for the independence of the judiciary that make it important to “nip[] in the bud” these practices. The Petition asserts that these tactics have been effective, wherein “Judge Newman’s colleagues have thus far succeeded in silencing her frequently dissenting voice on the court, despite her presidential appointment and lifetime tenure” and that the consequences they argue are not imaginary: citing Dennis Crouch’s Patently-Oblog, the Petition notes that since Judge Newman’s removal from the bench the rate of dissent has dropped from 12% to 4%, which is not accounted for by Judge Newman’s absence alone, giving credence to Judge Newman’s warnings.
The Petition closes with the admonition to the Court:
Attacks on the independence of the judiciary have been increasing from both the left and right, and from the executive, legislative, and even within the judicial branch. For those reasons—and for the reasons given above—it is imperative for the Court to step in and issue a strong statement in support of judicial independence and make clear that the only appropriate method of removing a federal judge is through the constitutional impeachment process.
* It is in the Statement section of the Petition that Judge Newman particularly points out Chief Judge Moore’s role (“acting as complainant and leading the administrative process”) in the efforts to remove the Judge from the Court. The Petition characterizes as “pretense” that there is any evidence that she is “physically and mentally unfit to continue serving as a judge” (quoting both her age (98) and conclusions from her own medical experts that she is an “unusually cognitively intact . . . woman” who appears “20 or more years younger than her stated age”). The Petition also takes the opportunity to remind that Court that “only two terms ago” her reasoning in dissent was used in Rudisill v. McDonough, 601 U.S. 294 (2024) (and in a footnote noting that her dissent was made “less than three months before Chief Judge Moore began pressuring her to resign under the pretense that [the] Judge was cognitively unfit to decide cases”). Elsewhere in the Petition, the further actions of the Judicial Council are prefaced by being of Judge Moore’s doing (e.g., “Chief Judge Moore has prohibited Judge Newman from sitting en banc,” “Chief Judge Moore has also cut Judge Newman off from the ceremonial functions of her court, as well as pre-publication opinion distributions and administrative matters,” “She has even prohibited Judge Newman from hiring new law clerks”).
** As a reminder, the response to these reports by the Judicial Counsel is to have their own experts denigrate Judge Newman’s experts’ methods and conclusions; see “Newman v. Moore — Down to a “Battle of the Experts”?“
*** A conclusion expanded upon in footnote 11 for those interested in the details, at least as Judge Newman sees it.
For additional information regarding this topic, please see:
One of the beneficial characteristics of the response to the COVID-19 pandemic were pledges from companies involved in developing vaccines (such as Moderna, Pfizer, BioNTech and others) not to enforce patents on relevant technology during the duration. That restraint has long-since vanished (as has the global pandemic effects of the virus) and there have been several lawsuits, in the U.S. and abroad, relating to various components of the vaccine.
Many of them surround lipid nanoparticle technology, which had been the subject of research and companies obtaining patent protection for several decades. This technology has now become the subject of several lawsuits. One, Alnylam Pharmaceuticals v. Pfizer and Alnylam Pharmaceuticals Inc v. Moderna Inc., resulted in settlement after several adverse decisions against Alnylam’s asserted claims in U.S. Patent Nos. 11,246,933 and 11,382,979, wherein the parties agreed that Moderna’s COVID vaccines did not infringe. Nevertheless Alnylam has continued its lawsuit against BioNTech and Pfizer on similar claims; seeAlnylam Pharmaceuticals v. Pfizer.
Arbutus Biopharma sued Moderna on its claims of U.S. Patent 9,404,127 to “stable” nucleic acid lipid particles, which were invalidated in an inter partes review proceeding by the Patent Trial and Appeal Board and affirmed by the Federal Circuit. Those claims recited certain physicochemical structures (termed “non-lamellar”). Arbutus has also sued BioNTech and Pfizer on claims to its LNP technology as claimed in U.S. Patent Nos. 8,492,359; 9,504,651; 11,141,378; and 11,318,098. On the other hand, Arbutus and Genevant Sciences recently settled their lawsuit with Moderna over LNP technology specifically comprising a particular cationic lipid claimed in U.S. Patent Nos. 8,058,069; 8,492,359; 8,822,668; 9,364,435; 9,504,651; and 11,141,378:
Relevant features of this settlement include an immediate (July 2026) payment by Moderna of $950 million with an additional $1.3 billion being subject to a determination on appeal regarding Moderna’s claim that these sums should be paid by the Federal Government because their COVID-19 vaccine, Spikemax®, was produced under the provisions of 28 U.S.C. § 1498(a). Moderna for its part also received a global nonexclusive license to patented technology for SM-102-containing mRNA vaccines for infectious diseases (specifically SPIKEVAX, mNEXSPIKE and mRESVIA; according to Arbutus’s Form 8-K filing with the Securities and Exchange Commission on March 5th, wherein the latter vaccine is directed to respiratory syncytial vaccine), and an agreement not to sue for “certain” (undisclosed) patents on Moderna’s products using the technology. It is unclear whether Moderna vaccines against diseases other than infectious disease would fall within the scope of this license (for example, Moderna’s anticancer vaccines, which have recently had positive clinical trial results).
