DROPLETS

The U.S. Supreme Court, in Hikma v. Amarin, has significantly bolstered the 'skinny label' pathway for generic drugs by holding that induced infringement requires affirmative conduct encouraging a patented use, not just routine commercial statements of generic equivalence. This raises the bar for brand-name patent enforcement. Concurrently, patent prosecution strategy faces a squeeze from two other fronts. The USPTO's Appeals Review Panel has endorsed the 'anti-harassment' rationale as a standalone basis for obviousness-type double patenting (ODP), creating uncertainty that now awaits a clarifying Federal Circuit ruling in In re Ablynx. At the same time, the Federal Circuit is applying the Supreme Court's Amgen precedent to heighten enablement and written description standards under 35 U.S.C. § 112, making it harder to secure broad genus claims. Recent decisions show that even method-of-treatment claims require robust data to be upheld. For life sciences clients, these developments demand an immediate review of litigation strategies, patent portfolio management, and claim-drafting pr

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On September 16, 2026, the SEC issued a landmark proposal to rescind Rule 14a-8, which compels companies to include shareholder proposals in proxy materials, citing a belief that the rule exceeds its statutory authority. A second proposal seeks to modernize proxy solicitations by eliminating the glossy annual report delivery requirement, shortening the broker search period from 20 to five business days, and removing the Notice of Exempt Solicitation filing.

Rescinding Rule 14a-8 would fundamentally alter US corporate governance, shifting the venue for shareholder access disputes from the SEC to state law and private ordering through corporate bylaws. This dramatically changes the strategic landscape for both shareholder proponents and public companies. The modernization rules would streamline compliance and potentially accelerate timelines for corporate actions.

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The EU has adopted the Empowering Consumers for the Green Transition Directive, which member states must begin applying from September 27, 2026. The new rules significantly amend the Unfair Commercial Practices Directive to prohibit common forms of 'greenwashing.' The directive’s scope is broad, capturing virtually any business-to-consumer communication across all sectors, from consumer goods to financial services.

For corporate counsel, the most critical changes are new per se bans on certain marketing claims. Companies will be prohibited from using generic environmental terms like 'green' or 'eco-friendly' without demonstrating recognized excellent environmental performance. Crucially, the directive also bans claims that a product has a neutral or positive environmental impact based on carbon offsetting. It further imposes stringent new requirements for any forward-looking environmental commitments, such as net-zero targets, which must now be supported by a clear, public, and independently verified implementation plan. Firms with EU consumer-facing operations should immediately au

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On September 17, 2026, the US Securities and Exchange Commission established a temporary framework for trading tokenized securities. The five-year 'Innovation Exemption' permits certain National Market System (NMS) stocks to trade on new 'Tokenized Securities Venues' (TSVs) using automated market makers, without the TSVs having to register as national securities exchanges or alternative trading systems. The order also exempts qualifying liquidity providers on these platforms from broker-dealer registration requirements. This development is significant as it creates the first regulated sandbox for integrating distributed ledger technology with the US equities market, potentially enabling innovations like 24/7 trading and near-instant settlement. Corporate issuers must now consider policies for the potential tokenization of their stock by third parties, while financial and technology firms have a limited-time opportunity to build and test new business models with greater regulatory certainty. The SEC is soliciting public comment on the temporary rules, and market participants will be w

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China’s Supreme People’s Court has issued its first comprehensive judicial guidance on artificial intelligence, establishing a national framework for civil and intellectual property disputes. The opinion allocates liability for infringing AI-generated content among developers, providers, and users based on factors like control and ability to prevent harm, and it allows courts to compel disclosure of training data sources from developers in non-infringement defenses. For patent law, it confirms that AI-assisted inventions are eligible for protection only when a natural person makes a substantive creative contribution. The guidance also offers a conditional liability shield for some open-source developers and adapts safe-harbor principles for generative AI providers. Critically, the SPC deliberately left two of the most contentious global AI legal questions unresolved: whether AI-generated content can be copyrighted and whether training models on copyrighted works is itself infringement. The guidance signals that Chinese courts will take a pragmatic, fault-based approach, and businesse

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On September 16, 2026, the SEC proposed one of the most significant changes to shareholder engagement in decades: the complete rescission of Exchange Act Rule 14a-8. This rule has for nearly 85 years required companies to include qualified shareholder proposals in their proxy materials. Citing an overreach of its statutory authority into matters of state corporate law, the Commission seeks to shift the entire framework for shareholder proposals to state law and individual companies’ governing documents. Concurrently, the SEC proposed amending Rule 14a-4(c) to expand a company's discretionary voting authority over proposals submitted outside the federal process, while also giving shareholders a new proxy-card checkbox to opt-out of granting such authority for their shares. If adopted, this would fundamentally alter the landscape for corporate governance and shareholder activism. The proposal faces a public comment period and likely legal challenges, and the changes would not affect the 2027 proxy season. Companies should begin monitoring state law developments, particularly in Delawar

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On September 16, 2026, the U.S. Securities and Exchange Commission proposed the full rescission of Rule 14a-8, the provision that for over 80 years has enabled shareholders to compel companies to include their proposals in corporate proxy materials. The SEC argues the rule has expanded beyond its original procedural scope, effectively creating a federal mandate on substantive corporate governance matters that should be left to state law and individual companies' governing documents. The proposal is coupled with amendments to Rule 14a-4(c) that would grant companies discretionary authority to vote against shareholder proposals pursued through separate solicitations.

