Association for Molecular Pathology v. Myriad Genetics, Inc.

569 U.S. 576 (2013)· Docket No. 12-398· Opinion by Justice Clarence Thomas (9-0 (Unanimous))

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Synthetic Biology, Genetics & Bio-Jurisprudence

Niche Legal Sub-Discipline Tags:

#natural-gene-isolation-barConstitutional Bar

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.

↳ Statutory Hook: 35 U.S.C. § 101 (Product of Nature Doctrine)

#crispr-germline-patent-gateActive Circuit Split

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.

↳ Statutory Hook: 35 U.S.C. § 102 & § 103 (Interference Priority)

Ontologically Correlated Precedents (1):Sorted by Shared Sub-Discipline Alignment

Broad v. UC Berkeley100% MATCH

#crispr-germline-patent-gate#natural-gene-isolation-bar

United (2018)Inspect Precedent

GOOD LAW · BINDING AUTHORITY

Unanimous SCOTUS holding defining the boundary between natural biological phenomena and synthetic genetic engineering.

OPERATIVE SIGNALS & RISK DISSECTION

BINDING PRECEDENT

Operative Judicial Rule

Isolating natural DNA sequences from the human genome is not patentable invention under 35 U.S.C. § 101.

Practical Tech Impact

Genomic diagnostics cannot be monopolized, while synthetic biology modifications and recombinant cDNA remain patentable.

Precedential Standing & Risk

Binding SCOTUS Precedent (9-0 Unanimous)

Formal Judicial Holding:

“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.”

Factual Background:

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.

Procedural Posture & Issue:

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.

Judicial Reasoning & Statutory Construction

1.Product of Nature: Myriad did not create or alter the genetic information encoded in the BRCA genes; discovering the location of a natural phenomenon is not an act of invention.
2.cDNA Distinctiveness: cDNA lacks the non-coding intron regions found in native human DNA, resulting in a distinct synthetic molecule engineered by human laboratory intervention.
3.Preemption of Life Science: Monopolizing natural genetic codes would severely impede medical diagnostics and genetic research.

Doctrinal Significance & Precedential Legacy:

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.

Statutory Hooks & Precedents Cited:

35 U.S.C. § 101Diamond v. Chakrabarty, 447 U.S. 303 (1980)Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012)

Downstream Impact:

Immediately lowered the cost of diagnostic genetic testing from $4,000 to under $250.Forms the bedrock standard for patentability in CRISPR guide RNAs, mRNA vaccines, and synthetic biology vectors.

Canonical Bluebook / APA Citation:Official CourtListener / Justia Repository

Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).