Expert Analysis

• New Orphan Drug Law Provides A Key Fix For Pharma Cos.

  

  The Consolidated Appropriations Act enacted last month restores the U.S. Food and Drug Administration's long-standing interpretation of "same disease or condition," related to orphan drug exclusivity, resolving years of regulatory uncertainty and litigation that have discouraged rare disease research, say attorneys at Spencer Fane.

• When Trade Secret Litigation And Criminal Law Collide

  

  An increasing convergence of trade secret litigation and white collar defense, especially with several recent criminal prosecutions from the Justice Department, should prompt businesses and counsel to adapt within the overlapping landscapes, says Kenneth Notter at MoloLamken.

• Opinion

  PTAB Needs Reform To Protect Inventors From Larger Cos.

  

  The Promoting and Respecting Economically Vital American Innovation Leadership Act is necessary because it will impose additional requirements on patent validity challenges and prevent large corporations from taking advantage of the Patent Trial and Appeal Board to overwhelm small inventors with repeated litigation, says Eb Bright at ExploraMed Development.

• Changes Coming To The SBIR And STTR Programs

  

  Legislation recently approved by Congress to reauthorize the Small Business Innovation Research and Small Business Technology Transfer Programs includes changes focused on national security that would improve transparency but also increase applicants' administrative burdens, slow the awards process and likely increase litigation, say attorneys at Fluet & Associates.

• Witness AI Usage Is The Next Privilege Battle In Civil Litigation

  

  Fact and expert witnesses now have immediate access to artificial intelligence systems capable of simulating deposition questioning, recommending answers and more, but this preparation occurs privately, invisibly and frequently under the mistaken assumption that it is harmless, says Bill Kanasky at Courtroom Sciences and Billy Davis at Taylor Nelson.

• Moderna Case Highlights Overlooked Hurdle In Biopharma IP

  

  The recent settlement of the patent litigation involving Moderna's COVID-19 vaccine in Delaware federal court shows that patent portfolios covering enabling platform technologies can create significant freedom-to-operate risk even when their owners are not direct competitors developing the therapeutic product, says Olga Berson at Thompson Coburn.

• How 2 Decisions Reframed Witness-Centered Trials

  

  The recent Maryland federal jury verdict in U.S. v. Goldstein and the U.S. Supreme Court decision in Villarreal v. Texas suggest that the traditional paradigm of American civil trial practice, with its emphasis on witness performance and assertive advocacy, may not reflect the ideal approach for the modern courtroom, says Joshua Robbins at Crowell & Moring.

• Why The Road To Final Four Runs Through The Courthouse

  

  As universities navigate a new college sports landscape in which courts decide eligibility, injunctions shape rosters and contract precision determines competitive stability, they should professionalize their NIL contracting, plan for emergency relief, and prepare for eligibility and damages disputes, say attorneys at Seyfarth.

• 5 Tips For Navigating Your Firm's All-Attorney Summit

  Excerpt from Practical Guidance

  

  Law firm retreats should be approached strategically, as they present valuable opportunities to advance both the firm's objectives and attorneys' professional development through meaningful participation, building and strengthening internal relationships, and proactive follow-up, says James Argionis at Cozen O’Connor.

• Series

  Coaching Soccer Makes Me A Better Lawyer

  

  Coaching youth soccer for my 7-year-old son's team has sharpened how I communicate with clients, prepare witnesses, work within teams and think about leadership, making me a more thoughtful and effective lawyer in many ways, says Joshua Holt at Smith Currie.

• Winter Olympics Put The Spotlight On IP Issues

  

  This year's Winter Olympics generated a handful of intellectual property controversies that highlight the key considerations that should be kept in mind when using creative works at sporting events, says attorneys at Squire Patton.

• Series

  Law School's Missed Lessons: The Human Element

  

  Law school teaches you to quickly apply intellect and logic when handling a legal issue, but every fact pattern also involves a person, making the ability to balance expertise with empathy critical to the growth of relationships with clients, colleagues and adversaries, says Rachel Adcox at Adcox Strategies.

• Avoid The Unexpected When Drafting License Agreements

  

  The Delaware Court of Chancery's recent decision in Commave v. Zevrain raises several practice points for attorneys drafting commercial contracts, underscoring the importance of considering anti-assignment provisions, specific exclusions and potential carveouts when drafting license agreements or other commercial contracts, say attorneys at Hogan Lovells.

• A Reliable Liability Shield For Government-Sponsored R&D

  

  The Federal Circuit's decision in Arlton v. AeroVironment last month confirms that the Section 1498 liability-shifting framework applies well beyond production contracts, providing powerful assurance that contractors performing government-directed work are shielded from patent infringement liability, say attorneys at Morgan Lewis.

• The Benefits Of Choosing A Niche Practice In The AI Age

  

  As artificial intelligence becomes increasingly accessible, lawyers with a niche practice may stand out as clients seek specialized judgment that automation cannot replicate, but it is important to choose a niche that is durable, engaging and a good personal fit, says Daniel Borneman at Lowenstein Sandler.