Expert Analysis


Engaging With FDA's New Complete Response Letter Policy

A citizen petition filed with the U.S. Food and Drug Administration last month puts renewed focus on the agency's practice of releasing complete response letters in near real time, materially altering the context in which life sciences companies communicate with investors regarding regulatory developments, say attorneys at Debevoise.


How Anthropic's Mythos May Upend Defense Cyber Rules

Anthropic’s recent announcement that Claude Mythos, an AI general-purpose language model, could soon enable virtually anyone to exploit vulnerabilities in major web browsers and operating systems marks an imminent increase in threat levels that current defense cybersecurity regulations were not designed to navigate, say attorneys at Fluet.


Data Center Developer Lessons From Maine's Vetoed Ban

The regulatory and political dynamics that recently led Maine’s governor to veto a popular bipartisan bill proposing a temporary data center development ban offer a useful template that developers can use to help their projects survive other states' attempts at moratoriums, say attorneys at Thompson Hine.


Tracking Tech Suit Is A Risk Management Reminder For Cos.

The Fifth Circuit recently heard oral argument in Rand v. Eyemart Express — an appeal that could reshape the legal landscape for businesses that deploy tracking tech on their websites — underscoring the importance of proactive risk management for companies across multiple industries, say attorneys at Blank Rome.


Submitting Ideas To AI Platforms May Affect Patent Rights

Recent judicial developments suggest that disclosing an invention to a consumer artificial intelligence platform constitutes public disclosure, making disciplined use of such tools and early filing strategies essential to preserving patent rights, say attorneys at Day Pitney.


Revised Fed Principles Balance Risk And Remediation

The Federal Reserve's recently updated supervisory principles sharpen standards for enforcement actions while rewarding self-identification and remediation, signaling a more transparent approach that could reduce uncertainty and reshape how banks manage examination risk and regulator engagement going forward, say attorneys at Davis Wright.


Big Issues Linger After Senate Prediction Market Trading Ban

Whether the Senate can — or should — extend prediction market trading restrictions beyond itself will test not only the boundaries of insider trading law, but also the structural limits of legislative power in an era where information itself has become a tradable asset, say attorneys at Benesch.


Series

Law School's Missed Lesson: Diagnose Before Arguing

Law school often skips over explicitly teaching students how to determine what kind of problem a case presents before they commit to a particular doctrinal path, which risks building arguments that are internally coherent but externally misaligned, says Melanie Oxhorn at Kobre & Kim.


Trump's Psychedelics EO Creates A Regulatory Collision

Sponsors pursuing U.S. Food and Drug Administration approval for psychedelic drug access must tackle how to generate regulatory-grade safety and efficacy data in controlled trials when President Donald Trump's recent executive order on psychedelics mandates uncontrolled access through Right to Try, say Kimberly Chew at Husch Blackwell and Odette Hauke at Odette Alina.


A Fed. Circ. Blueprint For Drafting Medical Device Patents

The Federal Circuit's decision in Constellation Designs v. LG last month, among other recent rulings, underscores the importance of emphasizing engineering, rather than clinical goals, when drafting patent claims for medical devices and software as a medical device, says Brandon Theiss at Volpe Koenig.


Decoding Arbitral Disputes: EU's Arb. Defense From Russia

The EU's latest package of restrictive measures against Russia marks a significant shift from merely resisting Russian jurisdictional tactics to proactively protecting arbitration and exclusive jurisdiction agreements, elevating the procedural importance of dispute resolution clauses, says Josep Galvez at 4-5 Gray's Inn Square.


DTSA Data Shows Hidden Value Of Ex Parte Seizure Filings

Ten years of Defend Trade Secrets Act data indicate that although there is a low success rate for civil seizure applications, intellectual property litigators should continue filing them anyway in order to better their odds of obtaining other provisional relief, say attorneys at Reed Smith.


What Model Risk Guidance Update Means For Banks

Federal prudential regulators recently issued new model risk management guidance for banks that is designed to reduce prescriptive supervisory expectations and instead focus more on material financial risk, so banking organizations should reassess their model inventories, apply the new materiality framework and update their internal policies, say attorneys at Orrick.


Recent Benchmarking Suits Highlight DOJ Enforcement Risks

The U.S. Department of Justice's recent settlements with RealPage and Agri Stats inform the level of antitrust risk surrounding the use of benchmarking services and suggest an aggressive enforcement approach, particularly with respect to granular data and nonprice data reporting, say attorneys at Axinn.


Becoming The Biz-Savvy GC That Portfolio Companies Need

Candidates for general counsel roles at private equity-backed portfolio companies should prioritize proving their sector-specific experience, commercial judgment and ease with uncertainty — and attorneys hoping to be candidates in five to 10 years should start working on those skills now, says Dimitri Mastrocola at Major Lindsey.


Bid Protest Spotlight: Discriminators, Fairness, Experience

In this month's bid protest roundup, Victoria Angle at MoFo surveys three recent decisions from the Government Accountability Office that show performance benchmarks may serve as qualitative discriminators, solicitation amendments and timelines must allow for fair competition, and past performance submissions must strictly comply with proposal requests.


AI Regulatory Gaps May Fuel FCA Enforcement Action

The intersection of artificial intelligence and False Claims Act enforcement presents legal risk for government contractors across several industries, particularly in the absence of a federal regulatory framework explicitly governing its development and use, say attorneys at O’Melveny.


Operational AI Washing: The Section 220 Information Strategy

Plaintiffs filing AI washing claims will likely use Section 220 of the Delaware General Corporation Law to obtain internal board records, but 2025 amendments have fundamentally changed the landscape of presuit shareholder document demands in ways that create both risk and opportunity for companies, say attorneys at Akerman.


AI Agents Will Test The Bounds Of Expert Witness Rules

Rule 702 of the Federal Rules of Evidence does not address whether a testifying expert must be human, but as the rule’s amended admissibility framework intersects with the accelerating capabilities of agentic AI, courts may be forced to confront whether AI-generated expertise fits within existing evidentiary doctrine, says Steven Cordero at Akerman.


What New PFAS Rule Means For Tracking And Disclosure

In the wake of the U.S. Environmental Protection Agency's publication of its rule adding PFHxS-Na to the Toxics Release Inventory, companies should identify this substance in their facilities and supply chains, and prepare for disclosures to both regulators and the public, says Ayodeji Ayolola at Gordon Rees.



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From quilting to clowning to raising miniature livestock, attorneys share how their unusual extracurricular activities enhance professional development.




Judges On AI

Do artificial intelligence tools have any practical judicial applications? In this Expert Analysis series, state and federal judges explore potential use cases for AI in adjudication and beyond.




Opinion


5th Circ.'s Abortion Pill Order Is Shaky On Multiple Grounds

The Fifth Circuit's recent order in Louisiana v. U.S. Food and Drug Administration, reinstating an in-person dispensing requirement for the abortion medication mifepristone, seems to turn federalism upside-down, and is also questionable for several other reasons, says Gregory Curtner at Curtner Law.

USPTO Must Address The Right Question In Sanofi Case

The U.S. Patent and Trademark Office Appeals Review Panel's questions in Ex parte Baurin indicate recognition of broader doctrinal issues, but rather than approaching from separate angles, the panel should concentrate on a single fundamental question about obviousness-type double patenting, says Jeremy Lowe at Spencer Fane.



Access to Justice Perspectives


Negotiating Power Imbalance In Pro Bono Client Relationships

The inherent power advantage of an attorney in a client relationship is magnified in pro bono representation, but lawyers can help ease this imbalance by implementing several principles, such as sharing control, identifying resource barriers and more, says Alicia Aiken at PLI.