DROPLETS
Hogan Lovells reports that at the October 6, 2026 Community Banking Research Conference in St. Louis, Fed Vice Chair for Supervision Michelle Bowman outlined the next phase of Fed reform, including a five-region supervisory structure.
Per Hogan Lovells, Federal Reserve Vice Chair for Supervision Michelle Bowman used her October 6, 2026 remarks at the Community Banking Research Conference in St. Louis to outline the next phase of the Fed's supervisory reform agenda, including a five-region supervisory structure. The only source in this cluster is a single law-firm alert, so the specifics — which functions or offices map to which regions, and how examination and enforcement portfolios would be allocated — are not described in the available material and should not be assumed.
Why counsel should care: supervisory architecture touches examination scheduling, examiner access, resolution planning, and the day-to-day burden of supervision for bank holding companies and their non-bank affiliates. Regionalization can also shift which staff office is the point of contact for remediation matters, which matters during any supervisory dispute or enforcement negotiation. The alert is an early flag, not a substitute for the speech text.
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Governor Newsom signed SB 574 on September 30, 2026, imposing statutory obligations on attorneys, arbitrators and judicial officers who use generative AI — a new compliance layer for every California-licensed lawyer and firm.
On September 30, 2026, California Governor Gavin Newsom signed Senate Bill 574, authored by Senator Thomas Umberg, establishing a statutory framework governing the use of generative artificial intelligence by attorneys, arbitrators, judicial officers and related professionals licensed in the state. According to the reporting, the bill regulates how GenAI may be used in the practice of law rather than leaving the question entirely to the courts and existing professional conduct authorities.
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The Eleventh Circuit held on September 1, 2026 that the False Claims Act's qui tam provisions do not violate the Appointments Clause, reversing a district court that had struck them down.
On September 1, 2026, the U.S. Court of Appeals for the Eleventh Circuit reversed a district court ruling that had declared the False Claims Act's qui tam whistleblower provisions unconstitutional under the Appointments Clause, reinstating the FCA's core enforcement mechanism across much of the Southeast. The significance reaches beyond the circuit's geography: a constitutional attack on the FCA's relator framework has now failed on appeal, which typically discourages further district-court efforts to dismantle the statute's structure and reduces defense leverage for separation-of-powers objections.
For government contractors, healthcare providers, manufacturers, and federal grant recipients the consequences are substantial. FCA qui tam settlements run into the billions of dollars annually, and private relator suits remain the largest single driver of FCA case volume. Defense teams should reassess whether Appointments Clause arguments remain worth preserving in pending matters, given their cost against a statute appellate courts are sustaining.
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A Northern District of California jury reportedly found Eli Lilly breached the implied covenant of good faith and fair dealing under its 2017 Nektar license, awarding $90M after defeating a separate claim.
According to a single practitioner source (Goodwin Procter, via JD Supra), a jury in the U.S. District Court for the Northern District of California returned a verdict on September 24, 2026 after roughly five days of deliberation, finding that Eli Lilly & Co. breached the implied covenant of good faith and fair dealing under its 2017 license agreement with Nektar Therapeutics and awarding $90 million. The source indicates Lilly defeated a related claim, though the available material does not describe the counts tried or the theories behind the defeated claim; those details should be confirmed against the docket and judgment forms.
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A unanimous Sixth Circuit panel on September 25, 2026 refused to block Ohio and Tennessee gambling enforcement against KalshiEX's sports-event contracts, deepening a split on CFTC swap jurisdiction and CEA preemption.
On September 25, 2026, a unanimous Sixth Circuit panel declined to enjoin Ohio and Tennessee from enforcing their gambling statutes against KalshiEX LLC's sports-event contracts, in KalshiEX LLC v. Schuler. According to the reported summary, the panel held those contracts are not "swaps" under the Commodity Exchange Act and that the CEA does not preempt state gambling law — a ruling that deepens an acknowledged circuit split and narrows the federal pathway Kalshi relied on to operate nationally.
Why counsel should care: the decision sits at the intersection of CFTC jurisdiction, federal preemption and state gaming enforcement, and it shapes venue strategy for regulated-market clients, brokerage and clearing intermediaries, and leagues or event rights holders facing suit in multiple states. It also signals continued judicial pushback on treating consumer-facing event contracts as CFTC-registered derivatives.
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A DHS proposed rule would block F-1 OPT recommendations and work authorization until a sponsoring university pays $70,000 for a student's first OPT and $30,000 for each later recommendation, including STEM extensions.
On October 8, 2026, DHS published a proposed rule (Docket No. ICEB-2026-0100) requiring SEVP-certified institutions to pay a $70,000 fee before a student's first optional practical training (OPT) recommendation and a $30,000 fee for each subsequent recommendation, including the STEM extension. Designated school officials would be barred from entering an OPT recommendation in SEVIS until payment, and USCIS would be barred from issuing the OPT employment authorization document without it. Implementation is proposed 60 days after any final rule, with students approved or recommended before that date grandfathered in. DHS estimates 2,478 affected schools and $8.4 billion to $16.5 billion in annual fees, invoking fraud and worker-protection rationales and INA 214(a) authority.
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A firm alert reports Newsom signed AB 1776 on Sept. 30, 2026, a COMPETE Act that would materially widen California Cartwright Act coverage.
Bryan Cave Leighton Paisner reports that on September 30, 2026, Governor Gavin Newsom signed AB 1776, the California COMPETE Act, which the firm describes as one of the most significant expansions of the Cartwright Act since the statute was adopted in 1907, and which — per the excerpt — for the first time extends Cartwright Act reach in some respect not previously covered. The cluster is truncated, so the specific new obligations, covered conduct, thresholds, penalties, and enforcement mechanics are not confirmed here and should be verified against the enrolled bill text before any reliance.
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The Supreme Court granted review in RiseandShine Corp. v. PepsiCo, No. 24-1016, a circuit split over whether a trademark's inherent strength is a jury question of fact or a judicial question of law.
The U.S. Supreme Court has taken up RiseandShine Corporation v. PepsiCo, Inc., No. 24-1016, which asks whether the inherent strength of a trademark — whether the mark is inherently distinctive as conceived or only distinctive because of acquired meaning — is a question of fact for a jury or a question of law for the judge. The grant is intended to resolve a division among the courts of appeals over the applicable standard of review.
Practitioners have reason to care well beyond the beverage context. Inherent strength is a threshold gate in almost every trademark action: courts treating it as a factual question must send the issue to a jury, while courts applying the legal-question framework can resolve it on a motion to dismiss or for summary judgment. The outcome could therefore reshape early-stage motion practice, discovery sequencing, and settlement leverage across a wide range of matters involving major-firm clients in many sectors.
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EuroHPC JU has issued a joint tender call for up to seven AI gigafactories in at least seven Member States, backed by up to EUR 5 billion of EU money plus matched national funding; tenders close 12 November 2026.
What happened: EuroHPC, under a Joint Procurement Agreement with national authorities, has called for tenders for up to seven AI gigafactories — four medium-scale, three large-scale. Up to EUR 10bn of EU and national public support aims to mobilise at least EUR 20bn of private capital; each site needs roughly EUR 4–5bn. Deadline: 12 November 2026, 16:00 Luxembourg time, via TED eTendering and the Funding and Tenders portal.
Why counsel should care: the call is prescriptive on sovereignty. Each site needs an EU-incorporated, EU-controlled Coordinator and an EU Hosting Entity; core operational data must stay in the EU; and bidders must plan integration of European-based software, potentially within four years of operations. Non-EU financing is not barred outright, but control tests reach equity stakes, loans, guarantees and veto rights — a structuring risk for non-European chipmakers, cloud providers and sovereign investors. Winners sign a six-and-a-half-year framework contract plus offtake contracts, with public compute purchases capped at the lower of a ceiling and 17% of capex.
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The Tennessee Supreme Court declined to authorize rule reforms on nonlawyer ownership of law firms and loosened the ABA accreditation requirement for entities providing legal services.
On October 2, 2026, the Tennessee Supreme Court decided In re: Regulatory Reforms to Increase Access to Quality Legal Representation (No. ADM2025-01403), declining to authorize the proposed reforms, leaving restrictions on nonlawyer ownership of law firms in place, and loosening the accreditation requirement — reportedly so entities need not hold American Bar Association accreditation. Because the cluster holds only one short, truncated item, the precise scope granted, any transition mechanics, and effective dates are not established here; the opinion should be read before relying on this.
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Directive 26-12 puts a new DOJ Fraud Division Corporate Enforcement Section in charge of corporate cases from intake to resolution, prioritizes health care, defense contracting, tax and tariff fraud, and export controls.
