Diagnostic Kits/Effects of patents and licenses on the provision of clinical genetic testing services: Difference between revisions

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*Cho et al. 2003 - This paper addresses the risks associated with the expansion of patents on genetic sequences as it relates to the availability of genetic testing services and the viability of continued genetic testing research.  The telephone survey conducted sought to survey clinical labs who performed genetic tests for research purposes.  While the sample was limited to members of the Association for Molecular Pathology those mentioned on the GeneTests.org website, one hundred and thirty two lab directors were interviewed for the survey.  Probably most importantly the study found, “Fifty-three percent of respondents reported deciding not to develop a new clinical genetic test because of a patent or license.” (Cho et al. 2003).  Perhaps even more startling,  “as a result of patent- or license-holders exercising their intellectual property rights, one-quarter of the laboratory directors in our sample stopped performing a genetic test that they had been offering.” (Cho et al. 2003).  The study shows that now only are labs declining to develop new tests but they are stopping their current genetic test offerings as a reaction to patent or license holders.  The paper concludes that the effects of genetic patenting are significant to the development and availability of genetic tests.   
*Cho et al. 2003 - This paper addresses the risks associated with the expansion of patents on genetic sequences as it relates to the availability of genetic testing services and the viability of continued genetic testing research.  The telephone survey conducted sought to survey clinical labs who performed genetic tests for research purposes.  While the sample was limited to members of the Association for Molecular Pathology those mentioned on the GeneTests.org website, one hundred and thirty two lab directors were interviewed for the survey.  Probably most importantly the study found, “Fifty-three percent of respondents reported deciding not to develop a new clinical genetic test because of a patent or license.” (Cho et al. 2003).  Perhaps even more startling,  “as a result of patent- or license-holders exercising their intellectual property rights, one-quarter of the laboratory directors in our sample stopped performing a genetic test that they had been offering.” (Cho et al. 2003).  The study shows that now only are labs declining to develop new tests but they are stopping their current genetic test offerings as a reaction to patent or license holders.  The paper concludes that the effects of genetic patenting are significant to the development and availability of genetic tests.   
**An interesting proposition raised in the analysis was the role of the Bayh-Dole Act.  The patent holders enforcing their patents were heavily represented by universities with patents resulting from government-sponsored research.  In fact, “The 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” (Cho et al. 2003).  The paper suggests that the Bayh-Dole Act may not be enhancing technology transfer in the area of genetic testing. 
**An interesting proposition raised in the analysis was the role of the Bayh-Dole Act.  The patent holders enforcing their patents were heavily represented by universities with patents resulting from government-sponsored research.  In fact, “The 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” (Cho et al. 2003).  The paper suggests that the Bayh-Dole Act may not be enhancing technology transfer in the area of genetic testing.
**Esther van Zimmeren et al. 2006 - Alternative models to access and use of diagnostic testing services are discussed in this article.  The risks of high transaction costs standing in the way of agreement for licensing of genetic patents drive the discussion to find alternative models of access.  The article recognizes both sides of the debate when it comes the degree that these risks are present in the current market.  On one hand it cites a study from the Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation (US National Research Council of the National Academies) which shows that there is currently no substantial evidence of a patent thicket.  On the other hand, it cites several studies that find patent holders of gene based diagnostics are more active in asserting their patents which have some support for the conclusion that diagnostic kit research is currently being inhibited. 
**The article provides a useful framework for understanding the relationship between existing patent pool and clearing house models.  Patent pools are frequently addressed in articles addressing patent access but discussion of clearinghouses is relatively rare.  The analysis of clearinghouses is broken into five types.  Two types of clearinghouses provide access to information on the patented inventions: information clearing houses and technology exchange clearing houses.  Information clearing houses provide basic information related to the technology.  They have a low barrier to entry but require constant maintenance.  The technology exchange clearing house model adds licensing information to the basic information related to the technology to provide a means for initiating negations.  There are three types of clearing houses are analyzed that not only offer access to information but also facilitate the use of the patented inventions: the open access clearing house, the standardized licenses clearing house, and the royalty collection clearing house.  The open access clearing house provides free use of patented inventions.  The standardized licenses clearing house provides standardized licenses for the use of patented inventions.  The royalty collection clearing house provides standardized licenses, royalty collection, monitoring of the patents, and a dispute resolution mechanism. 
**The authors propose the royalty collection clearing house as the best solution to the access and use issues surrounding diagnostic testing services.  Clearinghouses provide the advantages of simplifying licensing negotiations, increased visibility of the patent rights, streamlining of royalty collection, and possible decreased enforcement costs.  These advantages must be considered in opposition to the many current difficulties associated with operating a patent clearing house.  The difficulties and problems of clearinghouse include having the potential for anti-competitive effects, loss of patent holder control, high levels of patent holder participation are required for success, set up of the clearinghouse is complex, standardized licenses lack flexibility found in negotiated licenses, and trade secret secrecy data cannot be easily maintained.  In conclusion, the authors warn that more research needs to be carried out to help to minimize the difficulties of the clearinghouse model and further determine the feasibility of applying it to diagnostic testing services.

Revision as of 15:32, 10 September 2009

  • Cho et al. 2003 - This paper addresses the risks associated with the expansion of patents on genetic sequences as it relates to the availability of genetic testing services and the viability of continued genetic testing research. The telephone survey conducted sought to survey clinical labs who performed genetic tests for research purposes. While the sample was limited to members of the Association for Molecular Pathology those mentioned on the GeneTests.org website, one hundred and thirty two lab directors were interviewed for the survey. Probably most importantly the study found, “Fifty-three percent of respondents reported deciding not to develop a new clinical genetic test because of a patent or license.” (Cho et al. 2003). Perhaps even more startling, “as a result of patent- or license-holders exercising their intellectual property rights, one-quarter of the laboratory directors in our sample stopped performing a genetic test that they had been offering.” (Cho et al. 2003). The study shows that now only are labs declining to develop new tests but they are stopping their current genetic test offerings as a reaction to patent or license holders. The paper concludes that the effects of genetic patenting are significant to the development and availability of genetic tests.
    • An interesting proposition raised in the analysis was the role of the Bayh-Dole Act. The patent holders enforcing their patents were heavily represented by universities with patents resulting from government-sponsored research. In fact, “The 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” (Cho et al. 2003). The paper suggests that the Bayh-Dole Act may not be enhancing technology transfer in the area of genetic testing.
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