Diagnostic Kits/Bibliography by Research Question

Bibliographic entries used in each research question (1-12; defined by the Field Research Methodology).

Overview of Economics of Intellectual Property in Kits

• 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].
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• 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].
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• Jensen, K. & Murray, F., 2005. INTELLECTUAL PROPERTY: Enhanced: Intellectual Property Landscape of the Human Genome. Science, 310(5746), 239-240.
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• Merz, J.F., 1999. Disease Gene Patents: Overcoming Unethical Constraints on Clinical Laboratory Medicine. Clin Chem, 45(3), 324-330.(Merz 1999) Available at: http://www.clinchem.org/cgi/content/abstract/45/3/324 [Accessed August 5, 2009].
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• Mills, A.E. & Tereskerz, P., 2008. DNA-based patents: an empirical analysis. Nat Biotech, 26(9), 993-995.
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• Pressman, L. et al., 2006. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotech, 24(1), 31-39
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• Verbeure, B., Matthijs, G. & Van Overwalle, G., 2005. Analysing DNA patents in relation with diagnostic genetic testing. Eur J Hum Genet, 14(1), 26-33. Available at: http://www.nature.com/ejhg/journal/v14/n1/full/5201503a.html [Accessed August 11, 2009].
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Give an overall picture of the Kits' sector

• Council of Advisors on Science and Technology (PCAST), Priorities for Personalized Medicine, September 2008 Available at: http://www.ostp.gov/galleries/PCAST/pcast_report_v2.pdf
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• 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/
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• Lei et al. Patents versus patenting: implications of intellectual property protection for biological research. Nature Biotechnology (2009) vol. 27 (1) pp. 36-40. Available at: http://www.nature.com/nbt/journal/v27/n1/full/nbt0109-36.html
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• Ouellette, L.L., Access to Bio-Knowledge: From Gene Patents to Biomedical Materials. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1431580 [Accessed October 29, 2009].

• *Secretary’s Advisory Committee on Genetics, Health, and Society, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services, April 2008. Available at: http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf [Accessed July 8, 2009].
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Legal tools available for and in use by the actors of Kits' sector: IP in Kits

• Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. 560 F.3d 1366 C.A.Fed. (Mass., 2009)

• Classen Immunotherapies, Inc. v. Biogen IDEC, 304 Fed. Appx. 866 (Fed. Cir. 2008)

• Correspondence and Submissions Relating to CellPro March-In Petition. (2008, April 3). Retrieved April 17, 2010, from http://www.nih.gov/icd/od/foia/cellpro/index.htm

• Diamond v. Chakrabarty, 447 U.S. 303 (1980)

• 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].
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• Funk Brothers v. Kalo, 333 U.S. 127 (1948) ... 10-11, 15

• Gottschalk v. Benson, 409 U.S. 63 (1972) ... 9

• Holman, Christopher M., The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation. UMKC Law Review, Vol. 76, p. 295, 2007. Available at SSRN: http://ssrn.com/abstract=1090562

• Holman, Christopher. 2008 (Nov 4). "Applying Bilski to Biotechnology and the Life Sciences." Patently-O. http://www.patentlyo.com/patent/2008/11/applying-bilski.html.

• J.D, M.A.H.P. & Munzer, S.R., Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=241236 [Accessed October 30, 2009].

• Howlett, M.J. & Christie, A.F., An Analysis of the Approach of the European, Japanese and United States Patent Offices to Patenting Partial DNA Sequences (ESTs). SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=573184 [Accessed October 30, 2009].

• In re Bilski, 545 F.3d 943 (C.A.Fed., 2008.).

• In re Fisher, 421 F.3d 1365, 1371 (Fed.Cir. 2005).

• Microbiological Research Corp. v. Muna, 625 P.2d 690, 700 (Utah 1981)

• Mueller, J.M., Public Access Versus Proprietary Rights in Genomic Information: What Is the Proper Role of Intellectual Property Rights? SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1367849 [Accessed October 30, 2009].

• Noonan, Kevin. 2009 (Feb 5). "Applying In re Bilski to Diagnostic Method Claims." Patent Docs. http://www.patentdocs.org/2009/02/applying-in-re-bilski-to-diagnostic-method-claims.html

• Noonan, Kevin. 2009 (Sept 16). "Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2009)." Patent Docs. http://www.patentdocs.org/2009/09/prometheus-laboratories-inc-v-mayo-collaborative-services-fed-cir-2009.html

• O'Reilly v. Morse, 56 U.S. 62 (1853)

• Pressman, L. et al., 2006. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotech, 24(1), 31-39
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• Prometheus Laboratories, Inc. v. Mayo Collaborative Services. 2009 WL 2950232 C.A.Fed. (Cal.,2009).

