Guest post by Sue Friedman
On April 15, 2013, the U.S. Supreme Court heard arguments on whether Myriad Genetics’ patents on the BRCA genes, which are associated with hereditary breast and ovarian cancer, should be upheld. This case culminates a four-year legal tug-of-war between Myriad Genetics & Laboratories and a long list of individual, advocacy, and health care professional groups represented by the American Civil Liberties Union (ACLU) . The plaintiffs agree that regulations allowing exclusive gene patents negatively affect access to care and research.
I was fortunate when I was first tested for a BRCA mutation in 1998: my testing costs were covered by my health insurance. Although I was initially tested without genetic counseling, I eventually went to a large cancer center for a second opinion, met with a genetics expert, and gained access to up-to-date, credible information. It wasn’t until I started FORCE (Facing Our Risk of Cancer Empowered) that the deeper implications of patenting the BRCA genes became apparent to me.
In the Family, a 2009 documentary by producer Joanna Rudnick, highlights some negative consequences of Myriad’s gene patents. The film includes eye-opening interviews with Dr. Mark Skolnick, Myriad’s founder, and Dr. Mary-Claire King, who is credited with locating the BRCA gene. King’s research proved the existence of hereditary breast cancer gene mutations and laid groundwork that sent laboratories racing to be the first to isolate and clone the gene for genetic testing.
Rudnick questions how a gene—a product of nature—can be patented, stating, “It’s like patenting your thumb.” Skolnick replies by comparing Myriad’s gene patents to patents for iPods, telephones, and computers, cavalierly asserting, “I think the single greatest inventive thing I did was to create Myriad. We did it to win the race . . . and we won.” A recent article on NOVA Next highlights just how narrowly that race was won. Although a laboratory in the United Kingdom had already sequenced the BRCA2 gene, Myriad published and applied for a patent less than 24 hours before the British scientists could publish their manuscript. Had the British team’s findings been published just a day earlier, Myriad’s effort to patent the BRCA2 gene would have probably failed.
Rudnick asks Dr. Skolnick point-blank why the cost of BRCA testing continues to increase, to which he replies, “I think there’s a point at which we have to start looking at decreasing the cost of the test.” That decrease has never been realized. Four years later, BRCA testing is more expensive—Myriad charges $3,500—even though technology has reduced the cost of sequencing DNA. The February 6, 2013 edition of the Salt Lake Tribune reported that “Myriad projects full-year 2013 revenue will fall between $575 and $585 million . . . a 16 to 18 percent increase over fiscal 2012.”
Dr. King’s philosophy regarding the commerciality of gene patents starkly contrasts with Skolnick’s. “The critical thing about the patents we hold is that none of them are exclusively licensed. They are completely open for anyone to use for research purposes, and any company that wishes to license them can for a trivial amount of money,” she says. King’s last royalty check amounted to $2.73. It’s not difficult to imagine how different BRCA testing might be had King won the race to sequence the BRCA genes.
In the interview, Skolnick defends Myriad’s profits by saying “If we make this huge . . . investment in educating the market don’t we have a right to deliver the test?” Skolnick continues, “All I know is that doctors were not prepared to do this. We had to teach doctors.” In 2008 and again in 2009 FORCE testified to the Secretary’s Advisory Committee on Genetics Health and Society, expressing both our general concerns regarding direct-to-consumer marketing of genetic tests and our specific concerns about Myriad’s marketing practices, which encourage BRCA testing without prior genetic counseling from qualified experts. FORCE has documented and reported our concerns about Myriad’s methods of marketing BRCA testing, which we feel are harmful and misleading to the health care community and members of the HBOC community. We also concur with the ACLU that exclusive gene patents negatively affect access to care and innovation in research, as illustrated by our testimony to the United States Patent and Trademark Office.
The SCOTUS decision is critically important for anyone who is concerned specifically with hereditary disease. FORCE has filed an Amicus brief on behalf of plaintiffs in advance of the hearing. The Myriad case is just one example of how exclusive patents on genes can hurt consumers. Gene patents are a universal issue that ultimately affects all of us. Even if hereditary cancer does not run in your family, chances are that you have inherited a genetic predisposition to some disease. Imagine if a company were given exclusive control over all testing and research for a disease that runs in your family.
Early media reports indicated that SCOTUS appeared skeptical of the validity of gene patents and may rule in favor of the plaintiffs. A ruling is expected by the summer. In the meantime, FORCE will continue to speak out and advocate on this important issue and others that impact the community we serve. I strongly encourage people to become informed about the issue and to take the time to voice their opinion.
Sue Friedman, D.V.M., is the founder and executive director of Facing Our Risk of Cancer Empowered and coauthor of Confronting Hereditary Breast and Ovarian Cancer: Identify Your Risk, Understand Your Options, Change Your Destiny.