2007 Articles

A Hard Pill To Swallow

De La Rosa, Alfredo

Recently the Federal Circuit has adopted a sweeping new rule of inherent anticipation that essentially bars the patenting of metabolites and other biological degradations of chemical compounds. This new rule, adopted in Schering v. Geneva, could substantially affect both the willingness and the ability of pharmaceutical companies to develop in vivo metabolites, and other biological compositions. This result may occur because pharmaceutical companies cannot be assured that patent protection will be available for these discoveries. This paper explores the evolution of the doctrine of inherent anticipation, the manner in which the Federal Circuit has chosen to address this issue in relation to pharmaceuticals, and makes suggestions that will allow pharmaceutical companies to receive a return on their research while also protecting the public’s need for generic alternatives of pharmaceutical compositions to quickly come to market.