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SCOTUS Tosses Myriad’s Isolated DNA Claims

By Mari Serebrov
Washington Editor

In a decision that could erode the underpinnings of numerous diagnostic and biologic patent claims, the Supreme Court held this morning that naturally occurring DNA is not patent eligible.

However, the court’s unanimous decision in The Association for Molecular Pathology v. Myriad Genetics Inc. upheld the patent eligibility of composite DNA, which is synthetically created.

In striking down Myriad’s claims to the BRCA1 and BRCA2 genes, the court said the Salt Lake City diagnostics company “found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry” of the Patent Act, which renders laws of nature, natural phenomena and abstract ideas ineligible for patent protection.

Myriad’s claims detailed an extensive process of the discovery of the genes, “but extensive effort alone is insufficient to satisfy §101’s demands,” the court said. Rather than expressing its claims in terms of chemical composition or relying on the chemical changes that result from the isolation of a specific DNA segment, Myriad focuses its claims on the genetic information encoded in the genes, mutations of which can significantly increase the risk of breast and ovarian cancer.

The opinion, written by Justice Clarence Thomas, overturned the U.S. Court of Appeals for the Federal Circuit, which had determined the claims were patent eligible.