Note: We will be updating this page as we learn more about the implication of the rulings from our lawyers and partners.
What does this gene patent ruling mean for me?
1. As a result of this ruling, there will now be more companies that can develop BRCA 1 and2 tests, therefore women, and men, concerned about hereditary risk of breast and other cancers will have improved access to genetic testing. The same day the Supreme Court issued its ruling at least 5 companies announced they would offer BRCA testing at a fraction of Myriad’s BRACAnalysis test. Women who could not afford the $3,000-4,000 dollars for Myriad’s test or whose insurance did not have a contract with Myriad, will now have lower-cost options.
2. For the first time, women who are considering their medical options will have access to second opinions. Myriad’s test has never been peer-reviewed and the FDA does not regulate genetic tests. Second opinion testing is particularly important for women considering removing healthy organs to reduce the risk of cancer as well as for women who have received an ambiguous result from Myriad’s test.
3. All labs, clinics, researchers and doctors now have access to the human BRCA genes, opening the door to research and studies in new areas that may lead to clinical advances in diagnosis, risk reduction, and treatment in breast and other cancers.
4. Research and treatment for all hereditary diseases can now advance without fear of patent infringement. This sweeping ruling ensures that the fundamental building blocks of life, our DNA, are available for scientific and medical inquiry and advance.
What does the cDNA ruling mean for the decision to invalidate human genes?
The central question of this case centered on whether or not human genes (DNA) are a product of nature. Under U.S. patent law, products of nature are not patent eligible. The Court decision on the Myriad case determined that DNA is not patentable but cDNA is patent eligible. This means that unlike DNA, which is a product of nature, the Court defines cDNA as a human creation, and not a product of nature. However, declaring cDNA patent eligible is not the same as ruling on whether or not cDNA meets all the additional criteria and requirements for a patent license under the U.S. Patent Act. The Court did not endorse patents on cDNA in general. The case does not address these issues, and genetic and legal experts involved in this case believe that the cDNA issue will only be resolved in time.
The impact of this ruling for patients is not diminished even if cDNA patents are upheld because next generation sequencing means that laboratories can conduct genetic testing without using cDNA.
What is the impact of Myriad’s keeping all their biodata for themselves?
Myriad has been hoarding vast amounts of biodata accumulated as a result of BRCAnalysis testing for over 15 years. In an effort to counter Myriad’s data hoarding, in recent years, a team at UCSF led by Dr. Bob Nussbaum has been spearheading an effort to collect BRCA 1 and 2 variant data in ClinVar, an accessible archive of anonymized genotype/phenotype information hosted by the National Center for Biotechnology Information (NCBI). Obviously, Myriad’s 15 year patent gave them a monopoly and a head start.
Even after this ruling, Myriad gets to maintain their proprietary database and treat all genetic information therein as proprietary trade secrets rather than knowledge to be shared for the public good. The value of Myriad’s database will diminish over time as publicly funded research identifies disease-associated and neutral mutations. There are currently efforts to accelerate this. However, by freeing DNA, the building blocks of life, this far-reaching ruling opens the door to research and treatment for all hereditary diseases and firmly put patients before corporate profits.
Should people who got BRCAnalysis testing but not BART, now get BART testing?
If you have questions about whether or not your BRCA test was complete and whether or not to have the BART test, talk to a genetic counselor.
Does this invalidate all patents on isolated human genes?
The Court’s ruling applies to any patents on isolated genes including the many other patents the U.S. Patent and Trade Office has issued. In order for challenges to arise on other gene patents, a patent holder would have to try to enforce their patent rights in order for the question of the validity of that patent to be decided. We’ll have to see if any patent holder tries to enforce their rights against other labs.