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Isolated Human Genes Are Not Patentable; cDNA Is Patent Eligible Subject Matter

June 13, 2013

Hamilton Brook Smith Reynolds Alert

The Supreme Court unanimously ruled today in Association for Molecular Pathology v. Myriad Genetics that genes (naturally occurring DNA segments) isolated from the human body are not patent eligible under the Patent Act (35 U.S.C. § 101) because the claims at issue were directed to a “product of nature.”  The case involved several Myriad patents relating to the BRCA1 and BRCA2 genes (important in breast and ovarian cancer) with claims directed to “an isolated DNA coding for a BRCA1 polypeptide.”  The Court stated: “Myriad did not create anything…[I]t found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

In contrast to genomic DNA, the Court ruled that complementary DNA (cDNA) is patent eligible under § 101.  The Court held that cDNA is patent eligible because “the lab technician unquestionably creates something new when cDNA is made…As a result, cDNA is not a ‘product of nature’.”  Finally, the Court specifically stated that this decision did not involve the patentability of method claims, new applications of isolated genes, and the patentability of naturally occurring DNA in which the order of the nucleotides has been altered.

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