What Does the Future Hold in View of the Supreme Court Decision on Isolated Genes and cDNA?

In a long-anticipated ruling, the US Supreme Court acknowledged Myriad Genetics’ contribution in discovering the location and sequence of the BRCA1 and BRCA2 genes but concluded that “Myriad did not create anything” when it isolated those genes. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, slip op. at 12 (US June 13, 2013). The Court did, however, find that laboratory-engineered complementary DNA (cDNA) remains patent-eligible under 35 U.S.C. § 101. The Court explicitly stated that it did not address, among other things, the patent-eligibility of DNA sequences in which the naturally occurring nucleotides have been scientifically altered.

The Issue -

Before the Supreme Court were Myriad’s composition claims relating to isolated DNA sequences for the BRCA1 and BRCA2 genes and synthetically created cDNA related to these genes. Mutations in these genes are associated with a predisposition to breast and ovarian cancer.

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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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