The Impact of Patents on the Development of Genome-Based Clinical Diagnostics: An Analysis of Case Studies


Patent, intellectual property, genetic testing, licensing, anticommons

Document Type



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 U.S. 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.