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US Supreme Court to clarify patent eligibility of genes

The Supreme Court of the United States agreed on Friday to hear the Myriad case, which could provide much-needed clarification on the patent eligibility of genes

The lawsuit, The Association for Molecular Pathology v Myriad Genetics, concerns biotech company Myriad's patent claims relating to isolated DNA of the BRCA 1 and BRCA 2 genes, which can help doctors evaluate a patient's risk of breast cancer and ovarian cancer.

Myriad's claims also cover all possible mutations of the BRCA 1 and BRCA 2 genes and the test for the mutations. At present, scientists cannot perform this test without permission from Myriad.

The Supreme Court will reconsider a previous finding by the Court of Appeals for the Federal Circuit, which concluded that Myriad's composition of matter claims on the genes can be patented under Section 101.

The Federal Circuit initially decided the case in July 2011, overturning a previous district court ruling which found that Myriad's claims relating to isolated DNA molecules concern patent-ineligible products of nature. It also reversed the district court's conclusion that Myriad's method claim for analysing changes in the growth rates of transformed cells to test for possible cancer therapeutics is a scientific principle, and thus cannot be patented.

However, the Federal Circuit agreed with the district court's conclusion that Myriad's method claims for comparing DNA sequences are patent-ineligible "abstract, mental steps".

The plaintiffs later appealed to the Supreme Court, but the case was returned to the Federal Circuit in March this year following the Supreme Court's decision in Mayo v Prometheus.

Despite the Mayo v Prometheus decision, the Federal Circuit once again ruled in favour of Myriad in August. In September, the American Civil Liberties Union (ACLU) filed a petition asking the Supreme Court, for the second time, to reconsider the case. The Supreme Court is expected to rule on the matter by the end of 2013.

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