Expert Analysis

• Maximizing Law Firm Profitability In Uncertain Times

  

  As threats of an economic downturn loom, firms can boost profits by embracing the power of bottom-line management and creating an ecosystem where strategic financial oversight and robust timekeeping practices meet evolved client relations, says Shireen Hilal at Maior Strategic Consulting.

• Opinion

  The Patent Eligibility Restoration Act Merits Deliberation

  

  The recently introduced Patent Eligibility Restoration Act deserves serious consideration, discussion and debate instead of prejudgment based on entrenched philosophical positions, because of its potential to ameliorate confusion that has hurt investment in certain important industries, say Jonathan Stroud at Unified Patents and Kevin Noonan at McDonnell Boehnen.

• Trending At The PTAB: Changes To Director Review, Hearings

  

  This summer, the Patent Trial and Appeal Board introduced notable updates to both the director review process and the oral hearing guide, and they are already having an impact on practice, say Jameson Gardner and John Mulcahy at Finnegan.

• 7 Common Compliance Pitfalls For Multistate Pharmacies

  

  In light of a California bill recently introduced to prevent medication errors at understaffed chain pharmacies — which could add yet another regulatory hurdle for certain establishments operating across the U.S. — pharmacies operating in multistate capacities must proactively mitigate operational risks, say attorneys at Troutman Pepper.

• 5th Circ. Ruling Reminds Attys That CBP Can Search Devices

  

  The Fifth Circuit’s recent Malik v. Department of Homeland Security decision adds to the chorus of federal courts holding that border agents don’t need a warrant to search travelers’ electronic devices, so attorneys should consider certain special precautions to secure privileged information when reentering the U.S., says Jennifer Freel at Jackson Walker.

• FDA's Drug Software Draft Guidance Raises New Questions

  

  The U.S. Food and Drug Administration's long-awaited draft guidance regarding regulatory considerations for prescription drug use-related software functions as an informative starting point for developers, but many new and lingering questions must be answered before the regulatory limbo is resolved, say attorneys at King & Spalding.

• Series

  ESG Around The World: European Union

  

  As the EU makes ESG regulation a priority, companies — both those based in the EU and others just doing business there — need to keep abreast of myriad new legislation that has either already taken effect or will in the near future, as noncompliance could result in fines, damages and director liability, say attorneys at Steptoe & Johnson.

• Avoiding The Ethical Pitfalls Of Crowdfunded Legal Fees

  

  The crowdfunding of legal fees has become increasingly common, providing a new way for people to afford legal services, but attorneys who accept crowdsourced funds must remember several key ethical obligations to mitigate their risks, say Hilary Gerzhoy and Julienne Pasichow at HWG.

• 4 Pharma Industry Arguments Against CMS Drug Pricing Plan

  

  The Centers for Medicare & Medicaid Services is facing significant pushback regarding its plans for implementing the Inflation Reduction Act's Medicare drug price negotiation program, due to a number of potential repercussions for manufacturers, say attorneys at Mintz Levin.

• As AI Pricing Tools Evolve, So Does Antitrust Risk

  

  As the use of pricing algorithms has given rise to regulatory scrutiny and civil actions, such as RealPage Rental Software Antitrust Litigation in the Middle District of Tennessee and Gibson v. MGM in the District of Nevada, independent pricing decisions and other best practices can help limit antitrust risk, say attorneys at Axinn.

• Issues Ahead As Psychedelic Medicine Faces Pivotal Moment

  

  Recent regulatory changes and decriminalization efforts have opened doors for research and development in psychedelic medicine, but challenges like stigma, access and funding persist, meaning companies will need to address these issues to support the industry’s credibility, say consultants at FTI Consulting.

• Bracing For Regulatory Delays As Shutdown Looms

  

  As a government shutdown looms, stakeholders should plan for regulatory delays and note that more regulations could become vulnerable to congressional disapproval under the Congressional Review Act, say Matthew Shapanka and Holly Fechner at Covington.

• An Overview Of 6 PBM Bills Moving Through Congress

  

  As legislators turn to pharmacy benefit manager reform as a potential next step in addressing the cost of prescription drugs, six congressional committees have recently advanced PBM-related legislation with generally high bipartisan support, suggesting that a final package is likely to advance through Congress, say Rachel Stauffer and Katie Waldo at McDermott+Consulting.

• Exclusivity Loss Holds Power In Trade Secret Damages Claims

  

  A Pennsylvania federal court's recent decision in Elite Transit v. Cunningham adds to a growing body of case law that illustrates how the loss of trade secret exclusivity alone may be sufficient for claiming damages, even when commercialization of a trade secret has not occurred, say Christopher DeBaere and Julia Bloch at Archway Research.

• What Large Language Models Mean For Document Review

  

  Courts often subject parties using technology assisted review to greater scrutiny than parties conducting linear, manual document review, so parties using large language models for document review should expect even more attention, along with a corresponding need for quality control and validation, say attorneys at Sidley.