Myriad Genetics Finally Relinquishes Monopoly on BRCA Genes

Karuna Jaggar headshotBy Karuna Jaggar, Executive Director

Since 2009, we’ve been working to improve and expand access to genetic testing to help predict women’s breast cancer risk – specifically BRCA1 and BRCA2 genes, often referred to as the “breast cancer genes”. We’ve done this work with the dedicated and talented team at the ACLU as well as a number of committed partners across the world. This week, we saw a significant turning point as Myriad Genetics, the company that has held (and vigorously protected) a long-standing monopoly on BRCA testing, finally gave up their long fight to maintain a monopoly on these human genes. This is a huge win for women living with and at risk of breast cancer everywhere.

Even after the U.S. Supreme Court issued their historic (and unanimous) ruling in June 2013 that naturally occurring DNA is not patentable, Myriad filed suit after suit against other companies that offered genetic testing for the human BRCA 1 and BRCA 2 genes. Many people assume that the Supreme Court’s rulings are the final word, but as anyone who watches legal maneuverings knows, it is sometimes only the beginning.

Why would Myriad Genetics so persistently seem to disregard the Supreme Court’s ruling? How can Myriad lose at the Supreme Court and then spend the next 20 months (and millions of dollars) going after competitors which provide BRCA genetic testing?

The answer lies in the fact that Myriad had everything to gain (and only a fraction of their fortune to lose) in tangling up their smaller competitors in expensive and time-consuming lawsuits. With nearly $9 million in monthly revenue from BRCA testing, anything to prolong their monopoly by even a few months is money well spent for Myriad.

As the watchdog for the breast cancer movement, Breast Cancer Action is not in the business of siding with one company over another in corporate lawsuits. We hold all genetic testing companies to the same standards. We will work to make sure all genetic tests are properly validated—that is, the test results mean what the company says they mean. We will work to stop corporate hoarding of (and profiteering from) people’s biodata, which limits and slows research for the public good. We insist that any genetic test comes with independent professional genetic counseling to help walk people through their test results and what they mean. We work to ensure access for women who need the test, including uninsured and under-insured patients. And we guard against inappropriate corporate marketing that feeds on (and drives up) people’s fear or otherwise oversells the benefits of genetic testing.

We evaluate all companies offering genetic testing to these standards. We’ve long been critical of Myriad’s failures on these issues and we know that we need to hold companies that are new to the breast cancer genetic testing market to these same patient-centered standards.

Yet, when Myriad asked the courts to prohibit other companies from offering BRCA testing, we stepped in and joined the ACLU and others in filing a “friend of the court” brief explaining that Myriad’s monopoly harmed public interest. Myriad’s monopoly on the breast cancer genes has harmed women’s health in a number of ways: limited access because of high testing costs; no second opinions; hoarding data and limiting research for the public good; blocking the development and availability of alternative tests and targeted therapies; and inadequate information for underserved populations.

The Federal Circuit last month upheld the earlier decision by a federal district judge in Utah which allowed companies to continue BRCA testing even as they were being sued by Myriad. If Myriad’s lawsuits were always about extending their monopoly—rather than a sincere belief that their patents would be upheld despite the Supreme Court’s ruling—this ruling meant that Myriad was throwing money down the drain to pursue their legal claims. Game over.

And so this week, it appears Myriad has finally stopped their quest to retain their monopoly on the BRCA genes. They’ve announced they’re settling or will settle with other companies offering genetic testing for BRCA mutations.

While ending Myriad’s monopoly on the breast cancer genes is critical for women’s health, that doesn’t mean other companies who jump into the mix are necessarily doing the right thing by women’s health. As BCAction members know, corporations must always be held accountable – profits rule in our healthcare system, and we must be vigilant about making sure patient interests are prioritized.

This entry was posted in BCA Action Alerts.