Association for Molecular Pathology v. Myriad Genetics, Inc.

Supreme Court of the United States · 2013 · Property

569 U.S. 576 (2013)

Updated July 23, 2026

PropertyPatent eligibilityProducts of natureDNA patents35 U.S.C. § 101product of naturenatural phenomenaisolated DNA

Facts

Myriad discovered the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which substantially increase the risk of breast and ovarian cancer. After that discovery, Myriad obtained patents claiming, among other things, isolated DNA corresponding to those genes and synthetically created complementary DNA (cDNA). Myriad asserted those patents against others performing BRCA testing, and petitioners challenged the composition claims as invalid under § 101. It was undisputed that Myriad did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes; its contribution was locating and identifying their sequence.

Issue

Whether a naturally occurring segment of DNA is patent eligible under 35 U.S.C. § 101 merely because it has been isolated from the human genome, and whether synthetically created cDNA is patent eligible.

Rule

Section 101 contains an implicit exception for laws of nature, natural phenomena, and abstract ideas. A naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring, except that very short cDNA strands may be indistinguishable from natural DNA if no introns had to be removed.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Seattle, Helix Harbor Labs identifies a naturally occurring human gene sequence associated with resistance to a certain viral infection. The company seeks a patent claiming the isolated DNA segment with the exact nucleotide order found in human cells after cutting it away from surrounding chromosomal material.

Is the claimed composition most likely patent eligible under 35 U.S.C. § 101?

Explanation. The majority held that a naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated. The key point is that the inventor did not create or alter the genetic information encoded in the sequence; discovery of the gene's location and sequence is not enough. The Court rejected the view that isolation alone, including severing covalent bonds, makes the natural sequence patentable. (Derived from Association for Molecular Pathology v. Myriad Genetics, Inc. (2013).)