Expert Analysis

• Monsanto Ruling Bolsters Generic Drug Labeling Preemption

  

  The U.S. Supreme Court's recent decision in Monsanto Co. v. Durnell concerns herbicide labeling regulated by the Federal Insecticide, Fungicide, and Rodenticide Act, but also carries weighty implications for preemption of state law labeling claims against drug manufacturers, say Terry Henry and Ann Querns at Blank Rome and Melanie Leney at Aurobindo Pharma.

• Patent Eligibility Reforms Keep Chasing The Wrong Fixes

  

  Repeated efforts to create a consistent, predictable patent eligibility standard under Section 101 have centered on replacing judge-made exceptions with new statutory language, but the better fix is to align examination standards with how courts actually apply eligibility doctrine, says former Patent Trial and Appeal Board judge Amee Shah.

• Where The Justices Aligned In Appellate Authority Ruling

  

  The real story of the U.S. Supreme Court’s recent ruling in T.M. v. University of Maryland Medical System Corp., finding that a doctrine designed to curtail duplicative litigation prevents federal district courts from reviewing state court decisions, is in how the justices together revisited an obscure, century-old jurisdictional doctrine, says Alex Dimitrief at Zeughauser Group.

• Protecting Biotech Innovation In The Platform Knowledge Era

  

  Following the U.S. Food and Drug Administration's recent shift toward leveraging prior and platform knowledge in biotechnology, companies should protect their innovations by guarding against obviousness challenges and treating the entire development pipeline as a source of patentable innovation, says Aisha Hasan at Barnes & Thornburg.

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  Judges On AI: Examining Administrative, Organizational Uses

  

  U.S. District Judge Alan Albright of the Western District of Texas examines how artificial intelligence could transform a court's ability to deal with administrative work and organize materials when preparing for hearings or drafting opinions, thereby affording judges more time to resolve contested issues.

• USPTO-Fed. Circ. Split Complicates Machine Learning Patents

  

  The wide chasm between the USPTO's and the Federal Circuit's approach to eligibility for machine learning patents means that patent drafters must avoid functional claiming and specifications if they hope to avoid invalidation of a machine learning patent at the appellate court, says attorney Michael Kiklis.

• How 9th Circ. 'Shadow Trading' Case May Affect Private Credit

  

  Private credit firms should not wait for a result in the Ninth Circuit appeal in U.S. Securities and Exchange Commission v. Panuwat to address material nonpublic information exposure under existing statutes and take steps to ensure their internal policies and surveillance are ready for increased regulatory scrutiny, says Steve Brown at StarCompliance.

• AG Watch: Ohio AG Joins State Antitrust Enforcement Trend

  

  Amid the recent reprioritization in the federal government's competition enforcement agenda, two recent cases provide critical insight into how the Ohio attorney general will proceed in the relatively unprecedented trend of state attorneys general aggressively pursuing antitrust matters, say attorneys at BakerHostetler.

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  Being A Singer Makes Me A Better Lawyer

  

  Before law school, I spent seven years trying to make it as a professional singer in Los Angeles, and nearly everything I learned about preparation, humility, confidence and more has followed me into my legal practice, says Jessica Caterina at Moses & Singer.

• Mass. UHC Fraud Suit Signals States' Medicaid FCA Push

  

  Massachusetts' recently filed False Claims Act suit alleging UnitedHealthcare misrepresented the health status of enrollees in a Medicaid senior care organization plan it managed pushes forward a new phase of state-level scrutiny of managed care data and Medicaid payment mechanisms, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwendolyn Stamper at Vogel Slade.

• 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.