I spend a lot of time thinking about the intersection of FDA regulation and intellectual property, and I have been constructing a large dataset relating to the patents claiming different types of FDA-regulated products. Recently, I have also been thinking a great deal about the regulation of food (because Mizzou is now allowing me to teach Food Law & Policy, in addition to Drug & Device Law). These two areas of interest intersected this past week, giving me some modest insights into premarket review of food additives and some very modest data to contribute to discussions about the (in?)efficiency of FDA’s food additive review process.
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”
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’s what to read on SSRN, relating to FDA law, from September 2017. One piece contributes to a growing literature on the relationship between inter partes review and Hatch-Waxman litigation, and one piece dives into application of intended use doctrine to synthetic nicotine products.