Diagnostic Kits/Bibliography by Resource Type

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Under this segment, we are trying to reclassify the resources we found, which are organized into a bibliography by research question, into a bibliography classified based on its type or origin. This is a work in progress, thus for a complete bibliography you should refer to Bibliography by Research Question.

Academic Articles and Papers

  • 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.
  • 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].
  • 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.
  • Heller, M.A. & Eisenberg, R.A. Can patents deter innovation? The anticommons in biomedical research. Science 280, 698-701 (1998).
  • Hoag, H., 2004. Testing new ground. Nature, 429(6992), 682-3
  • 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].
  • Jensen, K. & Murray, F., 2005. Intellectual Property: Enhanced: Intellectual Property Landscape of the Human Genome. Science, 310(5746), 239-240.
  • Kalorama Information (Rosen). Diagnostic Test Service Commercialization: A Roadmap to Diagnostics in the 21st Century. (2008)
  • Kaye, J., Hawkins, N., and J. Taylor. (2007). Patents and translational research in genomics. Nature Biotechnology 25(7):739.
  • 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).
  • 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].
  • Merz, J.F., 2002. Patents limit medical potential of sequencing. Nature, 419(6910), 878.
  • Mills, A.E. & Tereskerz, P., 2008. DNA-based patents: an empirical analysis. Nat Biotech, 26(9), 993-995.
  • 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].
  • 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
  • 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
  • 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.
  • Pressman, L. et al., 2006. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotech, 24(1), 31-39
  • 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]
  • 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

Blogroll

Twitter

News

  • GEN- Genetic Engineering & Biotechnology News: Clinical Research & Diagnostics Channel (http://www.genengnews.com/transmed/)
    Content includes News, Articles, Tutorials, & Conferences/Meetings

Business Association' Publications

NGO Publications

Declarations and Manifestos

Governmental Resources and Reports

  • 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
  • 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
  • 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
  • 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.
  • 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

Newspapers and Opinions

Databases and Statistics and Patents

Interviews

Completed

Considered