Report September 2009

Status Report, ICP Project

Diagnostic Kits

General Status

Status of Scientific and Market Knowledge

• We have created a glossary of research vocabulary that has a allowed us to better define the field.
  • Some terms of note: Analyte Specific Reagents (ASRs) are key diagnostic reagents sold individually to CLIA-licensed Reference labs, which use them to construct in-house "homebrew" tests that are functionally equivalent to more rigorously-regulated diagnostic kits.
• History of the market (Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing)
  • A trend towards consolidation (all discussed on page 25)
    • "[T]he 1980s and 1990s saw the establishment of some 7000 independent reference labs." page 25
    • "In 2008, there are approximately 3000 small reference labs in the U.S." page 25
    • 1995 Labcorp of America: was formed by the merger of National Health Laboratories and Roche Biomedical Laboratories page 25
    • 1996 3 main players in the market: Labcorp of America, Corning, and SmithKline Beecham (Beckman) page 25
      • 1997 Corning created Quest Diagnostics as an entity to hold their laboratories page 25
      • 1999 Quest Diagnositics purchased the laboratories of SmithKline Beecham page 25
    • Since 1999, LabCorp and Quest have been the two largest independent labs in the U.S.

Status of Intellectual Property Knowledge

• We are developing a better understanding of the intellectual property landscape and have established that a wide variety of protections are used including: patent, trade secrets, NDAs, Non-compete, non-solicitation, confidentiality agreements. Economics of IP & IP
  • Patents
    • History of the market shows a trend towards consolidation (Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing)
    • There has been "an increase in patents on the inputs to drug discovery (“research tools”)." (Cohen et. al., 2003)
      • no substantially barriers have been found as a result of this increase in patents on the inputs to drug discovery (Cohen et. al., 2003)
      • no substantially barriers found to university research (Cohen et. al., 2003)
      • THE EXCEPTION: "Restrictions on the use of patented genetic diagnostics, where we see some evidence of patents interfering with university research, are an important exception. There is, also, some evidence of delays associated with negotiating access to patented research tools, and there are areas in which patents over targets limit access and where access to foundational discoveries can be restricted. There are also cases in which research is redirected to areas with more intellectual property (IP) freedom. Still, the vast majority of respondents say that there are no cases in which valuable research projects were stopped because of IP problems relating to research inputs." (Cohen et. al., 2003)
    • The perception of rising patent litigation rates in the area of DNA-based patents is most likely false (Mills, A.E. & Tereskerz, P., 2008)
    • A patent thicket?
      • 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, patent holders of gene based diagnostics are more active in asserting their patents which gives some support for the conclusion that diagnostic kit research is currently being inhibited. (Esther van Zimmeren et al. 2006)
    • Justifiable scope of protection for gene patents
      • This topic is rarely discussed in the literature (Verbeure, et al., 2005) but the implications of broad or narrow claim recognition are important to our research.
    • 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).
  • Licenses
    • Four licensing approaches: (Geertrui Van Overwalle et al., 2005)
      • Free access to the genetic sequences but royalty payments for the commercial test kits
      • Licensing to laboratories at a rate that makes the commercial test kit more economical
      • Exclusively licensing to a limited number of laboratories
      • Biological Innovation for Open Society license that makes improvements to the patent shared as a way to facilitate cooperative invention.
    • Licensing Behavior
      • The likelihood of granting a license for patented DNA sequenceswas was found to be similar for firms and nonprofits but nonprofits were far more likely to grant exclusive licenses. This use of exclusive licensing demands further study to find out if the use of these licenses is justified or merely a default practice with little substantive justification. (Henry, M. et al. 2002)
      • Changes in patent ownership and licensing complexities can have measurable effect on the development and performance of genetic testing. (Merz, J.F. et al., 2002)
      • The study found that for profit and non-profit entities approach patent and licenses differently: (*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)
    • • • Patenting Behavior
          • For profits more often fill patent applications for all new technologies and then deciding what to pursue based on commercial interest.
          • Non-profits were more selective about when to apply for a patent.
        • Licensing Behavior
          • For both entities, licensing was most often used as a method of commercialization. Licensing for research was very infrequent.
            • One important difference found was that nonprofits were more than twice as likely to license exclusively as compared to for-profit companies.

• • Trade Secret
    • The importance of this was made clear in our interview with Andrew W Torrance
    • Trade Secret is used to early development, and it supplements patent protection later in the value chain
    • Strong confidentially, non-solicitation, assignment, & Noncompete Agreements enable the protection of Trade Secret data.
    • Even with a patent license, the knowledge transferred by the patent is often not enough to reverse engineer

• No open business models have emerged in the literature or through interviews.

Bibliography and Paper Organization

• We have developed a bibliography with literary reviews of the key articles.
  • We have found that genetic diagnostic kits are probably best suited for this study
• We recently addresses the organizational needs of the paper in a few ways
  • We added a new Diagnostic Kits section called Structured_Rational_for_the_Paper
    • This section includes:
      • The Argument Framework
      • Bibliographic Needs
  • More importantly the heading for the Bibliography is now a link to a page that organizes the Bibliography according to the papers argument framework.

Work Completed

• Bibliography with Literature Review
• Glossary (v.1)
• The Problems of Patents on Diagnostic Testing Kits - exploratory brief (07/09)

Work Partially Completed

• Overview of Economics of Intellectual Property in Kits
• IP in Kits
• IP Profile of Universities working in Kits
• Commons based cases in Kits
• Interviews with experts on diagnostic kits
• Give an overall picture of the Kits' sector

Work Remaining

• Data, narratives and tools produced by the Kits' sector
• Competitive advantages in Kits
• IP Profile of Biggest for-profit companies in Kits
• IP Profile of non-profit companies in Kits
• IP Profile of Associations in Kits
• Peer-Production Business models in Kits
• Open Business models in Kits

Research Methodology in use

• Case studies
• Literature review
• Industry analysis
• Business reports and press releases
• University reports and press releases

Problems and Considerations

• How can we learn more about the use of trade secret protection of data?
• What information should we aim to obtain through interviews?
• Should we focus on genetic diagnostic tests exclusively?
• Are gene patents used in a method similar to drug patents?
• Should research on patent pools and clearinghouses be developed further or is the current research sufficient?
• We need more market data to support claims that test prices are high (ie. Myriad Genetics and BRCA1 and BRCA2)

Next Steps

• Continue to add information to the research methodology. Specifically, increase information about University contributions.
• Continue to interview experts in the field
• Look into the Bilski case (can't patent human steps) because this may determine the patentability of claims