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. 2010 Apr;12(4 Suppl):S71-82.
doi: 10.1097/GIM.0b013e3181d5a68e.

Impact of gene patents and licensing practices on access to genetic testing for Alzheimer disease

Katie Skeehan  1 , Christopher Heaney, Robert Cook-Deegan
Affiliations

Impact of gene patents and licensing practices on access to genetic testing for Alzheimer disease

Katie Skeehan et al. Genet Med. 2010 Apr.

Abstract

Genetic testing for Alzheimer disease includes genotyping for apolipoprotein E, for late-onset Alzheimer disease, and three rare autosomal dominant, early-onset forms of Alzheimer disease associated with different genes (APP, PSEN1, and PSEN2). According to researchers, patents have not impeded research in the field, nor were patents an important consideration in the quest for the genetic risk factors. Athena Diagnostics holds exclusive licenses from Duke University for three "method" patents covering apolipoprotein E genetic testing. Athena offers tests for apolipoprotein E and genes associated with early-onset, autosomal-dominant Alzheimer disease. One of those presenilin genes is patented and exclusively licensed to Athena; the other presenilin gene was patented but the patent was allowed to lapse; and one (amyloid precursor protein) is patented as a research tool. Direct-to-consumer testing is available for some Alzheimer disease-related genes, apparently without a license. Athena Diagnostics consolidated its position in the market for Alzheimer disease genetic testing by collecting exclusive rights to patents arising from university research. Duke University also used its licenses to Athena to enforce adherence to clinical guidelines, including elimination of the service from Smart Genetics, which was offering direct-to-consumer risk assessment based on apolipoprotein E genotyping.

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Conflict of interest statement

FUNDING AND CONFLICT OF INTEREST: This case study was carried out under grant P50 003391, co-funded by the National Human Genome Research Institute and US Department of Energy, and supplemented by funding from The Duke Endowment. The case study authors have no consultancies, stock ownership, grants, or equity interests that would create financial conflicts of interest. The Center for Genome Ethics, Law & Policy accepts no industry funding. Dr. Robert Cook-Deegan is listed on the British Medical Journal roster of physicians who have pledged to remain independent of industry funding <http://www.tseed.com/pdfs/bmj.pdf>.

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