Expert Analysis

• A Shifting Trend In FDA Form 483 Disclosure Obligations

  

  A New York federal court's Checkpoint Therapeutics decision extends a recent streak of dismissals of securities class actions alleging that pharmaceutical companies failed to disclose U.S. Food and Drug Administration Form 483 inspection reports, providing critical guidance for companies during the FDA approval process, say attorneys at Alston & Bird.

• Trending At The PTAB: IPR Memo And Its Fed. Circ. Backdrop

  

  There are new rules for when and how evidence other than patents or printed publications can be considered in inter partes reviews, and while this change is intended to reflect current Federal Circuit precedent, the U.S. Patent and Trademark Office's memo seems to acknowledge tension with last month's Shockwave decision, say attorneys at Finnegan.

• Lessons From 7th Circ.'s Deleted Chat Sanctions Ruling

  

  The Seventh Circuit’s recent decision in Pable v. Chicago Transit Authority, affirming the dismissal of an ex-employee’s retaliation claims, highlights the importance of properly handling the preservation of ephemeral messages and clarifies key sanctions issues, says Philip Favro at Favro Law.

• Breaking Down The Proposed Hemp Bill

  

  A proposed bill in the U.S. House of Representatives, recently approved by the House Appropriations Committee, contains a rider that would significantly change the definition of hemp and dramatically reshape the current hemp-derived product market, say attorneys at King & Spalding.

• Assessing Federal Securities Class Action Stats In '25 So Far

  

  The settlement amount as a percentage of damages in securities class actions has continued to decline in the first half of 2025, a trend that may be important for assessing exposure and risk in future securities litigation, say analysts at Analysis Group.

• Series

  Quilting Makes Me A Better Lawyer

  

  Turning intricate patterns of fabric and thread into quilts has taught me that craftsmanship, creative problem-solving and dedication to incremental progress are essential to creating something lasting that will help another person — just like in law, says Veronica McMillan at Kramon & Graham.

• How Agentic AI Is Testing The Limits Of Patent Law

  

  While a recent Swiss court ruling suggests that human-centric rules regarding inventorship will likely remain in place for the near future, it captures a core tension confronting patent systems worldwide as the technology producing patent-worthy ideas is becoming increasingly autonomous, says Matthew Carey at Marshall Gerstein.

• How To Prep For Potential Passage Of SAFER Banking Act

  

  The Secure and Fair Enforcement Regulation, or SAFER, Banking Act, could fundamentally reshape how financial institutions interact with cannabis businesses, so operators that move now to get their house in order will be best positioned to capitalize if and when change comes, says Alex Leonowicz at Howard & Howard.

• A Former PTAB Judge Weighs The End Of Remote Hearings

  

  Former Patent Trial and Appeal Board Judge Amanda Wieker, now at McGuireWoods, examines the costs and benefits of the PTAB's impending in-person hearing requirement, and offers suggestions for making the most out of this new regime.

• 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.