Expert Analysis

• 9th Circ. Scienter Ruling May Strengthen FDA's Leverage

  

  A recent Ninth Circuit decision in U.S. v. Marschall — regarding scienter and violations of the Federal Food Drug and Cosmetic Act — appears to give the U.S. Food and Drug Administration another arrow in its quiver to lob in the direction of any repeat offender, with potentially very broad applications, say Elena Quattrone and Zachary Taylor at Epstein Becker.

• In The World Of Legal Ethics, 10 Trends To Note From 2023

  

  Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

• What China's New Rare Disease Catalog Means For Drug Cos.

  

  A new list of rare diseases released by the Chinese government may present opportunities for multinational developers of designated orphan drugs to take advantage of preferential policies including exemption from clinical trials, priority review and tax incentives, say attorneys at Zhong Lun Law Firm.

• How Attorneys Can Be More Efficient This Holiday Season

  

  Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.

• 3 Defense Takeaways From The Bankman-Fried Trial

  

  FTX founder and former CEO Sam Bankman-Fried’s recent fraud conviction offers several key lessons for future white collar defendants, from the changing nature of cross-examination to the continued risks of taking the stand, say Jonathan Porter and Gregg Sofer at Husch Blackwell.

• Series

  Children's Book Writing Makes Me A Better Lawyer

  

  Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.

• How The PTAB Landscape Shifted In 2023

  

  Attorneys at Finnegan consider the impact of noteworthy Patent Trial and Appeal Board developments in 2023, including rulemaking, litigation, precedential decisions and director reviews that affected PTAB practice, and offer a reference for examining future proceedings and strategies.

• New Pharma Guidelines Bring Pitfalls For Compounders

  

  New guidelines from U.S. Pharmacopeia, which went into effect last month, require some extensive and potentially expensive compliance efforts from hospitals and compounding pharmacies, and smaller compounders could particularly struggle, says Natalia Mazina at Mazina Law.

• Opinion

  What Happens If High Court Rejects Releases In Purdue Ch. 11

  

  Reading the tea leaves following the U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, it appears likely that the justices will decide that bankruptcy courts lack the power to release third-party claims against nondebtors, which would result in one of three scenarios, says Gregory Germain at Syracuse University.

• FDA's Recent Litigation Records Are Strong, But Imperfect

  

  The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.

• Coming To Terms With Means-Plus-Function Patent Claims

  

  Made-up patent claim terms can open arguments that means-plus-function claim interpretation applies under the Patent Act, but a series of practice tips, including the use of structural language immediately after introducing a claim element, can help avoid such perceptions, says Brad Luchsinger at Harness IP.

• 5 Steps For Healthcare Companies After Biden's AI Order

  

  Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.

• Opinion

  Giving The Gov't Drug Patent March-In Authority Is Bad Policy

  

  The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.

• How Clients May Use AI To Monitor Attorneys

  Excerpt from Practical Guidance

  

  Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.

• 7 Enforcement Predictions For US Export Controls, Sanctions

  

  Federal agencies' assertions of coming increases in export-control and sanctions-violations enforcement are not new, but recent improvements in resources and inter-agency cooperation allow for certain predictions about how the administration’s latest approach to enforcement may be applied going forward, say attorneys at Akin.