Expert Analysis

• Opinion

  USPTO Must Address The Right Question In Sanofi Case

  

  The U.S. Patent and Trademark Office Appeals Review Panel's questions in Ex parte Baurin indicate recognition of broader doctrinal issues, but rather than approaching from separate angles, the panel should concentrate on a single fundamental question about obviousness-type double patenting, says Jeremy Lowe at Spencer Fane.

• DOJ's FCA Data-Miner Focus Raises Compliance Stakes

  

  A new U.S. Department of Justice initiative aims to help its Civil Division better vet False Claims Act suits brought by data-mining whistleblowers, signaling that data-driven qui tam enforcement is a priority and making it increasingly important for attorneys and companies to bolster compliance, documentation and internal data monitoring, say attorneys at Wiley.

• Mass. Draft Regs Signal Nationwide Scrutiny Of Junk Fees

  

  Massachusetts Attorney General Andrea Campbell's new draft regulations for assisted living facilities is only her latest move in the war on junk fees — and part of a national reordering of consumer protection enforcement in which states are aggressively and creatively asserting authority, says Steve Provazza at Arnall Golden.

• CFPB Rule Recalibrates Fair Lending Compliance

  

  A close reading of the Consumer Financial Protection Bureau's new final rule on fair lending enforcement reveals a thoughtful and disciplined effort to realign enforcement with statutory text, evidentiary rigor and practical compliance realities, says Alan Kaplinsky at Ballard Spahr.

• Operational AI Washing: A New Securities Class Action

  

  In rising claims of operational AI washing — plaintiffs alleging that artificial intelligence was invoked to explain corporate business decisions in ways that may obscure underlying financial distress — earnings calls, restructuring disclosures and board-level communications will serve as key defense evidence, say attorneys at Akerman.

• Where The Preemption Fight Over Prediction Markets Stands

  

  While the Third Circuit's recent ruling in Kalshi v. Flaherty remains a significant win for the federal government in its quest to regulate prediction markets, the Fourth, Sixth and Ninth Circuits appear more skeptical, indicating that this fight is likely headed for the Supreme Court, says Johnny ElHachem at Holland & Knight.

• 4 Emerging Approaches To AI Protective Order Language

  

  Over the last year, at least five federal district courts have issued or analyzed specific protective order provisions restricting the use of generative artificial intelligence platforms with protected materials, establishing that proactive AI-specific provisions are now standard practice and demonstrating that no single model works for every case, says Joel Bush at Kilpatrick.

• Assessing Material Adverse Event Clauses Amid Iran Conflict

  

  As deals signed before the current Middle East conflict come under pressure, determinations over material adverse effect clauses are arising in real time, and whether an MAE has been wrongfully invoked may be as consequential as whether it was validly established in the first place, say Amran Nawaz and Ralph Stobwasser at Secretariat.

• What Justices Are Focusing On In 'Skinny Label' Patent Case

  

  Though Hikma v. Amarin appears to be a patent dispute that could reshape inducement doctrine in the pharmaceutical context, oral argument suggests the U.S. Supreme Court may treat this as primarily a pleading-stage dispute, with important unresolved questions lurking beneath the surface, says Shashank Upadhye at Upadhye Tang.

• 1st Surveillance Pricing Law In Md. Reflects Broader Scrutiny

  

  A new law will make Maryland the first state to target data-driven or surveillance-based price manipulation, highlighting increased scrutiny from federal and state enforcement agencies and policymakers as they consider whether new laws are required to regulate dynamic pricing, say attorneys at Pillsbury.

• Binance Win Shows Constraints On Anti-Terrorism Act Claims

  

  The Southern District of New York's recent ruling in Troell v. Binance illustrates that the Second Circuit's earlier decision in Ashley v. Deutsche Bank is holding weight with courts, and companies facing aiding and abetting risk should thus monitor evolving case law and assess exposure based on nexus allegations, say attorneys at Freshfields.

• Understanding The Insider Trading Gap In Prediction Markets

  

  While the first-ever insider trading indictment involving a prediction market — the recent prosecution of a service member involved in the capture of Nicolás Maduro — comprised extreme facts and straightforward legal theories, future cases will test the bounds of insider trading law, say attorneys at Baker McKenzie.

• Accelerated Psychedelic Therapy Pathways Require Caution

  

  President Donald Trump's new executive order aiming to accelerate the approval of psychedelic drugs for the treatment of mental health disorders will likely bolster investigational psychedelic therapies, but parties within the psychedelic product supply chain will still need to prepare for potentially burdensome compliance requirements, say attorneys at Morgan Lewis.

• Heppner Ruling Left AI Privilege Risk For Lawyers Unresolved

  

  While a New York federal judge’s recent ruling in U.S. v. Heppner resolved a privilege question surrounding client-side artificial intelligence use, it did not address how to mitigate the risks that can arise when confidential information enters the operative context of an AI system used by an attorney, says Jianfei Chen at Quarles & Brady​​​​​​​.

• The Growing Importance Of Nature-Related Disclosures

  

  The International Sustainability Standards Board's recent vote to develop nonmandatory nature‑related disclosure guidance reduces immediate compliance pressure, but it does not eliminate the practical relevance of such risks for companies that already prepare sustainability reports or operate across jurisdictions with differing expectations, say attorneys at ArentFox Schiff.