Penned by Justice Clarence Thomas, the ruling stated that merely discovering the gene does not grant Myriad Genetics the right to profit from it.
The U.S. Supreme Court ruled unanimously Thursday that
scientists and biomedical companies cannot patent human genes such as
the one carried by Angelina Jolie that dramatically increases her risk of developing breast and ovarian cancer.
The case, in fact, involved a challenge to the patent held by Myriad Genetics on the test for the BRCA1 and BRCA2 genes, which Jolie underwent. Mutations in those genes increase the hereditary risk of developing both breast and ovarian cancer and, when Jolie discovered their presence in her DNA, she underwent a double mastectomy as a preventive measure.
Scientists and biomedical research companies have argued that isolating disease-linked genes from the human genome often requires years of painstaking research with costs running into the hundreds of millions of dollars. Patenting such findings for profit, they contend, is the only sure incentive for what often amounts to life-saving science. The American Civil Liberties Union, acting on behalf of a number of scientific and patients’ groups, disagreed, contending that patents are intended to protect “human-made inventions” and not pure “products of nature.”
The court agreed. Writing for his undivided colleagues, Justice Clarence Thomas said, “Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material. … Myriad did not create anything. 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 justices, however, agreed with the position taken in the case by the Obama Administration that cloned or “artificial genes — called “complementary or cDNA” — can be protected by patent, since their creation involves synthesizing information from a natural genetic template and then using it produce cloned genes. “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments," Thomas’ opinion said.
Myriad had used its patent on the BRCA genes to devise the only test for their presence, so that it profited every time a patient was screened. The company says the test costs just $100, but patients' groups allege it often runs much more.
"Today, the court struck down a major barrier to patient care and medical innovation," said ACLU senior attorney Sandra Park. "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."
"As a comprehensive and integrative breast center, our ultimate concern is the well-being of our patients — those with cancer, and those without," says Andy Funk, co-founder and executive chairman of Pink Lotus Breast Center, where Jolie underwent her double mastectomy, in a statement to : "We see a large number of patients with risk factors for breast cancer at the Pink Lotus Breast Center. … The ability to test for a BRCA gene mutation is critically important to us because a positive gene test significantly alters the recommendations we make."
"For patients with a possible BRCA gene mutation, the most significant aspect of this decision may be a drop in the price of the test, which has so far been dominated by Myriad Genetics via their gene patent," Funk adds. "With a price tag over $3,000, getting tested can pose a significant financial burden. A competitive environment could result in an affordable test that would allow BRCA gene testing to uninsured and underinsured women — a change that will save lives and that we undeniably support."
The case, in fact, involved a challenge to the patent held by Myriad Genetics on the test for the BRCA1 and BRCA2 genes, which Jolie underwent. Mutations in those genes increase the hereditary risk of developing both breast and ovarian cancer and, when Jolie discovered their presence in her DNA, she underwent a double mastectomy as a preventive measure.
Scientists and biomedical research companies have argued that isolating disease-linked genes from the human genome often requires years of painstaking research with costs running into the hundreds of millions of dollars. Patenting such findings for profit, they contend, is the only sure incentive for what often amounts to life-saving science. The American Civil Liberties Union, acting on behalf of a number of scientific and patients’ groups, disagreed, contending that patents are intended to protect “human-made inventions” and not pure “products of nature.”
The court agreed. Writing for his undivided colleagues, Justice Clarence Thomas said, “Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material. … Myriad did not create anything. 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 justices, however, agreed with the position taken in the case by the Obama Administration that cloned or “artificial genes — called “complementary or cDNA” — can be protected by patent, since their creation involves synthesizing information from a natural genetic template and then using it produce cloned genes. “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments," Thomas’ opinion said.
Myriad had used its patent on the BRCA genes to devise the only test for their presence, so that it profited every time a patient was screened. The company says the test costs just $100, but patients' groups allege it often runs much more.
"Today, the court struck down a major barrier to patient care and medical innovation," said ACLU senior attorney Sandra Park. "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."
"As a comprehensive and integrative breast center, our ultimate concern is the well-being of our patients — those with cancer, and those without," says Andy Funk, co-founder and executive chairman of Pink Lotus Breast Center, where Jolie underwent her double mastectomy, in a statement to : "We see a large number of patients with risk factors for breast cancer at the Pink Lotus Breast Center. … The ability to test for a BRCA gene mutation is critically important to us because a positive gene test significantly alters the recommendations we make."
"For patients with a possible BRCA gene mutation, the most significant aspect of this decision may be a drop in the price of the test, which has so far been dominated by Myriad Genetics via their gene patent," Funk adds. "With a price tag over $3,000, getting tested can pose a significant financial burden. A competitive environment could result in an affordable test that would allow BRCA gene testing to uninsured and underinsured women — a change that will save lives and that we undeniably support."
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