A Hard Pill to Swallow- Does Schering v. Geneva Endanger Research and Development within the Pharmaceutical Industry?


Recently the Federal Circuit has adopted a sweeping new rule of inherent anticipation that essentially bars the patenting of metabolites and other in vivo biological degradations of chemical compounds. The new rule, adopted in SCHERING v. GENEVA, could substantially affect both the willingness and ability of pharmaceutical companies to develop new drugs if they cannot be assured that patent protection will be available, regardless of whether the patented compound existed undiscovered in a prior art reference. This paper explores the evolution of the doctrine of inherent anticipation, the manner in which Federal Circuit has chosen to address the issue in relation to pharmaceuticals, and suggests potential ways that the pharmaceutical companies' need to receive a return on their research and development can be balanced against the public's need for generic alternatives of pharmaceuticals to become quickly available.


Intellectual Property Law | Science and Technology Law

Date of this Version

June 2006