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The U.S. Securities and Exchange Commission has proposed rescinding Rule 14a-8, the longstanding federal framework requiring companies to include shareholder proposals in their proxy materials. Citing statutory authority and policy concerns, the SEC argues the rule improperly federalizes an issue that should be governed by state corporate law. If rescinded, the ability of shareholders to submit proposals for a vote would depend entirely on the law of the company's state of incorporation and its governing documents. This represents a fundamental shift in corporate governance, potentially curbing a primary avenue for shareholder activism on issues from executive compensation to environmental policies. For public companies, the change could reduce the number of proposals but introduce significant uncertainty and varied state-level standards. A separate, concurrent proposal would modernize other proxy solicitation mechanics, including by eliminating the glossy annual report delivery requirement. The proposals are open for public comment, and any final rule rescinding 14a-8 is expected to

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The European Commission on September 17, 2026, proposed the “EU KIDS Act,” a sweeping regulation aimed at protecting minors online. The proposal would create significant new obligations for providers of “Social Media+” services, a category that includes social media, video-sharing platforms, online games, and AI companions or chatbots. Major tech clients and counsel should note the act’s three core pillars: tiered, age-based access restricting service use for different age bands under 18; mandatory, privacy-preserving age verification for both new and existing accounts; and extensive “safe by design” requirements. These design mandates include making minor accounts private by default, removing features like infinite scrolling, and placing new limits on recommender systems and AI interactions. With potential fines reaching 6% of worldwide annual turnover, the financial stakes are substantial. The act is not yet law and is unlikely to take effect before 2028, but affected companies should begin assessing its impact and monitoring the legislative process.

The US Securities and Exchange Commission has proposed rescinding Rule 14a-8, which has provided the framework for shareholder proposals at public companies since 1942. The agency argues the rule exceeds its statutory authority by intruding into state-law matters of corporate governance. If the proposal is adopted, the inclusion of shareholder proposals in company proxy materials would be governed by state corporate law and companies’ organizational documents.

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The UK government has introduced The Iran (Sanctions) (Amendment) Regulations 2026, which come into force on September 29, 2026, significantly expanding its sectoral sanctions against Iran. The move follows the 2025 "snapback" of JCPOA sanctions and brings the UK's regime into closer alignment with broader measures previously adopted by the EU. These new restrictions impact key industries, including finance, energy, shipping, and technology, by imposing prohibitions on investments in Iranian oil and gas, restricting UK-Iran banking relationships, and banning insurance services for persons connected with Iran. The rules also establish wide-ranging trade controls, blocking exports of energy-sector equipment and certain enterprise software, and barring imports of Iranian oil, gas, and petrochemicals. Companies with UK operations must urgently assess their trade and financial activities for exposure. A wind-down provision for some pre-existing software contracts is available until March 7, 2027, but it requires notification to the authorities. Non-compliance carries potential criminal an

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The U.S. Securities and Exchange Commission has issued two significant proposals that would reshape the proxy season. The primary proposal would rescind Rule 14a-8, eliminating the long-standing federal framework that allows shareholders to have proposals included in company proxy materials. The SEC's rationale is that the rule exceeds its statutory authority and that the right to present matters for a vote is properly governed by state corporate law. This would be a seismic shift in corporate governance, affecting how shareholders engage with companies on issues from executive compensation to environmental and social matters.

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The US Securities and Exchange Commission has released a landmark proposal, “Regulation Crypto Assets,” its first comprehensive rulemaking for the offering of certain digital assets. The 400-page release introduces a bespoke framework for crypto assets sold as part of an investment contract. It establishes two new registration exemptions: a “startup exemption” allowing raises of up to $5 million over four years with streamlined disclosures, and a two-tiered “fundraising exemption,” modeled on Regulation A, for raises up to $75 million per year with more extensive reporting.

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The U.S. Court of Appeals for the Second Circuit has unanimously affirmed the Tax Court’s decision in Soroban Capital Partners v. Commissioner, holding that the limited partner exception to self-employment tax is determined by a partner's functional role, not their formal title. The panel ruled that the exception in Internal Revenue Code section 1402(a)(13) applies only to passive investors, not to partners who actively run, manage, or control the partnership’s business. This decision is significant for investment funds, such as hedge funds and private equity firms, many of which are structured as limited partnerships. The ruling solidifies the IRS's position that income allocated to active principals, even if designated as limited partners, is subject to self-employment taxes. Law firms should advise fund clients, particularly those within the Second Circuit, to review their partners' roles and income allocations to ensure compliance and assess potential tax liabilities. The decision may deepen a divide among courts on how to apply the statutory language to modern partnerships.

Virginia's governor has signed Executive Order 22, establishing a comprehensive data center accountability framework that marks a significant policy shift in a critical market. The order creates immediate changes, banning state agencies from using non-disclosure agreements in data center negotiations and removing large projects (25 MW or greater) from expedited site-readiness and permitting programs. The framework also directs state agencies to develop new standards for noise, backup generator emissions, and water use, and creates a new "VA-LEAD" designation to guide state incentive decisions.

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The U.S. Department of Justice (DOJ) has updated its Justice Manual to formally change its enforcement policies for the False Claims Act (FCA). The revisions codify two key principles that had been developing in practice. First, the DOJ has limited its attorneys' ability to premise an FCA violation on mere noncompliance with agency guidance documents, requiring that alleged violations be anchored in specific statutes and regulations. While guidance can still be used as evidence of a defendant's knowledge, its legal interpretation can be challenged. Second, the department is now formally encouraging its attorneys to seek dismissal of meritless qui tam (whistleblower) lawsuits. The new policy requires an assessment for dismissal every time the government declines to intervene in a case and broadens the circumstances under which a dismissal can be sought. For companies in highly regulated industries, these changes provide new and stronger arguments to defend against FCA investigations and to advocate for the dismissal of weak whistleblower suits, potentially both before and after the go

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The New York Department of Financial Services (NYDFS) has issued an industry letter clarifying its expectations for cybersecurity risk assessments required under Part 500 of its regulations. The guidance does not establish new rules but signals what examiners will focus on, drawing from common deficiencies found in recent investigations.

Sophisticated counsel and their financial-services clients should care because the letter provides a clear roadmap of regulatory priorities. NYDFS specifically called out frequent gaps, including incomplete asset inventories, weak methodologies that fail to distinguish between inherent and residual risk, and inadequate consideration of emerging threats like AI, quantum computing, and third-party concentration risk. The guidance also stresses the need for better governance, such as assigning ownership for risks and integrating assessment results into enterprise-wide decision-making.

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The FDIC and OCC have finalized a joint rule that, for the first time, codifies a definition for "unsafe or unsound" banking practices. Effective November 2, 2026, the rule requires that a criticized practice, to be actionable, must be likely to cause material financial harm to the institution. This change, long sought by the industry, aims to shift examiners' focus from procedural or compliance-management issues toward core financial risks. The rule also heightens the standard for issuing a "Matter Requiring Attention" (MRA), requiring a reasonable expectation of material harm.

