The U.S. Supreme Court decided today that claims to isolated genomic DNA are not patentable subject matter and thus invalid. This decision rendered invalid patent claims owned by Myriad Genetics as well as thousands of patent claims of others to such molecules. However, Myriad’s claims to complementary DNA (cDNA) molecules were held to be valid.
In the decision, authored by Justice Thomas, the Court held that claims to isolated genomic DNA molecules fell squarely within the law of nature exception to patentable subject matter. According to the Court, Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, did not render the BRCA genes a “new...composition[s] of matter” under §101. The Court was not moved by Myriad’s argument that they undertook extensive effort to locate the gene sequences associated with an increased risk of breast cancer. The Court also rejected the argument that isolating DNA from the human genome severed chemical bonds and thereby created a non-naturally occurring molecule, pointing out that Myriad’s claims did not rely on the chemical changes that result from isolation. Instead, the claims focus on the genetic information encoded in the BRCA1 and BRCA2 genes. The Court also rejected the argument that the U.S. Patent and Trademark’s past practice of awarding gene patents was entitled to deference, pointing out that the U.S. government now argued to the Court that isolated genomic DNA was not patent eligible.
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