Expert Analysis

• Fed. Circ. In November: Looking For Patent 'Blaze Marks'

  

  The Federal Circuit's recent decision in Duke v. Sandoz serves as a warning that when patentees craft claims, they must provide adequate "blaze marks" that direct a skilled artisan to the specific claimed invention, and not just the individual claimed elements in isolation, say attorneys at Knobbe Martens.

• 2025's Most Notable State AG Activity By The Numbers

  

  State attorneys general were active in 2025, working across party lines to address federal regulatory gaps in artificial intelligence, take action on consumer protection issues, continue antitrust enforcement and announce large settlements on behalf of their citizens, say attorneys at Jenner & Block.

• Opinion

  The Case For Emulating, Not Dividing, The Ninth Circuit

  

  Champions for improved judicial administration should reject the unfounded criticisms driving recent Senate proposals to divide the Ninth Circuit and instead seek to replicate the court's unique strengths and successes, says Ninth Circuit Judge J. Clifford Wallace.

• How Rule 16.1 Streamlines And Validates Mass Tort Litigation

  

  The new Rule 16.1 of the Federal Rules of Civil Procedure not only serves a practical purpose by endorsing early, structured case management and dispositive motion practice in multidistrict litigation, but also explicitly affirms the importance of MDL practice in the justice system, says Rocco Strangio at Milestone.

• How 11th Circ.'s Zafirov Decision Could Upend Qui Tam Cases

  

  Oral argument before the Eleventh Circuit last month in U.S. ex rel. Zafirov v. Florida Medical Associates suggests that the court may affirm a lower court's opinion that the qui tam provisions of the False Claims Act are unconstitutional — which could wreak havoc on pending and future qui tam cases, say attorneys at Morgan Lewis.

• Key Trends For Life Sciences Cos. To Watch In 2026

  

  Following a year of drastic change at the U.S. Food and Drug Administration, two themes are likely to drive the coming year — a commitment to lowering the cost of drugs and an inherent tension between the priorities of the health agencies and the broader administration, say attorneys at Sheppard Mullin.

• Series

  Muay Thai Makes Me A Better Lawyer

  

  Muay Thai kickboxing has taught me that in order to win, one must stick to one's game plan and adapt under pressure, just as when facing challenges by opposing counsel or judges, says Mark Schork at Feldman Shepherd.

• The Next Pressure Point In Digital Health: Informed Consent

  

  Two new federal digital health initiatives will usher in a new era where virtual care, software-enabled devices and home-based monitoring are integrated into care and reimbursement models, with the impact of shifting rules and opportunities felt most immediately in the context of informed consent, says Kimberly Chew at Husch Blackwell.

• Series

  Law School's Missed Lessons: Intentional Career-Building

  

  A successful legal career is built through intention: understanding expectations, assessing strengths honestly and proactively seeking opportunities to grow and cultivating relationships that support your development, say Erika Drous and Hillary Mann at Morrison Foerster.

• Trending At The PTAB: The Policies That Are Redefining IPR

  

  The evolution of the Patent Trial and Appeal Board's inter partes review institution regime last year, coupled with the policy considerations behind that evolution, marks a shift toward greater gatekeeping of the U.S. Patent and Trademark Office's resources and patent enforcement rights, say attorneys at Finnegan.

• 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.