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

Robert Cook-Deegan, Christopher Derienzo, Julia Carbone, Subhashini Chandrasekharan, Christopher Heaney, Christopher Conover

Research output: Contribution to journalReview article

35 Citations (Scopus)

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.

Original languageEnglish (US)
JournalGenetics in Medicine
Volume12
Issue number4 SUPPL.
DOIs
StatePublished - Apr 2010
Externally publishedYes

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Patents
Genetic Testing
Licensure
Ovarian Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Breast Neoplasms
Genes
BRCA2 Gene
BRCA1 Gene
National Cancer Institute (U.S.)
Neoplasm Genes
Research
Health Services
Costs and Cost Analysis
Neoplasms

Keywords

  • APC
  • BRCA
  • Breast cancer
  • Colon cancer
  • Colorectal cancer
  • Familial adenomatous polyposis
  • FAP
  • Genetic testing
  • Intellectual property
  • Lynch syndrome
  • MSH
  • Myriad Genetics
  • Patents

ASJC Scopus subject areas

  • Genetics(clinical)

Cite this

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. / Cook-Deegan, Robert; Derienzo, Christopher; Carbone, Julia; Chandrasekharan, Subhashini; Heaney, Christopher; Conover, Christopher.

In: Genetics in Medicine, Vol. 12, No. 4 SUPPL., 04.2010.

Research output: Contribution to journalReview article

Cook-Deegan, Robert ; Derienzo, Christopher ; Carbone, Julia ; Chandrasekharan, Subhashini ; Heaney, Christopher ; Conover, Christopher. / 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. In: Genetics in Medicine. 2010 ; Vol. 12, No. 4 SUPPL.
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