Expert Analysis

• 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  New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by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.

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  Practicing Stoicism Makes Me A Better Lawyer

  

  Practicing Stoicism, by applying reason to ignore my emotions and govern my decisions, has enabled me to approach challenging situations in a structured way, ultimately providing advice singularly devoted to a client's interest, says John Baranello at Moses & Singer.

• Broader Eligibility For AI-Related Patents May Be Coming

  

  A series of recent developments from the U.S. Patent and Trademark Office appears to signal that claims involving improvement in the operation of a machine learning model are now more likely to be considered patent-eligible, and that patent examiners may focus on questions of novelty and nonobviousness and less so on subject matter eligibility, say attorneys at Kilpatrick.

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  The Biz Court Digest: Texas, One Year In

  

  A year after the Texas Business Court's first decision, it's clear that Texas didn't just copy Delaware and instead built something uniquely its own, combining specialization with constitutional accountability and creating a model that looks forward without losing touch with the state's democratic and statutory roots, says Chris Bankler at Jackson Walker.

• AI Product Safety Insights May Expand Foreseeability

  

  Product liability law has long held that companies are responsible for risks they knew about or should have known about — and with AI systems now able to assess and predict hazards during the design process, companies should expect that courts will likely treat such hazards as foreseeable, says Donald Fountain at Clark Fountain.

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  Law School's Missed Lessons: Educating Your Community

  

  Nearly two decades prosecuting scammers and elder fraud taught me that proactively educating the public about the risks they face and the rights they possess is essential to building trust within our communities, empowering otherwise vulnerable citizens and preventing wrongdoers from gaining a foothold, says Roger Handberg at GrayRobinson.

• Organ Transplant System Reforms Mark Regulatory Overhaul

  

  Recent oversight, enforcement and operational developments in the U.S. organ procurement and transplantation system, alongside challenges like the federal shutdown, highlight heightened regulatory scrutiny and the need for compliance to maintain public trust, say attorneys at Hall Render.

• Adapting To USPTO's Reduction Of Examiner Interview Time

  

  Reported changes to the U.S. Patent and Trademark Office's examiner performance appraisal plan will likely make interviews scarcer throughout the application process, potentially influencing patent allowance rates and increasing the importance of approaching each interview with a clear agenda and well-defined goals, say attorneys at Polsinelli.

• Federal Grantees May Soon Face More Limitations On Speech

  

  If courts accept the administration’s new interpretation of preexisting case law, which attempts to graft onto grant recipients the existing limitations on government contractors' free speech, a more deferential standard may soon apply in determining whether an agency’s refusal or termination of a grant was in violation of the First Amendment, say attorneys at Venable.

• 5 Crisis Lawyering Skills For An Age Of Uncertainty

  

  As attorneys increasingly face unprecedented and pervasive situations — from prosecutions of law enforcement officials to executive orders targeting law firms — they must develop several essential competencies of effective crisis lawyering, says Ray Brescia at Albany Law School.

• Anticipating FTC's Shift On Unfair Competition Enforcement

  

  As the Federal Trade Commission signals that it will continue to challenge unfair or deceptive acts and practices under Section 5 of the FTC Act, but with higher evidentiary standards, attorneys counseling healthcare, technology, energy or pharmaceuticals clients should note several practice tips, says Thomas Stratmann at George Mason University.