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
We believe that the BRCA gene patent has had a profound impact by delaying and slowing the development of targeted cancer therapies for people with BRCA mutations. PARP inhibitors are a class of drugs that were developed based on scientists’ knowledge of how hereditary cancers develop in people with BRCA mutations. The drugs showed activity and early studies were promising in several types of hereditary cancers including breast, ovarian, and prostate. PARP inhibitor research has been ongoing since 2005, and today, 7 years later, the drugs have yet to gain FDA approval. After meeting with the FDA, we were told that for targeted therapies that benefit a distinct population, (such as people with a BRCA mutation) to receive FDA approval, they require that any companion laboratory test identifying a 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 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 registrations didn't meet primary end-points, likely due to the broader study population chosen, which ultimately has derailed development and approval of these agents.
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. According to the article’s authors, “Among other things, such a strategy would run contrary—at least in spirit—to a policy against extending patent monopolies beyond their terms.” “In addition, the hoarding of immensely important clinical data does not seem likely ‘to promote the Progress of Science and useful Arts.’”
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.
References
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.
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