The US Supreme Court Is Deciding If Genes Can Be Patented – And Why We Should Care
Posted Apr 15 2013 7:45pm
When I was tested for the BRCA mutations – I was lucky. My insurance covered both the genetic counseling session as well as the egregiously expensive mutation screening. For a full panel, the test costs $4,000. For someone without insurance, or whose insurance company does not cover the test, that is a significant financial barrier which very few of us could break through.
But why is it so expensive? The answer is simple. Myriad Genetics, the company who “won the race” to patent the BRCA genes is the only entity legally allowed to carry out the mutation screening. And they’ve kept the cost of the test artificially (and laughably) high. Why? Because they can.
But Myriad has been challenged. In 2009 the American Civil Liberties Union filed a lawsuit challenging Myriad’s patent on genes. And today, the supreme court has heard oral arguments both from Myriad as well and the ACLU on the constitutionality of patenting genes. Myriad claims it’s no different that patenting a baseball bat made from a tree. The ACLU claims that Myriad has made no creation in this matter – our genes occur in nature and while the process uncovering them may be patented, the genes themselves cannot.
Why we should care? BRCA mutations affect 1 in 300 of us. Only 10% of breast cancers are attributed to these mutations. It matters because this case will set precedent for the future of our genes.
Let’s for a minute imagine a world where human genes are patentable (today 20% of human genes are patented). Imagine what that would do in terms of access to care and incentives to invest in research. Once one company has patented a gene, additional research relating to that gene belongs to them, effectively ruling out any other research. BRCA genes aren’t the only ones that matter in terms of disease prediction. Imagine you had to pay thousands of dollars to figure out whether you were highly susceptible to diabetes, heart disease, or other cancers. Imagine a scientific world where innovation is determined by a race to patent instead of research driven discoveries.
Sue Friedman, founder of FORCE wrote a post about the status of the BRCA genes and patents. I’ve quoted some of her article here which delves a bit deeper into the Myriad Corporation.
In the film, Joanna brilliantly follows the Myriad interview with an interview of Dr. Mary-Claire King, who was credited with identifying the location of the BRCA gene when she was a researcher at University of California at Berkeley. Dr. King has dedicated herself to the research that proved the existence of hereditary breast cancer gene mutations. Her research laid groundwork that sent many laboratories racing to be the first to isolate and clone the gene for genetic testing.
In Rudnick’s film, Dr. Skolnick says, “I think the single greatest inventive thing I did was to create Myriad. We did it to win the race…and we won.” Asked point-blank why the cost of the test is increasing, Dr. Skolnick replies, “that’s a good question, and I think there’s a point at which we have to start looking at decreasing the cost of the test.” Yet, four years after the documentary was released, the cost of testing has gone up—BRCA testing is more expensive, even though the technology for sequencing DNA has become less expensive.
The gist of Dr. King’s interview starkly contrasts with Dr. Skolnick’s statements. Dr. King speaks about genes for which she holds patents, saying, “The critical thing about the patents we hold is that none of them are exclusively licensed. So they are completely open for anyone to use for research purposes and any company that wishes to license them can license them for a trivial amount of money.” King mentions that her last royalty check amounted to $2.73. In contrast, the February 6 edition of the Salt Lake Tribune reports Myriad’s earnings: ”Myriad projects full-year 2013 revenue will fall between $575 million and $585 million. That would be a 16 percent to 18 percent increase over fiscal 2012.” The contrast is apparent and appalling.
Over the years, FORCE has appealed to government agencies and spoken to the health care community and the public regarding Myriad’s exclusive patent, and explained how the corporation’s marketing strategies and policies have increased the burden on the hereditary cancer community that we serve. In 2008 and again in 2009 we testified to the Secretary’s Advisory Committee on Genetics Health and Society , expressing our concerns with direct-to-consumer marketing of genetic tests, and specifically Myriad’s marketing practices, which we feel encourages BRCA testing without first receiving genetic counseling from qualified experts trained in cancer genetics. In our opinion, their aggressive marketing strategies have been harmful to members of our community.
For those who wish to learn more about Dr. King’s work, Decoding Annie Parker is a new movie that follows the parallel lives of Dr. King and Annie Parker, a Canadian woman whose family was impacted by hereditary cancer. Based on a true story, the film raises the profile of Dr. King’s contribution to the discovery of hereditary breast and ovarian cancer syndrome and the BRCA1 gene mutation. It is sure to resonate with many in our community. FORCE is a proud charity partner of the movie, which stars Helen Hunt as Dr. King. A special screening will be held April 2 in New York City. FORCE will hold screenings of the film in other cities. Stay tuned for updates.”
Well put Sue. And here’s hoping that in the not too distant future, millions of Americans can put that $4,000 to better use.