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


METHODS
As case studies, we selected four clinical applications of genetic testing (cystic fibrosis, maturity-onset diabetes of the young, long QT syndrome, and hereditary breast cancer) that use tests protected by > or =3 US patents. We summarized publically available information on relevant patents, test providers, licenses, and litigation.


RESULTS
For each case study, all tests of major genes/mutations were patented, and at least one party held the collective rights to conduct all relevant tests, often as a result of licensing agreements.


CONCLUSIONS
We did not find evidence that fragmentation of patent rights has inhibited commercialization of genetic testing services. However, as knowledge of genetic susceptibility increases, it will be important to consider the potential consequences of fragmented ownership of diagnostic gene patents.
Institute for Public Health Genetics, University of Washington, Seattle, WA, USA. brandonpierce@uchicago.edu
Brandon L
BL
Pierce
Christopher S
CS
Carlson
Patricia C
PC
Kuszler
Janet L
JL
Stanford
Melissa A
MA
Austin
D001943:Breast Neoplasms / Q000175:diagnosis / Q000235:genetics; D003550:Cystic Fibrosis / Q000175:diagnosis / Q000235:genetics; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000235:genetics; D005260:Female; D020022:Genetic Predisposition to Disease / Q000235:genetics*; D005820:Genetic Testing / Q000191:economics / Q000379:methods / Q000592:standards*; D015894:Genome, Human; D006801:Humans; D008133:Long QT Syndrome / Q000175:diagnosis / Q000235:genetics; D008297:Male; D009154:Mutation; D010067:Ownership / Q000331:legislation & jurisprudence; D010330:Patents as Topic; D014481:United States