Expert Analysis

• Patent Applicants Must Get Biologics Enablement Right

  

  As artificial intelligence increasingly becomes a core driver in drug discovery, it is critical for drug companies to adapt their drafting strategies to the unique features of AI-generated inventions, and to pay particularly close attention to enablement standards, says Sanandan Malhotra at Novo Nordisk.

• Series

  Law School's Missed Lessons: How To Start A Law Firm

  

  Launching and sustaining a law firm requires skills most law schools don't teach, but every lawyer should understand a few core principles that can make the leap calculated rather than reckless, says Sam Katz at Athlaw.

• Fed. Circ. Patent Decisions In 2025: An Empirical Review

  

  In 2025, the Federal Circuit's increased output was not enough to keep up with its ever-growing patent case load, and patent owners and applicants fared poorly overall as the court's affirmance rate fell, says Dan Bagatell at Perkins Coie.

• Regulatory Uncertainty Ahead For Organ Transplant System

  

  Pending court cases against a Centers for Medicare and Medicaid Services final rule that introduced a competition-centric model for assessing organ procurement organizations' performance will significantly influence the path forward for such organizations and transplant hospitals, say attorneys at Crowell & Moring.

• Key False Claims Act Trends From The Last Year

  

  The False Claims Act remains a powerful enforcement tool after some record verdicts and settlements in 2025, and while traditional fraud areas remain a priority, new initiatives are raising questions about its expanding application, says Veronica Nannis at Joseph Greenwald.

• Opinion

  It's Too Soon To Remove Suicide Warnings From GLP-1 Drugs

  

  The U.S. Food and Drug Administration's decision this month to order removal of warnings about the risk of suicidal thoughts from GLP-1 weight-loss drugs is premature — and from a safety and legal standpoint, the downside of acting too soon could be profound, says Sean Domnick at Rafferty Domnick.

• Series

  Hosting Exchange Students Makes Me A Better Lawyer

  

  Opening my home to foreign exchange students makes me a better lawyer not just because prioritizing visiting high schoolers forces me to hone my organization and time management skills but also because sharing the study-abroad experience with newcomers and locals reconnects me to my community, says Alison Lippa at Nicolaides Fink.

• FDA's 2025 Enforcement Scorecard Highlights Data Focus

  

  The U.S. Food and Drug Administration's increased enforcement activity in 2025 was driven by artificial intelligence and a focus on foreign manufacturers, necessitating proactive compliance strategies for an environment that is increasingly reliant on data, say attorneys at Reed Smith.

• How A 1947 Tugboat Ruling May Shape Work Product In AI Era

  

  Rapid advances in generative artificial intelligence test work-product principles first articulated in the U.S. Supreme Court’s nearly 80-year-old Hickman v. Taylor decision, as courts and ethics bodies confront whether disclosure of attorneys’ AI prompts and outputs would reveal their thought processes, say Larry Silver and Sasha Burton at Langsam Stevens.

• Navigating Privilege Law Patchwork In Dual-Purpose Comms

  

  Three years after the U.S. Supreme Court declined to resolve a circuit split in In re: Grand Jury, federal courts remain split as to when attorney-client privilege applies to dual-purpose legal and business communications, and understanding the fragmented landscape is essential for managing risks, say attorneys at Covington.

• How AI Drafting Should Transform Patent Filing Strategies

  

  As agentic artificial intelligence reduces the time and expense required to draft and file patents, companies should shift focus away from rationing drafting hours and more toward governing optionality, says Ian Schick at Paximal.

• 5 Advertising Law Trends That Will Shape 2026

  

  The legal landscape for advertisers will grow only more complex this year, with ongoing trends including a federal regulatory retreat, more aggressive action by the states, a focus on child privacy and expanded scrutiny of "natural" claims, say attorneys at Reed Smith.

• Cannabis Industry Faces An Inflection Point This Year

  

  Cannabis industry developments last year — from the passage of a new wholesale tax in Michigan, to an executive order accelerating the federal rescheduling process — presage a more mature phase of legalization this year, with hardening expectations and enforcement to come, says Alex Leonowicz at Howard & Howard.

• Series

  Fly-Fishing Makes Me A Better Lawyer

  

  Much like skilled attorneys, the best anglers prize preparation, presentation and patience while respecting their adversaries — both human and trout, says Rob Braverman at Braverman Greenspun.

• 4 Ways GCs Can Manage Growing Service Of Process Volume

  

  As automation and arbitration increase the volume of legal filings, in-house counsel must build scalable service of process systems that strengthen corporate governance and manage risk in real time, says Paul Mathews at Corporation Service Co.