On October 1, 2026, DOJ's new National Fraud Enforcement Division issued Directive 26-12, giving its Corporate Enforcement Section lead over corporate investigations from intake through any corporate resolution or litigation, and requiring prosecutors to give "great weight" to ten factors in charging and resolution decisions. Those factors include management knowledge of or involvement in a scheme, concealment from auditors or government agencies, conduct lasting three years or more, harm to 25 or more victims or $25 million or more in loss, and conduct touching three or more federal districts. Priority sectors are health care (controlled substances, FDCA violations), government and defense contracting, significant tax and tariff evasion, and import-export controls and forced labor. The directive also tasks leadership with designing whistleblower incentive programs that will extend to individuals who participated in the misconduct itself — a material change to the internal-reporting risk calculus.
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The Ninth Circuit rejected Americans for Prosperity's First Amendment challenge to Proposition 211, leaving Arizona's donor-disclosure regime live through the November midterms and potentially a template for other states.
In Americans for Prosperity v. Meyer (No. 24-2933, Sept. 30, 2026), the Ninth Circuit upheld Arizona's Proposition 211, rejecting arguments that its campaign-finance disclosure rules chill speech and impair free association. The panel described the statute's interest in informing voters as vital, called the burdens modest, and found the requirements narrowly tailored under exacting scrutiny, relying on Citizens United and NRSC v. FEC. Disclosure attaches when a covered person spends more than $50,000 statewide or $25,000 in any other race on campaign media spending, and reaches donors of more than $5,000 in traced original monies, intermediaries above $2,500, with ad disclaimers naming the three largest funders. Spending a group's own funds on advertising is outside the regime, and donors may opt out, though Akin reports some organizations simply decline opted-out gifts.
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Senate Energy and Environment committee leaders released bipartisan framework text aimed at speeding federal permitting, a potentially significant development for project developers facing multi-year review timelines.
According to a Husch Blackwell client alert, on September 30, 2026 the leaders of the Senate Energy and Natural Resources Committee and the Senate Environment and Public Works Committee unveiled a bipartisan permitting overhaul framework — a notable step after what the firm describes as years of false starts. The alert is a law-firm analysis rather than a primary source, and the excerpt does not set out the specific statutory text, timelines, agency reforms, or judicial-review provisions, so the scope of the proposal should be confirmed against the released draft before being relied upon.
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A new Department of Justice memorandum from the National Fraud Enforcement Division states where federal prosecutors intend to focus corporate fraud enforcement, consolidating a two-year shift in approach.
Reporting from a single source indicates that the U.S. Department of Justice has issued a new memorandum setting out the priorities of the National Fraud Enforcement Division, the unit DOJ announced in April 2026. The memo is described as capping roughly two years of successive DOJ memoranda and policies that progressively refined federal corporate fraud enforcement priorities.
For defense-side and compliance counsel, the significance is directional rather than mechanical: prosecutorial resources and charging discretion are finite, and a published statement of priorities typically signals which sectors, fraud typologies and case theories the government expects to pursue, and where it expects to decline cases. That matters for internal investigations, cooperation decisions and settlement posture well beyond any single matter. The available source describes the memo only at a high level, so the specific priority areas should be confirmed against the memorandum text itself.
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The Seventh Circuit revived a putative nationwide deceptive-marketing class action against Chobani over its Zero Sugar Greek yogurt, holding that FDA enforcement discretion does not preempt the state-law claims.
According to the available report, the U.S. Court of Appeals for the Seventh Circuit revived a putative nationwide class action alleging that Chobani deceptively marketed its Zero Sugar Greek yogurt, ruling that those claims are not preempted by the federal labeling regime — the snippet truncates the statutory citation, so the precise provision (commonly identified in this line of cases as the Federal Dietary Supplement Advertising and Labeling Act) should be confirmed against the opinion itself.
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CDTFA's proposed emergency rules under SB 122 would tax SaaS and digital products from 1 Jan 2027, shift collection duty to purchasers past a US$5m threshold, and permit multiple-points-of-use apportionment.
SB 122 (Stats. 2026, ch. 23), signed 29 June 2026, extends California sales and use tax to SaaS, remotely accessed software and other digital products from 1 January 2027, redefining "tangible personal property" to include digital products and associated copyright or patent interests, while excluding digital assets, audio and audiovisual works, books, digital infrastructure (IaaS/PaaS), video games and visual works. CDTFA has proposed emergency regulations that take effect on Office of Administrative Law approval, skipping standard notice and comment; the comment deadline was 24 September 2026 and the text remains subject to change.
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DHS would charge schools $70,000 for an initial OPT grant and $30,000 per later period, a proposal that could reshape how major employers recruit international graduates and how schools sponsor them.
On Oct. 7, 2026, DHS announced a proposed rule scheduled for Federal Register publication on Oct. 8 that would impose fees of $70,000 for an initial grant of Optional Practical Training (pre- or post-completion) and $30,000 for each subsequent period, including STEM OPT extensions. Under the proposal, payment would fall on the SEVP-certified school, which must pay before a designated school official recommends the student for OPT in SEVIS and before the student files with USCIS; the fee would not be tied to any particular employer. DHS frames the rule as an anti-fraud measure addressing problematic worksites and "pay-to-stay" arrangements.
Comment runs Oct. 8 through Nov. 9, 2026, with a separate 60-day Paperwork Reduction Act period; the rule may be revised before a final version issues, and current OPT rules stay in place until then.
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The SEC brought no charges against Climate Action 100+, but its October 7, 2026 report of investigation sets out when intermediary-facilitated voting coordination triggers Sections 13(d)/(g) reporting and Schedule 13G ineligibility.
On October 7, 2026, the SEC issued a Section 21(a) report of investigation into Climate Action 100+ and certain members over the 2021 ExxonMobil contested director election. The Commission brought no enforcement action and made no findings of violation, but it set out an analytical framework counsel should expect to recur: investors can be a "group" under Sections 13(d)(3) and 13(g)(3) through implied agreement or concerted action, provable circumstantially, where an intermediary pushes members to align on acquiring, holding, disposing or voting securities. Disclaimers do not control; actual conduct does. The report also flags Rule 13d-3(b) anti-evasion exposure for intermediary funding, and expressly declines to decide whether contributions to a coalition could make members "participants" in a solicitation under Schedule 14A — leaving that question open.
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The revised ESRS cut mandatory datapoints by over 60%, the new voluntary standard caps value-chain data demands, and non-EU parents face separate ESRS-40a rules projected for summer 2027.
On September 21, 2026, the revised European Sustainability Reporting Standards and a new Voluntary European Sustainability Reporting Standard were published in the Official Journal, completing the EU's simplification of the CSRD regime. Beyond the earlier increase in size thresholds that determine who reports, the revised ESRS removes more than 60% of mandatory datapoints and over 70% of total datapoints. The voluntary standard gives companies below mandatory scope a proportionate framework and implements the new "value chain cap," limiting what large CSRD reporters can demand from certain smaller value-chain companies.
Timing: the simplified ESRS enters into force November 10, 2026 and generally applies to financial years beginning on or after January 1, 2027, with wave-one companies able to apply a year early. The voluntary standard entered into force September 24, 2026. The Commission estimates cost savings above 30% per company, though realized savings will depend on existing reporting systems, governance and value-chain complexity.
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The new division, headed by an Assistant Attorney General, is already applying the department-wide Corporate Enforcement Policy — an early signal of where federal white-collar enforcement will be concentrated.
According to a Baker Botts client alert, the U.S. Department of Justice established earlier this year, for the first time in two decades, a new stand-alone fraud division, headed by an Assistant Attorney General. The alert describes the division as immediately putting the department-wide Corporate Enforcement Policy (CEP) to work.
Why sophisticated counsel should care: DOJ enforcement structure is a reliable predictor of where prosecutors will spend resources. A dedicated fraud division with senior leadership typically brings continuity of staffing and prosecutorial focus to fraud and False Claims Act-adjacent matters, and signals that cooperation credit, declination and penalty dynamics will now run through a single centralized chain rather than component by component. For companies under internal investigation, and for defense counsel mapping forum and settlement strategy, that changes who is across the table and how the CEP interacts with parallel state and qui tam exposure.
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DHS would charge SEVP-certified schools $70,000 for a student's first OPT recommendation and $30,000 for each later one, including STEM OPT extensions, with comments due November 9, 2026.
