Diagnostic Kits/Bibliography
Despite patent challenges, research continues
Interviews with personnel from firms, universities, and other organizations indicate that biomedical research typically proceeds despite challenges posed by a growing number of patents on research tools. Respondents address these challenges with licensing, inventing around patents, going offshore, the development and use of public databases and research tools, court challenges, and simply using the technology without a license (i.e., infringement), often informally invoking a de facto broad "research exemption."
- Goodman et al. The Value of Diagnostics: Innovation, Adoption and Diffusion Into Health Care. (2005) pp. 44-71. Available at: http://www.advamed.org/MemberPortal/About/Resources/
- Hoag, H., 2004. Testing new ground. Nature, 429(6992), 682-3
Proposed Solutions given the Perceived Problem of Access
- Esther van Zimmeren et al. 2006.Bulletin of the World Health Organization - A clearing house for diagnostic testing: the solution to ensure access to and use of patented genetic inventions? Available at: http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862006000500013 [Accessed August 10, 2009].
- Geertrui Van Overwalle et al., 2005. Models for facilitating access to patents on genetic inventions. Available at: http://www.nature.com/nrg/journal/v7/n2/full/nrg1765.html [Accessed August 10, 2009].
Biotech IP literature focus
Patents on genomic materials vs. compound "composition of matter" patents
The bulk of the "IP literature" around patents in biotechnology focuses either on (1) the number of patents on genomic materials (i.e., "50% of the genome is patented!") or (2) around the impact of the use of compound "composition of matter" patents on maintaining high drug prices and preventing generic manufacture.
Empirical analysis of the impact of gene patents on research is absent from the literature
While the impact of patents on drug prices is undeniable and carries a brutal human cost, very little literature is based on systematic, empirical analysis of the impact of the gene patents on research itself.
Are gene patents used in a method similar to drug patents?
Gene patents can, and occasionally are, used in a method similar to a drug patent. This occurs most frequently in gene diagnostic testing kits, which carry a regulatory profile similar to drugs, and similar if lower costs
The majority of gene patents are held by universities and remain unlicensed
But the vast majority of gene patents are obtained by universities and unlicensed, or by companies and unprosecuted.
- Henry, M. et al. 2002. DNA Patenting and Licensing Available at: http://www.bioethics.upenn.edu/prog/ethicsgenes/pdf/henry_etal_Science20020823.pdf [Accessed August 5, 2009].
- Henry, M.R., Cho, M.K., Weaver, M.A., Merz, J.F. A pilot survey on the licensing of DNA inventions. J. Law Med. Ethics, 31:442-449, 2003 Available at: http://www.bioethics.upenn.edu:16080/prog/ethicsgenes/ [Accessed September 10, 2009].
Empirical studies suggest the negative impact gene patents have on research is limited
Thus, the empirical surveys of research laboratories in genomics and proteomics report almost no negative impacts of patents on research.
- Cho, M.K. et al., 2003. Effects of patents and licenses on the provision of clinical genetic testing services. The Journal of Molecular Diagnostics: JMD, 5(1), 3-8. Available at: http://jmd.amjpathol.org/cgi/content/full/5/1/3 [Accessed August 10, 2009].
- Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing: A Roadmap to Diagnostics in the 21st Century - market research report. Available at: http://www.reportlinker.com/p091997/Diagnostic-Test-Service-Commercialization-in-Multiplex-and-Esoteric-Testing-A-Roadmap-to-Diagnostics-in-the-21st-Century.html?utm_source=LivePR&utm_medium=pr&utm_campaign=LivePR [Accessed August 6, 2009].
Choice of research is unaffected by patent activity
It is essential to distinguish between the number of patents extant on genetic materials, the impact of chemical patents on drug prices, the impact of genetic patents on diagnostic kits, and the day-to-day operations of a research lab. While much time and effort has been invested in chronicles of the first three, the consensus is that there is little impact on the fourth.