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Exclusive gene patent on BRCA: Adding burden to an already overburdened community

February 22, 2012

The United States Patent and Trademark Office (USPTO) is gathering information on the impact of gene patenting on genetic diagnostic in order to prepare a report to Congress under the America Invents Act. The USPTO is soliciting public commentary on this important issue by organizing public hearings. This past Thursday, Lisa Schlager, Vice President of Community Affairs and Public Policy testified on our behalf. It is our position that 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 adding additional burden to our already overburdened hereditary cancer community. You can read our more on our testimony here and our summary on the issue on our USPTO advocacy page.

In our thirteen years of advocating for and serving the hereditary cancer community, we have seen firsthand the adverse affects from exclusive gene patenting. We testified that:

  • Exclusive licensing of BRCA testing stifles research, including:
    • Research on PARP inhibitors, targeted therapy for BRCA-associated cancer: 
      Although PARP inhibitor research has been promising, seven years later the drugs have yet to gain FDA approval.  In a meeting with the FDA, FORCE was told that for targeted therapies that benefit a distinct population, (such as people with a BRCA mutation) to gain FDA approval, any companion laboratory test identifying the target population must be FDA approved as well. BRACAnalysis—Myriad’s test for BRCA mutations is NOT FDA approved. Myriad is a CLIA‐approved laboratory; they were never required to receive FDA approval in order to market their test, and it doesn’t appear that they currently have plans to seek FDA approval. Because Myriad holds the patent on the gene, no other lab can develop an FDA‐approved test to identify BRCA mutation carriers.  As a result, drug companies have opened up registration studies for the wider breast and ovarian cancer populations—comprised mostly of people who do not carry BRCA mutations. The two largest registration trials didn’t meet primary end‐points, likely due to the broader study population chosen. This has delayed development and approval of these agents.
    • Research that helps determine which BRCA genetic changes are deleterious and which are not
      BIC (Breast Information Core) is a large international consortium organized by the National Human Genome Research Institute (NHGRI), which is part of the National Institutes of Health.  BIC’s goal is to provide critical research to determine gene changes that may be cancer‐causing vs. those which aren’t. Around 2004, Myriad stopped contributing data to the BIC database.  About 7% of BRCA tests return with an inconclusive result and data from BIC is used to help better classify these variants to determine if they are cancer‐causing. According to a 2010 article in the Genomics Law Report, the company [Myriad] quietly stopped contributing data [to BIC] in favor of building its own database to retain a competitive advantage over other gene testing companies once their patent runs out.
  • Exclusive licensing negatively impacts BRCA test interpretation
    Myriad no longer contributing to the BIC database has impeded the interpretation of a type of test known as a Variant of Uncertain Significance (VUS). Once the patent does expire, the fact that Myriad no longer contributes mutation information to the BIC consortium will limit other laboratories’ ability to interpret certain test results. According to a 2011 article from the New York Times, withholding this data may provide a competitive benefit to Myriad over other laboratories after their patent expires. But it comes at the cost of critical information that could help provide information to families that have inconclusive genetic test results right now.
  • The excessive cost of testing limits access and negatively affects clinical care
    There is now evidence-based information demonstrating that identifying those who have the highest risk for breast and ovarian cancer can lower breast, ovarian, and all-cause mortality through genetic testing and surgical prevention. The cost of prevention, both in dollars and human lives, is less than the cost of treating cancer once it is diagnosed. Yet, people are being denied access to critical health information due to the excessive cost of BRCA testing. Financial assistance for BRCA testing is limited, especially for people who have any type of health insurance.With patent exclusivity and a monopoly on the test, Myriad has increased the cost of their test even as the cost of genetic technology and gene sequencing has gone down. Due to the exorbitant price, some insurers are no longer covering the cost of BRCA testing.

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.

The USPTO will be convening a second public hearing on Friday, March 9, 2012, beginning at 9 a.m., Pacific Standard Time (PST), and ending at 4 p.m. in San Diego, California. Testimony from both hearings will be available via webcast on the USPTO website. They are also accepting written public commentary sent by email to genetest@uspto.gov.

We would like to hear what you think about this issue. Please fill out our short survey and share your opinions on the impact of exclusive patents on BRCA or other genes.
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