On October 8, 2026, DHS proposed requiring SEVP-certified schools to pay $70,000 for a student's first OPT recommendation and $30,000 for each subsequent one, including a STEM OPT extension — up to $100,000 per student. The school must pay before the DSO can enter the recommendation in SEVIS or issue an updated Form I-20, and USCIS would not authorize employment until then. DHS says schools may pass costs to students or employers, a step likely shaped by state consumer protection rules, foreign gift reporting and enrollment agreements; refunds are discretionary and non-appealable. DHS estimates $8.4-16.5 billion annually and concedes fees could shrink participation.
Universities face budget, tuition and enrollment-agreement exposure, and STEM-sector employers face recruiting-pipeline disruption and possible pass-through costs. DHS also seeks comment on re-applying the initial fee at higher degree levels. Counsel should model pass-through risk, review disclosures, and watch whether universities pause new F-1 recruitment.
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A D. Del. court granted a preliminary injunction on September 30, 2026 barring Accord and Bio-Thera from launching interchangeable golimumab biosimilars.
In a sealed opinion issued September 30, 2026 in Case No. 1:26-cv-00222 (D. Del.), the court granted Janssen's motion for a preliminary injunction against the commercial launch of Accord and Bio-Thera's Simponi / Simponi Aria interchangeable biosimilars, Immgolis and Immgolis Intri. Because the opinion is sealed, the reasoning, the patent(s) construed or invalidated, and the scope of the injunction are not publicly available, and the ruling's practical significance should be assessed with caution until an unsealed version issues or the parties describe the holding.
Why it matters: preliminary injunctions in biosimilar litigation routinely reshuffle launch sequencing, at-risk launch costs, payer contracting, and settlement leverage across an entire biosimilar field, and the affected product competes in a crowded TNF-inhibitor market. A granted PI narrows the runway for challengers and signals that at least one court will entertain blocking relief on this biologic at the launch stage rather than after trial-level proceedings.
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A Direct Final Rule updating FDA's nonclinical testing terminology would formally weave new approach methodologies (NAMs) into drug-development vocabulary; whether FDA revises the text during the comment window is the near-term question.
In September 2026, FDA issued a Direct Final Rule on Nonclinical Testing Terminology, which Foley & Lardner describes as a further step toward integrating new approach methodologies (NAMs) — non-animal tools used to assess safety and efficacy — into drug development. Because a direct final rule is published for public comment and normally takes effect unless FDA withdraws or revises it during the comment window, the first question for counsel is whether the agency amends the language rather than the date clients plan around.
Terminology rules are rarely cosmetic. Terms such as animal study, toxicology, or nonclinical safety testing recur across INDs, NDAs and BLAs, as well as promotional claims and marketing authorization files; a controlling glossary can therefore shape what data sponsors must generate and how testing is characterized in submissions. The audience spans small molecule and biologic developers, contract research organizations, and investors diligencing pipeline assets.
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BigLaw clients should begin mapping how tokenized settlement of NMS stocks could affect disclosure, shareholder communications and transfer-agent workflows.
On September 17, 2026, the SEC approved a five-year trial permitting tokenized trading of NMS stocks, including exchange-listed shares. Details in the single available report are thin, and the approval's precise scope, conditions and effective date are not confirmed here.
Why it matters: tokenization would move a portion of U.S. equity trading and settlement onto distributed-ledger rails. For public-company counsel, that touches securities-law disclosure obligations, the definition and delivery of shareholder communications and notices, transfer-agent and registrar functions, insider-trading and shareholder-reporting controls tied to registered holders of record, and equity-plan administration where shares are issued into tokenized accounts. For broker-dealers, custodians and market operators, it reaches clearing, custody and best-execution questions. Exchange listing standards and corporate-action processing are equally implicated.
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A 1 October 2026 DOJ directive tells National Fraud Enforcement Division prosecutors to place "great weight" on ten new corporate charging factors, names four fraud priorities, and creates a Corporate Enforcement Section.
On 1 October 2026, Assistant Attorney General Colin M. McDonald issued DOJ Directive 26-12, setting out the National Fraud Enforcement Division's corporate enforcement principles. The memo names four priorities — health care (including FDCA violations and controlled-substance distribution), government procurement and other government functions, "significant" revenue evasion, and trade and imports (tariff evasion, forced labor and notably "services," signalling reach into visa-program abuse). Prosecutors must still apply the Justice Manual's Filip Factors, but should "place great weight" on ten additional ones: management knowledge, obstruction, schemes lasting three years or more, harm to taxpayer-funded programs, conduct spanning three or more districts, harm to 25 or more victims or $25 million or more in loss, dollar exfiltration to foreign adversaries, and immigration offenses.
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The Federal Reserve issued two companion notices of proposed rulemaking on September 24, 2026 to implement its statutory responsibilities for payment stablecoins under the GENIUS Act, opening a comment record for issuers and partners.
What happened: On September 24, 2026, the Board of Governors of the Federal Reserve System issued two companion notices of proposed rulemaking to implement the Board's responsibilities under the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act). These are proposals, not final rules, so nothing is in force and the requirements remain subject to notice and comment. Reporting on the two notices is thin; specific provisions, comment periods and effective dates are not detailed in the available material and should be confirmed against the Federal Register text.
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CMS's RAPID proposal would align FDA and CMS on IDE endpoints so qualifying breakthrough devices get a proposed Medicare NCD on authorization day and a final decision in 60-90 days; comments close Oct. 13.
CMS published an NCD notice with comment (91 Fed. Reg. 51710, Aug. 11, 2026) proposing RAPID, a voluntary pathway that would coordinate FDA and CMS at IDE pre-submission so that clinical outcomes serve both marketing authorization and Medicare coverage review. Comments are due October 13, 2026.
Eligibility is narrow: presumptive Class II breakthrough devices in FDA's TAP program planning a de novo request, or Class III breakthrough devices planning a PMA, each still at the IDE pre-submission stage. Devices already covered by a controlling NCD, not separately payable, excluded by law, or in vitro diagnostics would be ineligible; CMS says IVD coverage determinations should continue through existing contractor pathways. CMS also proposes pausing TCET for new candidates and prioritizing RAPID NCDs over the NCD Wait List.
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The SEC's September 17, 2026 temporary "Innovation Exemption" would let qualifying venues trade tokenized versions of exchange-listed U.S. stocks onchain for five years, a shift for broker-dealers and custodians.
On September 17, 2026 the Securities and Exchange Commission issued a temporary "Innovation Exemption" intended to facilitate onchain secondary trading of tokenized U.S. exchange-listed stocks, according to a White & Case client alert. The relief is framed as a five-year conditional pathway rather than a rulemaking, so its practical value will turn on conditions the summary does not set out — which entities and venues qualify, what token form and custody arrangements are permitted, and how disclosure, settlement finality and surveillance obligations compare with the equivalent Reg NMS equity framework.
For major-firm clients the interest is structural. Broker-dealers and exchanges evaluating whether to list or support tokenized equities; banks and qualified custodians weighing whether token balances can sit in client accounts; and issuers, market makers and fintechs looking for a compliant onchain venue all need to know whether the exemption alters distribution economics, margin and collateral treatment, or the location of books-of-record and regulatory responsibility.
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The Federal Circuit held that Rule 54(b) does not allow entry of final judgment on some asserted claims of a patent while other claims of the same patent remain unresolved.
The U.S. Court of Appeals for the Federal Circuit concluded that Federal Rule of Civil Procedure 54(b) does not permit a district court to enter final judgment on a subset of asserted patent claims while other asserted claims of the same patent remain unresolved. Rule 54(b) requires an express direction that no just reason exists for delaying entry of judgment, and courts have applied that requirement strictly to avoid piecemeal appellate review of a single patent.
Practicing patent litigators should take note of the procedural sequencing consequence. In multi-claim patent cases, trial plans contemplating an early Rule 54(b) motion on selected claims — often used to accelerate appellate review of a dispositive ruling or to influence settlement posture — may need restructuring. Teams should reassess whether such motions remain viable where the unresolved claims belong to the same patent as the claims targeted for final judgment, and should evaluate joinder, claim-construction, or invalidity sequencing strategies instead.
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The SEC has proposed eliminating the investment adviser pay-to-play rule, substituting existing antifraud and fiduciary obligations — putting municipal-adviser and state and local government client compensation policies back in play.
What happened: The Securities and Exchange Commission has proposed removing the investment adviser "pay-to-play" rule, which bars advisers from being paid by clients for soliciting government business where the adviser or its affiliates also do business with that government client. The Commission signalled it would rely on existing antifraud provisions, fiduciary duty, and compliance obligations instead of a dedicated prescriptive rule.
