Diagnostic Kits/Bibliography by Resource Type

Academic Articles and Papers

• Caulfield, Timothy, 2009. Do Gene Patents Hurt Research? Available at: http://www.scienceprogress.org/2009/10/do-gene-patents-hurt-research/comment-page-1/#comment-6370

• 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].
  • Highlights

• Cohen, W.M., Merrill, S.A. & Economy, N.R.C., 2003. Patents in the knowledge-based economy, National Academies Press.

• • Cook-Deegan, R., Chandrasekharan, S. & Angrist, M., 2009. The dangers of diagnostic monopolies. Nature, 458(7237), 405-406.
  • Highlights

• Eisenberg, R. Noncompliance, 2008. Nonenforcement, Nonproblem? Rethinking the Anticommons in Biomedical Research. Houston Law Review Available at: # www.houstonlawreview.org/archive/downloads/45-4_pdf/03_​Eisenberg.pdf [Accessed November 20, 2009].
  • Highlights

• Elfenbein, D.W., 2006. Publications, Patents, and the Market for University Inventions. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=739227 [Accessed October 2, 2009].

• Farkas and Holland. Direct-to-consumer genetic testing: two sides of the coin. The Journal of molecular diagnostics : JMD (2009) vol. 11 (4) pp. 263-5. [Accessed 14 Dec 2009: http://jmd.amjpathol.org/cgi/content/full/11/4/263]
  • Highlights

• Flockhart et al. Clinically Available Pharmacogenomics Tests. Clinical Pharmacology & Therapeutics (2009) Available at: http://www.nature.com/clpt/journal/v86/n1/abs/clpt200939a.html
  • Highlights

• Furness, et. al. The evaluation of diagnostic laboratory tests and complex biomarkers, (2008) Available at: http://www.phgfoundation.org/pages/work7.htm

• Garcia, L. & Shimizu, R., 1997. Evaluation of nine immunoassay kits (enzyme immunoassay and direct fluorescence) for detection of Giardia lamblia and Cryptosporidium parvum in human fecal specimens. J. Clin. Microbiol., 35(6), 1526-1529.

• 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].
  • Highlights

• Gibson, J., The Discovery of Invention: Gene Patents and the Question of Patentability. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1347087 [Accessed October 29, 2009].

• 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/
  • Highlights

• Helene Dernis, 2007. Nowcasting Patent Indicators, OECD, Directorate for Science, Technology and Industry. Available at: http://ideas.repec.org/p/oec/stiaaa/2007-3-en.html.

• Heller, M.A. & Eisenberg, R.A. Can patents deter innovation? The anticommons in biomedical research. Science 280, 698-701 (1998).

• 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].
  • Highlights

• 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].
  • Highlights

• Herder, M., Patents & the Progress of Personalized Medicine: Biomarkers Research as Lens. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1435468 [Accessed October 1, 2009].
  • Highlights

• Hoag, H., 2004. Testing new ground. Nature, 429(6992), 682-3
  • Highlights

• 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, C.M., 2008. GENETICS: Trends in Human Gene Patent Litigation. Science, 322(5899), 198-199.
• 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].

• Huys et al. Legal uncertainty in the area of genetic diagnostic testing. Nature Biotechnology (2009) vol. 27 (10) pp. 903-909. Available at http://www.nature.com/nbt/journal/v27/n10/abs/nbt1009-903.html [accessed Nov 2 2009].
  • Highlights

• 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].

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

• Kalorama Information (Rosen). Diagnostic Test Service Commercialization: A Roadmap to Diagnostics in the 21st Century. (2008)
  • Highlights

• Kane, E., Molecules and Conflict: Cancer, Patents, and Women's Health. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=960772 Accessed October 30, 2009.

• Kane, E., Patent-Mediated Standards in Genetic Testing. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1495820 Accessed October 29, 2009.

• Kaye, J., Hawkins, N., and J. Taylor. (2007). Patents and translational research in genomics. Nature Biotechnology 25(7):739.
  • Highlights

• 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
  • Highlights

• Laakmann, A. Restoring the Genetic Commons: A "Common Sense" Approach to Biotechnology Patent in Restoring the Genetic Commons, Michigan Telecommunications and Technology Law Review 14 MITTLR 43 (2007).

• 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
  • Highlights

• Macer, D.R.J., 2002. Patent or perish? An ethical approach to patenting human genes and proteins. The Pharmacogenomics Journal, 2(6), 361-366. Available at: http://www.nature.com/tpj/journal/v2/n6/full/6500140a.html [Accessed August 5, 2009].

