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On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document named Enhancing Understanding in Informed Consent (“Draft Guidance”). This release signifies a progressive stride in HHS’s ongoing endeavors to update and synchronize federal…

Antitrust actions significantly impacted the technology sector in 2023 and are poised to have substantial repercussions in the future, affecting both major tech companies and emerging enterprises. In addition to a focus on the largest technology companies, a prevalent theme in much of the antitrust activity in the tech space in 2023 was the examination…

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug Pricing Program (the “340B Program” or the “Program”). Specifically, industry stakeholders have until April 1st to submit comments to legislators regarding the…

United States Patent and Trademark Office (USPTO) officials recently reiterated to all patent examiners that they must provide clear, consistent analysis regarding means-plus-function and step-plus-function limitations. The goal of this USPTO memorandum is to provide applicants and courts with clarity on the USPTO’s position with respect to claim interpretation under 35 U.S.C. 112(f)….By: Womble Bond…

In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in the arm in a patent dispute related to pre-filled syringes (“PFSs”) used for injection of anti-VEGF biologic medicines into patients’ eyeballs…

The vast majority of extra-contractual/bad faith cases involve a carrier’s failure to secure a release of an insured by accepting a reasonable settlement opportunity within the policy limits. The absence of a reasonable settlement opportunity may complicate proof requirements in the bad faith case but may not be fatal to the claim as the Florida…

The on-screen retelling of the biggest miscarriage of justice in UK legal history has had dramatic effects off-screen, offering important lessons to anyone who may be thinking about class actions. Robert Jones, Satinder Soni, and John Hays consider the impact this case is having in England and share observations that may be relevant in the…

U.S. News and World Reports says that, in 2022, dog bites resulted in 48,596 visits by victims to an emergency room in California. That translates to 125 visits per every 100,000 Californians. Between 2018 and 2022, dog bites killed 28 residents in California. Fatalities nationwide during that period reached 96….By: Maison Law