Expert Analysis

• 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.

• How AI Executive Order Aims To Compete For Foreign Talent

  

  Immigration provisions within the Biden administration's executive order on artificial intelligence take a strategic approach to promoting the U.S. as a destination for AI and STEM talent by streamlining visa processing, enhancing educational and exchange programs, and improving current visa programs and pathways to permanent residency, says Eric Bord at Morgan Lewis.

• Series

  ESG Around The World: Singapore

  

  Singapore is keen to establish itself as a leading international financial center and a key player in the sustainable finance ecosystem, and key initiatives led by its government and other regulatory bodies have helped the Asian nation progress from its initially guarded attitude toward ESG investment and reporting, say attorneys at Morgan Lewis.

• Series

  The Pop Culture Docket: Judge D'Emic On Moby Grape

  

  The 1968 Moby Grape song "Murder in My Heart for the Judge" tells the tale of a fictional defendant treated with scorn by the judge, illustrating how much the legal system has evolved in the past 50 years, largely due to problem-solving courts and the principles of procedural justice, says Kings County Supreme Court Administrative Judge Matthew D'Emic.

• Navigating Asset Tracing Challenges In Bankruptcy

  

  A Virginia court’s recent ruling in Health Diagnostic Laboratory Inc.'s bankruptcy highlights the heightened demand for asset tracing and the strategic use of the lowest intermediate balance rule in recovering funds from commingled accounts, says Daniel Lowenthal at Patterson Belknap.

• Reading The Fine Print On FDA's Prescription Drug Ad Rule

  

  The U.S. Food and Drug Administration's new final rule regarding the disclosure of risks and side effects in ads for prescription drugs includes some broad and potentially subjective language, and some missed opportunities to address how traditional media formats have changed in recent years, say attorneys at Ropes & Gray.

• Perils Of Incorporation By Reference At The Federal Circuit

  

  The Federal Circuit's recent decision backing a Patent Trial and Appeal Board ruling against Medtronic illustrates the perils of arguments through incorporation by reference, which can result in waiver of arguments and an adverse decision on appeal, says Ryan Hagglund at Loeb & Loeb.

• Series

  Performing Music Makes Me A Better Lawyer

  

  The discipline of performing live music has directly and positively influenced my effectiveness as a litigator — serving as a reminder that practice, intuition and team building are all important elements of a successful law practice, says Jeff Wakolbinger at Bryan Cave.

• 'Patient' Definition Ruling Raises Discount Drug Questions

  

  A South Carolina federal court's recent decision in Genesis Health Care v. Becerra supports a broader definition of a "patient" eligible to receive discounted drugs under the Section 340B program, but raises a host of novel questions regarding how the decision will affect covered entities and enforcement actions, say attorneys at McDermott.

• Breaking Down High Court's New Code Of Conduct

  

  The U.S. Supreme Court recently adopted its first-ever code of conduct, and counsel will need to work closely with clients in navigating its provisions, from gift-giving to recusal bids, say Phillip Gordon and Mateo Forero at Holtzman Vogel.