Moderna has separately sued rivals Pfizer and BioNTech for infringing patents related to mRNA technology, U.S. Patent Nos. 10,702,600; 10,898,574; and 10,933,127, directed to beta-coronavirus mRNA and methods of use thereof. BioNTech challenged the ‘600 and ‘127 patents in inter partes review and the PTAB found them to be invalid. This decision is on appeal to the Federal Circuit.
BioNTech countersued Moderna in February, arguing Moderna’s next-generation COVID-19 shot, MNEXSPIKE, infringes its U.S. Patent No. 12,133,899.
A different and distinct patented component of this technology was the basis for Bayer to sue a number of COVID vaccine makers earlier this month. In those proceedings, Bayer filed suit separately against Moderna, Inc.; Moderna US, Inc.; and ModernaTx Inc.; Pfizer Inc.; BioNTech SE; BioNTech Mfg. GmbH; and BioNTech US Inc.; and Johnson & Johnson; Janssen Pharmaceutica NV; Janssen Pharmaceuticals Inc.; Janssen Biotech Inc.; and Janssen Vaccines & Prevention N.V. with respect to U.S. Patent No. 7,741,118. This technology is directed at the mRNA component of the vaccines, which reduces the number of polyadenylation signals (ATTTA) in an mRNA payload and as a result improves translation efficiency.
And for its part BioNTech has also filed suit against Moderna based on their mRNA technology. According to BioNTech’s complaint, claims in U.S. Patent No. 12,133,899 are infringed by the mRNA payload for Moderna’s mNEXSPIKE® vaccine against COVID (SARS-CoV-2) comprises a “streamlined vaccine design,” which triggers “an equally strong immune response to that of the complete spike protein” despite comprising only select domains thereof, specifically, a receptor binding domain, a secretory signal, a transmembrane domain, all from the SARS-CoV-s Spike protein, and a trimerization domain from the heterologous T4 fibritin protein. This permits the vaccine to be given to patients at lower dosages and is more stable during storage and transport. Finally, last summer BioNTech reached a settlement with Curevac over its U.S. Patent Nos. 10,760,070; 11,667,910; 11,786,590; 11,865,084; 11,883,486; 11,918,643; and 11,920,174 (among others, albeit not all of which were directed to coronavirus) over mRNA production and purification methods and pharmaceutical compositions produced thereby. In a complex settlement, BioNTech acquired Curevac and GlaxoSmithKline received a monetary settlement in recompense for a failed joint venture with Curevac.
One significant feature of all these lawsuits is that none of the Plaintiffs has asked the court for an injunction, a remnant of the ethical positions taken by patentees during the pandemic. Various combinations of companies that have had variable successes with developing and marketing COVID-19 vaccines are involved with or have concluded (by settlement or otherwise) their disputes over patents for technologies that have developed over time. The question now is the extent to which vaccines and other developing therapeutics will rely on these fundamental patents (and their relatives adapted to other uses, such as chronic diseases) and the extent to which, absent the pressures created by a global pandemic, the motivation and incentive for at least some level of cooperation remains for the benefit of mankind.
