The definitive Supreme Court rule holding that naturally occurring DNA sequences (such as BRCA1/BRCA2) are unpatentable products of nature, whereas synthetic cDNA remains eligible.
The global patent priority split evaluating whether transferring prokaryotic guide-RNA CRISPR systems into eukaryotic human cells was obvious under 35 U.S.C. § 103.
Unanimous SCOTUS holding defining the boundary between natural biological phenomena and synthetic genetic engineering.
Editorial assessment, not a commercial citator result. Verify against the primary source before relying on it.
Isolating natural DNA sequences from the human genome is not patentable invention under 35 U.S.C. § 101.
Genomic diagnostics cannot be monopolized, while synthetic biology modifications and recombinant cDNA remain patentable.
Binding SCOTUS Precedent (9-0 Unanimous)
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. However, complementary DNA (cDNA) is patent eligible because it is synthetic and does not occur naturally in the human genome.”
Myriad Genetics identified the precise chromosomal location and nucleotide sequence of the BRCA1 and BRCA2 genes, whose mutations dramatically increase hereditary breast and ovarian cancer risks. Myriad obtained patents claiming the isolated natural DNA sequences, effectively monopolizing all genetic diagnostic testing for BRCA mutations.
On writ of certiorari to the United States Court of Appeals for the Federal Circuit. The Federal Circuit had held that isolated natural DNA was patent-eligible.
Issue: Whether naturally occurring human gene sequences are patent-eligible under 35 U.S.C. § 101 merely because they have been isolated from the surrounding genome.
Myriad Genetics is the foundational charter of modern biotechnology IP. By invalidating patents on natural human genes, it established the threshold separating raw biological phenomena from patentable synthetic biology.
Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