Why sophisticated counsel should care: The rule sits squarely on the state and local government markets, where public pension and endowment boards, and officials negotiating municipal advisory and underwriting relationships, have leaned on the pay-to-play prohibition as a clean, bright-line limit on placement-agent economics. Several issuers and public interest groups have challenged the rule in litigation, and advisers have long reported that it complicates serving public-plan clients and deters some managers from the market. A repeal framed around general antifraud standards is materially different for compliance programmes.
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Justice Manual revisions announced September 18, 2026 curb FCA enforcement premised on sub-regulatory guidance and streamline dismissal of qui tam actions, reshaping government contract fraud exposure.
On September 18, 2026, the Department of Justice announced two revisions to the Justice Manual that change how the government litigates False Claims Act cases. The first limits DOJ's ability to base FCA enforcement on sub-regulatory guidance rather than statute, regulation, or binding interpretation. The second addresses the handling of dismissal of qui tam actions, altering the government's posture on relator-initiated claims.
Both bear directly on government contractors and their counsel. An FCA theory built on a nonbinding agency statement is a familiar vulnerability in qui tam litigation; a manual provision curtailing DOJ's use of such guidance narrows a recurring settlement and dismissal-leverage risk for defense-side firms. The qui tam dismissal revision may also shift timing considerations for relators weighing intervention in no-fee settlements, and for companies evaluating voluntary disclosure before exposure multiplies.
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Directive 26-12, issued October 1, 2026 by DOJ National Fraud Enforcement Division chief Colin McDonald, sets out new measures for the division's criminal corporate enforcement program.
On October 1, 2026, Colin McDonald, Chief of the Department of Justice's National Fraud Enforcement Division, issued Directive 26-12, stating new measures to enhance the Fraud Division's criminal corporate enforcement initiatives. The available reporting — a single King & Spalding alert — establishes the directive's issuance and subject matter but does not set out its specific provisions, so the operational details should be confirmed against the directive text before being relied on.
Even so, a directive from the office that leads DOJ's corporate criminal enforcement is the kind of signal white-collar defense counsel and corporate clients track closely. Division-level directives typically shape how prosecutors screen matters, whether charging strategy is built around cooperation credit, remediation and disclosure, and how aggressively existing investigations are pursued. Direction of travel matters well before a grand jury subpoena, civil investigative demand or search warrant arrives.
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Hogan Lovells reports that at the October 6, 2026 Community Banking Research Conference in St. Louis, Fed Vice Chair for Supervision Michelle Bowman outlined the next phase of Fed reform, including a five-region supervisory structure.
Per Hogan Lovells, Federal Reserve Vice Chair for Supervision Michelle Bowman used her October 6, 2026 remarks at the Community Banking Research Conference in St. Louis to outline the next phase of the Fed's supervisory reform agenda, including a five-region supervisory structure. The only source in this cluster is a single law-firm alert, so the specifics — which functions or offices map to which regions, and how examination and enforcement portfolios would be allocated — are not described in the available material and should not be assumed.
Why counsel should care: supervisory architecture touches examination scheduling, examiner access, resolution planning, and the day-to-day burden of supervision for bank holding companies and their non-bank affiliates. Regionalization can also shift which staff office is the point of contact for remediation matters, which matters during any supervisory dispute or enforcement negotiation. The alert is an early flag, not a substitute for the speech text.
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A firm alert reports Newsom signed AB 1776 on Sept. 30, 2026, a COMPETE Act that would materially widen California Cartwright Act coverage.
Bryan Cave Leighton Paisner reports that on September 30, 2026, Governor Gavin Newsom signed AB 1776, the California COMPETE Act, which the firm describes as one of the most significant expansions of the Cartwright Act since the statute was adopted in 1907, and which — per the excerpt — for the first time extends Cartwright Act reach in some respect not previously covered. The cluster is truncated, so the specific new obligations, covered conduct, thresholds, penalties, and enforcement mechanics are not confirmed here and should be verified against the enrolled bill text before any reliance.
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The Seventh Circuit revived a putative nationwide deceptive-marketing class action against Chobani over its Zero Sugar Greek yogurt, holding that FDA enforcement discretion does not preempt the state-law claims.
According to the available report, the U.S. Court of Appeals for the Seventh Circuit revived a putative nationwide class action alleging that Chobani deceptively marketed its Zero Sugar Greek yogurt, ruling that those claims are not preempted by the federal labeling regime — the snippet truncates the statutory citation, so the precise provision (commonly identified in this line of cases as the Federal Dietary Supplement Advertising and Labeling Act) should be confirmed against the opinion itself.
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Senate Energy and Environment committee leaders released bipartisan framework text aimed at speeding federal permitting, a potentially significant development for project developers facing multi-year review timelines.
According to a Husch Blackwell client alert, on September 30, 2026 the leaders of the Senate Energy and Natural Resources Committee and the Senate Environment and Public Works Committee unveiled a bipartisan permitting overhaul framework — a notable step after what the firm describes as years of false starts. The alert is a law-firm analysis rather than a primary source, and the excerpt does not set out the specific statutory text, timelines, agency reforms, or judicial-review provisions, so the scope of the proposal should be confirmed against the released draft before being relied upon.
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The revised ESRS cut mandatory datapoints by over 60%, the new voluntary standard caps value-chain data demands, and non-EU parents face separate ESRS-40a rules projected for summer 2027.
On September 21, 2026, the revised European Sustainability Reporting Standards and a new Voluntary European Sustainability Reporting Standard were published in the Official Journal, completing the EU's simplification of the CSRD regime. Beyond the earlier increase in size thresholds that determine who reports, the revised ESRS removes more than 60% of mandatory datapoints and over 70% of total datapoints. The voluntary standard gives companies below mandatory scope a proportionate framework and implements the new "value chain cap," limiting what large CSRD reporters can demand from certain smaller value-chain companies.
Timing: the simplified ESRS enters into force November 10, 2026 and generally applies to financial years beginning on or after January 1, 2027, with wave-one companies able to apply a year early. The voluntary standard entered into force September 24, 2026. The Commission estimates cost savings above 30% per company, though realized savings will depend on existing reporting systems, governance and value-chain complexity.
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A Direct Final Rule updating FDA's nonclinical testing terminology would formally weave new approach methodologies (NAMs) into drug-development vocabulary; whether FDA revises the text during the comment window is the near-term question.
In September 2026, FDA issued a Direct Final Rule on Nonclinical Testing Terminology, which Foley & Lardner describes as a further step toward integrating new approach methodologies (NAMs) — non-animal tools used to assess safety and efficacy — into drug development. Because a direct final rule is published for public comment and normally takes effect unless FDA withdraws or revises it during the comment window, the first question for counsel is whether the agency amends the language rather than the date clients plan around.
Terminology rules are rarely cosmetic. Terms such as animal study, toxicology, or nonclinical safety testing recur across INDs, NDAs and BLAs, as well as promotional claims and marketing authorization files; a controlling glossary can therefore shape what data sponsors must generate and how testing is characterized in submissions. The audience spans small molecule and biologic developers, contract research organizations, and investors diligencing pipeline assets.
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CMS's RAPID proposal would align FDA and CMS on IDE endpoints so qualifying breakthrough devices get a proposed Medicare NCD on authorization day and a final decision in 60-90 days; comments close Oct. 13.
CMS published an NCD notice with comment (91 Fed. Reg. 51710, Aug. 11, 2026) proposing RAPID, a voluntary pathway that would coordinate FDA and CMS at IDE pre-submission so that clinical outcomes serve both marketing authorization and Medicare coverage review. Comments are due October 13, 2026.
Eligibility is narrow: presumptive Class II breakthrough devices in FDA's TAP program planning a de novo request, or Class III breakthrough devices planning a PMA, each still at the IDE pre-submission stage. Devices already covered by a controlling NCD, not separately payable, excluded by law, or in vitro diagnostics would be ineligible; CMS says IVD coverage determinations should continue through existing contractor pathways. CMS also proposes pausing TCET for new candidates and prioritizing RAPID NCDs over the NCD Wait List.
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Hogan Lovells reports that at the October 6, 2026 Community Banking Research Conference in St. Louis, Fed Vice Chair for Supervision Michelle Bowman outlined the next phase of Fed reform, including a five-region supervisory structure.
Per Hogan Lovells, Federal Reserve Vice Chair for Supervision Michelle Bowman used her October 6, 2026 remarks at the Community Banking Research Conference in St. Louis to outline the next phase of the Fed's supervisory reform agenda, including a five-region supervisory structure. The only source in this cluster is a single law-firm alert, so the specifics — which functions or offices map to which regions, and how examination and enforcement portfolios would be allocated — are not described in the available material and should not be assumed.
