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].

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

• 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.

• 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.

NGO 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

• 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
  • 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

• 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).

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

Considered

• [Jordan Paradise] at Seton Hall Law
• [Korobkin] at UCLA
• Jason Bobe
• Dr. Joe Thakuria