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The Federal Deposit Insurance Corporation (FDIC) has issued a notice of proposed rulemaking to overhaul its framework for reviewing transactions under the Bank Merger Act. The proposal aims to increase the speed and predictability of the approval process by introducing tiered processing pathways—including rapid and expedited options for smaller or less complex deals—and by establishing new safe harbors for competition and financial stability. Key changes also include a revised methodology for analyzing competitive effects, which would treat bank, thrift, and credit union deposits equally for market share calculations. For sophisticated counsel and their banking clients, this proposal signals a significant and favorable shift from a more restrictive policy stance adopted in 2024. If finalized, the framework could materially reduce the time, cost, and uncertainty associated with obtaining FDIC approval, potentially encouraging more M&A activity. Interested parties should analyze the proposal's impact and consider submitting comments by the November 23, 2026 deadline, while also monitor

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A federal court in New York awarded ice cream maker Van Leeuwen $23.8 million and a permanent injunction against rival Rebel Creamery, finding Rebel intentionally infringed Van Leeuwen's trade dress for its ice cream pints. The court found Van Leeuwen successfully defined its trade dress through a combination of monochromatic pastel packaging, specific fonts, and a minimalist aesthetic across its "classic dairy" line.

Sophisticated counsel for consumer brands should note the court's analysis of what constitutes a "consistent overall look," finding that a few non-conforming products did not defeat the claim where the trade dress was defined as "primarily" using certain elements. The court also credited a survey showing a 34.3% net confusion rate—more than double the typical 15% benchmark—as compelling evidence. The large judgment, even after a 33% reduction to account for Rebel’s keto-specific market demand, highlights the significant financial exposure in trade dress litigation.

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The D.C. Circuit, in Vertex v. HHS, affirmed a broad interpretation of the federal Anti-Kickback Statute (AKS), holding that a manufacturer's proposed program to pay for fertility services for patients on its gene therapy constituted prohibited remuneration. The court rejected the argument that the AKS is limited to corrupt transactions, aligning with the Second and Fourth Circuits and creating a more challenging landscape for patient support programs.

Critically for regulatory practice, the court also invalidated Office of Inspector General (OIG) regulations that delayed or tolled the 60-day statutory deadline for issuing advisory opinions, a key compliance tool. The ruling establishes that the 60-day clock starts upon receipt of a request and cannot be extended by the agency. The court also faulted OIG for failing to meaningfully address evidence under the Beneficiary Inducement Statute, holding that conclusory denials violate the Administrative Procedure Act.

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A federal judge in Massachusetts granted a nationwide preliminary injunction on Sept. 14, 2026, halting a Department of Homeland Security final rule that was set to take effect the next day. The rule would have eliminated the long-standing 'duration of status' admission for F-1 students, J-1 exchange visitors, and I visa foreign media representatives, replacing it with fixed-term stays of up to four years, regardless of program length.

The enjoined rule would have created significant uncertainty and administrative burdens for universities, research institutions, and employers of foreign nationals. Students in programs longer than four years, such as Ph.D. candidates, would have been required to apply for extensions of stay with no guarantee of approval. The rule also would have reduced post-completion grace periods and complicated work authorization for those on Optional Practical Training (OPT), disrupting talent pipelines. The injunction preserves the status quo, averting immediate disruption.

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California has enacted SB 1050, a new law requiring clear and conspicuous disclosures for the use of AI-generated “synthetic performers” in advertisements disseminated within the state. A synthetic performer is defined as a human-like digital creation not based on any specific real person; depictions of actual individuals remain governed by existing right-of-publicity law. The mandated disclosure must appear near the digital performer and state that the performer is synthetic. Critically, violations are treated as false advertising and are actionable under California’s Unfair Competition Law, which provides for both civil enforcement and a private right of action. The law also prohibits the continued use of an ad found to be noncompliant, requiring it to be pulled or corrected immediately. The law includes a narrow carve-out for promotional material for expressive works like films or video games, but only if the synthetic performer's use in the ad mirrors its use in the underlying work. Companies advertising in California should now audit creative content, develop compliance protocol

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The SEC has proposed significant amendments to its proxy solicitation rules, aiming to modernize the process and reduce compliance burdens for public companies, BDCs, and registered funds. Key changes include eliminating the requirement to deliver a separate annual report to security holders, as the contents largely overlap with the Form 10-K already accessible on EDGAR. The proposal would also rescind the rule requiring—or allowing—the filing of a Notice of Exempt Solicitation, a change that could curb the ability of shareholder advocates, including those focused on ESG, to publicize their campaigns using the SEC's filing system. Other proposed amendments would remove the 20-business-day deadline for sending proxy statements that incorporate information by reference and shorten the mandatory broker search period from 20 to five business days. While the changes are largely procedural and intended to reflect modern technology, they represent a meaningful shift in the mechanics of proxy season and shareholder engagement. Market participants should monitor the rulemaking process, as the

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Massachusetts Governor Maura Healey has issued Executive Order 658, creating a new regulatory and permitting framework for data centers with over 25 MW of peak electricity demand. The order is part of a growing trend by states to manage the significant environmental and energy-grid impacts of the booming data center industry.

For sophisticated counsel and their developer, investor, and technology clients, the order imposes new compliance burdens affecting site selection, project finance, and operational costs. It mandates that new projects conform with a state "Framework for Responsible Data Center Development," which includes requirements for community benefit agreements, greenhouse gas emissions evaluations, and water resource protection. Crucially, the order directs state agencies to ensure developers procure sufficient incremental clean electricity and to establish rate schedules so that grid upgrade costs are not borne by other ratepayers. This follows similar regulatory actions or moratoriums considered or enacted in states like Maine, New York, and Texas.

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The life sciences IPO market showed a strong partial recovery in the first quarter of 2026, raising more capital than in all of 2025. However, access to public markets remains narrow, favoring late-stage companies with assets in high-demand areas such as oncology, obesity, and AI-driven drug discovery.

