Breast Cancer Gene Patents Invalidated

By Rachel Walden — April 5, 2010

Last summer, we shared that OBOS had joined an ACLU lawsuit challenging breast and ovarian cancer gene patents.

Briefly, the ACLU and the Public Patent Foundation (with plaintiffs including OBOS, pathology associations, and individuals) filed a lawsuit against the U.S Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation, “charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.” The suit focused on the BRCA1 and BRCA2 genes, mutations of which are related to increased risk of breast and/or ovarian cancers, and for which Myriad Genetics controlled the patents (effectively controlling the available testing for important mutations).

As Breast Cancer Action explained, “When one company controls all the testing, less information and resources are available to both patients and researchers.” The New York Times story on the ruling also explains that “Some doctors and researchers contend that this monopoly has long held up not only competing, cheaper tests but has also hindered gene-based research.”

Last Monday, a U.S. judge ruling in the case invalidated the patents, arguing that “the company deserved praise for what is ‘unquestionably a valuable scientific achievement,’ but not a patent because the ‘isolated DNA is not markedly different from native DNA as it exists in nature.'” Essentially, the relevant genes are found in nature and thus aren’t novel enough to qualify for patent protection.

The judge dismissed the claim that the U.S. Patent and Trademark Office’s issuing of the patents was unconstitutional. The complete ruling can be found here [PDF]. The ruling has the potential to make the study of and testing for important genetic variations cheaper and more readily available.

Genomics Law Report has a good overview of the ruling, and several ScienceBlogs authors are also talking about the case, with one calling the ruling “a monumental step towards bringing sanity to biotech patents.”

This Sunday, CBS aired an episode of 60 Minutes that prominently featured the case. As OBOS was a plaintiff to the suit, we also got a chuckle out of the title of this editorial at the NYDailyTimes: Our bodies, ourselves: Judge rightly rules that no one can patent human genes

The ACLU itself also has commentary on the ruling, calling it “a huge victory for women’s health and scientific freedom,” and NPR’s Richard Knox has an interview with an attorney who explains the ruling and its implications.

3 responses to “Breast Cancer Gene Patents Invalidated”

  1. In an industry that makes billions of dollars, I think this is a fair ruling. It makes sense that DNA can not be patented. Myriad Genetics felt that the expertise needed to isolate the DNA gave them the right to patent the genes. I’m glad the courts saw that DNA is a natural occurance in nature. What is important is that gene based research continue in a timely manner.

  2. That was very informative and well written. Mentioned below is an article on gene patent debate:

    “The amicus brief submitted by the Department of Justice (DOJ) in the Breast Cancer Gene patent appeal before the Federal Circuit has drawn great attention during the last week. A US District Court had earlier rejected isolated gene sequence claims in Myriad’s patent stating that they do not satisfy the patentable subject matter requirement because they are products of nature. Aggrieved by the decision of the District Court, Myriad appealed to the Federal Circuit. The Department of Justice has filed an amicus brief before the Federal Circuit stating that the District Court’s opinion was right with respect to genomic DNA sequences. As the DOJ’s opinion is very persuasive, it has once again brought the gene patent debate to life.

    The DOJ has clearly pointed out in its brief that cDNA sequences, vectors, recombinant plasmids and chimeric proteins are patentable but the genomic DNA sequence, which exists in human body is not patentable. As per DOJ, merely isolating the exact sequence as it exists in the body does not merit patent protection as it amounts to product of nature. The DOJ has in its brief logically pointed out that isolation of such a sequence and identifying the fact that it encodes a protein that causes breast cancer, which is a natural relationship, is not sufficient to make the sequence patentable.”……read more at

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