Taking Our Bodies Back: The Fight Against Gene Patenting

By Jane Zones, Ph.D.

For  40 years, control over one’s body has been a fundamental principle of the women’s health movement. We have fought and won many battles to preserve our right to make decisions about our own health and well-being. But over the last two decades, various corporations and institutions have secured patent protection on about 20 percent of the approximately 30,000 genes that make up the human genome.

Last year, the National Women’s Health Network, along with other public interest and scientific organizations and individuals, joined a suit initiated by the American Civil Liberties Union (ACLU) and the Public Patent Foundation at the Benjamin N. Cardozo School of Law that challenged Myriad Genetics’ ownership of BRCA1 and BRCA2, two genes associated with an increased risk of breast and ovarian cancer. The suit (Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al.) addressed whether the process of isolating certain genes makes the genes themselves patentable. It is established law that DNA is a “product of nature” and not patentable; the suit argued that genes are also products of nature and cannot be patented. It further argued that such patents violate the First Amendment, “stifle diagnostic testing and research that could lead to cures[,] and…limit women’s options regarding their medical care.”¹ 

In late March 2010, U.S. District Court Judge Robert Sweet ruled that “[p]roducts of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product.”²   The Genomics Law Report, an Internet publication, called the ruling “radical and astonishing in its sweep.”³  Myriad has announced that it plans to appeal the decision that invalidated its patents, in which case this issue could be ultimately resolved by the U.S. Supreme Court.

It took investments by scientists from many international institutions and substantial public funding to identify BRCA1 and BRCA2, genes that are considered to be tumor suppressors. Certain mutations reduce the BRCA1 and BRCA2 genes’ ability to curb the growth of cancer cells.  That’s why having a BRCA mutation significantly increases one’s risk for certain cancers: those with the mutations have a five-fold increased risk of developing breast cancer, and more than ten-fold increased risk for ovarian cancer.⁴   Other genes have since been found to be associated with increased risk for breast cancer, but BRCA1 and BRCA2 mutations appear to have a stronger effect.

Despite the collaborative effort to identify these genes, Myriad Genetics was the first to file for patents on BRCA1 and BRCA2, in 1994 and 1995.  Myriad’s patent created a monopoly on genetic testing women use to determine whether they carry mutations on these genes.  This means that women are unable to seek a second opinion or confirm Myriad’s test results (although, thankfully, the automated equipment used yields reliable results). While it costs more than $3,000 to get the test, many health insurers cover much of this expense. The price has doubled since the test was introduced, however, and income from the BRCA test accounts for most of the company’s $326 million profits from molecular analyses.⁵

Myriad’s private ownership also precludes scientists outside the corporation from conducting research on the two genes, barring the possibility of developing more effective screening or potential interventions to counteract genetic damage. 

The effect of these restrictions upon open research is controversial. Early hopes that genetic sequencing would yield information about the origins of specific diseases and generate effective treatments have not been realized.  Hundreds of genetic variants have been found to be associated with specific diseases, but the common variants only explain a portion of the genetic risk.  Scientists have come to the conclusion that common diseases are caused by large numbers of rare variations in the human genome that have yet to be catalogued.⁶

European laboratories began challenging Myriad’s worldwide patents in 2001; in 2004, the company’s patent rights were considerably restricted by the European Union’s Patent Office.⁶   In France and the United Kingdom, BRCA testing is overseen by the countries’ national health services and is conducted in stages. In those nations, the DNA search initially focuses on areas of the gene where mutations are most common. If none are discovered, other regions of the gene are analyzed until either a mutation is found or the whole gene is sequenced.  Negative results are the most expensive, so most people being tested have already undergone family history screening that indicates they have an unusually high risk for hereditary breast cancer.⁷

Myriad has invested in expensive automatic gene sequencing equipment that analyzes the entire gene, but cannot detect rare, atypical mutations, unlike the European process. But, in contrast to the European method, Myriad’s standardized testing is identical for everyone, costs the same amount, and is available to any individual who wants to be tested and can afford it. 

If the ACLU case reaches the Supreme Court, its narrow conservative majority may well rule that the decision prohibiting patent ownership of “products of nature” does not extend to human genes. This would allow corporations to own genetic material as commodities. If this happens, opponents of gene patenting are likely to pursue new strategies, and might urge Congress to make explicit patent law in this area in order to reverse the Court’s ruling.

Myriad’s BRCA patents expire in 2014 and 2015, but current legal rulings could have a large impact on other privately held gene patents.  A recent article in the Journal of the National Cancer Institute pointed out that the era of whole genome sequencing is upon us: “Gene sequencing technology is rapidly advancing with many companies and university-based labs now aiming to offer whole-genome sequencing for less than $1500.”²   That’s 30,000 genes sequenced for half the price of the two BRCAs!  But, this service could not be provided as long as genes are privately owned and unavailable for public analysis.

We don’t yet know what the final verdict is on this issue. We are hopeful that the Courts will continue to support scientific freedom and research to enhance women’s health.  We certainly hope for confirmation that people not only own their own genes but also have the right to information about their own bodies. This case tests the rights and freedoms of human beings as they match up to those of corporations.  To read more about this case, see the ACLU’s website: http://www.aclu.org/blog/free-speech-womens-rights/who-owns-your-genes-you-do.

Jane Zones is a long time member of the Network, and served on its board.  She currently serves on the Breast Cancer Action Board of Directors.

References:

1. ACLU, “ACLU Challenges Patents On Breast Cancer Genes: BRCA.” September 22, 2010. Online at http://www.aclu.org/free-speech-womens-rights/aclu-challenges-patents-breast-cancer-genes-0
2. Goozner, M, “Ruling on BRCA Gene Patents Could Have Limited Impact,” JNCI 2010; 102: 754-757.
3. Pollack, A, “After Patent On Genes Is Rejected, Taking Stock,” New York Times, March 31, 2010: B1. Available online at: http://www.nytimes.com/2010/03/31/business/31gene.html.
4. National Cancer Institute, “BRCA1 and BRCA2: Cancer Risk and Genetic Testing.”  Retrieved June 17, 2010 from http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA
5. Kesselheim AS, Mello MM, “Gene Patenting—Is the Pendulum Swinging Back?”  New England Journal of Medicine 2010; 362: 1855-1858.
6. Wade, N, “A Decade Later, Genetic Map Yields Few New Cures,” New York Times June 12, 2010: A1.
7. Wade, N, “A Decade Later, Genetic Map Yields Few New Cures,” New York Times June 12, 2010: A1.
8. Lowy, I, “What is a Hereditary Risk of Cancer?  A Historical and Comparative Perspective,” Radcliffe Institute, Cambridge, MA, Spring 2004.