Why counsel should care: supervisory architecture touches examination scheduling, examiner access, resolution planning, and the day-to-day burden of supervision for bank holding companies and their non-bank affiliates. Regionalization can also shift which staff office is the point of contact for remediation matters, which matters during any supervisory dispute or enforcement negotiation. The alert is an early flag, not a substitute for the speech text.
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A unanimous Sixth Circuit panel on September 25, 2026 refused to block Ohio and Tennessee gambling enforcement against KalshiEX's sports-event contracts, deepening a split on CFTC swap jurisdiction and CEA preemption.
On September 25, 2026, a unanimous Sixth Circuit panel declined to enjoin Ohio and Tennessee from enforcing their gambling statutes against KalshiEX LLC's sports-event contracts, in KalshiEX LLC v. Schuler. According to the reported summary, the panel held those contracts are not "swaps" under the Commodity Exchange Act and that the CEA does not preempt state gambling law — a ruling that deepens an acknowledged circuit split and narrows the federal pathway Kalshi relied on to operate nationally.
Why counsel should care: the decision sits at the intersection of CFTC jurisdiction, federal preemption and state gaming enforcement, and it shapes venue strategy for regulated-market clients, brokerage and clearing intermediaries, and leagues or event rights holders facing suit in multiple states. It also signals continued judicial pushback on treating consumer-facing event contracts as CFTC-registered derivatives.
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The SEC has proposed eliminating the investment adviser pay-to-play rule, substituting existing antifraud and fiduciary obligations — putting municipal-adviser and state and local government client compensation policies back in play.
What happened: The Securities and Exchange Commission has proposed removing the investment adviser "pay-to-play" rule, which bars advisers from being paid by clients for soliciting government business where the adviser or its affiliates also do business with that government client. The Commission signalled it would rely on existing antifraud provisions, fiduciary duty, and compliance obligations instead of a dedicated prescriptive rule.
Why sophisticated counsel should care: The rule sits squarely on the state and local government markets, where public pension and endowment boards, and officials negotiating municipal advisory and underwriting relationships, have leaned on the pay-to-play prohibition as a clean, bright-line limit on placement-agent economics. Several issuers and public interest groups have challenged the rule in litigation, and advisers have long reported that it complicates serving public-plan clients and deters some managers from the market. A repeal framed around general antifraud standards is materially different for compliance programmes.
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The Federal Reserve issued two companion notices of proposed rulemaking on September 24, 2026 to implement its statutory responsibilities for payment stablecoins under the GENIUS Act, opening a comment record for issuers and partners.
What happened: On September 24, 2026, the Board of Governors of the Federal Reserve System issued two companion notices of proposed rulemaking to implement the Board's responsibilities under the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act). These are proposals, not final rules, so nothing is in force and the requirements remain subject to notice and comment. Reporting on the two notices is thin; specific provisions, comment periods and effective dates are not detailed in the available material and should be confirmed against the Federal Register text.
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The SEC's September 17, 2026 temporary "Innovation Exemption" would let qualifying venues trade tokenized versions of exchange-listed U.S. stocks onchain for five years, a shift for broker-dealers and custodians.
On September 17, 2026 the Securities and Exchange Commission issued a temporary "Innovation Exemption" intended to facilitate onchain secondary trading of tokenized U.S. exchange-listed stocks, according to a White & Case client alert. The relief is framed as a five-year conditional pathway rather than a rulemaking, so its practical value will turn on conditions the summary does not set out — which entities and venues qualify, what token form and custody arrangements are permitted, and how disclosure, settlement finality and surveillance obligations compare with the equivalent Reg NMS equity framework.
For major-firm clients the interest is structural. Broker-dealers and exchanges evaluating whether to list or support tokenized equities; banks and qualified custodians weighing whether token balances can sit in client accounts; and issuers, market makers and fintechs looking for a compliant onchain venue all need to know whether the exemption alters distribution economics, margin and collateral treatment, or the location of books-of-record and regulatory responsibility.
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The Eleventh Circuit held on September 1, 2026 that the False Claims Act's qui tam provisions do not violate the Appointments Clause, reversing a district court that had struck them down.
On September 1, 2026, the U.S. Court of Appeals for the Eleventh Circuit reversed a district court ruling that had declared the False Claims Act's qui tam whistleblower provisions unconstitutional under the Appointments Clause, reinstating the FCA's core enforcement mechanism across much of the Southeast. The significance reaches beyond the circuit's geography: a constitutional attack on the FCA's relator framework has now failed on appeal, which typically discourages further district-court efforts to dismantle the statute's structure and reduces defense leverage for separation-of-powers objections.
For government contractors, healthcare providers, manufacturers, and federal grant recipients the consequences are substantial. FCA qui tam settlements run into the billions of dollars annually, and private relator suits remain the largest single driver of FCA case volume. Defense teams should reassess whether Appointments Clause arguments remain worth preserving in pending matters, given their cost against a statute appellate courts are sustaining.
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Justice Manual revisions announced September 18, 2026 curb FCA enforcement premised on sub-regulatory guidance and streamline dismissal of qui tam actions, reshaping government contract fraud exposure.
On September 18, 2026, the Department of Justice announced two revisions to the Justice Manual that change how the government litigates False Claims Act cases. The first limits DOJ's ability to base FCA enforcement on sub-regulatory guidance rather than statute, regulation, or binding interpretation. The second addresses the handling of dismissal of qui tam actions, altering the government's posture on relator-initiated claims.
Both bear directly on government contractors and their counsel. An FCA theory built on a nonbinding agency statement is a familiar vulnerability in qui tam litigation; a manual provision curtailing DOJ's use of such guidance narrows a recurring settlement and dismissal-leverage risk for defense-side firms. The qui tam dismissal revision may also shift timing considerations for relators weighing intervention in no-fee settlements, and for companies evaluating voluntary disclosure before exposure multiplies.
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A DHS proposed rule would block F-1 OPT recommendations and work authorization until a sponsoring university pays $70,000 for a student's first OPT and $30,000 for each later recommendation, including STEM extensions.
On October 8, 2026, DHS published a proposed rule (Docket No. ICEB-2026-0100) requiring SEVP-certified institutions to pay a $70,000 fee before a student's first optional practical training (OPT) recommendation and a $30,000 fee for each subsequent recommendation, including the STEM extension. Designated school officials would be barred from entering an OPT recommendation in SEVIS until payment, and USCIS would be barred from issuing the OPT employment authorization document without it. Implementation is proposed 60 days after any final rule, with students approved or recommended before that date grandfathered in. DHS estimates 2,478 affected schools and $8.4 billion to $16.5 billion in annual fees, invoking fraud and worker-protection rationales and INA 214(a) authority.
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DHS would charge schools $70,000 for an initial OPT grant and $30,000 per later period, a proposal that could reshape how major employers recruit international graduates and how schools sponsor them.
On Oct. 7, 2026, DHS announced a proposed rule scheduled for Federal Register publication on Oct. 8 that would impose fees of $70,000 for an initial grant of Optional Practical Training (pre- or post-completion) and $30,000 for each subsequent period, including STEM OPT extensions. Under the proposal, payment would fall on the SEVP-certified school, which must pay before a designated school official recommends the student for OPT in SEVIS and before the student files with USCIS; the fee would not be tied to any particular employer. DHS frames the rule as an anti-fraud measure addressing problematic worksites and "pay-to-stay" arrangements.
Comment runs Oct. 8 through Nov. 9, 2026, with a separate 60-day Paperwork Reduction Act period; the rule may be revised before a final version issues, and current OPT rules stay in place until then.
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DHS would charge SEVP-certified schools $70,000 for a student's first OPT recommendation and $30,000 for each later one, including STEM OPT extensions, with comments due November 9, 2026.
On October 8, 2026, DHS proposed requiring SEVP-certified schools to pay $70,000 for a student's first OPT recommendation and $30,000 for each subsequent one, including a STEM OPT extension — up to $100,000 per student. The school must pay before the DSO can enter the recommendation in SEVIS or issue an updated Form I-20, and USCIS would not authorize employment until then. DHS says schools may pass costs to students or employers, a step likely shaped by state consumer protection rules, foreign gift reporting and enrollment agreements; refunds are discretionary and non-appealable. DHS estimates $8.4-16.5 billion annually and concedes fees could shrink participation.
Universities face budget, tuition and enrollment-agreement exposure, and STEM-sector employers face recruiting-pipeline disruption and possible pass-through costs. DHS also seeks comment on re-applying the initial fee at higher degree levels. Counsel should model pass-through risk, review disclosures, and watch whether universities pause new F-1 recruitment.
