Isolated DNA Declared Patentable By US Court Of Appeals

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By Catherine Saez for Intellectual Property Watch

The United States Court of Appeals for the Federal Circuit released a decision today (16 August) on the patentability of genes in yet another twist to the so-called Myriad case. At stake was the patentability of two human genes associated with hereditary breast cancer and ovarian cancer. Myriad Genetics’ patents were challenged by the Association for Molecular Pathology.

The decision is available here [pdf].

In a 2-1 decision, the Court of Appeals decided to partially reverse a lower court’s ruling, according to a press release of the American Civil Liberties Union (ACLU).

Myriad Genetics hailed the decision. “Importantly, the Court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity,” Myriad President and CEO Peter Meldrum said in a release.

In March, the US Supreme Court remanded the case back to the Federal Circuit for further consideration, after the high court’s decision a few days before, on another case called Mayo Collaborative Services v. Prometheus Laboratories (IPW, IP Live, 27 March 2012).

The court ruled that isolated DNA molecules were parent eligible as were method claims to screening potential cancer therapeutics via changes in cell growth rates of transformed cells. It ruled, however that method claims which compare or analyse two gene sequences are not parent eligible.

The decision is considered a setback by the ACLU. Staff Attorney with the ACLU Women’s Rights Project, Sandra Park, said “This is a devastating decision for a women’s health,” in the release, referring to the monopoly of Myriad over the genes. According to the ACLU, this allows Myriad “to set the terms and cost of testing and makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results.” The ACLU also said this monopoly hindered further research on the genes.

Myriad denied that patents have hindered research on the two incriminated genes (BRCA1 and BRCA2) as the company never “denied, opposed or impeded any research studies” on those genes. In the same release, they said the cost of BRCA testing “is not prohibitive and patient access is extensive,” adding that patients could access the text “through private insurance, Medicare, Medicaid or Myriad’s Financial Assistance Program, which provides coverage at no charge to low-income, uninsured patients.”

The case should go back to the Supreme Court later this year, according to attorney Harold Wegner.

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  1. kavita says

    Its indeed a landmark decision in arena of patenting of isolated genes.Many issues like legal ,social,economic issues were raised plus ethical issues i.e (patenting of life forms) were raised
    and in case of ethical issue which were raised the answer is ” it is not the living organism i.e BRCA genes which is patented the process of composing the gene by way of chemical composition is patented”…and in connection with method claim that it is not patentable the answer is that isolated genes is patentable when once separated from body,or any screening is done,composition of matter is done as per “US code 35 Of 101”..As lots of hardwork and dedication is done in order to do research in patenting isolated gene this decision adds fruits to the efforts taken by myriad inc.


  1. […] US: Further developments in gene patent case Intellectual Property Watch reports on a U.S. Court of Appeals decision to partially reverse elements of a ruling by a lower court against patentability of two human genes associated with hereditary breast and ovarian cancer. The American Civil Liberties Union, who brought the original case, have called the decision a setback and “devastating… for a women’s health.” The case will now go to the U.S. Supreme Court. Knowledge Ecology International provide further analysis of the decision. Report | Analysis […]

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