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A US District Court has ruled that claims in seven patents supporting a widely used genetic test for inherited breast and ovarian cancer susceptibility are invalid.
The decision is likely to be challenged in the Court of Appeals — but if upheld, it could have huge implications for the biotechnology industry. It also stands in stark contrast to a 2008 decision by the appeals board of the European Patent Office, which supported the patents.
The plaintiffs in the case included individual physicians and patients as well as the Association for Molecular Pathology and the American College of Medical Genetics; they were represented by the American Civil Liberties Union (ACLU) and the New York–based Public Patent Foundation. The American Society of Human Genetics and the American Medical Association also filed briefs in support of the plaintiffs' challenge to the patents.
The plaintiffs called the patents illegal on the basis that they restrict both scientific research and patients' access to medical care and that patents on human genes violate patent law because genes are "products of nature".