Diagnostic Kits/Priorities for Personalized Medicine

Priorities for Personalized Medicine, Council of Advisors on Science and Technology (PCAST), September 2008 Available at: http://www.ostp.gov/galleries/PCAST/pcast_report_v2.pdf

• "The President’s Council of Advisors on Science and Technology (PCAST) believes that the convergence of scientific and clinical opportunity and public health need represented by personalized medicine warrants significant public and private sector action to facilitate the development and introduction into clinical practice of this promising class of new medical products." (page 1)
• This report remains relevent to our research due to its description of the diagnostic tools used in personalized medicine including:
  • Molecular Diagnostics
  • Personal Genomes and Genetic Profiles

• Recommended Patent Exemption: "The US Secretary’s Advisory Committee on Genetics,Health, and Society (SACGHS) has recommended the “creation of an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care purposes”.146 A more convoluted and narrow exemption could not have been thought up and it begs the question: how can an independent committee made up of experts in the fields of intellectual property law and the relevant sciences conclude that a human gene is an ‘invention’ and therefore legally entitled to patent protection? Is not the patent system only about protecting ‘inventions’ and not discoveries? (PCAST, 2008, page 28)