Report September 2009

Status Report, ICP Project

Biotechnology: 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)
      • A study found that for profit and non-profit entities approach patent and licenses differently: (Henry, M.R. et. al., 2003)
        • Patenting Behavior
          • For profits more often file 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

Alternative Energy

General Status

Status of Technology and Market Knowledge

• We have spent the month working on an update paper on the research we have completed to this point including:
  • History of the market for solar PV and solar CSP, wind, and tidal wave technologies.
  • History of the supply-push (R&D and demonstration funding) policies that have been used in the US to encourage development of these alternative energy technologies
  • History of the demand-pull (subsidy and deployment funding) policies that have been used to encourage the market for the alternative energy technologies.
  • A closer look at the breakdown of private R&D funding vs. public R&D funding and how much public R&D funding is being awarded to universities and academic research centers.
  • The more recent discussions related to the United Nations Framework Convention on Climate Change (UNFCCC) and the design of a replacement treaty to the Kyoto protocol which expires in 2012. Central to these discussions are debates about the use of compulsory licensing for clean technology that could be critical to climate change mitigation. This portion of the paper has taken our research in a distinctly different direction than our original plans had outlined:
    • The most current issues around IP in the alternative energy market are the debates around whether compulsory licensing should be used to compel developed countries to license their patents to developing countries when the technologies are critical to climate change mitigation efforts.
    • This debate involves a north-south world component, which was not the original focus of our research.
    • This debate concerns all clean technologies, rather than just alternative energy technologies (i.e. - in our research - solar wind, and tidal/wave).

Status of Intellectual Property Knowledge

• We have established that the main intellectual property tool we are research are patents. There is a component to the research that could theoretically involve copyright, but this is based on the publish of enzyme research for biofuels production, and biofuels are not one of our targeted technologies.
  • Patents
    • The market is quite young and each of our targeted technologies has a different history of market subsidies and development so the history of IP knowledge differs greatly.
    • There has been a general, overall increase in patents since the early 2000s in clean technologies, which are defined as both alternative energy technologies, and energy efficiency and carbon capture technologies. This has been tracked through the Clean Energy Patent Growth Index
    • Wind
      • Wind technology for electricity production had its genesis in the US in the 1970s. The main mechanical aspects of modern turbines were developed and patented in Denmark in the 1950s and today new patents are only being developed for improved efficiency systems like the drivetrains, blade aerodynamics, and gear boxes.
      • The wind turbine market has shown consolidation and companies like GE are known for aggressively defending their patents.
    • Solar
      • Solar photovoltaic (PV) and concentrating solar power (CSP) technologies have been on the market in the US since the 1970's but have suffered from very high costs and low efficiencies, which have necessitated large government subsidies. The subsidies have been subject to inconsistent application due to varying political priorities over the years and different administrations.
      • The market shows some consolidation, though many different companies manufacture many different parts of the panels, and the advent of thin-film panels has resulted in increasing patenting activity.
    • Tidal/Wave
      • The tidal/wave technology industry is a very recent development, and these technologies have very little adoption throughout the world.
      • Patenting has been increasing in these technologies, but the market is waiting for the encouragement of government subsidies to decrease costs to the developer, and there have been hold-ups due to the difficulty of receiving permits to conduct offshore test trials. These difficulties point toward the increased complications that will be faced in receiving permits to actually construct working offshore tidal/wave energy plants.

• • General IP knowledge
    • It is evident that, predictably, as more government and private R&D (as well as venture capital (VC) and private equity) funds are allocated toward these technologies, more patents are filed for. These measures indicate that new innovation is likely happening.
    • The complicated relationship of the technologies with government subsidies have created an artificial market which is subject to periods of feast or famine throughout the world. The US has been very inconsistent with subsidies and is therefore falling behind in technology development, while Europe and Japan has been largely consistent with subsidies and have attained more dominant positions in the market.
    • China, a late entrant to the alternative energy and clean technology race, has entered the market with prodigious subsidies and a rapidly growing manufacturing presence of low-cost wind and solar technology. they have established themselves as a dominant player in the technology market in a very short period of time.
    • the debates around compulsory licensing for critical climate change mitigation technologies have been pushed for by emerging economies such as China, India, and Brazil.
      • The US Secretary of Energy, Steven Chu, has agreed with the reasoning for sharing IP, but the US Chamber of Commerce has led a largely successful effort to ensure that the US will not loosen IPR for the UNFCCC treaty.

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

Bibliography and Paper Organization

• The bibliography continues to grow, though it is not up to date in the wiki due to the efforts to compete the update paper, which have necessitated a break from wiki work.
  • While we are trying to stay true to the original focus of the research on wind, solar and tidal technology in the US and select other countries, the debates around the UNFCCC discussions for the Copenhagen Summit in December 2009 are the most current examples of IP issues in this field.
  • Once the paper is complete all the relevant information that isn't already in the wiki will be entered.

Work Completed

• Overall picture of the field
• IP profile of the biggest for-profit companies in AE

Work Partially Completed

• Overview of economics of IP in AE
• Country AE profiles
• Innovations in wind, solar and tidal
• IP in AE
• Competitive Advantages in AE
• IP profile of non-profit companies in AE
• IP profile of universities in AE
• IP profile of Associations in AE
• Commons-based cases in AE

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