In order to bring a drug to market, manufacturers have long been required to demonstrate safety and effectiveness in clinical trials; however, Health and Human Services Secretary Robert F. Kennedy Jr. would like to change the Food and Drug Administration’s role to make it easier access experimental medicine. In an article on the FDA considering […]
On Monday, June 1, Professor Jacob Sherkow will deliver a lecture at the 15th Waseda-Penn Global Patent Law Conference in Japan. His talk will introduce the fundamentals of indirect patent infringement under U.S. law, with a focus on inducement doctrine under 35 U.S.C. § 271(b). Drawing on recent litigation and scholarship — including the “infringement […]
Professor Jacob Sherkow was a speaker at the recent CRISPRMED conference in Copenhagen, Denmark. He participated in a satellite meeting structured around the topic of Access, IP Landscape and FTO, and spoke specifically about “CRISPR Patent Licenses: Lessons from History.”
Professor Jason Mazzone joined Professor Vikram Amar in his “Brothers in Law” series for SCOTUSblog, written with his brother, Professor Akhil Amar of Yale Law School, to examine the ways in which President Donald Trump’s executive order ending birthright citizenship is unconstitutional. The article goes beyond the text of the 14th Amendment, and examines the […]
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 […]