Are Genes No Longer Patentable?

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In a much anticipated decision that has attracted the attention of pharmaceutical and biotech companies, medical researchers, physicians, attorneys and patients concerned about their risk for breast or ovarian cancer, Judge Robert W. Sweet of the U.S. District Court for the Southern District of New York ruled in favor of the plaintiffs on March 29, 2010 in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. The Court granted partial summary judgment that the claims of patents related to BRCA1 and BRCA2 are invalid on the grounds that genes are products of nature and, thus, constitute unpatentable subject matter. In particular, the Court held that composition claims on isolated DNA sequences and method claims on the use of those sequences for diagnosing breast and ovarian cancer fail to qualify as patentable subject matter under 35 U.S.C. §101. The lawsuit filed against the University of Utah Research Foundation, its licensee Myriad Genetics, and the USPTO, in May 2009 was organized by the American Civil Liberties Union, patients, physicians, and medical researchers. The decision marks the first time that a court has held patents on genes to be invalid as directed to non-statutory subject matter and will continue to be the subject of intense debate and scrutiny. It is estimated that 20% of the genome has been patented, amounting to thousands of patents that claim compositions of matter and methods of using those compositions.

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