Expert Analysis

• Upshot Of 'Skinny Label' Case May Go Beyond Pharma

  

  The U.S. Supreme Court's pending review of Hikma v. Amarin, over a drugmaker's "skinny label," carries implications for both generics and brand-name pharmaceutical manufacturers, and could shed light on how inducement doctrine should operate in other regulated industries where products have substantial lawful uses, says Jason Shull at Banner Witcoff.

• Assessing Factors Behind Biosimilar Uptake And Competition

  

  As biosimilar uptake remains uneven and questions linger over whether the Biologics Price Competition and Innovation Act can deliver robust competition between biologics and biosimilars, a case study of Humira and its biosimilars illustrates how many factors, including payor reimbursement and formulary strategy, collectively shape competitive dynamics, say analysts at Analysis Group.

• Traditional FCA Enforcement Surges Amid Shifting Priorities

  

  The U.S. Department of Justice’s January report on False Claims Act enforcement in fiscal year 2025 reveals that while the administration signaled its intent to expand FCA enforcement into new areas such as tariffs, for now the greatest exposure remains in traditional areas like healthcare — in which the risk is growing, say attorneys at Debevoise.

• NYC Bar Opinion Warns Attys On Use Of AI Recording Tools

  

  Attorneys who use artificial intelligence tools to record, transcribe and summarize conversations with clients should heed the New York City Bar Association’s recent opinion addressing the legal and ethical risks posed by such tools, and follow several best practices to avoid violating the Rules of Professional Conduct, say attorneys at Smith Gambrell.

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  The Biz Court Digest: Dispatches From Utah's Newest Court

  

  While a robust body of law hasn't yet developed since the Utah Business and Chancery Court's founding in October 2024, the number of cases filed there has recently picked up, and its existence illustrates Utah's desire to be top of mind for businesses across the country, says Evan Strassberg at Michael Best.

• Checking In On Biologics-Related Patent Review Trends

  

  Comprehensive analysis of Patent Trial and Appeal Board data since the PTAB's creation indicates that while inter partes review and post-grant review are potent weapons for challenging biologics-related patents, recent policy changes may reduce their effectiveness, say attorneys at Steptoe.

• 4 Quick Emotional Resets For Lawyers With Conflict Fatigue

  

  Though the emotional wear and tear of legal work can trap attorneys in conflict fatigue — leaving them unable to shake off tense interactions or return to a calm baseline — simple therapeutic techniques for resetting the nervous system can help break the cycle, says Chantel Cohen at CWC Coaching & Therapy.

• Rescheduling Cannabis Marks New Tax Era For Operators

  

  As the attorney general takes steps to move cannabis from Schedule I to Schedule III of the Controlled Substances Act, operators and advisers should prepare by considering the significant changes this will bring from tax, state, industry and market perspectives, says Michael Harlow at CohnReznick.

• Navigating Trade Secret Exceptions In Noncompete Bans

  

  Recent and ongoing developments in the noncompete landscape, including a potential decision from the Tenth Circuit in Edwards Lifesciences v. Thompson, could offer tools for employers to bring noncompete agreements within trade secret exceptions amid an era of heightened employee mobility, say attorneys at Sullivan & Cromwell.

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  Playing Tennis Makes Me A Better Lawyer

  

  An instinct to turn pain into purpose meant frequent trips to the tennis court, where learning to move ahead one point at a time was a lesson that also applied to the steep learning curve of patent prosecution law, says Daniel Henry at Marshall Gerstein.

• Expect Major Shifts In Patent And Trademark Policy This Year

  

  New leadership and initiatives promise to bring consequential changes to the U.S. Patent and Trademark Office's practices in 2026, likely favoring patent allowance and issuance, as well as streamlining trademark processes, say attorneys at Knobbe Martens.

• Class Actions At The Circuit Courts: January Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses five rulings from October and November, and identifies practice tips from cases involving consumer fraud, oil and gas leases, toxic torts, and wage and hour issues.

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  Judges On AI: How Judicial Use Informs Guardrails

  

  U.S. Magistrate Judge Maritza Dominguez Braswell at the U.S. District Court for the District of Colorado discusses why having a sense of how generative AI tools behave, where they add value, where they introduce risk and how they are reshaping the practice of law is key for today's judges.

• What US Cos. Must Know To Comply With Italy's AI Law

  

  Italy's newly effective artificial intelligence law means U.S. companies operating in Italy or serving Italian customers must now meet EU AI Act obligations as well as Italy-specific requirements, including immediately enforceable criminal penalties, designated national authorities and sector-specific mandates, say attorneys at Portolano Cavallo.

• Ag Bill Wording Presents Existential Threat To Hemp Industry

  

  A proposal in the agriculture appropriations bill for fiscal year 2026, which excludes almost everything synthesized from cannabis from the legal definition of “hemp,” would have catastrophic consequences for thousands of farmers, medical researchers and businesses by banning everything from intoxicating delta-9 THC products to topical CBD creams, says Alissa "Ali" Jubelirer at Benesch.