Project 1
Clinical Genetic Testing
Case Studies on the Impact of Gene Patents and Licensing Practices on Access to Genetic Testing
In mid-2006, the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) appointed a task force to address the impact of patenting and licensing on clinical access to genetic testing, chaired by Dr. James Evans of the University of North Carolina. In late December, the task force contacted the Duke Center for Public Genomics (CpG) about doing background research. The graduate and professional student capstone section of Duke's Health Policy Certificate program program made the task force its client. Professor Christopher Conover, the capstone director, and the six graduate and professional students were joined by CpG researchers. The group prepared analytical background and "case studies" of seven clinical conditions, and then presented their preliminary findings to the task force in March 2007. Two more case studies were added that summer through the CpG summer student research training program, and another in late 2007. CpG staff and investigators revised the initial student reports by adding more detailed patent landscapes, interviews with stakeholders, and detailed documentation.
In addition to presenting at several SACGHS and task force meetings and participating in teleconferences, we prepared a background analysis, eight case studies of 10 clinical conditions, a 100-page task force discussion guide, and a 40-page discussion guide for the full SACGHS. In total, the Duke CpG prepared over 500 pages of materials.
The case studies were released in March 2009 as a 300-page appendix to the SACGHS public comment draft of its forthcoming report. The case studies can be found here as Appendix 1.
Contents of Appendix 1
- Impact of Patents and Licensing Practices on Access to Genetic Testing for Inherited Susceptibility to Cancer: Comparing Breast and Ovarian Cancers to Colon Cancers
- Impact of Gene Patents and Licensing Practices on Access to Genetic Testing for Alzheimer’s Disease
- Impact of Gene Patents and Licensing Practices on Access to Genetic Testing for Cystic Fibrosis
- Impact of Gene Patents and Licensing Practices on Access to Genetic Testing for Hearing Loss
- Impact of Gene Patents and Licensing Practices on Access to Genetic Testing for Hereditary Hemochromatosis
- Impact of Gene Patents and Licensing Practices on Access to Genetic Testing for Long QT Syndrome
- Spinocerebellar Ataxia: Patient and Health Professional Perspectives on Whether and How Patents Affect Access to Clinical Genetic Testing
- Impact of Gene Patents and Licensing Practices on Access to Genetic Testing and Carrier Screening for Tay-Sachs and Canavan Disease
In addition, the team published a commentary in Nature, which notes how patenting and exclusive licensing could create genetic testing monopolies for clinical conditions, and suggests some solutions.
Cook-Deegan R, Chandrasekharan S, Angrist M. The dangers of diagnostic monopolies. Nature 2009 March 26; 458(7237):405-6. NIH MS ID 105466 (PMC ID - In Process.) Available here.
Supporting documents
William Rusconi. Presentation at the National Academies. Patenting and Licensing of the Breast Cancer Susceptibility Genes - BRCA1 and BRCA2. February 11, 2005. Available [here].