Sophisticated counsel should note that the more significant trend is not a full-scale IPO revival but a market reconfiguration toward alternative financing. While follow-on offerings and PIPEs remain steady, licensing deals have become a dominant capital source, with a reported $82.7 billion in transactions in Q1 2026 alone. This indicates a market that strongly favors de-risking strategies and third-party validation from established pharmaceutical partners over more speculative early-stage ventures.

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The US Food and Drug Administration (FDA) held a workshop signaling its willingness to work with drug sponsors on an approval pathway for testosterone therapy for menopausal women, a significant shift for a treatment currently available only through off-label use of male-indicated drugs or compounding. There is currently no FDA-approved testosterone product for women, and the agency's call to action creates a major opportunity for drug developers to address an unmet medical need and enter a new market.

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The UK's energy regulator, Ofgem, has published a consultation on a proposal to introduce an Oversubscribed Technologies Commitment Fee (OTCF) to manage the national grid connections queue. The move directly targets the Battery Energy Storage System (BESS) sector, where the queue is oversubscribed by approximately 61 gigawatts against a projected 2035 need. Ofgem is concerned that this oversubscription distorts network planning and could lead to consumers bearing £460 million in inefficient infrastructure costs for projects that never materialize.

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The Department of Justice has issued an unusual public warning concerning liability under the Foreign Agents Registration Act (FARA), signaling a potential shift in its enforcement posture. The Sept. 16 announcement reminded individuals and organizations of potential civil and criminal liability, specifically referencing public demonstrations and other advocacy undertaken for foreign interests. This development is notable because it appears to diverge from a February 2025 directive that had limited criminal FARA charges to conduct resembling traditional espionage. The warning puts a wide range of actors—including corporations, nonprofits, public-relations firms, and consultants—on notice that undisclosed foreign direction remains a key enforcement concern. Compounding the risk, the DOJ is now actively soliciting tips from the public regarding potential violations. Sophisticated counsel should advise clients with foreign relationships to reassess their public-facing activities and contemporaneously document their FARA analysis. All eyes are now on a long-pending FARA rulemaking, which

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Life sciences M&A activity surged in the first half of 2026, with deal value reaching $196 billion—a 141% increase over the same period last year and the strongest start since 2019. This dealmaking frenzy is driven by an impending patent cliff, which places an estimated $305 billion in revenue at risk for pharmaceutical companies over the next seven years. To address the shortfall, acquirers are deploying significant capital to purchase de-risked assets, primarily those in Phase II clinical trials or later. Hot areas for acquisition include cardiometabolic and obesity treatments, late-stage oncology, and immunology. A notable structuring trend is the increased use of Contingent Value Rights (CVRs), which now feature in about one-third of public target deals to bridge valuation gaps by tying payments to future milestones. Given their potential for disputes, practitioners should carefully negotiate CVR terms, particularly the "efforts" standards that govern a buyer's obligations post-closing. Analysts expect the high volume of "bolt-on" acquisitions to continue, with a potential "mega-

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The US Federal Communications Commission (FCC) is expanding its "Covered List," a key national security tool that blocks market access for communications equipment deemed to pose an unacceptable risk. Recent additions have moved beyond targeting specific companies to banning broad categories of technology—including drones, consumer routers, advanced robotics, and power inverters—based on their country of production. This shift means equipment can be blocked from receiving the FCC authorization required for US importation and sale, regardless of the manufacturer's nationality. The restrictions impact any company with global manufacturing, including US-headquartered firms producing abroad. Furthermore, the FCC is now scrutinizing internal components, demanding unprecedented visibility deep into supply chains. While a "conditional approval" process offers a potential exemption, it requires extensive disclosure of corporate structure and manufacturing details. Companies that import, make, or use connected devices must now urgently assess their supply-chain vulnerabilities as the governme

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The US Securities and Exchange Commission issued a five-year "Innovation Exemption" order creating a temporary, conditional pathway for on-chain secondary trading of tokenized NMS stocks. With market-structure legislation stalled, the SEC is using its exemptive authority to foster a controlled experiment in tokenized equity trading. The order provides legal certainty by exempting qualifying tokenized securities venues (TSVs) from the definition of an "exchange" and certain automated market maker (AMM) liquidity providers from the definition of a "dealer." This opens a new, albeit narrow, avenue for financial and technology firms to develop and test blockchain-based trading systems for traditional securities.

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The U.S. Court of Appeals for the D.C. Circuit has declined to stay the Drug Enforcement Administration's final rule rescheduling cannabis from Schedule I to Schedule III under the Controlled Substances Act. The ruling means cannabis will retain its new, less-restrictive classification while a legal challenge brought by anti-legalization groups proceeds on the merits. This decision provides a measure of temporary certainty for the cannabis industry. The move to Schedule III has major implications for state-licensed cannabis businesses, most notably by potentially offering relief from IRC Section 280E, which currently prohibits them from deducting standard business expenses. While the denial of a stay is a positive development for the industry, the ultimate fate of the rescheduling rule remains subject to the court's final decision. The parties have been instructed to propose a briefing schedule within 30 days, signaling that the substantive legal battle is now set to begin. A reversal on the merits would have significant negative consequences for the industry's financial and operatio

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The US Federal Deposit Insurance Corporation (FDIC) has issued a proposed rule to overhaul its review process for transactions under the Bank Merger Act. The proposal aims to increase efficiency and predictability for the approximately 2,700 state nonmember banks supervised by the agency. Key changes include creating tiered processing timelines with a "rapid processing" track for de minimis deals, modernizing the competitive effects analysis to include credit unions in the initial Herfindahl-Hirschman Index (HHI) screen, and codifying a safe harbor for transactions that do not significantly increase market concentration.

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New York Governor Kathy Hochul signed legislation creating new rights for employees to access and challenge their personnel records, effective November 8, 2026. The law, which adds Section 210-b to the New York Labor Law, marks a significant change in a state where employees previously had no such guaranteed access.

All public and private employers in New York must now prepare to handle written requests from current and former employees for copies of their personnel files, which must be provided free of charge within five business days. The law also imposes a novel affirmative duty on employers to notify an employee within 10 days of placing any information in their record that could be used negatively against them. Further, it establishes a process for employees to dispute information and requires record retention for three years post-employment.

