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.

• 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.

• 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.

• 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.

• 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.