• McGill Centre for Intellectual Property Policy, 2005, Biotechnology and Intellectual Property: Reinventing the Commons: Workshop Report. Available at: www.cipp.mcgill.ca/data/events/00000017_en.pdf [Accessed November 20, 2009].
  • Highlights

• Merz, J.F. et al., 2002. Diagnostic testing fails the test. Nature, 415(6872), 577-579.(Garcia & Shimizu 1997) Available at: http://repository.upenn.edu/bioethics_papers/48/ [Accessed August 5, 2009].
  • Highlights

• Merz, J.F., 2002. Patents limit medical potential of sequencing. Nature, 419(6910), 878.
  • Highlights

• 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].
  • Highlights

• Mills, A.E. & Tereskerz, P., 2008. DNA-based patents: an empirical analysis. Nat Biotech, 26(9), 993-995.
  • Highlights

• Mills, A.E. & Tereskerz, P.M., 2007. Changing patent strategies: what will they mean for the industry? Nat Biotech, 25(8), 867-868.

• Morrison & Foerster : Legal Updates & News : Press Releases : Morrison & Foerster Represents ACON Laboratories in $175 Million Acquisition by Inverness Medical Innovations, Resolving Patent Litigation Between the Two Companies Over Rapid Diagnostic Techno. Available at: http://www.mofo.com/news/media/files/pr02058.html [Accessed August 5, 2009].
  • Highlights

• 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].

• Muller, A et. al., Protecting Biotechnological Inventions in Brazil and Abroad: Draft, Scope and Protecting Biotechnological Inventions in Brazil and Abroad: Draft, Scope, and Interpretation of Claims 2002, Albany Law Journal of Science and Technology, 13 ALBLJST 145 (2002).

• Nelson. The market economy, and the scientific commons. Research Policy (2004) vol. 33 (3) pp. 455-471
  • Highlights

• 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].

• Palombi. The Search for Alternatives to Patents in the 21st Century.(2009) pp. 1-42
  • Highlights

• Paradise, J., European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for United States Patent Law and Public Policy: A Case Study of the Myriad Genetics' BRCA Patent Controversy. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=897507 [Accessed October 30, 2009].

• Palombi, L. The Search for Alternatives to Patents in the 21st Century. (2009) Available at http://cgkd.anu.edu.au/menus/publications.php#palombi
  • Highlights

• Phillips, K.a., Van Bebber, S. & Issa, A.M., 2006. Diagnostics and biomarker development: priming the pipeline. Nature reviews. Drug discovery, 5(6), 463-9.
  • Highlights

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

• Shapiro, C., Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard-Setting, 2001, Innovation Policy and the Economy (Vol. I) (Jaffe, Adam B. et al., eds), pp. 119-150, MIT Press, Available at: http://faculty.haas.berkeley.edu/shapiro/thicket.pdf [Accessed December 6, 2009]

• Torrance, A.W., Patenting Human Evolution. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1300615 [Accessed October 30, 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].
  • Highlights

• 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].
  • Highlights

• Walsh JP, Arora A, Cohen WM. Effects of research tool patents and licensing on biomedical innovation. In: Cohen WM, Merrel SA, (editors). Patents in the knowledge-based economy. Washington (DC): The National Academies Press; 2003. p. 285-340.

• Walsh, J. , Cho, C. & Cohen, W.M. Patents, Material Transfers and Access to Research Inputs in Biomedical Research (Final Report to the National Academy of Sciences' Committee [on] Intellectual Property Rights in Genomic and Protein-Related Research Inventions, 20 September 2005).

• Wilson et al., Biomarker Development, Commercialization, and Regulation: Individualization of Medicine Lost in Translation, 81 Clinical Pharmacology & Therapeutics 153 (2007).

• Wolrad Prinz zu Waldeck und Pyrmont, Research Tool Patents After Integra v. Merck—Have They Reached a Safe Harbor?, 14 Mich. Telecomm. Tech. L. Rev. 367 (2008), available at http://www.mttlr.org/volfourteen/waldeck.pdf

Blogs & Social Media

Blogs

• Genomics Law Report (http://www.genomicslawreport.com/)

  "News and analysis from the intersection of genomics, personalized medicine and the law"

  NCI’s New BRCA1 Test: Broader Utility and Another Challenge to Traditional Genetic Tests

  Is the ACCP’s Call for Greater Governmental Regulation of DTC Genetics Premature?

• Patent Docs (http://www.patentdocs.org/)

  "Biotech & Pharma Patent Law & News Blog"

  Supreme Court Bilski Argument

• Holman's Biotech IP Blog (http://holmansbiotechipblog.blogspot.com/)

  "University of Missouri-Kansas City School of Law Professor's analysis and commentary on the intersection of biotechnology and intellectual property.

