title: Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: comparing breast and ovarian cancers with colon cancers.
abstract: Genetic testing for inherited susceptibility to breast and ovarian cancer can be compared with similar testing for colorectal cancer as a "natural experiment." Inherited susceptibility accounts for a similar fraction of both cancers and genetic testing results guide decisions about options for prophylactic surgery in both sets of conditions. One major difference is that in the United States, Myriad Genetics is the sole provider of genetic testing, because it has sole control of relevant patents for BRCA1 and BRCA2 genes, whereas genetic testing for familial colorectal cancer is available from multiple laboratories. Colorectal cancer-associated genes are also patented, but they have been nonexclusively licensed. Prices for BRCA1 and 2 testing do not reflect an obvious price premium attributable to exclusive patent rights compared with colorectal cancer testing, and indeed, Myriad's per unit costs are somewhat lower for BRCA1/2 testing than testing for colorectal cancer susceptibility. Myriad has not enforced patents against basic research and negotiated a Memorandum of Understanding with the National Cancer Institute in 1999 for institutional BRCA testing in clinical research. The main impact of patenting and licensing in BRCA compared with colorectal cancer is the business model of genetic testing, with a sole provider for BRCA and multiple laboratories for colorectal cancer genetic testing. Myriad's sole-provider model has not worked in jurisdictions outside the United States, largely because of differences in breadth of patent protection, responses of government health services, and difficulty in patent enforcement.
authors.affiliation: Center for Public Genomics, Center for Genome Ethics, Law and Policy, Institute for Genome Sciences and Policy, Duke University, Durham, NC 27708, USA. gelp@duke.edu
authors.forename: Robert
authors.initials: R
authors.lastname: Cook-Deegan
authors.forename: Christopher
authors.initials: C
authors.lastname: DeRienzo
authors.forename: Julia
authors.initials: J
authors.lastname: Carbone
authors.forename: Subhashini
authors.initials: S
authors.lastname: Chandrasekharan
authors.forename: Christopher
authors.initials: C
authors.lastname: Heaney
authors.forename: Christopher
authors.initials: C
authors.lastname: Conover
mesh_terms: D019313:BRCA1 Protein / Q000235:genetics; D024682:BRCA2 Protein / Q000235:genetics; D001943:Breast Neoplasms / Q000175:diagnosis / Q000235:genetics*; D003110:Colonic Neoplasms / Q000175:diagnosis / Q000235:genetics*; D003362:Cost-Benefit Analysis; D005260:Female; D005796:Genes; D020022:Genetic Predisposition to Disease / Q000235:genetics*; D005820:Genetic Testing / Q000191:economics / Q000941:ethics*; D006297:Health Services Accessibility / Q000191:economics / Q000941:ethics; D006801:Humans; D008007:Licensure, Medical / Q000941:ethics*; D008297:Male; D010051:Ovarian Neoplasms / Q000175:diagnosis / Q000235:genetics*; D010330:Patents as Topic / Q000941:ethics*
chemical_list: D019313:BRCA1 Protein; D024682:BRCA2 Protein
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