Court's HRSA Policy Reversal Leaves 340B Rules Murky

A D.C. federal court's recent decision in Premier v. U.S. Department of Health limits the Health Resources and Services Administration's ability to enforce long-standing Section 340B interpretations through subregulatory guidance, leaving open core statutory questions about purchasing models, inventory classification and program oversight, says Martha Cramer at Hooper Lundy.

Series

Officiating Football Makes Me A Better Lawyer

Though they may seem to have little in common, officiating football has sharpened many of the same skills that define effective lawyering in management-side labor and employment: preparation, judgment, composure, credibility and ability to make difficult decisions in real time, says Josh Nadreau at Fisher Phillips.

Fresenius Ruling May Shift Anti-Kickback Enforcement

The Ninth Circuit's recent decision in Fresenius v. Bonta suggests that businesses have a First Amendment right to donate to certain charities, even if those donations are motivated by economic self-interest, potentially calling into question years of Anti-Kickback Statute proceedings against pharmaceutical manufacturers for making similar donations, says Jonah Knobler at Patterson Belknap.

Written Consent Ruling May Signal Change For Telemarketing

The Fifth Circuit's ruling in Bradford v. Sovereign Pest Control is a takedown of the Federal Communications Commission's prior express written consent regulation, and because Loper Bright empowers courts to disregard agency interpretations, Telephone Consumer Protection Act litigants now have an opportunity to challenge previously settled FCC regulations, orders and interpretations, say attorneys at Manatt.

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Law School's Missed Lessons: How To Draft Pleadings

Most law school graduates step into their first jobs without ever having drafted a complaint, answer, motion or other type of pleading, but that gap can be closed by understanding the strategy embedded in every filing, writing with clarity and purpose, and seeking feedback at every step, says Eric Yakaitis at Haug Barron.

At The Fed. Circ., Means-Plus-Function Is Not Quite Dead

Recent Federal Circuit opinions confirm that means-plus-function claims continue to be drafted, issued, litigated and even infringed — but minding the restrictions imposed over the years by courts and statute requires three steps, says Jay Yates at Patterson & Sheridan.

E-Discovery Quarterly: Recent Rulings On ESI Control

Several recent federal court decisions have perpetuated a split over what constitutes “control” of electronically stored information — with judges divided on whether the standard should turn on a party's legal right or practical ability to obtain the information, say attorneys at Sidley.

Opinion

USPTO Should Let Inventors Valuate Patents In Prosecution

By building patent valuation into the application process, rather than waiting until potential litigation years down the line, the U.S. Patent and Trademark Office would streamline the process for inventors protecting and enforcing their patents, says John Powers at Powers IP.

2 Discovery Rulings Break With Heppner On AI Privilege Issue

While a New York federal court’s recent ruling in U.S. v. Heppner suggests that some litigants’ communications with AI tools are discoverable, two other recent federal court decisions demonstrate that such interactions generally qualify for work-product protection under the Federal Rules of Civil Procedure, says Joshua Dunn at Brown Rudnick.

Series

Isshin-Ryu Karate Makes Me A Better Lawyer

My involvement in martial arts, specifically Isshin-ryu, which has principles rooted in the eight codes of karate, has been one of the most foundational in the development of my personality, and particularly my approach to challenges — including in my practice of law, says Kaitlyn Stone at Barnes & Thornburg.

Microplastics On Water Contaminant List Could Spur Claims

The U.S. Environmental Protection Agency's proposal to include microplastics in its draft sixth Contaminant Candidate List under the Safe Drinking Water Act could influence consumer fraud claims and enforcement by state attorneys general, as well as claims against manufacturers from entities facing regulatory compliance costs, says Arie Feltman-Frank at Jenner & Block.

USPTO's AI Search Pilot May Reshape Patent Filing Strategy

The U.S. Patent and Trademark Office's new artificial intelligence search pilot aims to introduce earlier visibility into the prior art landscape, potentially influencing patent filing considerations and shifting the role of counsel to an earlier stage of the prosecution process, say attorneys at Foley & Lardner.

Peptide Policy Is Shifting Toward Sanctioned Compounding

The policy landscape for peptides is undergoing a significant shift under the Trump administration, moving toward a complex system of verified compounding and complementary enforcement that will likely bring peptides firmly back into the sphere of legitimate consumer products, say attorneys at Sheppard.

Keys To Building Defensible Psychedelic Therapy Programs

Given the rapidly evolving legal environment for psychedelic therapies and heightened liability and compliance risks facing providers, meticulous documentation, robust risk management protocols, and proactive engagement with professional organizations and insurers are essential strategies, say Kimberly Chew at Husch Blackwell and L. Alison McInnes at Mindful Health Solutions.

Opinion

State Bars Need To Get Specific About AI Confidentiality

Lawyers need to put actual client information into artificial intelligence tools to get their full value, but they cannot confidently do so until state bars offer clear, formal authority on which plan tiers of the three most popular generative AI tools are safe to use when sharing specific client details, says attorney Nick Berk.