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A Northern District of California jury reportedly found Eli Lilly breached the implied covenant of good faith and fair dealing under its 2017 Nektar license, awarding $90M after defeating a separate claim.
According to a single practitioner source (Goodwin Procter, via JD Supra), a jury in the U.S. District Court for the Northern District of California returned a verdict on September 24, 2026 after roughly five days of deliberation, finding that Eli Lilly & Co. breached the implied covenant of good faith and fair dealing under its 2017 license agreement with Nektar Therapeutics and awarding $90 million. The source indicates Lilly defeated a related claim, though the available material does not describe the counts tried or the theories behind the defeated claim; those details should be confirmed against the docket and judgment forms.
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The Federal Circuit held that Rule 54(b) does not allow entry of final judgment on some asserted claims of a patent while other claims of the same patent remain unresolved.
The U.S. Court of Appeals for the Federal Circuit concluded that Federal Rule of Civil Procedure 54(b) does not permit a district court to enter final judgment on a subset of asserted patent claims while other asserted claims of the same patent remain unresolved. Rule 54(b) requires an express direction that no just reason exists for delaying entry of judgment, and courts have applied that requirement strictly to avoid piecemeal appellate review of a single patent.
Practicing patent litigators should take note of the procedural sequencing consequence. In multi-claim patent cases, trial plans contemplating an early Rule 54(b) motion on selected claims — often used to accelerate appellate review of a dispositive ruling or to influence settlement posture — may need restructuring. Teams should reassess whether such motions remain viable where the unresolved claims belong to the same patent as the claims targeted for final judgment, and should evaluate joinder, claim-construction, or invalidity sequencing strategies instead.
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The Supreme Court granted review in RiseandShine Corp. v. PepsiCo, No. 24-1016, a circuit split over whether a trademark's inherent strength is a jury question of fact or a judicial question of law.
The U.S. Supreme Court has taken up RiseandShine Corporation v. PepsiCo, Inc., No. 24-1016, which asks whether the inherent strength of a trademark — whether the mark is inherently distinctive as conceived or only distinctive because of acquired meaning — is a question of fact for a jury or a question of law for the judge. The grant is intended to resolve a division among the courts of appeals over the applicable standard of review.
Practitioners have reason to care well beyond the beverage context. Inherent strength is a threshold gate in almost every trademark action: courts treating it as a factual question must send the issue to a jury, while courts applying the legal-question framework can resolve it on a motion to dismiss or for summary judgment. The outcome could therefore reshape early-stage motion practice, discovery sequencing, and settlement leverage across a wide range of matters involving major-firm clients in many sectors.
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A D. Del. court granted a preliminary injunction on September 30, 2026 barring Accord and Bio-Thera from launching interchangeable golimumab biosimilars.
In a sealed opinion issued September 30, 2026 in Case No. 1:26-cv-00222 (D. Del.), the court granted Janssen's motion for a preliminary injunction against the commercial launch of Accord and Bio-Thera's Simponi / Simponi Aria interchangeable biosimilars, Immgolis and Immgolis Intri. Because the opinion is sealed, the reasoning, the patent(s) construed or invalidated, and the scope of the injunction are not publicly available, and the ruling's practical significance should be assessed with caution until an unsealed version issues or the parties describe the holding.
Why it matters: preliminary injunctions in biosimilar litigation routinely reshuffle launch sequencing, at-risk launch costs, payer contracting, and settlement leverage across an entire biosimilar field, and the affected product competes in a crowded TNF-inhibitor market. A granted PI narrows the runway for challengers and signals that at least one court will entertain blocking relief on this biologic at the launch stage rather than after trial-level proceedings.
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Governor Newsom signed SB 574 on September 30, 2026, imposing statutory obligations on attorneys, arbitrators and judicial officers who use generative AI — a new compliance layer for every California-licensed lawyer and firm.
On September 30, 2026, California Governor Gavin Newsom signed Senate Bill 574, authored by Senator Thomas Umberg, establishing a statutory framework governing the use of generative artificial intelligence by attorneys, arbitrators, judicial officers and related professionals licensed in the state. According to the reporting, the bill regulates how GenAI may be used in the practice of law rather than leaving the question entirely to the courts and existing professional conduct authorities.
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The Tennessee Supreme Court declined to authorize rule reforms on nonlawyer ownership of law firms and loosened the ABA accreditation requirement for entities providing legal services.
On October 2, 2026, the Tennessee Supreme Court decided In re: Regulatory Reforms to Increase Access to Quality Legal Representation (No. ADM2025-01403), declining to authorize the proposed reforms, leaving restrictions on nonlawyer ownership of law firms in place, and loosening the accreditation requirement — reportedly so entities need not hold American Bar Association accreditation. Because the cluster holds only one short, truncated item, the precise scope granted, any transition mechanics, and effective dates are not established here; the opinion should be read before relying on this.
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The Ninth Circuit rejected Americans for Prosperity's First Amendment challenge to Proposition 211, leaving Arizona's donor-disclosure regime live through the November midterms and potentially a template for other states.
In Americans for Prosperity v. Meyer (No. 24-2933, Sept. 30, 2026), the Ninth Circuit upheld Arizona's Proposition 211, rejecting arguments that its campaign-finance disclosure rules chill speech and impair free association. The panel described the statute's interest in informing voters as vital, called the burdens modest, and found the requirements narrowly tailored under exacting scrutiny, relying on Citizens United and NRSC v. FEC. Disclosure attaches when a covered person spends more than $50,000 statewide or $25,000 in any other race on campaign media spending, and reaches donors of more than $5,000 in traced original monies, intermediaries above $2,500, with ad disclaimers naming the three largest funders. Spending a group's own funds on advertising is outside the regime, and donors may opt out, though Akin reports some organizations simply decline opted-out gifts.
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The SEC brought no charges against Climate Action 100+, but its October 7, 2026 report of investigation sets out when intermediary-facilitated voting coordination triggers Sections 13(d)/(g) reporting and Schedule 13G ineligibility.
On October 7, 2026, the SEC issued a Section 21(a) report of investigation into Climate Action 100+ and certain members over the 2021 ExxonMobil contested director election. The Commission brought no enforcement action and made no findings of violation, but it set out an analytical framework counsel should expect to recur: investors can be a "group" under Sections 13(d)(3) and 13(g)(3) through implied agreement or concerted action, provable circumstantially, where an intermediary pushes members to align on acquiring, holding, disposing or voting securities. Disclaimers do not control; actual conduct does. The report also flags Rule 13d-3(b) anti-evasion exposure for intermediary funding, and expressly declines to decide whether contributions to a coalition could make members "participants" in a solicitation under Schedule 14A — leaving that question open.
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BigLaw clients should begin mapping how tokenized settlement of NMS stocks could affect disclosure, shareholder communications and transfer-agent workflows.
On September 17, 2026, the SEC approved a five-year trial permitting tokenized trading of NMS stocks, including exchange-listed shares. Details in the single available report are thin, and the approval's precise scope, conditions and effective date are not confirmed here.
Why it matters: tokenization would move a portion of U.S. equity trading and settlement onto distributed-ledger rails. For public-company counsel, that touches securities-law disclosure obligations, the definition and delivery of shareholder communications and notices, transfer-agent and registrar functions, insider-trading and shareholder-reporting controls tied to registered holders of record, and equity-plan administration where shares are issued into tokenized accounts. For broker-dealers, custodians and market operators, it reaches clearing, custody and best-execution questions. Exchange listing standards and corporate-action processing are equally implicated.
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CDTFA's proposed emergency rules under SB 122 would tax SaaS and digital products from 1 Jan 2027, shift collection duty to purchasers past a US$5m threshold, and permit multiple-points-of-use apportionment.
SB 122 (Stats. 2026, ch. 23), signed 29 June 2026, extends California sales and use tax to SaaS, remotely accessed software and other digital products from 1 January 2027, redefining "tangible personal property" to include digital products and associated copyright or patent interests, while excluding digital assets, audio and audiovisual works, books, digital infrastructure (IaaS/PaaS), video games and visual works. CDTFA has proposed emergency regulations that take effect on Office of Administrative Law approval, skipping standard notice and comment; the comment deadline was 24 September 2026 and the text remains subject to change.
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EuroHPC JU has issued a joint tender call for up to seven AI gigafactories in at least seven Member States, backed by up to EUR 5 billion of EU money plus matched national funding; tenders close 12 November 2026.
What happened: EuroHPC, under a Joint Procurement Agreement with national authorities, has called for tenders for up to seven AI gigafactories — four medium-scale, three large-scale. Up to EUR 10bn of EU and national public support aims to mobilise at least EUR 20bn of private capital; each site needs roughly EUR 4–5bn. Deadline: 12 November 2026, 16:00 Luxembourg time, via TED eTendering and the Funding and Tenders portal.
