Patents in genomics and human genetics.
Annual review of genomics and human genetics 2010 Sep 22; 11: 383-425
Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts-and sometimes fails to adapt-to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive post-discovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted patents, but jurisprudence trends away from upholding the broadest and potentially most troublesome patent claims.
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Gene patents and licensing: case studies prepared for the Secretary's Advisory Committee on Genetics, Health, and Society. Cook-Deegan, Robert; Heaney, Christopher (2010-04)Researchers at the Center for Public Genomics at Duke University analyzed how patenting and licensing affect clinical access to genetic testing in the United States. The research was requested by the Secretary's Advisory ...
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 (2010-04)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 ...
Impact of gene patents and licensing practices on access to genetic testing for Alzheimer disease. Skeehan, Katie; Heaney, Christopher; Cook-Deegan, Robert (2010-04)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 ...