Expert Analysis

• FDA User Fee Talks Offer Clues On Upcoming Reforms

  

  As the U.S. Food and Drug Administration undergoes the User Fee Act reauthorization process and renegotiates its user fee agreements over the next several months, the agency's consultation meetings with relevant industries can shed light on the FDA's priorities, and provides stakeholders an opportunity to participate in the reform process, say attorneys at Holland & Knight.

• 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.

• FDA Framework For Personalized Therapies Raises Questions

  

  The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies reflects the agency's focus on rare-disease drugs, but numerous significant, unresolved issues cast uncertainty on how effective the framework will be in practice, say attorneys at Ropes & Gray.

• Emissions Permits May Not Override Pollution Exclusions

  

  Two recent coverage rulings from the Illinois Supreme Court and the Third Circuit suggest a trend among appellate courts to deny coverage under pollution exclusions, even when the emissions happened pursuant to a government permit, say attorneys at Simpson Thacher.

• 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.

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  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.

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  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.

• CMS Healthcare Enforcement Initiatives May Cause Disruption

  

  The Centers for Medicare & Medicaid Services' recently announced enforcement actions against healthcare fraud mark a significant escalation, and CMS' prior approach in the hospice sector suggests that even compliant providers and suppliers should brace for impact, 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.

• How PBMs Can Adapt To Plan Sponsors' Disclosure Demands

  

  As federal reforms, growing state regulation and litigation threats push plan sponsors to expect visibility into revenue streams, pharmacy benefit managers should leverage transparency strategically, including by simplifying how they get paid, offering clients audit-ready data and co-designing contracts that are easy for fiduciaries to explain and defend, says Kristie Blase at Frazer + Blase.

• What New Animal Welfare Enforcement Push Means For Cos.

  

  The Trump administration's recently announced multiagency focus on violations of the Animal Welfare Act and related laws will likely lead to broader enforcement actions across industries, heightened scrutiny of compliance standards and a need for businesses to adopt effective risk management practices, says Shennie Patel at Crowell & Moring.

• How To Engage With Gov't's Direct-To-Consumer Drug Policy

  

  The U.S. Department of Health and Human Services' recent request for industry input on manufacturers' direct-to-consumer drug sales reflects the government's caution in this arena, and allows stakeholders a rare opportunity to help shape policy, says Mary Kohler at Kohler Health Law.

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  Podcasting Makes Me A Better Lawyer

  

  Podcasting has changed how I ask questions and connect with people, sharpening my ability to listen without interrupting or prejudging, and bringing me closer to what law is meant to be: a human profession grounded in understanding, judgment and trust, says Donna DiMaggio Berger at Becker.

• 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.