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A confluence of recent developments is reshaping patent litigation strategy at the US International Trade Commission (ITC). The Federal Circuit’s 2025 decision in Lashify v. ITC broadened the scope of activities that can establish a domestic industry, potentially opening the forum to more patent owners, though the ITC’s analysis of the “significance” of those activities remains a key battleground. Separately, proposed ITC rules from April 2026 would, if adopted, require parties to disclose litigation funding and other financial interests, adding a new layer of scrutiny regarding conflicts, standing, and control. For standard-essential patents (SEPs), the ITC continues to be a forum for gaining settlement leverage in global licensing talks, even without recent exclusion orders. Finally, USPTO guidance has made the timing of parallel Patent Trial and Appeal Board (PTAB) challenges more critical, as an accelerated ITC schedule may preempt a PTAB validity decision. Litigants must now monitor the financial disclosure rulemaking and carefully weigh how these evolving standards affect case

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The U.S. Treasury Department sanctioned 36 entities and individuals for allegedly supporting Iran's aviation sector, which it says the regime uses to transport weapons and illicit cargo. The action, part of "Operation Economic Outcast," targets 27 Iranian airlines and various third-country front companies accused of facilitating the procurement of U.S.-origin aircraft. Concurrently, the Financial Crimes Enforcement Network (FinCEN) issued an alert for financial institutions, outlining specific red-flag indicators of illicit procurement schemes. Sophisticated clients care because this coordinated action significantly expands sanctions risk for the aviation, logistics, and finance industries. The new designations require immediate updates to screening protocols, while FinCEN’s alert establishes a higher bar for anti-money laundering compliance and due diligence. This signals intensified enforcement against intermediaries and facilitators of sanctions evasion. Financial institutions should immediately integrate the new red flags into their monitoring systems and use the requested keywor

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The US Court of Appeals for the Ninth Circuit held that an employee who initially pursues claims in arbitration can later elect to proceed in court after discovery reveals facts supporting a claim covered by the Ending Forced Arbitration Act (EFAA). In Ding v. Structure Therapeutics, the plaintiff began arbitrating discrimination claims but later sued in court after uncovering evidence she argued supported a sex-based hostile work environment claim.

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Mexico’s executive branch has introduced a bill for a complete rewrite of the General Law of Ecological Balance and Environmental Protection (LGEEPA), the nation's primary environmental statute since 1988. Sophisticated counsel and clients with operations in Mexico should note that the proposed changes are substantial. Maximum fines for violations could increase forty-fold, reaching over US$20 million for certain offenses involving protected areas or threats to human health. The reform would also create a public Environmental Offenders Registry, which could bar listed companies from government contracts and negatively affect access to financing and insurance. Other significant changes include longer project permitting timelines, expanded mandatory environmental insurance requirements, and a centralization of regulatory authority at the federal level. The bill is expected to be debated in Congress, where its final text may be modified. Companies should begin analyzing how the proposed requirements would impact their compliance programs, permitting strategies, and ESG disclosures.

This guide provides a multi-disciplinary roadmap for organizations to manage the risks of quantum computers breaking current public-key cryptography. It urges companies to appoint a post-quantum cryptography (PQC) owner, conduct quantum-specific risk assessments, create a complete inventory of cryptographic systems, and develop a migration plan aligned with new NIST standards (FIPS 203, 204, 205).

Sophisticated clients care because the transition to PQC is a complex, long-term initiative. Failure to prepare creates foreseeable legal and regulatory risk, exposing organizations to "Harvest Now, Decrypt Later" attacks, where adversaries steal encrypted data today to decrypt with future quantum computers. This is especially critical for technology companies with long-lived products and firms in regulated sectors.

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The US Securities and Exchange Commission (SEC) and the Food and Drug Administration (FDA) have signed a memorandum of understanding creating a formal framework for sharing nonpublic information. The agreement is designed to enhance both agencies’ ability to execute their missions by allowing the SEC to more easily access sensitive data about FDA-regulated companies, including information on clinical trial results, product approval status, and other regulatory correspondence that could be material to investors.

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A series of recent developments signals a significant shift in U.S. labor law. National Labor Relations Board (NLRB) General Counsel Crystal Carey issued a memorandum outlining her intent to challenge numerous Biden-era precedents on topics like severance agreements, work rules, and union organizing. This memo offers a roadmap for the policy reversals expected from the Board's new Republican majority. In a related development, the Second Circuit rejected the NLRB’s Tesla standard for dress codes restricting union insignia, remanding the case for a more balanced approach that weighs employer interests. Concurrently, some states are expanding labor rights for workers outside federal protection. California and Illinois have created state-run collective bargaining frameworks for rideshare drivers classified as independent contractors. This emerging state-level regulation may face federal preemption challenges, as seen in a New Jersey federal court ruling that the National Labor Relations Act preempts the state’s cannabis-industry “labor peace agreement” law, which is now on appeal. Cou

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The proposed US BIOSECURE Act, which is advancing through Congress, would prohibit federal agencies from contracting with or extending loans and grants to companies that use biotechnology equipment or services from certain Chinese "companies of concern." This poses a significant risk for pharmaceutical and life sciences companies whose global supply chains rely heavily on major Chinese contract research, development, and manufacturing organizations for everything from discovery to clinical trials and commercial production.

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The Office of the Comptroller of the Currency (OCC) and the Federal Deposit Insurance Corporation (FDIC) have jointly issued a notice of proposed rulemaking to amend regulations under the Community Reinvestment Act (CRA). The Federal Reserve Board, however, has not joined the proposal, creating the potential for a fragmented regulatory landscape.

The proposed changes would significantly increase the asset-size thresholds for classifying banks as small, intermediate, or large, which would reduce the compliance burden for a substantial number of institutions. The proposal also seeks to narrow the focus of CRA evaluations to a bank’s core credit services and major product lines, while tightening the criteria for community development grants to prevent what some critics see as politically motivated donations to advocacy groups.

