Expert Analysis

• How Home Infusion Providers Can Adapt To Enrollment Pause

  

  Recent Centers for Medicare & Medicaid Services moratoria on new enrollments of home health agencies, medical equipment companies and hospices make home infusion providers' compliance obligations more complex and ambiguous, requiring new careful consideration of specific enrollment requirements and limitations, say attorneys at Quarles & Brady.

• USPTO Practitioner Roster Reflects A More Veteran Workforce

  

  An analysis of the U.S. Patent and Trademark Office's Office of Enrollment and Discipline practitioner roster reveals a widening demographic imbalance between new practitioners and those with more experience, but despite this trend, an expected falloff in practitioner numbers has yet to arrive, says Ian Schick at Paximal.

• How 'Markedly Different' Test Shapes Patent Eligibility Debate

  

  Following last month's U.S. Senate hearing on the proposed Patent Eligibility Restoration Act, it is important to examine how courts and the U.S. Patent and Trademark Office have applied the 46-year-old "markedly different characteristics" framework to determine eligibility of composition-of-matter claims, say attorneys at WilmerHale.

• Opinion

  2nd Circ. Tylenol Ruling Misapplies Daubert Gatekeeping

  

  The Second Circuit's recent ruling in Rutledge v. Walgreen Co., holding that a lower court should not have excluded experts alleging links between prenatal acetaminophen use and autism, threatens to swallow the Daubert standard by limiting courts' consideration of scientific consensus in assessing reliability of expert testimony, say attorneys at Benesch.

• 5 Antitrust Lessons On Bundled Discounts After Medtronic

  

  The recent California federal court decision upholding a $381.7 million verdict against Medtronic offers practitioners a clearer road map for navigating bundled discount claims under Section 2 of the Sherman Act, and the practical implications are substantial, say attorneys at Norton Rose.

• Opinion

  After Monsanto, Defense Bar Must Build Case Against Lohr

  

  The U.S. Supreme Court's recent decision in Monsanto v. Durnell has helped to demolish the foundation for its problematic 1996 ruling in Medtronic v. Lohr — so now defense counsel should lay the groundwork for the high court to overturn Lohr, say attorneys at Blank Rome.

• A New Era Of Scrutiny For China-Linked Pharma Deals

  

  As Congress considers bipartisan legislation that would heighten regulatory scrutiny for life sciences deals involving Chinese biotech entities, companies should reassess the risks and due diligence requirements that will come with using heavily China-dependent pipelines, says Jen Maki at Ankura.

• Series

  Being A Sommelier Makes Me A Better Lawyer

  

  Being a sommelier has quietly shaped how I practice law by changing the way I think, communicate and connect with people, and offers a constant reminder that expertise is about making your knowledge useful and accessible to others, says Kara Du at Sheppard.

• 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.