Diagnostic Kits/Overview of Economics of Intellectual Property in Kits
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Where does the literature says IP works and does not work?
Introduction
When IP does work
When IP doesn't work
Summary of the Risks Associated with Patent Protections of Genetic Testing Data Access
- Searching for genetic patents is difficult. Solutions have arisen in the form of topic specific databases. (Verbeure, et al., 2005)
Bayh-Dole
- The Bayh-Dole Act may not be serving its purpose in the genetic testing context. If genetic research is inhibited by patenting behaviors then the fact that at least one study found “[t]he majority of the patent holders enforcing their patents were universities or research institutes, and more than half of their patents resulted from government-sponsored research” means that the act holds a central role in creating a barrier to access (Cho et al. 2003).
Patent Protection
- The rise of patent protections over genetic testing research may cause labs to decline to develop new tests and stop their current genetic test offerings. (Cho et al. 2003)
- Patenting of genetic testing can “increase the costs of genetic diagnostics, slow the development of new medicines, stifle academic research, and discourage investment in downstream R&D” (Jensen, K. & Murray, F., 2005)
- There is evidence that patents are not necessary for the quick transformation of the genetic markers to a clinical test (Merz, J.F. et al., 2002)
Licensing
- Licensing behavior can have a measurable effect on the development and performance of genetic testing laboratory studies. Many changes in ownership and degree of patent enforcement lead to market confusion, which has a chilling effect on new and current research. (Merz, J.F. et al., 2002) On the other hand, these licensing effects may actually be a decrease in market rather than effects of licensing behavior (Merz, J.F. et al., 2002)