Expert Analysis

• Assessing FDA Pathways For Genome-Edited Plant Foods

  

  The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

• Opinion

  Proposed MDL Management Rule Needs Refining

  

  Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.

• Why Oncology Deal Making Continues To Fuel Biotech M&A

  

  The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.

• Opinion

  Judicial Independence Is Imperative This Election Year

  

  As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.

• Opinion

  NIST March-In Framework Is As Problematic As 2021 Proposal

  

  While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

• Document Retention Best Practices To Lower Litigation Risks

  

  As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.

• Series

  Riding My Peloton Bike Makes Me A Better Lawyer

  

  Using the Peloton platform for cycling, running, rowing and more taught me that fostering a mind-body connection will not only benefit you physically and emotionally, but also inspire stamina, focus, discipline and empathy in your legal career, says Christopher Ward at Polsinelli.

• Ala. Frozen Embryo Ruling Creates Risks for Managed Care Orgs

  

  The Alabama Supreme Court's decision in LePage v. Center for Reproductive Medicine last month, declaring that frozen embryos count as children, has not only upended the abortion debate but also raised questions for managed care organizations and healthcare providers that provide, offer or facilitate fertility treatment nationwide, say attorneys at Reed Smith.

• Spartan Arbitration Tactics Against Well-Funded Opponents

  

  Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

• Uncertainty Surrounds Patent Eligibility Restoration Bill

  

  A recent U.S. Senate hearing regarding the Patent Eligibility Restoration Act, a bill that aims to overhaul patent eligibility law and establish clearer statutory exclusions, marks a pivotal moment in the ongoing patent eligibility debate, but the law’s fate remains uncertain as discussions continue, say attorneys at Marshall Gerstein.

• CSA Case Could Shift Intrastate Commercial Cannabis

  

  In Canna Provisions v. Merrick Garland, cannabis companies argue that the Controlled Substances Act is unconstitutional as applied to intrastate commercial cannabis activity; the Massachusetts federal court's eventual decision will be important to the cannabis industry for several reasons, including that the threat of federal enforcement would disappear overnight, says Hilary Bricken at Husch Blackwell.

• How AI May Be Used In Fintech Fraud — And Fraud Detection

  

  Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.

• What Recent Study Shows About AI's Promise For Legal Tasks

  

  Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.

• Fed. Circ. Patent Lesson: No Contradiction, No Indefiniteness

  

  The Federal Circuit’s recent ruling in Maxwell v. Amperex Technology highlights the complexities of construing patent claims when seemingly contradictory limitations are present, and that when a narrowing limitation overrides a broader one, they do not necessarily contradict each other, says Roy Wepner at Kaplan Breyer.

• 11th Circ. FMLA Ruling Deepens Divide Over Causation

  

  The Eleventh Circuit's recent ruling in Lapham v. Walgreen distinguishes the circuit as the loudest advocate for the but-for causation standard for assessing Family and Medical Leave Act retaliation claims, though employers in other jurisdictions may encounter less favorable standards and the U.S. Supreme Court will likely have to address the circuit split eventually, say attorneys at Benesch.