Intellectual Property Legal News -The Supreme Court Holds Human Genes Are Unpatentable

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In a unanimous decision written by Justice Thomas, the Supreme Court held that naturally-occurring DNA sequences are unpatentable. The Court has long held that certain subject matter is not patent eligible under 35 USC § 101. Patent exempt subject matter includes laws of nature, natural phenomenon, and abstract ideas. In this case, the Court found that human genes are products of nature. The Court further found that cDNA sequences, which are copies of non-intron containing mRNA sequences created in the laboratory, are patent eligible.

The case before the Court involved several patents issued to Myriad Genetics, Inc. (“Myriad”) that were directed to two genes known as BRCA1 and BRCA2. Mutations in these genes can increase a woman’s risk of developing breast and ovarian cancer. The scientists at Myriad had discovered the genes, determined their nucleotide sequence and their chromosomal location. The Court found that locating and isolating the genes did not make them new compositions of matter. The Court acknowledged that the genes were important and useful, but nevertheless concluded that “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them.” Thus, the “genes and the information they code are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.”

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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