Expert Analysis

• How Cos. Should Prepare For Democratic Oversight

  

  Companies should begin preparing now for a new, Democratic-majority Congress — understanding how the oversight landscape has changed in recent years and monitoring leadership elections, new rules and potential select committees, say attorneys at Wiley.

• How Analytical Advances Reshape Biologic Patent Strategy

  

  As regulators shift away from relying on comparative clinical efficacy studies in biosimilar development, and more toward analytical data, practitioners should pay closer attention to post-translational modifications when evaluating patentability, says Gina Nellesen at Global Patent Group.

• Opinion

  Justices Must Protect Enforcement In DOL Fine Power Case

  

  In deciding whether the U.S. Department of Labor’s in-house court has the power to decide monetary penalties arising from H-2A violations, the U.S. Supreme Court must preserve a practical route to relief for workers and a constitutional forum for employers to contest liability, say Michelle Dromgold-Sermen, Jessica Vasquez-Luna and Julissa Barrera at George Mason University.

• Series

  Open-Water Swimming Makes Me A Better Lawyer

  

  Swimming long distances in open waters is not necessarily an escape from my intellectual property practice, but a complementary discipline that similarly rewards sustained attention, intellectual curiosity, resilience and the ability to pursue a distant objective without losing command of the immediate task, says Christina MacDougall at Morgan Lewis.

• 3 Factors That Can Make Or Break A Subchapter V Case

  

  The Bankruptcy Threshold Adjustment Act may soon increase the debt limit for Subchapter V bankruptcy, making the process available to more business, but their success within it depends on the debtors' efficiency, credibility and accurate financial assessments, say Michael Martinez at Grier Wright and Mary Grasta at Stretto.

• Conflicting Rulings Cloud NCAA Eligibility Rule

  

  The NCAA's adoption of the five-to-five eligibility rule has resulted in a genuinely fractured landscape, with the qualification for members of the class of 2022 essentially dependent upon the location of the athlete and the institution rather than on the underlying facts of the case, says Andrew Hope at Buchanan Ingersoll.

• What To Expect From Calif.'s Incoming Health AI Laws

  

  California's new statewide ground rules for artificial intelligence in clinical care, set to take effect on Jan. 1, reveal the Legislature's choice to regulate healthcare AI primarily though institutions, rather than direct product regulation, and providers should shape their compliance plans accordingly, say attorneys at Reed Smith.

• Opinion

  The Invisible AI Danger That May Undermine Legal Profession

  

  A public database tracking cases involving hallucinations generated by artificial intelligence recently surpassed 2,200 entries, but the bigger risk underlying attorneys’ use of such tools is that they will slowly surrender their judgment to AI and lose analytical skills, says Massachusetts District Court Associate Justice Brian Palmucci.

• SEC's 'Innovation Exemption' Isn't A Substitute For Legislation

  

  The U.S. Securities and Exchange Commission's recently announced innovation exemption, allowing trading in certain tokenized securities on permissioned on-chain trading platforms, is a temporary and conditional solution for a specific market model, not a general exemption for on-chain securities trading, says Niels Lemmers at Flow Traders.

• Consistency Is Key In Pipeline Incident Investigations

  

  A pipeline release that causes worker injury does not trigger one investigation, but five or more, running on different timetables, under different statutes, and new federal procedures may soon add more complexity — but companies must maintain one centralized record to ensure consistency throughout, say attorneys at Squire Patton.

• How Cos. Using AI Agents Can Avoid Protected Data Incidents

  

  For businesses whose deployed artificial intelligence agents could enter other companies' systems and steal protected data, deployers can take several steps before an incident to test the configured agent, such as limiting it to approved systems and destinations and requiring human escalation when tasks stall, says Steven Carlson at von Briesen & Roper.

• FDA Classification Setback Bodes Well For Wound Care Cos.

  

  A Georgia federal court's recent decision in MiMedx v. U.S. Food and Drug Administration constrains the FDA's analytical framework for classifying certain wound care products as biological products, carrying important ramifications for manufacturers seeking to avoid heightened regulatory requirements, say attorneys at Hyman Phelps.

• Logistics Update: Handling Iran War Supply Chain Limitations

  

  The war in Iran is straining global logistics by introducing practical, commercial, legal and claims limitations for both operators and customers — so all supply chain participants must understand the resulting legal issues, and how to respond to them, says Jonathan Todd at Benesch.

• 9th Circ. Waters Ruling Shows Sackett's Ripple Effects

  

  The Ninth Circuit's recent decision in Inland Empire Waterkeeper v. Corona Clay demonstrates that the U.S. Supreme Court's "waters of the U.S." ruling in Sackett v. U.S. Environmental Protection Agency can reopen cases already tried to verdict, thus changing expectations around citizen suits and stormwater enforcement in California, says Jacob Lubarsky at Rogers Joseph.

• FTC Highlights Path To Preserve Board Rights In A Rival Co.

  

  The Federal Trade Commission's move to add key guardrails permitting firearms manufacturer Beretta to retain two directors as it takes a 25% stake in competitor Ruger illustrates how parties may maintain board rights in certain circumstances without running afoul of Section 8 of the Clayton Act, say attorneys at Davis Polk.