The impact of patents on the development of genome-based clinical diagnostics: an analysis of case studies.

Publication Type:

Journal Article


Genetics in medicine : official journal of the American College of Medical Genetics, Volume 11, Issue 3, p.202-9 (2009)


2009, Breast Neoplasms, Center-Authored Paper, Cystic Fibrosis, Diabetes Mellitus, Type 2, Female, Genetic Predisposition to Disease, Genetic Testing, Genome, Human, Humans, Long QT Syndrome, Male, Mutation, Ownership, Patents as Topic, Public Health Sciences Division, United States


Fragmented ownership of diagnostic gene patents has the potential to create an "anticommons" in the area of genomic diagnostics, making it difficult and expensive to assemble the patent rights necessary to develop a panel of genetic tests. The objectives of this study were to identify US patents that protect existing panels of genetic tests, describe how (or if) test providers acquired rights to these patents, and determine if fragmented patent ownership has inhibited the commercialization of these panels.