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Expert Analysis

• The Future Of Lab-Test Regs After FDA Rescinds Rule

  

  The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.

• SDNY Ruling Reinforces Joint Steering Committee Obligations

  

  The recent Southern District of New York decision in ChemImage v. Johnson & Johnson makes joint steering committees a valuable tool in strategic relationships, as provisions for such committees can now be wielded to demand attention to core issues, say Lisa Bernstein at the University of Chicago Law School, and Reginald Goeke and Brad Peterson at Mayer Brown.

• What 2 Profs Noticed As Transactional Law Students Used AI

  

  After a semester using generative artificial intelligence tools with students in an entrepreneurship law clinic, we came away with numerous observations about the opportunities and challenges such tools present to new transactional lawyers, say professors at Cornell Law School.

• What Patent Claim 'Invalidity' Means In Different Forums

  

  A recent Federal Circuit order allowing a patent suit to proceed despite similar claims being invalidated in an inter partes review underscores how fractured the patent litigation landscape has become, leading to critical nuances in how district courts, the U.S. International Trade Commission and Patent Trial and Appeal Board treat invalidity, says Jason Hoffman at BakerHostetler.

• Rebuttal

  BigLaw Settlements Should Not Spur Ethics Deregulation

  

  A recent Law360 op-ed argued that loosening law firm funding restrictions would make BigLaw firms less inclined to settle with the Trump administration, but deregulating legal financing ethics may well prove to be not merely ineffective, but counterproductive, says Laurel Kilgour at the American Economic Liberties Project.

• How Big Pharma Has Responded To FTC Delisting Demands

  

  Looking at some statistics concerning how pharmaceutical companies have responded to the Federal Trade Commission's recent challenges to Orange Book listings raises several possible hypotheses about the FTC's strategy and effectiveness, say Ratib Ali and Celia Lu at Competition Dynamics.

• 5 Ways Lawyers Can Earn Back The Public's Trust

  

  Amid salacious headlines about lawyers behaving badly and recent polls showing the public’s increasingly unfavorable view of attorneys, we must make meaningful changes to our culture to rebuild trust in the legal system, says Carl Taylor at Carl Taylor Law.

• USPTO's AI Tool Redefines Design Patent Landscape

  

  The U.S. Patent and Trademark Office's newly introduced DesignVision tool for artificial intelligence-powered image searching represents a dramatic shift in how design patent applications are examined, necessitating new strategies for patent practitioners, says Matthew Epstein at Dinsmore.

• Class Actions At The Circuit Courts: August Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses key takeaways from federal appellate decisions involving topics including antitrust, immigration, consumer fraud, birthright citizenship under the Fourteenth Amendment, and product defects.

• Series

  Hiking Makes Me A Better Lawyer

  

  On the trail, I have thought often about the parallels between hiking and high-stakes patent litigation, and why strategizing, preparation, perseverance and joy are important skills for success in both endeavors, says Barbara Fiacco at Foley Hoag.

• What US-India Trade Deal Will Mean For Indian Pharma

  

  Complicated by newly imposed tariffs from the U.S., the outcome of the U.S.-India trade talks is poised to reshape not just trade policy, but also the strategic alignment of the two countries' pharmaceutical ecosystems, says Jashaswi Ghosh at Holon Law Partners.

• Opinion

  Time For Full Disclosure Of Third-Party Funding In MDLs

  

  It is appropriate that the Federal Advisory Committee on Civil Rules is considering a rule to require disclosure of third-party litigation funding in civil litigation — something that is particularly needed in multidistrict litigation, which now comprises more than half of all civil cases in the federal courts, says Eric Hudson at Butler Snow.

• Series

  Law School's Missed Lessons: Negotiation Skills

  

  I took one negotiation course in law school, but most of the techniques I rely on today I learned in practice, where I've discovered that the process is less about tricks or tactics, and more about clarity, preparation and communication, says Grant Schrantz at Haug Barron.

• Conflicting Developments In Homelessness Legal Landscape

  

  Looking at an executive order and Third Circuit opinion from last month highlights the ongoing tension in homelessness-related legal issues facing state and local governments, property owners, and individuals experiencing homelessness, says Josh Collins, an attorney for the City of South Salt Lake.

• AG Watch: Texas Embraces The MAHA Movement

  

  Attorneys at Kelley Drye examine Texas Attorney General Ken Paxton's actions related to the federal Make America Healthy Again movement, and how these actions hinge on representations or omissions by the target companies as opposed to specific analyses of the potential health risks.