Why counsel should care: the call is prescriptive on sovereignty. Each site needs an EU-incorporated, EU-controlled Coordinator and an EU Hosting Entity; core operational data must stay in the EU; and bidders must plan integration of European-based software, potentially within four years of operations. Non-EU financing is not barred outright, but control tests reach equity stakes, loans, guarantees and veto rights — a structuring risk for non-European chipmakers, cloud providers and sovereign investors. Winners sign a six-and-a-half-year framework contract plus offtake contracts, with public compute purchases capped at the lower of a ceiling and 17% of capex.
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Directive 26-12 puts a new DOJ Fraud Division Corporate Enforcement Section in charge of corporate cases from intake to resolution, prioritizes health care, defense contracting, tax and tariff fraud, and export controls.
On October 1, 2026, DOJ's new National Fraud Enforcement Division issued Directive 26-12, giving its Corporate Enforcement Section lead over corporate investigations from intake through any corporate resolution or litigation, and requiring prosecutors to give "great weight" to ten factors in charging and resolution decisions. Those factors include management knowledge of or involvement in a scheme, concealment from auditors or government agencies, conduct lasting three years or more, harm to 25 or more victims or $25 million or more in loss, and conduct touching three or more federal districts. Priority sectors are health care (controlled substances, FDCA violations), government and defense contracting, significant tax and tariff evasion, and import-export controls and forced labor. The directive also tasks leadership with designing whistleblower incentive programs that will extend to individuals who participated in the misconduct itself — a material change to the internal-reporting risk calculus.
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A new Department of Justice memorandum from the National Fraud Enforcement Division states where federal prosecutors intend to focus corporate fraud enforcement, consolidating a two-year shift in approach.
Reporting from a single source indicates that the U.S. Department of Justice has issued a new memorandum setting out the priorities of the National Fraud Enforcement Division, the unit DOJ announced in April 2026. The memo is described as capping roughly two years of successive DOJ memoranda and policies that progressively refined federal corporate fraud enforcement priorities.
For defense-side and compliance counsel, the significance is directional rather than mechanical: prosecutorial resources and charging discretion are finite, and a published statement of priorities typically signals which sectors, fraud typologies and case theories the government expects to pursue, and where it expects to decline cases. That matters for internal investigations, cooperation decisions and settlement posture well beyond any single matter. The available source describes the memo only at a high level, so the specific priority areas should be confirmed against the memorandum text itself.
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The new division, headed by an Assistant Attorney General, is already applying the department-wide Corporate Enforcement Policy — an early signal of where federal white-collar enforcement will be concentrated.
According to a Baker Botts client alert, the U.S. Department of Justice established earlier this year, for the first time in two decades, a new stand-alone fraud division, headed by an Assistant Attorney General. The alert describes the division as immediately putting the department-wide Corporate Enforcement Policy (CEP) to work.
Why sophisticated counsel should care: DOJ enforcement structure is a reliable predictor of where prosecutors will spend resources. A dedicated fraud division with senior leadership typically brings continuity of staffing and prosecutorial focus to fraud and False Claims Act-adjacent matters, and signals that cooperation credit, declination and penalty dynamics will now run through a single centralized chain rather than component by component. For companies under internal investigation, and for defense counsel mapping forum and settlement strategy, that changes who is across the table and how the CEP interacts with parallel state and qui tam exposure.
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A 1 October 2026 DOJ directive tells National Fraud Enforcement Division prosecutors to place "great weight" on ten new corporate charging factors, names four fraud priorities, and creates a Corporate Enforcement Section.
On 1 October 2026, Assistant Attorney General Colin M. McDonald issued DOJ Directive 26-12, setting out the National Fraud Enforcement Division's corporate enforcement principles. The memo names four priorities — health care (including FDCA violations and controlled-substance distribution), government procurement and other government functions, "significant" revenue evasion, and trade and imports (tariff evasion, forced labor and notably "services," signalling reach into visa-program abuse). Prosecutors must still apply the Justice Manual's Filip Factors, but should "place great weight" on ten additional ones: management knowledge, obstruction, schemes lasting three years or more, harm to taxpayer-funded programs, conduct spanning three or more districts, harm to 25 or more victims or $25 million or more in loss, dollar exfiltration to foreign adversaries, and immigration offenses.
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Directive 26-12, issued October 1, 2026 by DOJ National Fraud Enforcement Division chief Colin McDonald, sets out new measures for the division's criminal corporate enforcement program.
On October 1, 2026, Colin McDonald, Chief of the Department of Justice's National Fraud Enforcement Division, issued Directive 26-12, stating new measures to enhance the Fraud Division's criminal corporate enforcement initiatives. The available reporting — a single King & Spalding alert — establishes the directive's issuance and subject matter but does not set out its specific provisions, so the operational details should be confirmed against the directive text before being relied on.
Even so, a directive from the office that leads DOJ's corporate criminal enforcement is the kind of signal white-collar defense counsel and corporate clients track closely. Division-level directives typically shape how prosecutors screen matters, whether charging strategy is built around cooperation credit, remediation and disclosure, and how aggressively existing investigations are pursued. Direction of travel matters well before a grand jury subpoena, civil investigative demand or search warrant arrives.
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Grade 3 — worth a glance, not the full analysis.
- Firm alert: tighter judicial-review safeguards for devices in competition probes
A Mayer Brown alert says courts are reinforcing prior-authorisation and privacy safeguards when competition authorities seize or image personal devices during investigations.
- California Pay Data Reports to Use SOC Job Categories for May 2027
California's May 2027 pay data reports will shift from 10 EEO-1 job categories to 23 categories based on federal SOC codes, and employers are urged to map roles and test reporting systems during 2026.
- Federal Circuit vacates denial of Rule 11 sanctions, fees in Epic case
The Federal Circuit vacated and remanded a district court's denial of Rule 11 sanctions and attorneys' fees, faulting it for not addressing pre-suit notice of potential patent ineligibility under 35 U.S.C. § 285.
- FCA finalises overall-risk-assessment guidance for cryptoasset firms
The UK FCA has published two final non-Handbook guidance documents on how firms in its new cryptoasset prudential regime should approach their overall risk assessment obligation; the excerpt is truncated, so scope is unconfirmed.
- Trade Secret Holders Urged to Move Fast on Preliminary Relief
Goodwin Procter advises trade secret claimants to build a record of imminent, irreparable harm and move promptly, since delay can undercut the emergency relief their claims depend on.
- EPA and Army Corps Advance Toward a New 'Waters of the United States' Scope
A forthcoming EPA and Army Corps rulemaking would redraw Clean Water Act jurisdiction and Section 404 permitting exposure, but the cluster discloses no proposal text or timetable.
- AFRC and SFC sign new MoU on Hong Kong financial reporting oversight
Hong Kong's Accounting and Financial Reporting Council and the SFC signed a new MoU on 28 September 2026, replacing the SFC's 2021 arrangement with the former FRC to tighten coordination on audit and market conduct.
- Federal Circuit Clarifies Patent Marking Duties Owed to Licensees
VDPP, LLC v. Volkswagen Group of America (Fed. Cir. 2026) holds patent owners must make reasonable efforts to ensure licensees comply with statutory patent marking requirements.
- FOMC minutes and a UK PRA threshold-indexation proposal anchor Oct. 7 updates
A law-firm roundup of Oct. 7 releases covers the Sept. 15-16 FOMC minutes, a rise in short-term inflation expectations, OCC fraud outreach in Minnesota, and a PRA proposal to index 128 prudential thresholds to nominal GDP.
- DEA ALJ Pauses Marijuana Rescheduling Over GAO Scheduling Report
The DEA's chief administrative law judge stayed the marijuana rescheduling docket to consider a new Government Accountability Office report on drug scheduling, with agency responses due October 13, 2026.
- NYPSC Drafts GEIS Scope Required by State Data Center Moratorium
The New York State Public Service Commission has issued a draft scope for the Generic Environmental Impact Statement required under the state's data center moratorium, a procedural step utilities and developers should track.
- HKEX competitiveness consultation conclusions and digital asset guidance flagged
Latham's Hong Kong digest flags HKEX consultation conclusions on listing framework competitiveness, new guidance on digital asset-related activities, and a temporary waiver extending new listing application validity.
- UK illegal-working liability widened to supply chains from 1 October 2026
Section 48 of the Border Security, Asylum and Immigration Act 2025 extends right-to-work checks and civil penalties to subcontractors and online matching services, reaching firms that never engaged the worker.
