Expert Analysis

• FDA Warning Letter Tightens Reins On 'Research Only' Labels

  

  A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

• Practical Pointers After Fed. Circ. Double-Patenting Decision

  

  With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.

• Highlights From The 2024 ABA Antitrust Spring Meeting

  

  U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.

• Strategies For Challenging A Fla. Grand Jury Report's Release

  

  A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.

• Patent Lessons From 8 Federal Circuit Reversals In March

  

  A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

• A Look At Ex Parte Seizures 8 Years Post-DTSA

  

  In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.

• Series

  Whitewater Kayaking Makes Me A Better Lawyer

  

  Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.

• AI In The Operating Room: Liability Issues For Device Makers

  

  As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.

• Del. Lessons For Director-Nominees On Sharing With Activists

  

  The Delaware Chancery Court's recent decision in Icahn Partners v. deSouza finding that a director wasn't permitted to share certain privileged information with the activist stockholders that nominated him shows the need for companies to consider imposing appropriate confidentiality requirements on directors, say attorneys at Sullivan & Cromwell.

• 10 Years After Alice, Predictability Debate Lingers

  

  A decade after the U.S. Supreme Court’s Alice ruling, critics continue to argue that the subject matter eligibility framework it established yields inconsistent results, but that contention is disproved by affirmance data from the Federal Circuit, district courts and the Patent Trial and Appeal Board, say Dennis Abdelnour and David Thomas at Honigman.

• This Earth Day, Consider How Your Firm Can Go Greener

  

  As Earth Day approaches, law firms and attorneys should consider adopting more sustainable practices to reduce their carbon footprint — from minimizing single-use plastics to purchasing carbon offsets for air travel — which ultimately can also reduce costs for clients, say M’Lynn Phillips and Lisa Walters at IMS Legal Strategies.

• Questions Persist After Ruling Skirts $925M TCPA Award Issue

  

  After an Oregon federal court's recent Wakefield v. ViSalus ruling that the doctrine of constitutional avoidance precluded it from deciding whether a $925 million Telephone Consumer Protection Act damages award was constitutionally sound, further guidance is needed on when statutory damages violate due process, says Michael Klotz at O'Melveny.

• Benzene Contamination Concerns: Drugmakers' Next Steps

  

  After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.

• Opinion

  States Should Follow Federal Lead On Expert Evidence Rules

  

  The recently amended Federal Rule of Evidence 702 will help ensure expert testimony in federal courts reflects adequate data and reliable methods properly applied to a given case, and state courts — home to the overwhelming majority of U.S. litigation — should adopt similar changes, says retired attorney Michael Harrington.

• The Pros And Cons Of NIST's Proposed March-In Framework

  

  Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.