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Court Allows Challenge to Patents on Breast Cancer Genes

Judge Robert Sweet in the U.S. District Court for the Southern District of New York has allowed a challenge to two gene patents owned by Myriad Genetics.  The ACLU, on behalf of scientific organizations, researchers, genetic counselors, and individual women, is contesting the validity of gene patents in general, and is challenging the patents on the BRCA-1 and BRCA-2 genes in particular.  The complaint alleges that gene patents are unpatentable subject matter under 35 U.S.C § 101, and that such patents violate the First and Fourteenth Amendments.

Are Genes Patentable?

Naturally occurring things, even if newly discovered, may not be patented.  The ACLU asserts that the isolated genes in Myriad’s patents are no different from the genes that occur in nature.  The ACLU’s lawsuit seeks to invalidate Myriad’s patents.  They also argue that the patent covers basic human knowledge or thought (more specifically, the process of comparing the mutated gene to the normal one) and is therefore a violation of the First Amendment.  If the court accepts this reasoning, genes will no longer be patentable material under § 101.

Why It Matters: The BRCA Genes and Cancer

The BRCA-1 and BRCA-2 genes are linked to hereditary breast and ovarian cancer.  Women with mutations in these genes have a 40-85% chance of developing breast cancer, and suffer an increased risk for ovarian cancer as well.  Diagnostic tests can reveal these mutations, allowing women to better assess their risk.  Many women who have the mutated genes can undergo screening for the cancers earlier and more frequently than usual; some may even elect to have prophylactic surgeries.  Results can also serve to alert female relatives that they are more likely to have the mutation.  However, since Myriad holds patents on BRCA-1 and BRCA-2, it currently possesses a right to exclude others from performing these diagnostic tests.

The ACLU’s complaint points out that Myriad has failed to license its patent widely, which carries with it important implications.  Given that there are no alternatives, Myriad may freely price their diagnostics; many argue that the current rate ($3000 per test) is too expensive for many of the women who need to be tested.  Additionally, without other laboratories conducting similar tests, women are unable to secure second opinions.

The Big Picture

About 20% of human genes are patented.  Patent holders can prevent a researcher from studying or testing a particular gene.  Many of these genes, like BRCA-1 and BRCA-2, are associated with serious illness, including Alzheimer’s, muscular dystrophy, and colon cancer.  The ability to screen for genetic predispositions to these and similar diseases represents a great advance in personalized and predictive care.  There is concern, however, that allowing gene patents might slow development in this area.  The ACLU claims that, with gene patents, there is no opportunity to invent around the patent or to build upon and improve it.  They argue that this produces a disincentive to innovate.

As the court wrote in its opinion denying Myriad’s motion to dismiss, “the resolution of these issues will have far-reaching implications, not only for gene-based health care . . .  but also for the future course of biomedical research.”

For additional reading: Medical News Today, GEN

The ACLU’s complaint is available here.

By Claire Devine and Kyle de Neve.

About the Author

Claire Devine

Claire is a 2L at Columbia Law School.
  • Dov Henis

    Wives May Patent Husbands?
    RNA Or DNA Genes, Organisms, Should Not Be Patentable
    Organisms Should Not Be Patentable

    Key Cancer Patents Killed
    http://www.the-scientist.com/blog/display/57265/

    All organisms, regardless of size, natural or modified by humans, should not be patentable.

    Otherwise where is the limit???

    My wife of few years might yet apply to patent me…?!

    Dov Henis
    (Comments From The 22nd Century)
    03.2010 Updated Life Manifest
    http://www.the-scientist.com/community/posts/list/54.page#5065

  • zubair279

    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 http://www.patentpill.com/2010/11/gene-patent-debate-is-alive-again.html

  • zubair279

    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 http://www.patentpill.com/2010/11/gene-patent-debate-is-alive-again.html

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