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Testimony to USPTO on impact of exclusive gene patents

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Read our prior testimony to the USPTO.

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The awarding of an exclusive patent for the BRCA 1 and BRCA 2 gene to Myriad Genetics has adversely affected access to care and research specific to hereditary breast and ovarian cancer. The United States Patent and Trademark Office (USPTO) is conducting hearings to determine:

  • The impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses;
  • The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test;
  • The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures; and
  • The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

FORCE's concerns

  • We are concerned and testified that exclusive licensing of BRCA testing stifles research, including:
    • Research on PARP inhibitors, targeted therapy for BRCA-associated cancer
    • Research that helps determine which BRCA genetic changes are deleterious and which are not
  • We believe exclusive licensing negatively impacts test interpretation
  • Further, we believe that the excessive cost of testing limits access and negatively affects clinical care

FORCE recommendations to USPTO

FORCE asked the USPTO to place a moratorium on issuing further gene patents until the impact on access to care and research had been better studied. Additionally, in 2010, the Secretary’s Advisory Committee on Genetics Health and Society (a panel of experts convened through NIH to report to the Secretary of Health on issues related to genetics and health care) submitted a report to Secretary of Health Sebelius on the topic of gene patenting. We encouraged the USPTO to adopt, or at the very least, to cite the SACGHS recommendations when reporting to Congress on the results of their hearings.¬†You can read more about our testimony here.

 

Page updated 02/17/13

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