A consequence of the gradual decline in COVID infections worldwide has been a less gradual increase in patent litigation by the many entities having patent rights for the vaccines or components of them. This is particularly true of the so-called “mRNA” vaccines, which have been the subject of development by many companies over the past thirty to forty years. The subject matter of these patents have included the mRNA “payload” itself, which can comprise structural modifications such as containing various pseudouridine residues and percentage substitution in the molecule, as well as the genetic structure of the mRNA itself. Perhaps even more complexity can be found in the protective “covering” of the mRNA (which is notoriously labile without such protections), examples of which are illustrated in the upper righthand quadrant of this drawing:
The Moderna vaccine formulation (relevant to Plaintiff’s complaint for infringement) is set forth in the chart below:
In their complaint (Arbutus Biopharma Corp. & Genevant Biosciences GmbH v. Moderna, U.S. District Court for the District of Delaware, No. 1:22-cv-00252), Plaintiffs Arbutus and Genevant alleged that Moderna infringed claims of U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378. Arbutus/Genevant asserted these patents were infringed by Moderna for incorporating into its Spikemax® COVID vaccine lipid nanoparticles (LNP) comprising an ionizable cationic lipid (designated SM-102):
a phospholipid (DSPC); cholesterol; and a conjugated lipid that inhibits aggregation of particles (a PEG-lipid conjugate), with certain advantageous percentages of the components and with encapsulated mRNA. Claim 1 from each patent is set forth in this table:
In press releases from the parties, it was announced that Moderna had settled, and that the settlement terms included an immediate $950 million payment (to be paid in July, 2026) that settled all infringement damages; and a provision for a further $1.3 billion in damages depending on the outcome of Moderna’s appeal regarding its allegations that the Federal government was responsible for these monies under the provisions of 28 U.S.C. § 1498(a). In this regard a district court denied Moderna’s partial motion to dismiss (on jurisdictional grounds), holding that Moderna was not entitled to Section 1498 protection because the accused infringing vaccines were not limited to government use, despite the Department of Justice filing a brief to the contrary. This court in this case on February 2nd held that production of Moderna’s vaccine under “Operation Warp Speed” did not override Plaintiffs’ patent rights. Arbutus/Genevant retain the rights to pursue claims before the Court of Federal Claims should Moderna prevail on its Section 1498 appeal, and Moderna will pay $1.3 billion to Arbutus/Genevant should they not. Moderna also received a global nonexclusive license to patented technology for SM-102-containing mRNA vaccines for infectious diseases (specifically SPIKEVAX, mNEXSPIKE and mRESVIA (according to Arbutus’s Form 8-K filing with the Securities and Exchange Commission on March 5th), and an agreement not to sue for “certain” (undisclosed) patents on Moderna’s products using the technology; it is unclear whether Moderna vaccines against diseases other than infectious disease would fall within the scope of this license (for example, Moderna’s anticancer vaccines, which have recently had positive clinical trial results; see “Merck-Moderna cancer vaccine sustains 49% melanoma risk reduction at 5 years“). See “Roivant Sciences Ltd. (ROIV) Discusses $2.25 Billion Global Settlement Resolving COVID Vaccine Patent Litigation Transcript” for further details. Moderna also agreed for the District Court to enter judgment that four of Arbutus/Genevant’s asserted patents were not invalid. Finally, the agreement (according to the SEC disclosure) encompasses international disputes between the parties over this technology. At present, these include lawsuits in Canada, Japan, and Switzerland and two actions before the Unified Patent Court (UPC), which seek relief for 28 countries including France, Germany, Greece, Italy, Ireland, and Spain.
For further context, Moderna has received $48 billion in past global vaccine sales (according to Reuters).
These plaintiffs filed a similar lawsuit against Pfizer/BioNTech over the LNP technology in their vaccine in 2023. That lawsuit is still ongoing.
Moderna has separately sued rivals Pfizer and BioNTech for infringing patents related to mRNA technology. And BioNTech countersued Moderna in February, arguing Moderna’s next-generation COVID-19 shot, MNEXSPIKE, infringes its U.S. Patent No. 12,133,899.
Earlier this month, Bayer filed suit separately against Moderna, Inc.; Moderna US, Inc.; and ModernaTx Inc.; Pfizer Inc.; BioNTech SE; BioNTech Mfg. GmbH; and BioNTech US Inc.; and Johnson & Johnson; Janssen Pharmaceutica NV; Janssen Pharmaceuticals Inc.; Janssen Biotech Inc.; and Janssen Vaccines & Prevention N.V. with respect to U.S. Patent No. 7,741,118, which reduces the number of polyadenylation signals (ATTTA) in an mRNA payload and as a result improves translation efficiency.
It appears unlikely that these judicial contretemps will end any time soon.
Patent Docs 