Personalized medicine: impact of subject matter and utility requirements on patentability in the United States

Abstract

Personalized medicine is a relatively new field that recognizes and takes advantage of a patient's individual genetic and physiologic make-up, as well as specific environmental influences. Obtaining and defending patents this field, however, can raise legal issues, such as those relating to ‘subject matter’ patentability and ‘utility,’ two requirements under US law. This perspective article provides an analysis of certain US patent cases relevant to these requirements, including Lab. Corp. v. Metabolite pertaining to subject matter patentability of certain types of diagnostic methods, and In re Fisher addressing the utility of certain DNA-related research tools. Understanding such cases can provide guidance as to how to avoid certain pitfalls when preparing, prosecuting and defending patents in the field of personalized medicine.

Keywords::

• diagnostic methods
• gene-related research tools
• kits
• patent law
• personalized medicine
• subject matter patentability
• utility