Expert Analysis

• Federal AI Action Plan Marks A Shift For Health And Bio Fields

  

  The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.

• Preparing For DEA Rescheduling Of 2 Research Chemicals

  

  A recent decision to allow the U.S. Drug Enforcement Administration to reclassify two research psychedelics in Schedule I under the Controlled Substances Act may pose significant barriers to scientific study, including stringent registration requirements, heightened security protocols and burdensome reporting obligations, say Kimberly Chew at Husch Blackwell and Jackie von Salm at Psilera.

• Why EpicentRx Ruling Is A Major Win For Business Certainty

  

  The California Supreme Court's recent decision in EpicentRx v. Superior Court removes a significant source of uncertainty that plagued commercial litigation in California by clarifying that forum selection clauses shouldn't be invalidated solely because the selected forum lacks the right to a jury trial, say attorneys at Clark Hill.

• A Change In Big Pharma Response To FTC Delisting Warnings

  

  While the effect of Federal Trade Commission notices to pharmaceutical companies about allegedly improper patent listings in the U.S. Food and Drug Administration's Orange Book had been de minimis through the end of last year, July data shows an increase in delistings, say Ratib Ali and Celia Lu at Competition Dynamics.

• As Product Recalls Rise, So Do The Stakes For The Bar

  

  Recent recall announcements affecting over 800,000 Ford vehicles highlight how product recalls have become more frequent, complex and safety-critical than ever, raising key practice questions for counsel, and raising the stakes in product liability litigation, says Ken Fulginiti at Fulginiti Law.

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  Adapting To Private Practice: From Texas AUSA To BigLaw

  

  As I learned when I transitioned from an assistant U.S. attorney to a BigLaw partner, the move from government to private practice is not without its hurdles, but it offers immense potential for growth and the opportunity to use highly transferable skills developed in public service, says Jeffery Vaden at Bracewell.

• Data Undermines USPTO's 'Settled Expectations' Doctrine

  

  An analysis of inter partes review proceedings filed since 2012 appears to refute the U.S. Patent and Trademark Office's recent stance that patent owners develop a strong settled expectation that their patents will not be challenged after being in force for six years, say Jonathan DeFosse and Samuel Smith at Sheppard Mullin, and Kenzo Kasai at NGB Corp.

• Advice For 1st-Gen Lawyers Entering The Legal Profession

  

  Nikki Hurtado at The Ferraro Law Firm tells her story of being a first-generation lawyer and how others who begin their professional journeys without the benefit of playbooks handed down by relatives can turn this disadvantage into their greatest strength.

• High Court E-Cig Ruling Opens Door For FDA Challenges

  

  There will likely be more challenges to marketing denial orders brought before the Fifth Circuit following the Supreme Court's recent ruling in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., where litigants have generally had greater success, say attorneys at Troutman Pepper.

• Fed. Circ. In July: Instability In IPR Requirements

  

  The Federal Circuit's decision in Shockwave v. Cardiovascular last month provided an important, albeit short-lived, clarification to the type of evidence that can be used in an inter partes review challenge, say attorneys at Knobbe Martens.

• Structuring Noncompetes In License And Collaboration Deals

  

  As companies grappling with coming patent cliffs look to mergers and acquisitions to compensate, contracting parties assessing biopharma license and collaboration agreements should prepare to agree on noncompetes that ensure the parties' respective objectives are met and that their incentives are aligned, both under their collaboration and beyond, says Jeff Jay at Freshfields.

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  Coaching Cheerleading Makes Me A Better Lawyer

  

  At first glance, cheerleading and litigation may seem like worlds apart, but both require precision, adaptability, leadership and the ability to stay composed under pressure — all of which have sharpened how I approach my work in the emotionally complex world of mass torts and personal injury, says Rashanda Bruce at Robins Kaplan.

• 7 Ways To Fetch Patents In The World Of Working Animals

  

  Though developers rarely file patents related to working animals, and animal training techniques are generally considered unpatentable, certain aspects of training and developing animals may be ripe for patent protection, say Matthew Avery at Baker Botts, Makenzi Galvan at Perkins Coie and Lute Yang at Orrick.

• 9th Circ.'s Kickback Ruling Strengthens A Prosecutorial Tool

  

  The Ninth Circuit's decision last month in U.S. v. Schena, interpreting the Eliminating Kickbacks in Recovery Act to prohibit kickback conduct between the principal and individuals who do not directly interact with patients, serves as a wake-up call to the booming clinical laboratory testing industry, say attorneys at Kendall Brill.

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  Law School's Missed Lessons: How To Make A Deal

  

  Preparing lawyers for the nuances of a transactional practice is not a strong suit for most law schools, but, in practice, there are six principles that can help young M&A lawyers become seasoned, trusted deal advisers, says Chuck Morton at Venable.