The Supreme Court decision in Mayo v. Prometheus and the Court’s remand of Myriad have provoked a lot of angst on the part of those in the life sciences. Still, the degree to which these cases might prove cataclysmic is tough to forecast, and those who think Chicken Little is overdoing it have some basis for skepticism. So in the spirit of Prometheus and Epimetheus, the sibling Greek deities whose names translate respectively as forethought and afterthought, let’s examine the prospects for patents in this strange new world. First, let’s ask Epimetheus about the Supreme Court decision in KSR v....
The February advisory committee hearing for cranial electrotherapy stimulator (CES) devices was chock full of controversy during the course of the hearing, but one of the companies with an offering in this space is arguing that FDA violated its own rules in the conduct of the hearing and has filed a citizen's petition regarding FDA's proposed classification of CES devices as class III devices.