Diagnostic Kits/SACGHS Gene Patents and Licensing Practices: Difference between revisions
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Concerns: | Concerns: | ||
*Change in laboratory research due to actual or anticipated patent or license enforcement. | *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 | *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. | *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 | *Exclusive licenses affect on method validation and proficiency testing by peers | ||
Revision as of 11:00, 1 October 2009
Secretary's Advisory Committee on Genetics, Health, and SocietyâPublic 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
- 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