Expert Analysis

• FDA Draft Guidance Maps Payor Strategy For Psychedelics

  

  Recently revised guidance from the U.S. Food and Drug Administration will operationalize a framework permitting drug developers to share product information with insurance companies, giving psychedelic therapeutics developers a road map for building a successful payor infrastructure before approval, says Kimberly Chew at Husch Blackwell.

• How 2nd Circ. Raised The Bar For Pleading Securities Fraud

  

  In Huey v. Anavex, the Second Circuit recently appeared to increase the burden on securities fraud plaintiffs in pleading loss causation where no immediate share price decline follows the corrective disclosure, generating new questions that district courts must grapple with, say attorneys at Skadden.

• Quantifying Damages In Product Launch Delay Allegations

  

  In delayed generic-drug entry cases that have generated substantial settlements in recent years, damages are often measured by profits lost during the delay window, but this model can fail to account for potentially significant economic harm that occurs after that window, say analysts at Kroll.

• 3rd Circ. ERISA Ruling Stresses Process Over Perfect Returns

  

  The Third Circuit's recent decision in Quest Diagnostics affirms that a sound fiduciary process — not perfect investment returns — defeats Employee Retirement Income Security Act claims, signaling that courts will keep scrutinizing how fiduciaries decide, and sponsors who can show their work should remain protected, say attorneys at Nixon Peabody.

• Fed. Circ. Licensing Rulings Shed Light On Patentee Standing

  

  Two recent decisions from the Federal Circuit provide a useful framework for evaluating whether a patent license agreement preserves a sufficient exclusionary interest to support future patent infringement claims, say attorneys at Venable.

• Series

  Being A Magician Makes Me A Better Lawyer

  

  The skills I've developed as a lifelong magician have translated directly into tangible benefits in the courtroom because performing magic and trying cases both live at the intersection of psychology, storytelling, timing and disciplined rehearsal, says Mark Dombroff at Fox Rothschild.

• How Pfizer Won Fed. Circ. Patent Dispute By 1 Carbon Atom

  

  The Federal Circuit's recent refusal to revive a patent in Enanta Pharmaceuticals v. Pfizer over an alleged typo creating a one-atom difference in a COVID-19 treatment application hands defendants a template for potentially converting a triable fact question into an early dispositive ruling, say attorneys at Polsinelli.

• What Data Says About Biologics-Related Ex Parte Challenges

  

  An analysis of the 67 ex parte reexaminations used to challenge biologics patents over the last 13 years reveals that reexamination may emerge as an alternative to inter partes review and postgrant review, despite facing a number of procedural disadvantages, say attorneys at Steptoe.

• FDA Moves Leave Peptides In A Legal Gray Zone

  

  While the U.S. Food and Drug Administration has taken a concrete step forward on reclassifying certain peptides, the practical consequence of their interim status cannot be overstated — these substances are no longer designated as posing a significant safety risk, but they have not been affirmatively authorized for compounding, say attorneys at Sheppard.

• Series

  Bass Fishing Makes Me A Better Lawyer

  

  Landing a trophy striped bass and closing a big deal both require cultivating the patience to finesse — not force — your way to desired outcomes, changing course when your old approach isn’t working and learning from the ones that got away, says Jon Ruiss at Alston & Bird.

• How Reincorporating In Texas May Alter Earnout Disputes

  

  While the DExit debate has focused on shareholder suits, far less attention has been paid to what reincorporating in Texas means for M&A disputes, making it particularly important to understand the nuances between Delaware and Texas earnout jurisprudence, say attorneys at Selendy Gay.

• Roundup

  The Most Talked-About Supreme Court Decisions Of 2026

  

  This term, 11 U.S. Supreme Court decisions quickly became hot topics among Law360's guest writers.

• Coordinating Life Sciences IP Strategies In The US And EU

  

  As postgrant practice for life sciences patents is restructured in the U.S. and European Union simultaneously, patent owners will need to implement transatlantic coordination that treats international proceedings as components of a single intellectual property risk architecture, says Paul Calvo at Sterne Kessler.

• What Durnell Ruling Means For Mo. Roundup Settlement

  

  While the U.S. Supreme Court’s recent ruling in Monsanto v. Durnell forecloses the failure-to-warn theory that carried most of the claims against Monsanto in a pending class action in Missouri state court, it leaves untouched the question of whether the class was assembled merely to contain the defendant's liability, says attorney Gregg Goldfarb.

• Why Biotech Cos. Need Litigation Plans Before Bad News

  

  Biotech companies should take proactive steps to respond to the growing trend of securities litigation filed against them, due to the inherently uncertain nature of their business models and heightened scrutiny of clinical trial disclosures, regulatory communications and investor-facing statements, says Wesley Horton at FBFK.