Supreme Court Hears Case Against Myriad Genetics: Why Patents Hurt Women's Health
By Rachel Walden — April 18, 2013
On Monday, the Supreme Court heard oral arguments in the lawsuit against Myriad Genetics, challenging the company’s right to hold patents on two genes linked to increased risk of breast and ovarian cancer: BRCA1 an BRCA2.
The primary concern — which Our Bodies Ourselves, a co-plaintiff in the case, shares — is that human genes shouldn’t be patentable because they occur in nature. Allowing the patents restricts access to testing and research on these genes, and negatively affects women’s health.
Nina Totenberg, in her coverage for NPR, highlights the significance of the Court’s decision, expected later this year: “There is no way to overstate the importance of this case to the future of science and medicine.”
The oral arguments boiled down to two key opposing points. The attorney for the Association for Molecular Pathology and other plaintiffs in the case argued that the genes cannot be patented because they are found in nature. The attorney for Myriad Genetics essentially argued that because the company found and isolated the gene, it should be able to patent it. There was a great deal of discussion about this point, with analogies such as whether finding and removing a plant from the Amazon should entitle someone to patent that plant as an “invention.”
Major medical organizations have argued that the patents force people in the United States to “undergo tests that are inferior to and more costly than those available in other countries,” with the consequence that “no woman in America can get an independent second opinion about her condition before deciding to have her healthy breasts or ovaries removed in order to avoid cancer.”
In explaining the consequences of allowing the patents, the ACLU has written:
The patents on BRCA1 and BRCA2 are harmful to patients and create barriers to medical and scientific advancement. Myriad has a monopoly on BRCA genetic testing in the U.S. and therefore controls the type and price of testing. Thus, while genetic testing technologies have advanced to the point where all 23,000 human genes can be sequenced for $1000, Myriad has raised its price for BRCA genetic testing to over $4000 in the last few years and still does not capture all known BRCA mutations. Other laboratories cannot provide second opinions, and they cannot include the BRCA genes when offering testing of the multiple genes that are now associated with breast and ovarian cancer risk. Gene patents also have a chilling effect on research. Researchers must either obtain permission from the patentholder, or run the risk of being sued. And by virtue of its patents, Myriad controls most of the data about the BRCA genes and has refused to share that information with the scientific community.
Reporting from the courtroom, Breast Cancer Action praised those who made their voices heard in opposition to the patents:
It was a thrill to meet so many wonderful people working hard for women’s health, and it was incredibly moving to hear from the powerful women who stood up to tell their personal stories. We know that Myriad’s patents on our genes are wrong, and we hope that the Supreme Court will take this opportunity to come down on the right side of women’s health.
More coverage of the case:
- SCOTUSblog: First Myriad reactions; Argument recap: Analogies to the rescue; Justices debate gene patenting issues: In Plain English
- More from Nina Totenberg at NPR: Justices Appear Skeptical Of Patenting Human Genes
- PBS NewsHour: Supreme Court Tackles Case of Patent Law, Human Genetics
- The ACLU provides an overview of the case, timeline, and other background on their website.
For further information and resources, see OBOS’s previous posts:
From a legal and scientific standpoint, these patents are not directed to a naturally occurring “gene”, or any DNA molecule that is normally found in nature. Instead, the patent claim is to a cDNA, a molecule used only in laboratories.
If the plantiff’s only argument is that these cDNA are found in nature, they are going to loose the case; it is not factually true. I wonder what their actual argument is?
My understanding is that the particular mutations were determined to be correlated with disease by the inventors in this case; without their research, we would have no idea that these genes have anything to do with disease. It’s unclear to me why drug companies would continue to do this research if anyone could trivially use their results.
Heather, thanks for your comment. The oral arguments are linked in the post above, but here’s the URL if you’d like to read more, including discussion from the Justices about the issue you raise about incentives for companies to continue such research: http://www.supremecourt.gov/oral_arguments/argument_transcripts/12-398-amc7.pdf
You’re correct that much of the discussion did center around the cDNA, and whether cDNA is appropriately eligible for patenting. The arguments focused in part around the notion that cDNA represents a sequence with introns removed that is produced/capable of being produced naturally around the mRNA process, with argument about whether the cDNA is therefore a creation of the lab or of nature.
There was also discussion in the oral arguments of the patentability of the isolated gene sequence itself, independent of any additional manipulation – this does seem to be at issue. Myriad’s attorney made an argument in part focused around the decision of where to start and stop in the sequence, in looking at the gene, that “there was invention in the decision of where to begin the gene and where to end the gene.”
Another interesting discussion of this and the arguments in general is posted on Stanford Law School’s Center for Law and the Biosciences blog: http://blogs.law.stanford.edu/lawandbiosciences/2013/04/15/amp-v-myriad-genetics-oral-argument-recap/
We asked Sandra Park, the lawyer for the case, to respond to Heather’s comment. Her reply is below:
The patents are on naturally-occurring genes that have simply been “isolated,” or removed from the cell. The medical and scientific communities — as expressed by the American Medical Association, the American Society of Human Genetics, patient advocacy groups, and famed geneticists like James Watson and Eric Lander — are opposed to these patents because they lock up basic elements of human biology: our genes. A 2010 report from the federal Department of Health and Human Services established that the patent incentive was not necessary to either identify genes or develop testing. Companies are still of course able to patent tests, drugs, and other true “inventions” they develop.