Diagnostic Kits/SACGHS Gene Patents and Licensing Practices

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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).

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 in which, for example, a single entity holding critical

  • 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.

Case Studies

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