Diagnostic Kits/Intellectual Property Landscape of the Human Genome

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Jensen, K. & Murray, F., 2005. INTELLECTUAL PROPERTY: Enhanced: Intellectual Property Landscape of the Human Genome. Science, 310(5746), 239-240.

  • Jensen, K. & Murray, F., 2005 - This article clearly articulates the possible risks associated with patent and genetic testing. Among the risks discussed is the possible “increase the costs of genetic diagnostics, slow the development of new medicines, stifle academic research, and discourage investment in downstream R&D” (Jensen, K. & Murray, F., 2005). While the article cites these arguments, it also claims there is a lack of empirical data to support these patent policy arguments.
    • The study developed a detailed map “using bioinformatics methods to compare nucleotide sequences claimed in U.S. patents to the human genome” (Jensen, K. & Murray, F., 2005). The map is a gene-oriented graph of IP rights as they relate to specific physical loci on the human genome. The results show “20% of human genes are explicitly claimed as U.S. IP” (Jensen, K. & Murray, F., 2005). The study also found that the patent coverage is not evenly distributed. “Although large expanses of the genome are unpatented, some genes have up to 20 patents asserting rights to various gene uses and manifestations including diagnostic uses, single nucleotide polymorphisms (SNPs), cell lines, and constructs containing the gene” (Jensen, K. & Murray, F., 2005). Patent ownership distribution was also considered. Most of the top patent assignees are US-based. Another risk considered is the fragmentation of gene ownership which “raises the possibility that innovators may incur considerable costs securing access to genes via structuring complex licensing agreements.” (Jensen, K. & Murray, F., 2005).

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