- ASIC issues first review findings on mandatory sustainability reports
Australia's securities regulator has published Report 839, setting out observations from its review of sustainability reports lodged by Group 1 reporting entities for the year ended 31 December 2025.
- IRS Package: Trump Accounts Auto-Enrollment, 25F Regs, 71 Items Obsoleted
IRS roundup: automatic Trump Accounts enrollment from about October 1, 2026, proposed and temporary regs on the Section 25F scholarship credit and Section 1062 farmland installment, plus 71 guidance items obsoleted.
- Supreme Court hears argument on pleading bar for ERISA prudence claims
The high court heard argument in Anderson v. Intel on what a plaintiff must plead to survive dismissal of an ERISA imprudence claim — a ruling that could reshape 401(k) and pension prudence litigation.
- Scottish Courts Reaffirm Threshold for UK GDPR Damages Claims
Scottish courts have restated that an individual must show more than distress alone to recover compensation under the UK GDPR, a signal for how privacy damages claims are both pleaded and defended north of the border.
- CFTC Scrutiny of Carbon Credit Registries Draws Compliance Questions
Jones Day analysis flags that US commodities-regulator scrutiny of carbon credit registries carries implications for registry operators, project developers and buyers of voluntary credits.
- Dental Monitoring v. Align Tech draws fresh USPTO prior art guidance
A new Federal Circuit decision on prior art disclosure is prompting prosecution-strategy changes; an Akerman client alert offers tips, though the specific holding is not detailed in available reporting.
- Supreme Court again declines to revisit McDonnell Douglas framework
The Court denied certiorari in two October 2026 petitions, leaving the summary-judgment framework intact for now even as Thomas and Gorsuch and some Fifth Circuit judges press to abandon it.
- Japan Promulgates APPI Amendments Passed by Diet in July
Japan's Diet passed amendments to the Act on the Protection of Personal Information on July 10, 2026, promulgated July 17, with most provisions taking effect on a date to be prescribed.
- SEC Innovation Exemption Lets Third Parties Tokenize Public Company Stock
A Morgan Lewis client alert advises that under the SEC's Innovation Exemption, third parties may tokenize and facilitate trading in a public company's stock without issuer sponsorship, provided the tokenization is published.
- FCC Amends TCPA Consent Revocation Rules, Seeks Further Comment
The FCC amended its TCPA consent revocation rules at its September open meeting and opened a further comment docket, changing what covered callers and marketers must do to honor and evidence consumer opt-outs.
- Washington, D.C. bars medical debt from consumer credit reports
A DC law now prohibits health care providers and debt collectors from reporting medical debt to credit reporting agencies, creating a new state compliance obligation for provider billing, patient finance and collections teams.
- Ninth Circuit declines to unwind California right-of-publicity class certification
The Ninth Circuit left in place a district court's certification of damages and injunctive classes in a California statutory right-of-publicity dispute, reinforcing that certification is not the stage for a condensed merits trial.
- California AB 1697 Delays Stay-or-Pay Ban to 2027, Widens Exceptions
AB 1697 moves AB 692's operative date to January 1, 2027, drops the outset-of-employment limit for the discretionary bonus exception and adds a new advanced-PTO carve-out, giving employers a year to rework repayment terms.
- UK Nuclear Regulation Bill poised to widen ONR remit and centralise ALARP
Vinson & Elinks reports the UK Nuclear Regulation Bill, due this parliamentary session, would broaden the ONR's remit, create a Commission for Nuclear Regulation and move tolerability-of-risk definitions to government.
- Los Angeles Measure ULA Survives Statewide Reform Withdrawal
Los Angeles' Measure ULA gross receipts tax remains in effect after California withdrew a June 2026 ballot measure that could have significantly curtailed it, pushing reform to other channels.
- AI tools reshape England and Wales employment disputes ahead of 2027 reforms
A Mayer Brown practitioner analysis argues generative AI is enabling more sophisticated employee grievances while the unfair dismissal qualifying period drops to six months and the compensation cap is abolished from 1 January 2027.
- FTC's proposed Robinson-Patman settlement with Southern Glazer
A proposed FTC settlement in its Robinson-Patman Act case against wine and spirits distributor Southern Glazer may signal how the agency intends to police discriminatory pricing in alcohol distribution.
- New Jersey ABC test for independent contractor status now in effect
A New Jersey regulation codifying the ABC test for worker classification is now in effect, with opponents already contesting it — relevant to contingent-workforce classification exposure.
- Federal Circuit Denies Eli Lilly En Banc Rehearing in Teva Patent Appeal
The Federal Circuit on September 30, 2026 denied Eli Lilly's petition for rehearing en banc in the Teva v. Eli Lilly dispute over Ajovy and Emgality, leaving the panel's reversal of judgment for Teva as the operative result.
- Texas Comptroller Proposes Dropping Sales Tax on Marketplace and Platform Fees
The Texas Comptroller signed an executive order directing a proposed amendment to 34 Tex. Admin. Code § 3.330 that would remove marketplace and platform fees from taxable data processing services, with a 30-day comment period to follow.
- Delaware HB 380 Tightens Sensitive-Data and Vendor Contract Rules
Signed September 2, 2026, HB 380 amends the Delaware Personal Data Privacy Act with new sensitive-data restrictions and third-party contract requirements worth reviewing for Delaware consumer data.
- Texas Comptroller Moves to End Tax on Medical Records, Health Tech
Following earlier signals, the Texas Comptroller has acted on his office's expansive data processing tax readings, a change that could affect how hospitals, health IT vendors and other healthcare businesses are taxed in the state.
- Bipartisan Bill Proposes Curbs on Corporate Ownership of Physician Practices
Sensators Wyden, Merkley and Warren with Reps. Hoyle, Ocasio-Cortez and Subramanyam introduced the Stop Corporate Takeovers of Physicians Act of 2026, targeting corporate control and investment in medical practices.
- FCA Consults on Loosening Fund Limits on Crypto ETNs
The UK Financial Conduct Authority is consulting on relaxing restrictions that bar investment funds from holding exchange-traded notes referencing cryptoassets.
- France's Anti-Fraud Law Extends Vigilance Duties to Prime Contractors
France's June 25, 2026 anti-fraud law reverses a 2025 Supreme Court ruling, making prime contractors jointly liable for subcontractors' unpaid taxes, social contributions and wages by December 26, 2026 at the latest.
- UK Consultation Proposes Overhaul of Corporate Reporting for UK PLCs
Latham & Watkins flags a UK government consultation published 7 September 2026 proposing wide-ranging reform to the corporate reporting framework for UK PLCs.
- Luxembourg CSSF publishes first FAQ on tokenising investment funds
The CSSF released the first version of its tokenisation FAQ on 2 October 2026, also clarifying its expectations for control agents.
- Bipartisan Senate Permitting Bill Targets Federal Environmental Review
Introduced September 30 by the chairs and ranking members of the Senate Environment and Public Works and Energy and Natural Resources Committees, the Act targets federal environmental review and energy-project approvals.
- CFTC Opens Crypto Market Structure Rulemaking With ANPRM
The CFTC released an Advanced Notice of Proposed Rulemaking on crypto market structure, signalling that a federal spot-market framework is coming even as the SEC advances its own digital asset agenda.
- Australia Treasury consultation proposes wider MIS sector data collection
Perkins Coie reports that on 23 September 2026 Treasury released a consultation paper proposing substantially expanded data collection across Australia's managed investment scheme sector, covering registered and unregistered schemes.
- NM PFAS Rule Enjoined; CA Pesticide Tracking Law; Oregon EPR Ruling Heads to Appeal
Shook Hardy's October substances newsletter flags a court stay on New Mexico PFAS labeling, California's new PFAS pesticide-tracking statute, and an appeal of a ruling upholding Oregon's EPR framework.
- DOL Opinion: Commute to Remote Break Room for Meals Not Compensable
A U.S. Department of Labor opinion concludes that time spent travelling to and from a distant break room to eat a meal is generally non-compensable, useful to wage-and-hour counsel on break practices.
- DOL Opinion Letters Clear Meal Breaks, Nonprofit Volunteering, Tip Pools
Three WHD opinion letters (Sept. 7, 2026) address unpaid meal breaks plus walk time, nonprofit staff volunteering, and why supervisors who meet the executive duties test cannot keep pooled tip-outs.
- OCC Moves to Dismiss States' Mortgage Escrow Preemption Suit
The OCC has answered a multistate lawsuit challenging its mortgage escrow preemption actions with a motion to dismiss combining a merits argument and three procedural grounds.