Expert Analysis

• How Calif. Ruling Defines Drug Cos.' R&D Responsibilities

  

  The California Supreme Court's recent ruling in the Gilead Tenofovir Cases, which held that drugmakers have no duty to bring allegedly safer alternatives to market more quickly, is a win for pharmaceutical companies — but not a grant of blanket immunity for all early-stage drug development decisions, say attorneys at King & Spalding.

• Midyear Trends, Takeaways As Securities Class Actions Surge

  

  High numbers of securities class actions through June suggest filings will stay elevated, with factors like changing enforcement attitudes, media scrutiny and the proliferation of potential defendants serving as both cause and effect in increased litigation involving AI-related disclosures, health and tech companies, and foreign issuers, say attorneys at Alston & Bird.

• Series

  Going To Hardcore Shows Makes Me A Better Lawyer

  

  While government contracts law and the hardcore scene may seem entirely unrelated, in my experience, both are about community, focus, being prepared for the unexpected and managing chaos, says Isaac Natter at Fluet.

• 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.