Expert Analysis

• How Orange Book Antitrust Scrutiny Is Intensifying

  

  Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.

• What To Know As Children's Privacy Law Rapidly Evolves

  

  If your business hasn't been paying attention to growing state and federal efforts to protect children online, now is the time to start — there is no sign of this regulation slowing down, and more aggressive enforcement actions are to be expected in the coming year, says Susan Rohol at Willkie Farr.

• Opinion

  OFAC Sanctions Deserve To Be Challenged Post-Chevron

  

  The U.S. Supreme Court's Loper Bright decision opens the door to challenges against the Office of Foreign Assets Control's sanctions regime, the unintended consequences of which raise serious questions about the wisdom of what appears to be a scorched-earth approach, says Solomon Shinerock at Lewis Baach.

• Behind The Delay Of Final HSR Premerger Filing Rules

  

  Erin Toomey at Epiq discusses the wait for the final version of the revised Hart-Scott-Rodino premerger filing requirements that were first introduced in June 2023, the factors that might be behind the delay, and how to plan for the potential data-focused rule change

• What Cos. Should Know About New Global Plastics Regs

  

  As the global regulatory landscape for plastics and recycling changes rapidly — with new policies coming into effect in California, at the federal level, in the European Union and at the United Nations — businesses that operate across jurisdictions must stay informed to remain compliant, mitigate legal risk and achieve stewardship goals, say attorneys at O'Melveny.

• How Calif. Ruling Alters Worker Arb. Agreement Enforcement

  

  The California Supreme Court’s recent ruling in Ramirez v. Charter Communications should caution employers that while workers’ arbitration agreements will no longer be deemed unenforceable based on their number of unconscionable provisions, they must still be fair and balanced, says Sander van der Heide at CDF Labor.

• Opinion

  After Jarkesy, IRS Must Course-Correct On Captive Insurance

  

  The U.S. Supreme Court’s recent Securities and Exchange Commission v. Jarkesy decision has profound implications for other agencies, including the IRS, which must stop ignoring due process and curtailing congressional intent in its policing of captive insurance arrangements, says Peter Dawson at the 831(b) Institute.

• Congress Quietly Amends FEPA: What Cos. Should Do Now

  

  Last week, Congress revised the Foreign Extortion Prevention Act — passed last year to criminalize demand-side foreign bribery — to address inconsistencies and better harmonize the law with the Foreign Corrupt Practices Act, and companies should review their compliance programs accordingly, say Mark Mendelsohn and Benjamin Klein at Paul Weiss.

• Why FDIC Banks May Want To Consider Fed Membership

  

  With the Federal Deposit Insurance Corp. recently ratcheting up bank supervision and proposing idiosyncratic new policies, state-chartered nonmember banks may want to explore the benefits of becoming Federal Reserve members and consider practical steps to make the switch, say Max Bonici and Connor Webb at Venable.

• Dissecting Treasury's Call For Input On AI In Financial Sector

  

  The U.S. Department of the Treasury's request for comments on the potential benefits and challenges AI may pose to the financial services sector, which asks how stakeholders are addressing and mitigating increased fraud risks, reflects the federal government's continued interest in AI's effects across the economy, say attorneys at Hogan Lovells.

• The Rise Of State And Local Environmental Leadership

  

  While Congress is deadlocked, and a U.S. Supreme Court with a hostility toward the administrative state aggressively dismantles federal environmental oversight, state and local governments are stepping up with policies to shape a more sustainable future for all species, says Jonathan Rosenbloom at Albany Law School.

• Opinion

  The FTC Needs To Challenge The Novo-Catalent Deal

  

  Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.

• Series

  After Chevron: Slowing Down AI In Medical Research

  

  The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

• Opinion

  Conception Is The Proper Test For AI-Assisted Inventions

  

  The U.S. Patent and Trademark Office should adopt the conception standard for reviewing AI-assisted inventions, and require the disclosure of artificial intelligence prompts and responses because they are material to patentability, which would then simplify the patent examiner’s invention decision, says Thomas Hamlin at Robins Kaplan.

• A Closer Look At New SDNY And EDNY Local Rules

  

  New local rules in the U.S. District Courts for the Southern and Eastern Districts of New York went into effect earlier this month, and include both stylistic changes to make legal writing more accessible, and substantive changes to make processes and filings more efficient, say Andrew Van Houter and Jennifer Montan at Faegre Drinker.