We asked Sandra Park, a staff attorney with the ACLU Women’s Rights Project and one of the lead attorneys on our legal challenge to Myriad Genetics’ patents on the “breast cancer genes,” to answer a few questions about this landmark case. The case is The Association of Molecular Pathology, et al v. Myriad Genetics and will be heard by the Supreme Court on April 15th. Breast Cancer Action is the only breast cancer organization that is a plaintiff in this case.
1. Why did the ACLU decide to take on a legal challenge to human gene patents?
This is the first patent case ever brought by the ACLU, so we studied the issue closely and consulted with many people before deciding to get involved. Ultimately, we realized that gene patents, and the policy of the U.S. Patent and Trademark Office of granting these patents, must be challenged because of the important civil liberties concerns they raise. Gene patents stand in the way of scientific innovation and medical care because they allow the patent holder to lock up all possible uses of the gene. Nobody can examine, study, or develop anything based on the gene without permission from the patent holder (in this case, Myriad Genetics). As a result, gene patents undermine scientific inquiry and freedom, bodily integrity, and particularly in the case of the BRCA1 and BRCA2 genes, women’s health.
2. What are the potential outcomes of this case, both in the U.S. and globally? Could this case invalidate all human gene patents?
If the U.S. Supreme Court invalidates the BRCA patents, that ruling will impact the validity of the many other, similar gene patents that have been issued. It is estimated that 20% of human genes have been patented, including genes associated with colon cancer, Alzheimer’s disease, and muscular dystrophy. Countries around the world often take cues from the U.S. patent system and so the ruling could influence other countries’ policies as well.
3. What is the crux of the case against patenting human genes?
For over a century, the U.S. Supreme Court has said that products and laws of nature cannot be patented. Our case simply asks the Court to apply this precedent to human genes.
Myriad argues that it somehow invented the BRCA genes once it “isolated,” or removed, the genes from the rest of our genome. By that logic, we should grant patents on iron once removed from rock, or on a kidney once removed from the body for transplant.
Myriad was the first to identify the link between mutations on these genes and breast cancer. It made an important contribution to scientific knowledge. But it defies law and common sense to force the public to rely on a single company to fully investigate the wide range of scientific, medical, and commercial uses of something as fundamental to our health and humanity as a gene. We see the consequences already: labs across the U.S. are ready to offer patients more comprehensive, lower priced testing for cancer risk than Myriad provides, but cannot include the BRCA genes in their tests because of the patents.
4. Would you describe this case as landmark or historic? If so, why?
This is a landmark case, for many reasons. Foremost, this is the first case ever brought challenging whether human genes can be patented. The answer to this question will have a huge impact on the future course of medicine and scientific research. Second, it is a case brought by a diverse group of twenty plaintiffs, including Breast Cancer Action, patients, geneticists, and scientific professional associations. The commitment of the plaintiffs demonstrates that patent law is not just about one company versus another; patents affect real people, with real consequences for how patients access medical care and what clinical standards and research are pursued. Third, the case highlights how some patents can stand in the way of scientific advancement, in violation of the U.S. Constitution’s requirement that patents “promote the progress of science.” Permitting monopolies on individual genes runs contrary to the constitutional purpose of our patent system.
To learn more about why human gene patents are a critical women’s health issue, and learn how you can get involved in this landmark case, click here.