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Supreme Court rules human genes cannot be patented
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The U.S. Supreme Court has ruled unanimously today that genes and the information they encode are not eligible for patents.
The case involved patents held by Utah-based company Myriad Genetics for two genes, BRCA1/2, used to test if a woman has a greater risk for developing ovarian or breast cancer.
“Myriad did not create anything,” according to Justice Clarence Thomas, who wrote the court’s decision. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
The decision, however, leaves open the door for patents on synthetic versions of gene material because, the court wrote, “it is not naturally occurring.”
"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, senior staff attorney with the ACLU Women's Rights Project. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."
Mutations in BRCA1/2 genes can significantly increase an individual’s risk of developing breast and ovarian cancer. The court's decision in Association for Molecular Pathology v. Myriad Genetics pointed out that average American woman has a 12% to 13% risk for developing breast cancer. However, the risk can range between 50% and 80% for breast cancer and between 20% and 50% for ovarian cancer among women with certain genetic mutations.
Myriad emphasized that the decision left intact more than 500 "valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test."
“We believe the court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Peter D. Meldrum, president and CEO in a written statement. "More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall health care costs."
Justice Antonin Scalia joined the overall judgment of the court, excluding some sections that delved into details of molecular biology. In a separate written opinion, Scalia said he was "unable to affirm those details on my own knowledge or even my own belief." But he affirmed that "having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state."
Perspective
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Rebecca Nagy, MS, CGC
In the immediate wake of the Supreme Court ruling, there was much speculation about the effect this would have on patients, health care and the biotech industry. As the dust settles, many questions still remain, but several things are clear.
For individuals with hereditary breast or ovarian cancers, this ruling is a victory. As predicted by many, the cost of testing for BRCA1 and BRCA2 has already dropped significantly, with several different labs offering a much more affordable test within hours of the decision. Reduced pricing may increase the number of insurers willing to cover the test, which will result in increased access to testing. In addition, labs can now include BRCA1 and BRCA2 in their multi-gene panel tests. These tests, which hit the market in the last several years, analyze as many as 25 genes or more at once and provide a more comprehensive assessment of a person’s genetic risk for a given disease. Prior to the ruling, BRCA1 and BRCA2 could not be included in these panels, requiring women to go through multiple tests using different labs with a price of $6,000 or more. Since the ruling, several laboratories have already added BRCA1 and BRCA2 to their panels, offering testing for about 25 genes at a cost equivalent to what was being charged just for BRCA1 and BRCA2 prior to the ruling.
With increased testing options comes increased complexity. Many of these panels include genes for which we have little clinical information, and most do not have published practice guidelines. When considering which test to order, clinicians will need to collect and review patient family history to determine which test might provide the best assessment for that particular family. Providing effective pre- and post-test genetic counseling and accurate results interpretation also will be critical to ensure that individuals receive accurate information and make informed decisions, some of which are irreversible and life-altering.
It is still unclear how the ruling will affect the biotech industry. Experts have come down on both sides. Those in opposition to the ruling claim it will stifle discovery and innovation. Those in favor claim that the ability to patent specific testing methods and synthetic DNA, such as cDNA, will allow enough freedom for the diagnostic testing market to remain profitable.
Regardless of what might fall out of the decision in the world of biotech, for the patients and those caring for them, June 13 was certainly a day to celebrate. Women with hereditary breast or ovarian cancers and their families now have more choices and access to high-quality, affordable genetic testing.
Perspective
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Michael Tolentino, MD
This ruling is a two-edged sword. The inability to patent genes is a victory for researchers focused on pure academic discovery, but a loss for biotechnology innovation that is more focused on applied therapeutic research. Only the future will tell if this helps accelerate the discovery of disease cures or slows it down.
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