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The US National Association of Insurance Commissioners (NAIC) is signaling a significant shift from principles-based guidance to direct supervisory tools and examinations for technology governance. Recent initiatives show regulators focusing on how insurers' controls for AI, third-party data, and cybersecurity work in practice. Insurers can no longer just maintain policies; they must be prepared to produce evidence of effective governance.

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France has broadened the scope of its foreign investment screening regime, a critical diligence item for cross-border transactions involving French targets. Under a new decree (No. 2026-718) that took effect August 17, 2026, the government's prior-approval requirement now applies more broadly to acquisitions by non-European investors. Previously, the threshold requiring review for an acquisition of 10% or more of the voting rights in a publicly traded company was limited to French companies listed on a regulated market in France. The decree expands this oversight to target companies listed on certain specified foreign regulated markets as well. The list of covered foreign markets was established by a separate ministerial order. This change significantly increases the number of potential transactions subject to review by the French Minister of the Economy, empowering the government to block or impose conditions on deals it deems a threat to national interests. Counsel for non-EU investors must now expand their FDI diligence to verify the listing location of any French target company t

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Virginia's governor has signed Executive Order No. 22, creating a new regulatory framework for the state's booming data center industry. The order targets the sector's significant energy and environmental footprint by directing state agencies to develop new rules and guidance over the next several months.

Sophisticated counsel and their developer clients must now navigate a changed landscape. The order ends state assistance from certain programs for projects with anticipated peak demand over 25 MW and bans non-disclosure agreements that conceal project details and community impacts. It also mandates the development of regulations for noise, backup-generator emissions, and water use, along with a community engagement toolkit for local governments.

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The SEC has proposed amendments to modernize several proxy solicitation rules, reflecting a broader agency effort to update regulations for the digital age. The proposed changes would eliminate the 20-business-day minimum delivery period for proxy statements that incorporate documents by reference, a requirement the SEC views as obsolete given the accessibility of filings on EDGAR. The proposal would also rescind the rule requiring large shareholders to file a Notice of Exempt Solicitation, which would require companies to monitor other channels like press releases to track activist campaigns. Other key changes include shortening the mandatory broker search period from 20 to five business days before a meeting's record date and eliminating the requirement to deliver a separate annual report to shareholders for companies that have already filed a Form 10-K. While these rules are not yet final, they signal a significant shift toward streamlining corporate disclosures and reducing administrative burdens. Counsel should monitor the rulemaking, as final rules could materially alter proxy

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This guide explains a strategic shift in institutional real estate from direct asset acquisition to 'platform investing'—the practice of buying stakes in the operating companies that source, develop, and manage properties. This model targets both property-level returns and the enterprise-value growth of the management business itself. For capital allocators, platform investing offers access to specialized management teams, proprietary deal flow, and stronger alignment of interests in a market where operational excellence is critical for value creation. For real estate operators, it provides stable, long-term capital that helps them navigate market cycles, fund overhead, and scale quickly to seize opportunities. These transactions are complex, blending M&A and real estate principles. Counsel must conduct diligence not only on the property portfolio but also on the operating company's management team, contracts, intellectual property, and liabilities. Governance and incentive structures are key to balancing investor protection with the platform's entrepreneurial agility.

Although food, drugs, and cosmetics are generally excluded from the Consumer Product Safety Act's definition of a 'consumer product,' their packaging is not. This distinction creates a significant compliance trap for companies focused solely on FDA regulations. A mechanical hazard posed by packaging—such as a detachable cap creating a choking risk or a glass container prone to breaking and causing lacerations—can trigger a duty to report to the Consumer Product Safety Commission (CPSC). Sophisticated counsel must be aware that this reporting obligation under Section 15(b) of the CPSA arises within 24 hours of the company learning of information that reasonably supports the conclusion of a reportable issue. Failure to make a timely report can result in significant civil penalties. Companies in this space should proactively establish compliance programs to identify, investigate, and evaluate potential packaging hazards to determine whether a CPSC report is warranted, even before any injuries have been reported.

The U.S. Department of Labor (DOL) has issued a final rule, effective September 21, 2026, rescinding key disability-related affirmative action requirements for federal contractors under Section 503 of the Rehabilitation Act. The rule eliminates the 7% disability utilization goal, ends the mandate for contractors to invite applicants and employees to self-identify their disability status, and removes associated data collection and analysis obligations that have been in place since 2013.

Sophisticated counsel should note the DOL's rationale, which cited potential conflicts with the Americans with Disabilities Act (ADA) and argued the utilization goal could induce the use of prohibited quotas. This reversal significantly alters the compliance landscape, requiring a shift from quantitative benchmarks to qualitative assessments of program effectiveness. While core nondiscrimination, reasonable accommodation, and outreach obligations remain, this change demands a strategic rethinking of how contractors design and measure their disability affirmative action programs (AAPs).

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A comprehensive U.S. crypto-market structure bill, the Clarity Act, has failed to advance in the Senate following disagreements on stablecoin yields, AML/consumer protection rules, DeFi oversight, and specific ethics provisions. The legislative vacuum is now being filled by federal financial regulators, which have immediately begun to assert their authority. The SEC published an "Innovation Exemption" for certain tokenized securities venues, while the CFTC issued a no-action letter for "passive software providers" and submitted its own draft crypto rules to the White House. Concurrently, the OCC granted national trust bank charters to three stablecoin issuers. This shift from a legislative to a regulatory-led framework creates a complex compliance environment. Sophisticated counsel should advise clients that the development likely favors large, well-resourced financial institutions that can navigate the emergent multi-agency patchwork, potentially disadvantaging smaller banks and accelerating market consolidation. The next development to watch is the CFTC's proposed rules, expected t

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US prudential regulators, including the Federal Reserve, FDIC, and OCC, have proposed revised guidance for how banks and credit unions manage risks associated with third-party relationships. The proposal would replace the 2023 framework with a more flexible, "principles-based" approach, moving away from what regulators saw as an overly prescriptive, "check-the-box" exercise. This change is intended to encourage responsible innovation and partnerships with fintech companies by allowing institutions to tailor their oversight based on the specific risk level of each relationship.

