On Monday, a federal court judge ruled that it was illegal for the BRCA1 and BRCA2 genes to be patented. This is very important news—and I will tell you why.

This ruling followed a lawsuit brought by a group of patients and scientist who were represented by the American Civil Liberties Union (ACLU) and Public Patent Foundation. Significantly, it marks the first time a court had found patents on genes unlawful. The ruling also calls into question whether the patents now held on about 2,000 other human gene are also valid.

The lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patent on the BRCA genes, argued that allowing scientists to patent genes would restrict scientific research and access to medical care. It also charged that it should be illegal to patent genes because they are products of nature that have been discovered, and not something that has been created or invented.

By patenting the BRCA1 and BRCA2 genes, and not the test it had developed, Myriad Genetics ensured it was the only company that could perform BRCA1/2 genetic testing. This meant that Myriad could charge whatever it wanted for the test, because they were the only ones who could do it. There also was no way for a woman to get a second test done from another company to ensure the first test’s accuracy.

The patent also prevented any researcher from studying the genes without first getting the company’s permission.

All of us have BRCA1/2 genes. A small percentage of women have mutations in these genes that increase their risk of breast and ovarian cancer. Men who have these mutations are at increased risk for breast and prostate cancer. Genetic testing can provide individuals with a family history of breast and/or ovarian cancer important information that can be used to determine prevention and treatment options. Also, recent studies suggest that certain forms of chemotherapy may be more effective in women who have a BRCA mutation. Yet, because of the patent, there was no way for any women who might have wanted a second test performed by another lab using another test to get one. This is strikingly different from other tests—like those that assess whether a tumor is hormone sensitive or HER2-positive or to assess whether a tumor has spread—that  that used to make treatment decisions.

Last year, the American Civil Liberties Union asked me to submit a declaration in support of the plaintiff’s case. I was pleased to do so because I firmly believed that the patents on the BRCA1 and BRCA2 gene—and any other gene for that matter—were obstacles to the clinical care of breast cancer patients and did not further the progress of medicine. I’m very happy the judge agreed! But it’s not over. Myriad Genetics says it intends to appeal the decision to the Court of Appeals for the Federal Circuit.

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8 Responses to BRCA Gene Patent Ruled Invalid

  1. Laura says:

    Firstly, Thank You Dr. Love, the ACLU, Breast Cancer Action, and others, for your work on gene patenting insanity reversals.

    I just know the Court Of Appeals will side with genes being discovered, not created, and you can’t “own” them. Total arrogance and greed.

    Now corporations, not only think they are “people”, now they think their God.

  2. Lynn Godmilow says:

    Dr. Love,
    I am a retired genetic counselor who worked with Dr. Arupa Ganguly at the University of Pennsylvania Department of Genetics. We offered BRCA1 and later BRCA2 testing before it was clinically available anywhere else. We were forced by Myriad to stop offering testing because of their patent and so it is especially gratifying to me that the court has decided that genes indeed cannot and should not be patented. Thank you for your support!

  3. pat handley says:

    The genetic test I took after my mother died of ovarian cancer cost thousands of dollars. Perhaps now more women will be able to be tested because that company won’t have a monopoly and the test will become affordable. Thank you from my heart and from all these women!

  4. Patricia says:

    Thank you Dr. Love, ACLU, the Court & ALL for standing tall for what is right! It is important that this practice be stoped – after all research & tests are to HELP find cures Not make it impossible & that is what some of these companies & researchers are doing by having a lock on these very important tests. We must keep up the fight!

  5. Barbara Treadwell says:

    Hi Dr. Love,

    Thanks, as always, for your peresistance on behalf of so many of us. My blood is at Myriad right now, awaiting the results of a repeat BRCA12 test with the addition of the BART. UCSF still uses this lab, but I trust the arrogance of Myriad will be righted through this court ruling. You are a champion of what’s right and I applaud and appreciate your efforts.


  6. Lin Vana says:

    I’m so glad to read this news. My mother died of ovarian cancer in 2003 and I would like to have myself genetically tested. I haven’t been able to do so due to cost. Perhaps without the monopoly that Myriad has enjoyed, I will finally be able to afford the test. I hope the legal appeals don’t take too long…

  7. Bob says:

    “There also was no way for a woman to get a second test done from another company to ensure the first test’s accuracy.”

    Couldn’t anyone license the genes to operate a second test? Anyway, I see a lot here about the value of genetic testing to humanity arguing for genes being unpatentable. I wonder if such arguments would apply to any new therapy which cured type 2 diabetes. Or any very valuable therapy at all. Or, maybe we should say that only discoveries of minimal value ought to be patentable, but important ones shouldn’t be.

  8. suzwriter says:

    This will free up researchers and companies to work on known genes such as BRCA1 and BRCA2, but might it not make companies less likely to research new genes because they will find it harder to get patent protection? http://tinyurl.com/6zqz9xl

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