Twitter

http://twitter.com/100ideas/geneticdx - 8 experts on genetic/genomic diagnostics and personalized medicine

News

• GEN- Genetic Engineering & Biotechnology News: Clinical Research & Diagnostics Channel (http://www.genengnews.com/transmed/)

  Content includes News, Articles, Tutorials, & Conferences/Meetings

• NanoLogix Provides Operations Update and Notification of Shareholder Meeting - FOXBusiness.com. Available at: http://www.foxbusiness.com/story/markets/industries/health-care/nanologix-provides-operations-update-notification-shareholder-meeting/ [Accessed August 5, 2009].

• PGx News - Information Portal for Pharmacogenomics (http://www.pgxnews.org/web/)

  Pharmacogenomics news, updated daily

• Saez, C., Changing Winds For Gene Patenting In the US? Stakeholders React To Draft Report, October 2009 Available at: http://www.ip-watch.org/weblog/2009/10/29/changing-winds-for-gene-patenting-in-the-us-stakeholders-react-to-draft-report/

• Walters, L., 2006. Professor Examines Licensing of DNA Patents Available at: http://www.genome.gov/Pages/Newsroom/NHGRIRelatedReleases/LicensingofDNAPatents.pdf [Accessed August 5, 2009].

Business Association' Publications

• The Economic Impact of Licensed Commercialized Inventions Originating in University Research, 1996-2007, Biotechnology Industry Organization (BIO) Available at http://www.bio.org/ip/techtransfer/BIO_final_report_9_3_09_rev_2.pdf.

Civil Society Organizations Publications

• American Civil Liberties Union : BRCA: Genes and Patents. Available at: http://www.aclu.org/freespeech/gen/39556res20090512.html [Accessed August 5, 2009].

Declarations and Manifestos

• Nature on Open Data
• The Manchester Manifesto

Governmental Resources and Reports

• Australian Law Reform Commission. Genes and ingenuity: gene patenting and human health report. (2004) pp. 678. Available at http://www.austlii.edu.au/au/other/alrc/publications/reports/99/. Accessed 27 Jan 2010
  • Highlights

• Ayme et al. Patenting and licensing in genetic testing: recommendations of the European Society of Human Genetics. European Journal of Human Genetics (2008) vol. 16 Suppl 1 pp. S10-9
  • Highlights

• 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].
  • Highlights

• National Institutes of Health (NIH), Public Health Service, DHHS, NIH Principles and Guidelines for Sharing of Biomedical Resources -- Final (December 1999) Available at: http://www.ott.nih.gov/policy/research_tool.aspx
  • Highlights

• National Research Council of the National Academies — Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation. Reaping the benefits of genomic and proteomic research: intellectual property rights, innovation, and public health. Washington (DC): The National Academies Press; 2005. Available from http://www.nap.edu/catalog/11487.html, Also Available from: http://books.google.com/books?id=crZWVfYNmtgC&lpg=PP1&ots=jaiZTMGZOU&dq=Reaping%20the%20Benefits%20of%20Genomic%20and%20Proteomic%20Research%3A%20Intellectual%20Property%20Rights%2C%20Innovation%2C%20and%20Public%20Health&pg=PP1#v=onepage&q=&f=false

• Priorities for Personalized Medicine, Council of Advisors on Science and Technology (PCAST), September 2008 Available at: http://www.ostp.gov/galleries/PCAST/pcast_report_v2.pdf
  • Highlights

• Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (Draft Report for Public Comment) [excerpts]. Biotechnology Law Report, 28(3), 417-442 (2009). Available at: http://oba.od.nih.gov/SACGHS/sacghs_documents.html#GHSDOC_011
  • Highlights

• *Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests - September 17, 2009
  • Highlights

• *Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests - Appendix 1: Compendium of Case Studies on the Impact of Gene Patents and Licensing Practices on Access to Genetic Testing. (2009) Available at: http://oba.od.nih.gov/SACGHS/sacghs_documents.html#GHSDOC_011.
  • highlights

• *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].
  • Highlights

Market Reports

• 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].
  • Highlights

Databases and Statistics and Patents

• DPD: DNA Patent Database. Available at: http://dnapatents.georgetown.edu/ [Accessed August 10, 2009].

• World Patent Report: A Statistical Review 2008 Available at: http://www.wipo.int/ipstats/en/statistics/patents/wipo_pub_931.html

Interviews

Completed

• Mark Redmond (via LinkedIn)
• Andrew Torrance

Recommended

• [Jordan Paradise] at Seton Hall Law
• [Korobkin] at UCLA

Upcoming?

• Jason Bobe
• Dr. Joe Thakuria