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Supreme Court ruling on gene patents viewed as ‘victory for medicine’
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The US Supreme Court’s unanimous ruling that genes and the information they encode are not eligible for patents already has led to a reduction in cost for genetic testing that can help evaluate individuals’ cancer risks, experts told HemOnc Today.
The price reduction may increase the number of insurers willing to cover such tests, which could dramatically expand access, they added.
“The Supreme Court got this right,” Beth Y. Karlan, MD, director of the Women’s Cancer Program and director of the division of gynecologic oncology at Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute, told HemOnc Today in a perspective that accompanies this article. “Their decision is a victory for the US populace, science and medicine. We must now capitalize on this decision and deliver advances in individualized risk prediction, prevention and personalized treatment strategies.”
The case involved patents held by Utah-based Myriad Genetics for two genes, BRCA1 and BRCA2.
“Myriad did not create anything,” said 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 they are “not naturally occurring,” the court wrote.
Mutations in BRCA1 and BRCA2 genes can significantly increase an individual’s risk of developing breast and ovarian cancer.
Women who have an inherited mutation in BRCA1 or BRCA2 are at five times greater risk for breast cancer than women who do not have the mutation, according to NCI.
The average woman in the United States has a 1.4% chance of being diagnosed with ovarian cancer, but the risk is 15% to 40% among BRCA1 or BRCA2 mutation carriers.
Myriad acquired patents on the BRCA1 and BRCA2 genes in the mid-1990s. Since then, it has been the only commercial provider of BRCA1 and BRCA2 testing services in the United States.
“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.”
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 [complementary DNA], and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” Peter D. Meldrum, president and CEO of Myriad, said 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 “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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Beth Y. Karlan, MD
We are already seeing the impact of the Supreme Court’s decision to end the ability to patent human genes, specifically the BRCA1 and BRCA2 genes. Many women are already requesting genetic testing for cancer susceptibility, and many laboratories are already adding these genes to their comprehensive cancer risk gene panels at no or minimal additional cost. Coming on the heels of Angelina Jolie’s announcement that she underwent prophylactic mastectomies to avoid a future diagnosis of breast cancer after learning she carried a deleterious BRCA1 mutation, the court’s decision has given women and men an accessible means to act on this empowering knowledge. The Supreme Court got this right. Their decision is a victory for the US populace, science and medicine. We must now capitalize on this decision and deliver advances in individualized risk prediction, prevention and personalized treatment strategies. I believe thousands of lives will be saved.
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.
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