Federal Circuit Holds that "Isolated DNA Molecules" Are Patentable Subject Matter and Method Claims Merely "Comparing" or "Analyzing" Are Not

The Federal Circuit issued its much-anticipated decision in The Association for Molecular Pathology v. United States Patent and Trademark Office on July 29, 2011. The case concerns Myriad Genetics, Inc. and its patents covering two “isolated” human genes, BRCA1 and BRCA2.

In the 55-page opinion, written by Judge Lourie, the Federal Circuit held that composition claims covering two isolated human genes are patentable subject matter but method claims devoted to methods of "analyzing" or "comparing" a patient's isolated DNA sequence with the "normal" sequence are not patentable subject matter. The challenged composition claims cover isolated genes BRCA1 and BRCA2 (collectively, "BRCA1/2" or "BRCA") and certain alterations, or mutations, in these genes associated with a predisposition to breast and ovarian cancers. Representative composition claims include Claims 1, 2 and 5 of U.S. Patent No. 5,747,282 (the "'282 patent") and representative method claims include claim 1 of United States Patent No. 5,709,999 (the "'999 patent"). All but one of the challenged method claims cover methods of "analyzing" or "comparing" a patient's BRCA sequence with the normal sequence to identify the presence of cancer-predisposing mutations. The one exception is Claim 20 of the '282 patent.

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