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    Isolated DNA Declared Patentable By US Court Of Appeals

    Published on 17 August 2012 @ 2:49 am

    Intellectual Property Watch

    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.

     

    Comments

    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.

    2. Too much Information: Links for week ending 24 August | The Barefoot Technologist says:

      [...] 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 [...]

    3. IP Osgoode » U.S. Court of Appeals Stands Tall on the Subject of Gene Patents in the Wake of the Mayo v Prometheus Ruling says:

      [...] that their gene patents have not hindered research on the DNA sequences that they cover. It is expected that this case will be appealed to the United States Supreme [...]


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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

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