569 U.S. 576 (2013)
Association for Molecular Pathology v. Myriad Genetics is a landmark United States Supreme Court decision defining the contours of patent eligibility for genetic material under 35 U.S.C.
Whether segments of human DNA that have been isolated from the genome, as well as cDNA synthesized from mRNA, are patent-eligible subject matter under 35 U.S.C. § 101, or whether they are unpatentable products of nature.
Under 35 U.S.C. § 101, laws of nature, natural phenomena, and abstract ideas are not patent eligible. A claimed composition that is a product of nature is ineligible unless it reflects a human-made invention with markedly different characteristics from any found in nature (Diamond v. Chakrabarty) and more than the mere discovery of a natural phenomenon (Funk Brothers). Merely isolating or discovering a natural product does not render it patent eligible, but a lab-created DNA construct that does not occur in nature—such as cDNA—may be eligible, provided it claims human-made invention rather than natural information.
Naturally occurring DNA segments are products of nature and are not patent eligible merely because they have been isolated. However, cDNA, which is synthetically created and lacks non-coding regions (introns), is generally patent eligible because it is not naturally occurring, except to the extent that very short cDNA sequences may be indistinguishable from naturally occurring DNA.
Myriad is pivotal for biotechnology and patent law: it forecloses exclusive rights over naturally occurring human genes, facilitating broader access to genetic testing and research, while preserving incentives to develop engineered DNA constructs like cDNA and innovative diagnostic methods. For practitioners and students, the case refines Section 101's product-of-nature doctrine, highlights the Court's focus on informational content and functional equivalence over formalistic chemical differences, and underscores careful claim drafting to emphasize human-made alterations or applications. It also illustrates the Court's incremental approach to patent eligibility after Mayo, leaving substantial questions about method and diagnostic claims to further litigation and legislative action.