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Since early 2025, the USPTO Director has consolidated authority over instituting inter partes review (IPR) proceedings, creating a more restrictive and unpredictable environment at the Patent Trial and Appeal Board (PTAB). This shift has caused IPR institution rates to plummet from over 60% in late 2024 to below 40% by mid-2026. For major-firm clients, particularly in the life sciences, this trend strengthens existing patent portfolios by making them harder to challenge. The Director is now the sole decision-maker on institution and is using expanded discretionary grounds for denial, such as revived Fintiv factors and new "settled expectations" for older patents. These decisions are often issued as summary orders, limiting transparency and grounds for appeal. The Director has also intervened late-stage to vacate instituted proceedings, increasing uncertainty for all parties. Counsel should advise clients that as IPRs become less viable, patent challengers are shifting to other forums like ex parte reexaminations, and the scope of the Director's authority is now being challenged befor

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Developers of AI-enabled mental health products face a rapidly evolving and complex regulatory landscape in the United States, marked by increasing scrutiny from federal agencies and a growing patchwork of state laws. This multi-front oversight creates significant compliance challenges and liability risks, including from private litigation. Sophisticated counsel should advise clients that regulatory analysis hinges on a product's specific functions and marketing claims. Key federal considerations include potential classification as a medical device by the FDA and enforcement actions by the FTC regarding deceptive claims or violations of the Health Breach Notification Rule. At the state level, a wave of new legislation imposes varied requirements for AI disclosure, crisis-response protocols, and limitations on the unauthorized practice of medicine or psychology. Furthermore, new state consumer health privacy laws add another layer of complexity. Companies in this space must proactively monitor these developments and implement robust governance, including clear user disclosures, scope

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The European Union has published simplified European Sustainability Reporting Standards (ESRS) and new voluntary standards (VESRS) in its Official Journal, finalizing a key part of its effort to reduce the administrative burden of the Corporate Sustainability Reporting Directive (CSRD). The package significantly cuts the number of mandatory reporting datapoints—by over 60%, according to the Commission—and raises the financial thresholds for companies to fall within the CSRD's scope, though member states must still transpose these threshold changes. For major-firm clients, these revisions will materially alter compliance strategies, potentially reducing data collection costs. The new voluntary standards also create a framework for smaller, out-of-scope value-chain partners facing data requests from larger customers. The simplified ESRS will apply to financial years starting on or after January 1, 2027, with an early adoption option for 2026. Counsel should also monitor the separate EFRAG consultation on reporting standards for certain non-EU companies, which is expected to be finalize

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Charter Communications's $34.5 billion acquisition of Cox Communications provides a valuable case study in the current US regulatory landscape for major telecom M&A. While the deal cleared federal Hart-Scott-Rodino antitrust review quickly and without a Second Request from the DOJ, it faced a much longer and more complex path with communications regulators. The Federal Communications Commission approved the transaction based on a series of voluntary commitments from Charter regarding rural infrastructure, jobs, and wages, a process the agency now appears to favor over imposing its own conditions. At the state level, however, the review was even more intensive. Public utility commissions, particularly in California, conducted lengthy proceedings that resulted in binding settlement agreements with costly, multi-year commitments on low-income broadband access, network upgrades, and consumer protections. For sophisticated counsel, the deal highlights a key strategic consideration: federal antitrust clearance is only one piece of the puzzle. Parties to future transactions in regulated ind

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On September 2, 2026, the Financial Crimes Enforcement Network (FinCEN) and federal banking agencies including the Fed, FDIC, and OCC issued a joint statement clarifying the application of Suspicious Activity Report (SAR) confidentiality to customer communications. The guidance affirms that the Bank Secrecy Act does not prohibit banks from discussing underlying facts, transactions, or documents with customers, even if those details form the basis of a SAR.

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The European Commission adopted a Delegated Regulation on September 14, 2026, that amends the EU’s list of controlled dual-use goods, software, and technology. The update formally aligns the EU’s export control regime with its commitments to international non-proliferation arrangements, including the Wassenaar Arrangement and the Australia Group. The new controls target emerging and strategically significant technologies, most notably in the semiconductor manufacturing, advanced computing, aerospace, and advanced materials sectors. Specific additions include certain types of atomic layer deposition equipment, advanced computing integrated circuits, and ceramic matrix composites. The amendments also modify technical parameters for existing controls, which may bring previously uncontrolled items within scope. Companies exporting from or within the EU, particularly in the tech and aerospace industries, must now review their products and technology against the updated list to determine if new export licenses are required. The regulation is subject to a two-month scrutiny period by the Co

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Drawing on reports that major AI developers have lost control of some AI models, expert commentary suggests that malicious uses of artificial intelligence are outpacing defensive applications. This new class of AI-driven threat can reportedly find and exploit system vulnerabilities at unprecedented speed, threatening to overcome established cybersecurity safeguards like multi-factor authentication and encryption with increasing regularity. For corporate clients, this development means that the legal standard for "reasonable safeguards" is in flux and that an overreliance on purely technical defenses has become a high-risk strategy. Sophisticated counsel should advise clients to pivot their cybersecurity posture from prevention to preparedness. Key priorities include implementing aggressive data minimization and retention policies to reduce the attack surface, enhancing data mapping to maintain visibility, and conducting more rigorous due diligence on all vendors, especially those providing AI tools. Incident response plans must be updated and tested against these faster, more sophist

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The New York Attorney General's office has issued a public alert encouraging employees in the artificial intelligence sector to report safety concerns and potentially illegal activities directly to the government. The September 17 announcement specifically directs potential whistleblowers to the NYAG's existing online portal, which allows for anonymous submissions. This move signals a proactive enforcement posture from a key state regulator, even before New York's Responsible AI Safety and Education (RAISE) Act becomes effective on January 1, 2027. For companies developing or deploying AI, this development creates significant risk. The emphasis on an anonymous, external reporting channel could encourage employees to bypass internal compliance and reporting systems, depriving companies of the chance to investigate and remediate issues proactively. This escalation in regulatory scrutiny, which may be emulated by other states, requires AI-focused companies to immediately review their internal governance, investigation protocols, and anti-retaliation policies to ensure they are robust en

