On December 14, the Federal Circuit handed down the latest decision in the dispute between Sandoz and Amgen concerning the process for patent litigation under the Biologics Price Competition and Innovation Act amendments to the Public Health Service Act (PHSA). The matter was on remand from the Supreme Court. Judge Lourie, writing for a unanimous panel, concluded that Sandoz had not waived its argument that Amgen’s state law claims were preempted by federal law and, moreover, that those state law claims were indeed preempted. A dive into the decision below, with apologies for the length. Continue reading “You Can Dance if You Want To”
Cross-posted on Stanford’s Law and the Biosciences Blog
In late November, FDA posted a statement on its website about the “self-administration of gene therapy”—which various media outlets interpreted as a reaction to some companies recently posting videos of consumers “self-experimenting” with gene therapy. One question that arose in some of the reporting—and in an exchange on twitter—is, what is FDA’s authority to regulate do-it-yourself (DIY) gene therapy?
Here are three more new and noteworthy articles from October and November, including Professor Robin Feldman’s new empirical study of the pharmaceutical industry.
Here is what is new and interesting from the last two months. I’ll start with two articles on off-label promotion and two articles relating to tobacco regulation.