FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding and insurance and privacy.
We believe that the exclusive gene patents of the BRCA 1 and BRCA 2 genes held by Myriad Laboratories has had a detrimental impact on the community we serve.
We requested that as the USPTO studies the impact of gene patenting on genetic diagnostic tests, they consider a number of important issues. We feel that the patenting of BRCA 1 and BRCA 2 has negatively affected the community we serve and has added to the already disproportionate cancer burden that our constituency shoulders. FORCE commented specifically on the impact exclusive licensing has on the areas of clinical care and research:
Gene patenting stifles research
Exclusive licensing has negative impact on test interpretation
Myriad no longer contributing to the BIC database has impeded research on 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. In effect, this will extend Myriad’s monopoly on testing. Based on a 2010 article from the New York Times it appears that withholding this data may provide a competitive benefit to Myriad over other laboratories after their patent expires at the cost of critical information that could help provide information to families that have inconclusive genetic test results right now.
Excessive costs of testing impacts 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, including Medicaid. Thus, if a health insurance company denies coverage for BRCA testing, patients often are faced with paying 100% of the costs out-of-pocket, or forgoing this valuable diagnostic test altogether.
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. The full-sequencing BRCA testing costs about $3500, making it cost-prohibitive for many people. Further, Myriad charges an additional $750 for expanded testing known as BART to look for mutations known as large rearrangements in some people who test negative with full BRCA sequencing.
Due to the exorbitant cost of testing, some payers (most recently Tricare, which insures over 9 million members of the Armed Forces, including active duty service members, retirees, spouses and dependents) are no longer covering BRCA testing for their patients.
In 2010, the Secretary’s Advisory Committee on Genetics Health and Society submitted a report to Secretary of Health Sebelius on the topic of gene patenting. 'sACGHS studied the issues extensively, and has expertise in regards to genetic testing, research and related costs. We encouraged the USPTO to adopt, or at the very least, to cite the SACGHS recommendations when reporting to Congress on the results of these hearings. Additionally, we suggested that it might be prudent to place a moratorium on the issuance of gene patents until their impact has been studied in greater depth.
How Will Myriad Respond to the Next Generation of BRCA Testing? Genomics Law Report. March 2011.
Despite Gene Patent Victory, Myriad Genetics Faces Challenges. Andrew Pollack. New York Times, August, 2011.
Page updated 02/18/12