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Expert Analysis

• 5 Open Questions About FDA's AI-Assisted Review Plans

  

  The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.

• Prospects And Challenges For Expert Evidence At The UPC

  

  Expert testimony on economic or damages-related issues will likely play a larger part in Unified Patent Court proceedings in the near future, potentially presenting unique challenges for experts, counsel and judges alike, say analysts at Charles River.

• Attacks On Judicial Independence Tend To Manifest In 3 Ways

  

  Attacks on judicial independence now run the gamut from gross (bald-faced interference) to systemic (structural changes) to insidious (efforts to undermine public trust), so lawyers, judges and the public must recognize the fateful moment in which we live and defend the rule of law every day, says Jim Moliterno at Washington and Lee University.

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  Law School's Missed Lessons: Appreciating Civil Procedure

  

  If you’re like me, law school’s often complex and theoretical approach to teaching civil procedure may have contributed to an early struggle with the topic, but when seen from a practical perspective, new lawyers may find they enjoy mastering these rules, says Chloe Villagomez at Foster Garvey.

• Calif. Bar Exam Fiasco Shows Why Attys Must Disclose AI Use

  

  The recent revelation that a handful of questions from the controversial California bar exam administered in February were drafted using generative artificial intelligence demonstrates the continued importance of disclosure for attorneys who use AI tools, say attorneys at Troutman.

• In 2nd Place, Va. 'Rocket Docket' Remains Old Reliable

  

  The U.S. District Court for the Eastern District of Virginia was again one of the fastest civil trial courts in the nation last year, and an interview with the court’s newest judge provides insights into why it continues to soar, says Robert Tata at Hunton.

• Parsing A Lack Of Antitrust Info-Sharing Enforcement Clarity

  

  Information sharing among competing firms has recently faced dramatic changes in antitrust agency guidance, while courts grapple with the permissible scope of pricing algorithms, leaving companies in limbo, but potential Trump administration changes could offer some reprieve, say attorneys at Axinn.

• What FCA Liability Looks Like In The Cybersecurity Realm

  

  ​Two recent settlements highlight how whistleblowers and the U.S. Department of Justice have been utilizing the False Claims Act to allege fraud predicated on violations of cybersecurity standards — timely lessons given new bipartisan legislation introducing potential FCA liability for artificial intelligence use, say​ attorneys Rachel Rose and Julie Bracker.

• Foreign Sovereign Entities Should Heed 9th Circ. IP Ruling

  

  After the Ninth Circuit recently held that four Chinese state-controlled companies were not immune from criminal indictment for alleged economic espionage, foreign sovereign-controlled entities should assess whether their operations and affiliation with their parent states qualify for sovereign immunity under the common law, say attorneys at Cleary.

• How Attorneys Can Become Change Agents For Racial Equity

  

  As the administration targets diversity, equity and inclusion efforts and law firms consider pulling back from their programs, lawyers who care about racial equity and justice can employ four strategies to create microspaces of justice, which can then be parlayed into drivers of transformational change, says Susan Sturm at Columbia Law School.

• CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits

  

  Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.

• Strategies For Litigating In The Unified Patent Court

  

  Since opening its gates two years ago, the European Unified Patent Court has transformed the patent litigation landscape and global litigation strategies, but parties seeking to take advantage of the court's robust processes must be prepared for the front-loaded character of UPC proceedings, say attorneys at McDermott.

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  Running Marathons Makes Me A Better Lawyer

  

  After almost five years of running marathons, I’ve learned that both the race itself and the training process sharpen skills that directly translate to the practice of law, including discipline, dedication, endurance, problem-solving and mental toughness, says Lauren Meadows at Swift Currie.

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  Law School's Missed Lessons: Supporting A Trial Team

  

  While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.

• Compliance Essentials To Mitigate AI Crime Enforcement Risk

  

  As artificial intelligence systems move closer to accurately mimicking human decision-making, companies must understand how the U.S. Department of Justice might prosecute them for crimes committed by AI tools — and how to mitigate enforcement risks, say attorneys at Paul Hastings.