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The FAR Council has released the second major batch of proposed rules in its comprehensive "Revolutionary FAR Overhaul" (RFO), advancing a significant modernization of federal procurement regulations. The new rules, issued September 18 with comments due October 19, propose material changes across 16 FAR parts that will affect most government contractors. Among the most impactful proposals is a revision to the strict “late is late” rule in FAR Part 15, which would grant contracting officers discretion to accept proposals submitted after a deadline if deemed to be in the government’s best interest. Other key changes include clarifying commercial item acquisition procedures for construction, mandating small business set-asides below the simplified acquisition threshold, reverting to the traditional “reasonable likelihood” standard for exercising options, and explicitly authorizing consumption-based pricing models. Counsel for federal contractors should review the proposals closely to assess their impact on bidding strategies and contract administration and consider submitting comments b

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The U.S. Court of Appeals for the Ninth Circuit reversed a district court's denial of a preliminary injunction, holding that the plaintiff tribes are likely to succeed on their claim that Kalshi's event contracts are Class III gaming under the Indian Gaming Regulatory Act (IGRA). The panel rejected Kalshi's characterization of its products as financial swaps, employing a functional analysis that found them to be the “stuff of sports betting” and noting their operational similarity to traditional sportsbooks. This decision creates significant legal risk for the burgeoning prediction market industry, particularly for platforms accessible from tribal lands where tribes often hold exclusive gaming rights. The court also rejected arguments that the Commodity Exchange Act (CEA) preempts other federal laws like IGRA, adding to a growing circuit split on how to regulate these novel products. With divergent rulings from multiple circuits, market participants should watch for a likely grant of certiorari by the U.S. Supreme Court to resolve the widespread legal uncertainty.

The EU's Empowering Consumers for the Green Transition Directive (GTD) becomes applicable across the bloc on September 27, 2026. It bans green claims based solely on carbon offsetting, regulates generic terms like "eco-friendly," and requires verifiable plans for future environmental performance commitments.

Enforcement is already active. A French court prospectively applied GTD principles to convict TotalEnergies for its "carbon neutrality by 2050" ambition, faulting a lack of transparency. Other French rulings have penalized Volvic for "carbon neutral" and "100% recycled" claims on packaging and fined SHEIN for unsubstantiated emissions-reduction assertions. Coordinated EU regulatory actions are also targeting airlines and energy companies over similar claims, signaling a low tolerance for "greenwashing." The UK's Competition and Markets Authority is pursuing a convergent path with its own guidance and the threat of turnover-based fines.

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The U.S. Securities and Exchange Commission has proposed several amendments to its proxy solicitation rules, aiming to modernize the process and reduce costs for public companies. The proposed changes, issued on September 16, 2026, would significantly alter current mechanics. Key proposals include shortening the required broker search period from at least 20 business days before a record date to just five. The plan would also eliminate the 20-day advance delivery requirement for proxy statements that incorporate information by reference, a rule the SEC deems outdated given the accessibility of documents on its EDGAR system. Furthermore, companies that have filed their annual Form 10-K would no longer need to prepare and deliver a separate "glossy" annual report. The proposal also seeks to rescind the requirement for certain large shareholders to file a Notice of Exempt Solicitation. These updates would streamline compliance and reduce administrative burdens during proxy season. The proposals are now subject to a 60-day public comment period following publication in the Federal Regist

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The House Financial Services Committee has approved H.R. 10184, the Consumer Financial Protection Accountability and Reform Act, on a party-line 28-21 vote. The legislation’s most significant provision would subject the Consumer Financial Protection Bureau (CFPB) to the annual congressional appropriations process, ending its current funding structure through the Federal Reserve. The bill also seeks to impose new rulemaking requirements, including defining the term “abusive,” alter the agency’s supervisory and enforcement powers, and clarify the legal weight of its published guidance.

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A Paris trial court has found that environmental claims on water bottles, including “carbon neutral” and “100% recyclable,” constituted misleading commercial practices under French law. The June 23, 2026, judgment distinguished between the two types of claims. The court found “carbon neutral” was likely to mislead consumers because the claim was made without sufficient explanation of how neutrality was achieved, particularly the balance between emissions reduction and carbon offsetting. The court ruled that the “100% recycled” and “100% recyclable” statements were factually inaccurate, as parts of the packaging like the cap and label did not meet that standard. The decision is a key development in the European crackdown on “greenwashing,” showing that courts demand rigorous substantiation for marketing claims. Notably, the tribunal cited a new EU directive and other recent regulations—not yet in force for the facts at issue—to reinforce its interpretation, signaling a clear trajectory toward stricter enforcement. While the defendant intends to appeal the ruling, which included a €75,

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The FDIC has proposed a rule to ensure regulatory parity between out-of-state, state-chartered banks and national banks, regardless of physical presence. The proposal would amend 12 CFR Part 331 so that if a host state's laws do not apply to a national bank, they likewise do not apply to a state-chartered bank operating there, even without a branch. This move was prompted by litigation over an Illinois interchange fee law, which revealed uncertainty about whether existing protections under Section 24(j) of the FDI Act extended to state banks without a host-state branch. By closing this parity gap, the FDIC aims to align regulations with modern banking practices, where activity increasingly occurs through non-branch channels. For affected banks, the rule could provide significant compliance cost savings, which the FDIC estimated at over $300 million for the Illinois law alone. The proposal will not affect rules governing interest rates on loans. A 60-day comment period will open upon the notice’s publication in the Federal Register.

The FDIC has proposed a significant overhaul of its framework for reviewing bank mergers. The new rule would introduce a five-day 'deemed approval' process for 'de minimis' transactions that fall below HSR thresholds and meet other criteria, potentially accelerating smaller deals. For all transactions, the competitive-effects analysis would be updated to include credit union shares and centrally booked deposits in the Herfindahl–Hirschman Index calculation, with a new safe harbor for transactions resulting in an HHI of 1,800 or less. The proposal also establishes structured processing timelines of 90 to 150 days, depending on institution size, and sets a clear quantitative test for what constitutes a 'merger in substance.' Sophisticated counsel should advise clients on how these proposed changes could affect future M&A strategy. The immediate next step is the 60-day public comment period following the proposal's publication in the Federal Register, offering an opportunity to shape the final rule.