Diagnostic Kits/Overview of Economics of Intellectual Property in Kits

Where does the literature says IP works and does not work?

old notes IP

Is there data on "how much of an increase of the tendency towards enclosure or towards openness"

(ADDED TO PAPER)

• 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.
• The beginning of patenting (Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing)
  • "Myriad Genetics, Athena Laboratories (now part of Thermo Fisher) and Nymox Pharmaceuticals were among the first companies to offer their patented and proprietary assays as a service in their own laboratories." page 26
  • The patenting was controversial: The lack of access was "seen as unethical and preventing widespread access to what were considered important tests. Further, both companies pursued labs that infringed on their patent positions by offering these tests and threatened litigation." page 26
  • The report says that the controvery over these patent protects has diminished since then.

• There is a debate about the existence of a patent thicket in the current market. The Zimmeren 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. (Esther van Zimmeren et al. 2006)
  • 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. (Esther van Zimmeren et al. 2006)

• Scope of Patent Protection
  • An article by Verbeure concludes “continuous care should be taken to confer a justifiable scope of protection to gene patents” (Verbeure, et al., 2005). The report does not go as far as to conclude that patent and licensing strategies are interfering with clinical genetic testing services but that “due to the recent events, there is a strong feeling of breach of the implicit social contract comprised in the patenting system that needs to be addressed” (Verbeure, et al., 2005).

• Patent Filings by Field of Technology in World Patent Report- A Statistical Review 2008
  • Biotechnology
    • 2001: 45,573
    • 2002: 47,576
    • 2003: 44,632
    • 2004: 41,993
    • 2005: 40,861
    • Annual Growth -2.7%
  • Pharmaceuticals
    • 2001: 69,355
    • 2002: 69,160
    • 2003: 66,050
    • 2004: 68,650
    • 2005: 74,254
    • Annual Growth 1.7%

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