News about the Innovation Law and Tech Program or news about faculty or students that relates to law and technology
Utah has introduced a first-in-the-nation pilot program that allows AI to independently renew certain prescriptions for patients with chronic conditions. The 12-month initiative, which launched in January 2026, uses an AI system developed by the health tech company Doctronic, and operates under a special state “regulatory sandbox” designed to test emerging technologies. A New England […]
Professor Jacob Sherkow has extensive scholarship in the area of patents and has been cited as an expert many times on the issue of drug labels being used in patent cases. In the case of Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc., currently before the United States Supreme Court, Sherkow has authored an amicus […]
In a settlement deal over claims Moderna infringed upon patents owned by Roviant in its COVID-19 vaccine, Moderna has agreed to pay up to $2.25 billion. The settlement, however, has a unique structure in which Moderna will pay $950 million up front and then another $1.3 million if an appeal to have parts of its […]
In his latest paper, Professor Jacob Sherkow argues that recent court decisions that treat safety information on a drug’s package as key evidence in patent cases against generic-drug manufacturers have been incorrectly adjudicated and should be reversed by the Supreme Court. “Those lower court decisions, which embrace a legal theory we call ‘infringement by label,’ […]
Professor Jake Sherkow spoke to Bloomberg Law on several occasions in February, regarding patent lawsuits that are making their way through the courts. One of the lawsuits, filed by Novo Nordisk A/S against Hims & Hers Health Inc., takes aim at the practice of drug compounding and highlights the ambiguity between the FDA’s compounding framework […]
Drug labels required by the U.S. Food and Drug Administration are meant to help ensure safe and effective use of prescription drugs; however, recent court decisions have problematically treated those labels as key evidence in patent infringement cases, with drug companies engaging in what Professor Jacob Sherkow calls “patent gamesmanship” that could potentially limit access […]
Professor Jacob Sherkow recently presented his work on patent infringement at three separate events. He presented a paper, “Compounding Patent Infringement” at the Stanford Patent Scholars Roundtable in January, and in February he presented “Infringement by Drug Label” at the Health Law Colloquium at the Ohio State University Moritz College of Law as well as […]
Replacing animal testing for drug trials is promising, but Professor Sara Gerke and her co-authors on a new paper on the subject believe caution is warranted before adopting change. Gerke recently spoke to the Illinois News Bureau about the paper. “The primary goal of the FDA is to make animal testing the exception in 3-5 […]
As artificial intelligence technology becomes more commonplace, questions about its ethical use are of more salience. In the AMA Journal of Ethics, Professor Sara Gerke examines one area of interest in this field: how ambient listening and transcription technology influences medical doctors’ documentation practices and clinical encounters. In her article, Gerke and her co-author seek […]
“Infringement by label” is when a court treats drug labels as if they were patent claims, assessing whether their text merely “contains” a patented method of use, and it is also the subject of the latest scholarly research from Professor Jacob Sherkow. Writing in the Stanford Law Review, Sherkow explains how infringement by label threatens […]