Expert Analysis

• Calif. Drug Ruling Affirms Defect-Centric Liability Framework

  

  The California Supreme Court's decision in Gilead Tenofovir Cases this week rejects a novel duty-to-innovate theory of negligence that could have reshaped product liability exposure well beyond the pharmaceutical industry, instead signaling that negligence claims premised on nondefective products are unlikely to succeed, say attorneys at Dechert.

• Navigating Court Divergence On Method Claims And Venue

  

  After the U.S. Supreme Court's recent Hikma v. Amarin decision putting a spotlight on the pleading standard for inducement, patent litigants must adapt to courts' differing approaches to how separate method steps affect the determination of patent venue validity, say attorneys at Weil.

• NJ Supreme Court Ruling Exposes D&O Gaps For PE Boards

  

  The New Jersey Supreme Court's recent decision in Mist Pharmaceuticals v. Berkley Insurance, barring directors and officers coverage, serves as a cautionary tale for private equity executives serving in overlapping roles at sponsor and portfolio companies, say attorneys at Reed Smith.

• Fed. Circ. In June: When Courts Can't Correct Patent Errors

  

  The Federal Circuit's recent decision in Enanta v. Pfizer explores and clarifies the limits of what can be corrected in a patent application, even if the error is obvious, say attorneys at Knobbe Martens.

• Patent Eligibility Bulletin: New USPTO Guidance And AI Risks

  

  In the second quarter of 2026, the U.S. Patent and Trademark Office updated its subject matter eligibility declarations in line with its increasingly permissive patent eligibility stance, while the Federal Circuit rigorously applied the Alice framework in a decision that highlighted risks facing patent claims that utilize artificial intelligence and machine learning, say attorneys at Banner Witcoff.

• A Shift In How Policymakers Are Approaching PBM Regulation

  

  Recent federal and state legislative and regulatory activity involving pharmacy benefit managers represent a change in focus from transparency to PBM compensation structures, vertical integration and competitive effects, say attorneys at Barclay Damon.

• 11th Circ. Opioid Appeal May Shift Public Nuisance Coverage

  

  The Eleventh Circuit's recent ruling certifying to the Florida and Georgia Supreme Courts the question of whether insurers must provide coverage against suits claiming policyholders improperly distributed opioids may ultimately result in a counterbalance to the Delaware line of cases denying coverage for government opioid suits, say attorneys at Pillsbury.

• Opinion

  States Should Reconsider Forced PBM Divestiture Laws

  

  State legislatures are attempting to enact policies intended to force pharmacy benefit managers to divest from pharmacies, but these laws would have the practical effect of reducing patient access and competition, potentially violating the U.S. Constitution in the process, says former Utah Attorney General John Swallow.

• Series

  Teaching SEC Investigations Makes Me A Better Lawyer

  

  Instructing a law school course on U.S. Securities and Exchange Commission investigations has made me a more thoughtful, deliberate practitioner because it requires me to continually reassess and challenge what I know about securities law enforcement, how I know it and how best to explain it, says David Chase at Miami Law.

• 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.

• Series

  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.