Expert Analysis

• Analyzing FDA Draft Guidance On Clinical Trial Diversity

  

  In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.

• What's New In The AI Healthcare Regulatory Space

  

  Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.

• Takeaways From EU's Initial Findings On Apple's App Store

  

  A deep dive into the European Commission's recent preliminary findings that Apple's App Store rules are in breach of the Digital Markets Act reveal that enforcement of the EU's Big Tech law might go beyond the literal text of the regulation and more toward the spirit of compliance, say William Dolan and Pratik Agarwal at Rule Garza.

• Class Actions At The Circuit Courts: July Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers cases touching on pre- and post-conviction detainment conditions, communications with class representatives, when the American Pipe tolling doctrine stops applying to modified classes, and more.

• 7th Circ. Motorola Ruling Raises Stakes Of DTSA Litigation

  

  The Seventh Circuit’s recent ruling in Motorola v. Hytera gives plaintiffs a powerful tool to recover damages, greatly increasing the incentive to bring Defend Trade Secrets Act claims against defendants with large global sales because those sales could generate large settlements, say attorneys at MoFo.

• Dueling Calif. Rulings Offer Insight On 401(k) Forfeiture Suits

  

  Two recent decisions from California federal courts regarding novel Employee Retirement Income Security Act claims around 401(k) forfeitures provide early tea leaves for companies that may face similar litigation, offering reasons for both optimism and concern over the future direction of the law, say Ashley Johnson and Jennafer Tryck at Gibson Dunn.

• 3 Policyholder Tips After Calif. Ruling Denying D&O Coverage

  

  A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.

• 1 Year At The UPC: Implications For Transatlantic Disputes

  

  In its first year, the Unified Patent Court has issued important decisions on procedures like provisional measures, but complexities remain when it comes to coordinating proceedings across jurisdictions like the U.S. due to differences in timelines and discovery practices, say attorneys at McDermott.

• Patent Ruling Shows A Minor Typo Can Lead To A Major Loss

  

  A federal court’s recent ruling in SIPCO v. Jasco, where patent infringement claims were dismissed because of a typo made during prosecution, highlights key moments in the terminal disclaimer application process where double-checking the patent number is especially crucial, say attorneys at Mintz.

• Opinion

  Now More Than Ever, Lawyers Must Exhibit Professionalism

  

  As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.

• How Tech Trackers May Implicate HIPAA After Hospital Ruling

  

  A recent Texas federal court order in American Hospital Association v. Becerra adds a legal protection on key data, clarifying when tracking technologies implicate the Health Insurance Portability and Accountability Act, so organizations should ensure all technology used is known and accounted for, say John Howard and Myriah Jaworski at Clark Hill.

• What FTX Case Taught Us About Digital Asset Recoverability

  

  FTX's Chapter 11 plan has drawn lots of attention, but the focus should be on the anticipated outcome for investors, which counters several myths about digital currencies, innovation and recoverability, says Kyla Curley at StoneTurn.

• Series

  Serving In The National Guard Makes Me A Better Lawyer

  

  My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.

• Will Texas Stock Exchange Provide Regulatory Haven?

  

  While the newly proposed Texas Stock Exchange may represent a market reaction to increasingly complex regulations, those looking to list on a national securities exchange should consider that their choice of an exchange may not relieve them of some of the most burdensome public company requirements, say Elizabeth McNichol and Ryan Lilley at Katten.

• Opinion

  Proposed Terminal Disclaimers Rule Harms Colleges, Startups

  

  Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.