Diagnostic Kits/Patents and the Progress of Personalized Medicine

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].

Types of biomarkers:

1. Diagnostic biomarkers: "identify the presence of disease at the earliest stage, before clinical manifestation. (Wilson et al., 2007)
2. Prognostic biomarkers "stratify risk of disease progression in patients undergoing definitive therapy." (Wilson et al., 2007)
3. Predictive biomarkers: identify patients most likely to respond to specific interventions." (Wilson et al., 2007)
4. Therapeutic biomarkers: "provide a quantifiable measure of response to therapy in patients undergoing treatment." (Wilson et al., 2007)
5. Toxicity biomarkers: "biomarkers can be used to identify patients at risk for developing adverse reactions to individual therapeutics." (Wilson et al., 2007)

Types of "genetic testing" services

1. Diagnostics: "companies can go to market as soon as they have phenotype-gene association information and the necessary genetic sequencing equipment in hand. (Herder, M., 2009)
2. Pharmacogenomics(also pharmacogenetics): personalized medicine through incorporate genetic information into drug choice
3. Theragnostics: focuses on "integration of information from a diverse set of biomarkers" (Herder, M., 2009)

Regulatory framework

• Regulation is carried out by the FDA and/or the Centers for Medicare and Medicaid Services (CMS)
  • Testing requires both analytically and clinically valid
  • Currently there is ambiguity in the process

Intellectual Property

• Case law
  • Metabolite Laboratories, Inc. v. Laboratory Corp. of America Holdings

• Bayh-Dole Act
  • developed as a result: technology transfer offices
  • The Good:
    • "joint decision of Stanford University and the University of California to license the Cohen-Boyer recombinant DNA technology--non-exclusively to any and all interested parties for a nominal fee--is widely credited with enabling a new era of molecular biology, and spawning the commercial biotech sector."
  • The Bad
    • The University of Utah identified a gene ("BRCA1") that is associated with breast and ovarian cancer. The University TTO spun-off Myriad Genetics Inc., with exclusively licensed the patent to BRCA1.
    • Myriad also patented BRCA2.

Empirical Data Patents

• Jon F. Merz et al., Industry Opposes Genomic Legislation, 20 Nature Biotechnology 657 (2002).
• Mildred K. Cho et al., Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services, 5 J. Molecular Diagnostics 3, 5 (2003).

Researchers

• "actors are ignoring patents of others, and this allows research to continue" (page 215)

Proposed Genomics and Personalized Medicine Act of 2008 (H.R. 6498)

• "Amongst other objectives, the bill aims to clarify the respective roles of the FDA and CMS with respect to biomarkers and other technologies to reduce redundancy, which should reduce the disincentives associated with seeking regulatory approval." (page 223)
• encouraged "companion diagnostics" and "genetic screening tools"
• establish a tax credit related to qualified companion diagnostic tests

Conclusion

• "deciding not to patent a particular biomarker discovery at the earliest practicable opportunity will lead to higher quality innovations that, subsequently, can become the subject of more valuable (economically and socially) patents--what we might term truly choice patents." (page 225)
• With biomarkers: university typically license "at a very early stage, almost always long before a patent is granted and often before a patent application is even filed. (page 225-226)
  • Daniel W. Elfenbein, Publications, Patents, and the Market for University Inventions, 63 J. Econ. Behav. & Org. 688, 693-95 (2007).

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