Diagnostic Kits/The Argument Framework

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literature relevant to each section is organized here.

Outstanding Questions

Our debate should be structured around the debate from IP scholars ("problems with patents") and what the empirical research points to ("not that much problem with patents")...we need to understand clearly both sides and be able to write about it

  • COMMENTS:
    • (Eisenberg, 2008) The problem may exist where isn't being measured: downstream of initial research at the product development stage.
    • SACGHS Final Report confuses this split in understanding by finding that patents don't incentive in this area, therefore they should be removed as barriers.

Finally, how they impact in kits...remembering the research inputs (genetic information, for instance) is different from research output (a product, such as a kit)


Thus, while we may have a "research commons" being formed by projects such as the human genomics + scientific practices of ignoring patents (as stated in the June report), we may have blocking patents later on the research outputs

  • MTAs?
    • COMMENTS:
      • Maybe, (Zhen Lei, 2009) (a survey of ninety-three US agricultural biology faculty)
        • barriers found:
          • not patents but material transfer agreements (MTAs)
            • use has increased
            • delay has increased
      • Maybe (Walsh,2007) looks at Academic Biomedical Research
      • Of the academics surveyed, "about 75% had made at least one request for materials or data in the past two years, but 18% of requests to academics and 33% of requests to industry went unfulfilled (page 29 of [1]
  • Do perceived patent licensing / infringement concerns convince researchers to focus on other areas?
    • COMMENTS:
      • I think see this mentioned as a potential problem but currently have no empirical evidence.
  • Do exclusive non-sublicensed patent licenses limit incremental improvement? Do non-exclusively licensed diagnostics experience more incremental improvement than exclusively licensed diagnostics?
    • I don't think we have conclusive information about this
      • Technological advance in particular is evolutionary- developers are often in competition with each other to improve upon the existing technology, and to echo the notes above, "strong science enables the process of designing and inventing to be more productive than it would be were the science base weaker... strong science [only] provides tools for problem solving," rather than actual practical solutions. (Nelson, 2004)
      • "In determining an intellectual property strategy for an NIH-funded invention useful primarily as a research tool, Recipients should analyze whether further research, development and private investment are needed to realize this primary usefulness. If it is not, the goals of the Act can be met through publication, deposit in an appropriate databank or repository, widespread non-exclusive licensing or any other number of dissemination techniques." (Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests)
  • Do exclusive licenses limit consumer access to genetic diagnostic products (cost and/or access?)
    • COMMENTS:
      • penumbra effect
        • tests with genes in common lead to one lab having a functional monopoly over the group of diseases that require the common gene or mutation Cook-Deegan et. al., 2009.
      • The Myriad Story
      • Cook-Deegan, 2009
        • Effect of patents on price: tests without a monopoly are priced similarly to tests with a monopoly
        • HOWEVER: Effect of patents on standards of care: Monopoly rights holders can often set the standard of care (because they are the only tester)

Despite patent challenges, research continues

Interviews with personnel from firms, universities, and other organizations indicate that biomedical research typically proceeds despite challenges posed by a growing number of patents on research tools. Respondents address these challenges with licensing, inventing around patents, going offshore, the development and use of public databases and research tools, court challenges, and simply using the technology without a license (i.e., infringement), often informally invoking a de facto broad "research exemption."

Biotech IP literature focus

Patents on genomic materials vs. compound "composition of matter" patents

The bulk of the "IP literature" around patents in biotechnology focuses either on (1) the number of patents on genomic materials (i.e., "50% of the genome is patented!") or (2) around the impact of the use of compound "composition of matter" patents on maintaining high drug prices and preventing generic manufacture.

Empirical analysis of the impact of gene patents on research is absent from the literature

While the impact of patents on drug prices is undeniable and carries a brutal human cost, very little literature is based on systematic, empirical analysis of the impact of the gene patents on research itself.

Are gene patents used in a method similar to drug patents?

Gene patents can, and occasionally are, used in a method similar to a drug patent. This occurs most frequently in gene diagnostic testing kits, which carry a regulatory profile similar to drugs, and similar if lower costs

The majority of gene patents are held by universities and remain unlicensed

But the vast majority of gene patents are obtained by universities and unlicensed, or by companies and unprosecuted.

Empirical studies suggest the negative impact gene patents have on research is limited

Thus, the empirical surveys of research laboratories in genomics and proteomics report almost no negative impacts of patents on research.

Choice of research is unaffected by patent activity

It is essential to distinguish between the number of patents extant on genetic materials, the impact of chemical patents on drug prices, the impact of genetic patents on diagnostic kits, and the day-to-day operations of a research lab. While much time and effort has been invested in chronicles of the first three, the consensus is that there is little impact on the fourth.

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