Expert Analysis

• Patent Eligibility Bulletin: Steps To Consider As USPTO Shifts

  

  Recent memoranda from the U.S. Patent and Trademark Office, along with some of the first patents issued under Director John Squires, indicate a recalibration of the subject matter eligibility landscape, signaling a renewed emphasis on concrete technological improvements and a potentially pro-AI stance, say attorneys at Banner Witcoff.

• Tax Court Ruling Signals Cross-Border Loan Scrutiny

  

  The U.S. Tax Court’s recent decision in Aventis v. Commissioner compounds ongoing regulatory focus on debt originations and should prompt practitioners to assess their existing cross-border lending structures for potential exposure to U.S. federal income tax, say attorneys at Eversheds.

• Lessons From Justices' Split On Major Questions Doctrine

  

  The justices' varied opinions in Learning Resources v. Trump, which held the International Emergency Economy Powers Act did not confer the power to impose tariffs, offer a meaningful window into the U.S. Supreme Court's perspective on the major questions doctrine that will likely shape lower courts' approach to executive action challenges, say attorneys at Venable.

• Drug Wholesaler's DPA Shows Imperfect Efforts Still Count

  

  Atlantic Biologicals’ recent deferred prosecution agreement with federal prosecutors for allegedly distributing controlled substances to pill mill pharmacies demonstrates that even subpar cooperation, when combined with genuine remediation and strategic advocacy, can yield outcomes that protect a company's long-term interests, says Jonathan Porter at Husch Blackwell.

• Key Takeaways As HRSA Aims To Revive 340B Rebate Pilot

  

  The U.S. Department of Health and Human Services' recent request for feedback on the 340B Rebate Model Pilot Program demonstrates that it intends to correct the model's procedural defects, which is positive news for participating manufacturers, but a setback for covered entities, say attorneys at Manatt.

• When MDLs Drag, State Courts Can Speed Mass Tort Results

  

  Understanding the structural dynamics that can delay resolution in multidistrict litigation is essential to understanding why a state court strategy is sometimes not merely attractive, but necessary for plaintiffs seeking timely and just outcomes, say attorneys at DiCello Levitt.

• Leveraging MDLs And State Courts In Mass Tort Strategy

  

  Multidistrict litigation's quiet drift from a pretrial coordination device to a de facto national court for mass torts poses a strategic question for plaintiffs counsel — whether an MDL will yield timely trials, meaningful accountability and fair value for clients, or whether a state court strategy will be more effective, say attorneys at DiCello Levitt.

• Unique Issues Facing Brand-Compounder Patent Litigation

  

  Recent litigation and potential enforcement action against Hims & Hers Health raise questions about how compounders and branded pharmaceuticals companies would be positioned in patent litigation as compared to generics companies, which would require strategies different from those that would be used in traditional Hatch-Waxman Act litigation, say attorneys at Morgan Lewis.

• Series

  Volunteering With Scouts Makes Me A Better Lawyer

  

  Serving as an assistant scoutmaster for my son’s troop reaffirmed several skills and principles crucial to lawyering — from the importance of disconnecting to the value of morality, says Michael Warren at McManis Faulkner.

• Series

  Law School's Missed Lessons: In Court, It's About Storytelling

  

  Law school provides doctrine, cases and hypotheticals, but when lawyers step into the courtroom, they must learn the importance of clarity, credibility, memorability and preparation — in other words, how to tell simple, effective stories, say Nicholas Steverson and Danielle Trujillo at Wheeler Trigg, and Lisa DeCaro at Courtroom Performance.

• Pros And Cons Of FDA's Push For Nonprescription Drugs

  

  The U.S. Food and Drug Administration's recent moves to shift more prescription drugs to over-the-counter status could increase access to important medications, but also bring potential safety risks and other trade-offs for drug companies, say attorneys at Hogan Lovells.

• How Recent Del. Rulings Clarify M&A Deal Fraud Carveouts

  

  Two recent Delaware decisions have provided clarity regarding when a party can or cannot rely on representations made during the course of an M&A transaction, particularly on the scope and enforceability of antireliance provisions, and on representations they knew or should have known were false, says Anthony Boccamazzo at Olshan Frome.

• High Court's 'Skinny Label' Case May Tackle Wider Questions

  

  The U.S. Supreme Court's upcoming decision in Hikma v. Amarin will have important ramifications for broader debates over what defines a generic version of a drug, and the pending case is already altering patent practice, say attorneys at Taft.

• Aligning Microsoft Tools With NYC Bar AI Recording Guidance

  

  The New York City Bar Association’s recently issued formal opinion, providing ethical guidance on artificial intelligence-assisted recording, transcription and summarization, raises immediate questions about data governance and e-discovery for companies that use Microsoft 365 and Copilot, say Staci Kaliner, Martin Tully and John Collins at Redgrave.

• 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.