Expert Analysis

• 4 Trends Shaping Drug And Medical Device Law For 2026

  

  2025 saw some significant legal developments with potential impact for drug and device manufacturers, ranging from growing skepticism in science and regulatory entities to new regulation of artificial intelligence, say attorneys at Faegre Drinker.

• Trending At The PTAB: The Journey Of IPR Institution In 2025

  

  Over the course of 2025, inter partes review institution at the Patent Trial and Appeal Board evolved into a more restrictive, policy-driven regime with reshaped discretionary briefing and assessment, and increasing procedural requirements, say attorneys at Finnegan.

• A Meaningful Shift In FDA's Biosimilarity Analysis

  

  The U.S. Food and Drug Administration's potential pivot away from routinely requiring comparative efficacy studies for interchangeable biosimilar applications would not lower regulatory standards, but instead allow applicants to allocate resources toward establishing more probative evidence, says Theodore Thompson at Stinson.

• 4 Developments That Defined The 2025 Ethics Landscape

  

  The legal profession spent 2025 at the edge of its ethical comfort zone as courts, firms and regulators confronted how fast-moving technologies and new business models collide with long-standing professional duties, signaling that the profession is entering a period of sustained disruption that will continue into 2026, says Hilary Gerzhoy at HWG Law.

• Navigating AI In The Legal Industry

  

  As artificial intelligence becomes an increasingly integral part of legal practice, Law360 guest commentary this year examined evolving ethical obligations, how the plaintiffs bar is using AI to level the playing field against corporate defense teams, and the attendant risks of adoption.

• How Fractional GCs Can Manage Risks Of Engagement

  

  As more organizations eliminate their in-house legal departments in favor of outsourcing legal work, fractional general counsel roles offer practitioners an engaging and flexible way to practice at a high level, but they can also present legal, ethical and operational risks that must be proactively managed, say attorneys at Boies Schiller.

• 2025 Legal Milestones That Will Shape Psychedelics Sector

  

  As 2025 draws to a close, psychedelic drug development stands at an inflection point, experiencing unprecedented momentum through recent sweeping regulatory changes and landmark clinical milestones, amid rapidly evolving regulatory expectations, say Odette Hauke at Odette Alina LLC and Kimberly Chew at Husch Blackwell.

• Series

  Nature Photography Makes Me A Better Lawyer

  

  Nature photography reminds me to focus on what is in front of me and to slow down to achieve success, and, in embracing the value of viewing situations through different lenses, offers skills transferable to the practice of law, says Brian Willett at Saul Ewing.

• What Defense Teams Must Know About PFAS Testing Methods

  

  Whether testing for per- and polyfluoroalkyl substances produces results meaningful for litigation depends on the validity of the sampling methodology — so effectively defending these claims requires understanding the scientific and legal implications of different PFAS testing protocols, say attorneys at Hollingsworth.

• Series

  Law School's Missed Lessons: Practical Problem Solving

  

  Issue-spotting skills are well honed in law school, but practicing attorneys must also identify clients’ problems and true goals, and then be able to provide solutions, says Mary Kate Hogan at Quarles & Brady.

• Intellectual Property Challenges In AI-Driven Drug Discovery

  

  Given the adoption of artificial intelligence-based drug discovery platforms and the U.S. Patent and Trademark Office's recent guidance on determining inventorship in AI-assisted inventions, practitioners must consider unprecedented questions regarding inventorship, patentability standards and infringement liability, says Paul Calvo at Sterne Kessler.

• Reel Justice: 'The Mastermind' And Juror Decision-Making

  

  The recent art heist film “The Mastermind” forces viewers to discern the protagonist’s ambiguous motives and reconcile contradictions, offering lessons for attorneys about how a well-crafted trial narrative can tap into the psychological phenomena underlying juror decision-making, says Veronica Finkelstein at Wilmington University.

• Learning From 2025 FCA Trends Targeting PE In Healthcare

  

  False Claims Act enforcement trends and legislative developments from this year signal intensifying state and federal scrutiny of private equity's growing footprint in healthcare, and the urgency of compliance, says Lisa Re at Arnold & Porter.

• Software Patents May Face New Eligibility Scrutiny

  

  November guidance from the U.S. Patent and Trademark Office, along with recent litigation trends from the Federal Circuit, may encourage new challenges in the USPTO and district courts to artificial intelligence and software patents that rely on generic computing functions without concrete details, say attorneys at Venable.

• Opinion

  A Uniform Federal Rule Would Curb Gen AI Missteps In Court

  

  To address the patchwork of courts’ standing orders on generative artificial intelligence, curbing abuses and relieving the burden on judges, the federal judiciary should consider amending its civil procedure rules to require litigants to certify they’ve reviewed legal filings for accuracy, say attorneys at Shook Hardy.