Diagnostic Kits/The licensing of DNA patents by US academic institutions
Pressman, L. et al., 2006. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotech, 24(1), 31-39
"Our analysis reveals not only that large US research universities are active participants in DNA patenting and licensing, but also that common assumptions about licensing strategies often fail to capture the nuances and complexities of technology transfer in practice."
Genes are tools and outputs of research
- Research tools: "ideas, data, materials or methods used to conduct research." (Pressman, L. et al., 2006)
- "The gene patent subset of DNA patents has also been drawn into the research tools debate because genes are not only inputs to developing genetic tests and therapeutic proteins, and thus directly relevant to medically important products and services, but are also crucially important tools for ongoing research." (Pressman, L. et al., 2006)
Licensing
- The National Institutes of Health is a major source of resource biomedical funding.
- The funding power held by the National Institutes of Health has allowed it to create "guidelines for grantee institutions about how to license biomedical research resources arising from federally funded research." (Pressman, L. et al., 2006)
- Agreeing to comply with the licensing guidelines is a factor in receiving National Institutes of Health funding.
- These guidelines apply to all genomic inventions and are published under: Best practices for the licensing of genomic inventions. Federal Register 70, 18413-18415 (2005).
- The guidelines favor "broad and nonexclusive" licenses
DNA Patent Ownership Data
- "Roughly 78% of US DNA patents are owned by for-profit entities and 22% by nonprofits." (Pressman, L. et al., 2006)
Research-Use Rights Academic institutions involved in the research survey retained research-use rights for themselves (a shop right) and included a right to transfer these research-use rights to other nonprofit institutions in their license.
Academic Licensing Data Of the 19 responding tech transfer offices, "approximately 70% of the 2,607 managed patents have either been licensed in the past or are still under license." (Pressman, L. et al., 2006)
Exclusivity
- two types were considered by this study:
- exclusive, all fields of use
- exclusive, by field of use
- Data on exclusivity is unclear because it often does not differentiate between these two types.
- Many times, company type, determines level of exclusivity
- "Startups have, in nearly all cases, exclusive licenses, although only about two-thirds have 'exclusive, all fields of use' licenses" (Pressman, L. et al., 2006)
- The larger the company, the less likely the license is to be exclusive
- Milestones (required showings of progress) are almost twice as likely in exclusive licenses as compared to non exclusive licenses. (Pressman, L. et al., 2006)
- "Several reports from national and international bodies note that genetic testing applications require far less investment after initial gene discovery than development of therapeutic proteins, and so the rationale for exclusive intellectual property rights may be less compelling7, 8, 9, 10, 11." (Pressman, L. et al., 2006)
- Footnote 8 Commission on Intellectual Property Rights. Integrating Intellectual Property Rights and Development Policy (Commission on Intellectual Property Rights, London, September 2002). http://www.iprcommission.org/papers/pdfs/final_report/CIPRfullfinal.pdf (accessed October 13, 2005).