Diagnostic Kits/SACGHS Gene Patents and Licensing Practices

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 (Draft Report for Public Comment) [excerpts]. Biotechnology Law Report, 28(3), 417-442 (2009). Available at: http://oba.od.nih.gov/SACGHS/sacghs_documents.html#GHSDOC_011

Concerns:

• Change in laboratory research due to actual or anticipated patent or license enforcement.
• The inability to "invent around" the a genetic patent to create an equivalent, but non-infringing test
• Potential for "hold-out" issues
• The ability of technology owners to charge unfair or disproportional fees despite owners inability to fully implement the test.
• Exclusive licenses affect on method validation and proficiency testing by peers
• The need for multiple patents and multiple licensing agreements with different patent holders leading to complexities that act as a barrier to product development.

Current Effect of Concerns?

• there is a lack of evidence that patenting poses a problem with access to DNA-based technology or the development of new technologies,
• Despite this lack of evidence, "there is persistent concern that some DNA-based patents may be too broad or obvious and that overly broad claims and/or restrictive licensing may be (or may be poised to) adversely affect public access to and use of these new inventions, especially in the context of diagnostics ...."

Case Studies

• testing for Canavan's disease
• testing for BRCA1/2 for breast cancer

Types of Patents Associated with Genetic Tests

1. processes "a series of steps to produce a given result"
2. machines "apparatuses"
3. manufactures "defined broadly to capture useful technology"
4. compositions of matter "synthesized chemical compounds and composite articles"

Key Findings from the Case Studies

• "whether the prospect of a patent encouraged researchers to search for gene-disease associations that could be developed into a genetic test"
  • patents were not the major force motivating scientist
• "the role patents play in the development or commercialization of a genetic test based on a discovered gene-disease association"
• an incentive to commercially develop a genetic test
• "the effect of patent(s) and licensing practices on the price of a genetic test"
  • could not reach definite conclusions due to lack of comprehensive data
• "the effect of patent(s) and licensing practices on the availability of a genetic test"
  • no evidence of any limitations on availability
• "how patent(s) on a genetic test and the related licensing practices affected the ability of others to innovate on the test"
  • The more licensed providers, the more innovation. Sole providers were not innovative.
• "the prospect that a patent or licensing practice may cause a particular harm to genetic testing in the future."
  • the barrier is possible in the future

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