Expert Analysis

• Navigating DEA Quotas: Key To Psychedelics Industry Growth

  

  As new compounds like DOI enter the Schedule I landscape, manufacturers who anticipate U.S. Drug Enforcement Administration quota regulations, and build quota management into their broader strategy, will be best equipped to meet the growing demand, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega.

• Series

  Mindfulness Meditation Makes Me A Better Lawyer

  

  Mindful meditation enables me to drop the ego, and in helping me to keep sight of what’s important, permits me to learn from the other side and become a reliable counselor, says Roy Wyman at Bass Berry.

• Growth, Harmonization In Focus As Hague System Turns 100

  

  One hundred years after its establishment, the Hague System has grown into an important pillar of international design protection, offering a promising path toward even greater harmonization in design law as its geographic reach continues to expand, say attorneys at Sterne Kessler.

• Lessons From 7th Circ. Decision Affirming $183M FCA Verdict

  

  The Seventh Circuit's decision to uphold a $183 million False Claims Act award against Eli Lilly engages substantively with recurring materiality and scienter questions and provides insights into appellate review of complex trial court judgments, say Ellen London at London & Naor, Li Yu at Bernstein Litowitz and Kimberly Friday at Osborn Maledon.

• Opinion

  Punitive Damages Awards Should Be Limited To 1st Instance

  

  Recent verdicts in different cases against Johnson & Johnson and Monsanto showcase a trend of multiple punitive damages being awarded to different plaintiffs for the same course of conduct by a single defendant, a practice that should be deemed unconstitutional by the U.S. Supreme Court, says Jacob Mihm at Polales Horton.

• How Calif. High Court Is Rethinking Forum Selection Clauses

  

  Two recent cases before the California Supreme Court show that the state is shifting toward greater enforcement of freely negotiated forum selection clauses between sophisticated parties, so litigators need to revisit old assumptions about the breadth of California's public policy exception, says Josh Patashnik at Perkins Coie.

• AI Litigation Tools Can Enhance Case Assessment, Strategy

  

  Civil litigators can use artificial intelligence tools to strengthen case assessment and aid in early strategy development, as long as they address the risks and ethical considerations that accompany these uses, say attorneys at Barnes & Thornburg.

• Attys Beware: Generative AI Can Also Hallucinate Metadata

  

  In addition to the well-known problem of AI-generated hallucinations in legal documents, AI tools can also hallucinate metadata — threatening the integrity of discovery, the reliability of evidence and the ability to definitively identify the provenance of electronic documents, say attorneys at Law & Forensics.

• Lessons From Fed. Circ. On Expert Testimony In Patent Cases

  

  Several recent decisions from the Federal Circuit are notable for their treatment of expert testimony, with relevance to the three pillars of every patent case — infringement, invalidity and damages — and offer lessons on ensuring that expert testimony is both admissible and sufficient to support the jury's verdict, say attorneys at Honigman.

• When Atty Ethics Violations Give Rise To Causes Of Action

  

  Though the Model Rules of Professional Conduct make clear that a violation of the rules does not automatically create a cause of action, attorneys should beware of a few scenarios in which they could face lawsuits for ethical lapses, says Brian Faughnan at Faughnan Law.

• What's New In FDA's Latest Cell And Gene Therapy Guidance

  

  New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by streamlining development and review pathways, say attorneys at Holland & Knight.

• Trending At The PTAB: A Potential Barrier To Serial Challenges

  

  New rules proposed by the U.S. Patent and Trademark Office may appear similar to previous rules at first glance, but are actually much broader in how they would limit petitioners' ability to challenge a patent more than once, say attorneys at Finnegan.

• What's Changing For Cos. In New Calif. Hazardous Waste Plan

  

  While the latest hazardous waste management plan from California's Department of Toxic Substances Control still awaits final approval, companies can begin aligning internal systems now with the plan's new requirements for environmental justice, waste and disposal reduction, waste criteria, and capacity planning, says Thierry Montoya at Frost Brown.

• Fed. Circ. In September: The Printed Matter Doctrine Expands

  

  The Federal Circuit’s recent decision in Bayer v. Mylan represents an extension of the doctrine that adding new words to an existing product or method will not support patentability unless there is a functional relationship, bringing new considerations for both patent holders and challengers, say attorneys at Knobbe Martens.

• Justices' LabCorp Punt Leaves Deeper Class Cert. Circuit Split

  

  In its ruling in LabCorp v. Davis, the U.S. Supreme Court left unresolved a standing-related class certification issue that has plagued class action jurisprudence for years — and subsequent conflicting decisions among federal circuit courts have left district courts and litigants struggling with conflicting and uncertain standards, say attorneys at Cozen O'Connor.