• Verbeure, B. et al., 2006. Patent pools and diagnostic testing. Trends in Biotechnology, 24(3), 115-120.(Verbeure et al. 2006) Available at: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TCW-4J4HK5P-1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=8c0fd5a6f1431a3cbfc9ff2f37470c3b [Accessed August 8, 2009].
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• 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].
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IP Profile of Biggest for-profit companies in Kits

• Component Database, Available at: http://www.medibix.com/CompanySearch.jsp?cs_choice=c&clt_choice=t&treepath=16842&stype=i [last accessed April 17, 2010]

• DNA testing providers, Available at: http://dnatestindex.com/providers/ [last accessed April 17, 2010]

IP Profile of non-profit companies in Kits

• Coriell Personal Medicine Collaborative, Available at: cpmc.coriell.org [last accessed April 17, 2010].

• Diagnostics for All, Available at: http://www.dfa.org/ [last accessed April 17, 2010] (Whitesides paper microfluidics - based diagnostics; tests non-DNA biomarkers).

• Personal Genome Project at Harvard Available at: http://www.personalgenomes.org/ [last accessed April 17, 2010].

IP Profile of Universities working in Kits

• 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].
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• Pressman, L. et al., 2006. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotech, 24(1), 31-39
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IP Profile of Associations in Kits

• Biotechnology Industry Organization (BIO), Available at: http://www.bio.org/ [last accessed April, 17, 2010] (the world's largest biotechnology organization).

• Personalized Medicine Coalition, Available at: http://www.personalizedmedicinecoalition.org/ [last accessed April, 17, 2010].

Commons based cases in Kits

• BioBricks Foundation Available at: http://openwetware.org/wiki/The_BioBricks_Foundation:Legal [last accessed April, 17, 2010].

• Biomarkers Consortium, Available at: http://www.biomarkersconsortium.org/ [last accessed April, 17, 2010].

• Dequeker, Elisabeth et. al., Quality control in molecular genetic testing, Nature Reviews Genetics 2, 717–723 (1 September 2001).

• DNA Patent Database, Available at: http://dnapatents.georgetown.edu/ [last accessed April, 17, 2010].

• Genetic Testing Reference Materials Coordination Program (GeT-RM), Available at: http://wwwn.cdc.gov/dls/genetics/rmmaterials/default.aspx [last accessed April, 17, 2010].

• Kalman, Lisa et. al., Development and Characterization of Reference Materials for MTHFR, SERPINA1, RET, BRCA1, and BRCA2 Genetic Testing, Journal of Molecular Diagnostics 2009, Vol. 11, No. 6

• Kling. Diagnosis or drug? Will pharmaceutical companies or diagnostics manufacturers earn more from personalized medicine? EMBO reports (2007) vol. 8 (10) pp. 903-6. Accessed December 14, 2009 at http://www.nature.com/embor/journal/v8/n10/full/7401080.html
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• National Cancer Institute, NCI's Clinical Trials Cooperative Group Program. Available at: http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group [last accessed April, 17, 2010].

• National Institutes of Health, Translating Scientific Discoveries Into Medical Practice , http://www.niaid.nih.gov/labsandresources/techdev/Pages/default.aspx [last accessed April, 17, 2010].

• National Institutes of Health, Uniform Biological Material Transfer Agreement, Available at: http://www.niaid.nih.gov/labsandresources/techdev/Pages/default.aspx [last accessed April, 17, 2010].

• Open Educational Resources for Cancer, Available at: http://oerc.merlot.org/index.html [last accessed April, 17, 2010].

• Registry of Standard Biological Parts, Available at: http://partsregistry.org/Main_Page [last accessed April, 17, 2010].

• SNPedia, Available at: http://www.snpedia.com/index.php/SNPedia [last accessed April, 17, 2010] (SNPedia is a wiki investigating human genetics).

• Trait-o-matic, Available at: http://snp.med.harvard.edu/ [last accessed April, 17, 2010].

• Pratt, Victoria. Development of Genomic Reference Materials for Cystic Fibrosis Genetic Testing, Journal of Molecular Diagnostics 2009, Vol. 11, No. 3

• Promethease, Available at: http://www.snpedia.com/index.php/Promethease [last accessed April, 17, 2010].

• Wilson, Jean Amos., Consensus Characterization of 16 FMR1 Reference Materials: A Consortium Study, Available at: http://jmd.amjpathol.org/cgi/content/abstract/jmoldx.2008.070105v1 [last accessed April, 17, 2010].

Peer-Production Business models in Kits

• CHDWiki: Congenital Heart Defects, Available at: http://homes.esat.kuleuven.be/~bioiuser/chdwiki/index.php/Main_Page [last accessed April, 17, 2010]

Open Business models in Kits

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