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Supreme Court Rejects Patents on 2 Naturally Occurring Genes

The views expressed are those of the author and are not necessarily those of Scientific American.


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When Angelina Jolie announced last month that she decided to get a prophylactic double mastectomy, she based her decision on the presence of the BRCA1 gene in her body—a gene that was detected via a costly medical test.

The Supreme Court today unanimously struck down patents on BRCA1 and BRCA2—two genes linked to hereditary forms of breast and ovarian cancer—when the genes occur in the body. Myriad did not create or alter any of the genetic information of the BCRA1 and BRCA2 genes, and thus does not satisfy patenting requirements, according to the decision. “Myriad discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes,” Justice Clarence Thomas wrote for the court.

This ruling could lead to cheaper tests for individuals who may be at increased risk of developing cancer. If Myriad Genetics were allowed to hold exclusive patents on these genes, the company would have maintained sole rights to create medical tests that indicate whether an individual has mutations that would lead to  elevated risk of developing these cancers.

The ruling should also affect the medical research community. Because the genes were patented, any researcher who found a new way to isolate the genes would not have been able to use it, since Myriad held patents on the genes themselves. The court’s decision removes that restriction.

On average, women have a 12 to 13 percent risk of developing breast cancer over their lifetimes, but that risk spikes with the presence of mutations in the BRCA1 and BRCA2 genes—jumping to between 50 and 80 percent for breast cancer and 20 and 50 percent for ovarian cancer, the decision notes.

Myriad had identified the exact location of the BRCA1 and BRCA2 genes; it had not discovered that heredity plays a role in establishing risk of breast and ovarian cancer. “Myriad did not create anything,” Thomas wrote.  “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.” “I’m just incredibly relieved,” says Lisbeth Ceriani, a breast cancer survivor and original plaintiff who struggled to afford Myriad’s test.

Jolie wrote in the New York Times last month that “the cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women.”

The court also determined that synthetically created DNA, cDNA, which contains the same information as its natural cousin but omits portions within the DNA segment that do not code for proteins, is patentable. Sandra Park, a senior staff attorney for the American Civil Liberties Union, says that this decision will not impact genetic testing since cDNA is not necessary for that process.

 

About the Author: Dina Fine Maron is the associate editor for health and medicine at Scientific American. Follow on Twitter @Dina_Maron.

The views expressed are those of the author and are not necessarily those of Scientific American.





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  1. 1. sault 3:35 pm 06/13/2013

    Key pieces of information missing here. Was it a 9-0 decision or a contentious 5-4 one? What was the name of the case…Myriad v. ??? What was the lower court’s ruling and was it confirmed or overturned with this SCOTUS ruling? Are there similar cases pending?

    Link to this
  2. 2. Shmick 5:57 pm 06/13/2013

    “unanimously” usually means everyone agreed…

    Link to this
  3. 3. Cstevenson 9:35 pm 06/13/2013

    The Supreme Court’s landmark ruling that human genes are not patentable has set the stage for a new era of access to genetic information. Next, we must fill the information gap left by restricted data access and free our data! Free the Data! is a grass-roots campaign that will create an open, searchable database of genetic information allowing for better diagnosis and care, while protecting patient privacy. Share your BRCA test results or join the campaign to support data access at http://www.free-the-data.org

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  4. 4. jafrates 11:27 pm 06/13/2013

    sault: The case was Association for Molecular Pathology v. Myriad Genetics, Inc. The lower court’s ruling was affirmed in part and reversed in part. There are dozens of cases pertaining to genetics in the courts.

    Link to this
  5. 5. sault 10:50 am 06/14/2013

    Cool, missed the “unanimously struck down” part of the article looking for an x – y tally of justices deciding with or against the majority.

    Link to this
  6. 6. greenhome123 2:45 pm 06/14/2013

    Just get a DNA test from 23andme, which I believe is currently $99. It test for this mutation as well as many other, and gives you likelihood of getting many common diseases based on your genes.

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  7. 7. Plain-2009 4:59 pm 06/14/2013

    I am very busy.
    I am going , with your permit, to make a comment based only on the title.
    I agree to grant copyrights to the writer of a book, that last a lifetime, and beyond.
    Writing a book is (more often than not) extreme work.
    A patent, on he other hand, should be granted only for a brief period of time.
    The patent owner should be able to recover the investment made.
    But to recover an investment is more a matter of understanding the marketplace rather than anything else.
    How many time an investment like that has been recover by somebody else (without doing any investment of any kind) rather that the real and genuine inventor?
    Knowledge belongs to humankind.
    It is about time of eliminating the patent system.
    I understand it may be a surprising statement.
    There is no intention to harm anybody. Quite the opposite.
    The idea is a better world and fair play.
    A lot of basic knowledge has already been established.

    Link to this
  8. 8. Mr. Mxyzptlk III 10:15 pm 06/14/2013

    The five Republicans on the Supreme Court did not reflexively capitulate to Corporate America. The End Times must indeed be nigh.

    Link to this

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