Expert Analysis

• FDA's Biosimilarity Guidance Holds Uncertain Implications

  

  The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar competition, and could affect biosimilar access in unexpected ways, say analysts at Analysis Group.

• 5 Different AI Systems Raise Distinct Privilege Issues

  

  A New York federal court’s recent U.S. v. Heppner decision, holding that a defendant’s use of Claude was not privileged, only addressed one narrow artificial intelligence system, but lawyers must recognize that the spectrum of AI tools raises different confidentiality and privilege questions, says Heidi Nadel at HP.

• Making Effective Use Of DOD's 'Patent Holiday' Program

  

  The U.S. Department of Defense's new defense patent holiday program, designed to let companies experiment with otherwise latent technology without paying typical up-front fees, can help contractors enter new technical domains and markets, but requires careful attention to export controls and patent infringement risks, say attorneys at Sterne Kessler.

• Labubu Shows Value Of Patents When Viral Brands Plateau

  

  The rapid ascent of Labubu dolls demonstrated how character-driven products can scale globally without relying heavily on U.S. patents, but risk profiles change as growth stabilizes, and copyright and trade dress protections may not provide enough protection in the long term, says Tina Dorr at Barnes & Thornburg.

• Opinion

  AI-Assisted Arbitration Needs Safeguards To Ensure Fairness

  

  As tribunals and arbitral institutions increasingly use artificial intelligence tools in their decision-making processes, ​​​​​​​clear disclosure standards and procedural safeguards are necessary to ensure that efficiency gains do not erode the fairness principles on which arbitration depends, says Alexander Lima at Wesco International.

• What Recent Dataset Suits Signal For AI Training Litigation

  

  Plaintiffs are moving away from abstract debates about artificial intelligence at large and toward dataset provenance, and three filings illustrate how provenance is pled using public dataset documentation, archives and discovery‑ready allegations about copying, retention and downstream handling, says Yulia Leshchenko at Name & Fame.

• Series

  Playing Piano Makes Me A Better Lawyer

  

  Playing piano and practicing law share many parallels relating to managing complexity: Just as hearing an entire musical passage in my head allows me to reliably deliver the message, thinking about the audience's impression helps me create a legal narrative that keeps the reader engaged, says Michael Shepherd at Fish & Richardson.

• AI Trade Secret Conviction Highlights Espionage Risks

  

  A California federal court's conviction last month of an ex-Google engineer who stole artificial intelligence trade secrets for the benefit of China is the latest in a series of foreign economic espionage cases and illustrates the urgent need for U.S. companies to implement robust security measures, says attorney Peter Toren.

• How To Counter 7 Logical Fallacies In Legal Arguments

  

  Many legal arguments are riddled with reasoning flaws that can effectively distract or persuade the fact-finder, but these tactics lose much of their power when attorneys recognize and strategically shine a light on them, says Allison Rocker at Baker McKenzie.

• AI-Generated Doc Ruling Guides Attys On Privilege Risks

  

  A New York federal court's ruling, in U.S. v. Heppner, that documents created by a defendant using an artificial intelligence tool were not privileged, can serve as a guide to attorneys for retaining attorney-client or work-product privilege over client documents created with AI, say attorneys at Sher Tremonte.

• How To Turn EU AI Act Disclosures Into Patent Assets

  

  As the Aug. 2 deadline approaches to comply with provisions of the EU Artificial Intelligence Act governing high-risk AI systems, intellectual property and AI leaders should consider steps to leverage documentation requirements to surface patentable subject matter, reinforce inventive-step narratives and align regulatory timelines with patent filing strategy, say Lestin Kenton, Roozbeh Gorgin and Ananth Josyula at Sterne Kessler.

• The Law Firm Merger Diaries: Leadership Strategy After Day 1

  

  For law firm leaders, ensuring a newly combined law firm lives up to its promise, both in its first days of operation and well after, includes tough decisions, clear and specific communication, and cheerleading, says Peter Michaud at Ballard Spahr.

• Fed. Circ. In Jan.: On The Validity Of Expert Testimony

  

  The Federal Circuit's recent decision in Barry v. DePuy, addressing whether expert testimony is admissible even if it does not strictly adhere to the court's claim construction, suggests that exclusion via a Daubert motion is appropriate only when the line to improper testimony is clearly crossed, say attorneys at Knobbe Martens.

• Reel Justice: 'Sentimental Value' And Witness Anxiety

  

  "Sentimental Value" reminds us that anxiety can interfere with performance, but unlike actors, witnesses cannot rehearse their lines or control the script, so a lawyer's role is not to eliminate stress, but to create conditions where the accuracy of a witness's testimony survives under pressure, says Veronica Finkelstein at Wilmington University.

• Calif.'s Civility Push Shows Why Professionalism Is Vital

  

  The California Bar’s campaign against discourteous behavior by attorneys, including a newly required annual civility oath, reflects a growing concern among states that professionalism in law needs shoring up — and recognizes that maintaining composure even when stressed is key to both succeeding professionally and maintaining faith in the legal system, says Lucy Wang at Hinshaw.