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The Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), ruled that naturally occurring human genes cannot be patented merely because they have been isolated from tissue, while affirming that synthetic complementary DNA (cDNA) remains patent-eligible.
Short answer
In Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), the U.S. Supreme Court unanimously held that isolated genomic DNA is an unpatentable product of nature under 35 U.S.C. § 101. However, synthetically created complementary DNA (cDNA) is patent-eligible because laboratory researchers splice out non-coding introns to create an engineered molecule that does not occur naturally.
Definition and scope
The case resolved a decade-long dispute over patent eligibility under 35 U.S.C. § 101, which governs statutory patent protection for new and useful processes, machines, manufactures, or compositions of matter. Section 101 carries three long-standing judicial exceptions: laws of nature, natural phenomena, and abstract ideas. For foundational rules governing these exceptions, see the guide to 35 U.S.C. § 101 patentable subject matter.
The litigation began when the Association for Molecular Pathology (AMP), clinical geneticists, pathologists, cancer patients, and the ACLU challenged patents held by Myriad Genetics and the USPTO. Myriad held exclusive patents covering isolated nucleotide sequences for human BRCA1 and BRCA2 genes, whose mutations indicate elevated risks for hereditary breast and ovarian cancer. Myriad used its patents to prohibit independent laboratories from offering clinical BRCA testing or confirmatory second opinions.
A central precedent was Diamond v. Chakrabarty, 447 U.S. 303 (1980), which established that human-made living organisms are patent-eligible if they exhibit markedly different characteristics from anything found in nature. In modern biotechnology research, the legal boundary between extracting a natural molecule and creating a synthetic composition governs institutional IP development. Myriad argued that severing covalent bonds to isolate genes created a new composition, whereas AMP argued that genomic DNA remained an unpatentable natural phenomenon.
How it works or how it is used in practice
Delivering the unanimous opinion, Justice Clarence Thomas separated natural genetic discovery from human invention:
Genomic DNA (gDNA) and Informational Encoding
Myriad argued that isolating DNA created a new chemical entity by cleaving chemical bonds. The Supreme Court rejected this chemical formalism, noting that Myriad’s claims focused not on novel chemical bonds, but on the genetic information encoded by nucleotide sequences. Because this genetic code exists naturally in the human body, locating a gene and isolating it from chromatin is an act of discovery, not invention under Section 101.
Complementary DNA (cDNA) Synthesis
In contrast, the Court held that complementary DNA is patent-eligible. In the laboratory, researchers reverse-transcribe messenger RNA (mRNA) into cDNA. Because natural cellular transcription splices out non-coding introns, the resulting synthetic cDNA consists solely of continuous protein-coding exons. Because an intron-free nucleotide sequence does not exist naturally in human chromatin, cDNA constitutes an engineered, patent-eligible composition of matter.
Academic and Technology Transfer Practice
Following the ruling, university technology transfer offices re-evaluated their patent portfolios, shifting away from isolated sequence claims toward engineered plasmids, expression vectors, fusion proteins, and modified delivery vehicles. This practice aligns with modern licensing strategies detailed in biotech technology licensing and foundational rules on the patentability of biological subject matter.
Types or related concepts
The eligibility of biological assets under 35 U.S.C. § 101 post-Myriad is summarized below:
| Biomolecule or Asset Class | Eligibility Status (35 U.S.C. § 101) | Controlling Legal Standard | Operational Research Impact |
|---|---|---|---|
| Isolated genomic DNA (gDNA) | Patent-ineligible | AMP v. Myriad Genetics, 569 U.S. 576 (2013) | Allows open gene sequencing, unrestricted diagnostic testing, and unhindered academic inquiry. |
| Complementary DNA (cDNA) | Patent-eligible | AMP v. Myriad Genetics, 569 U.S. 576 (2013) | Protects synthetic expression cassettes, recombinant biologics, and engineered cDNA libraries. |
| Engineered microorganisms & cells | Patent-eligible | Diamond v. Chakrabarty, 447 U.S. 303 (1980) | Safeguards modified microbial strains, synthetic biology chassis, and engineered vectors. |
| Diagnostic sequence correlations | Patent-ineligible | Mayo v. Prometheus (2012) & In re BRCA1/2 (Fed. Cir. 2014) | Prohibits patenting the comparison of patient DNA to reference sequences without inventive steps. |
| Engineered delivery vectors & probes | Patent-eligible | 35 U.S.C. § 101 & AMP v. Myriad dicta | Permits patents for tagged synthetic probes, non-natural viral vectors, and lipid nanoparticles. |
Where it matters for labs, clinics or supply decisions
The decision reshaped molecular pathology and biotechnology operations across several practical domains:
- Multiplex NGS Panel Adoption: Before the ruling, clinical laboratories could not include BRCA1 or BRCA2 on cancer gene panels without risking patent infringement. Invalidation allowed laboratories to launch multiplex next-generation sequencing (NGS) panels immediately, reducing costs and turnaround times.
- Variant Data Sharing vs. Trade Secrets: As examined by Barbara J. Evans (Genetics in Medicine, 2014), losing patent exclusivity led some diagnostic firms to protect variant interpretation databases as trade secrets. To counter data fragmentation, medical genetics networks expanded open archives like ClinVar, supported by standardized ACMG/AMP variant classification criteria.
- Grant and Translation Priorities: Translational programs like the BIRAC BIG biotechnology ignition grant direct funding toward novel functional assays, engineered cell lines, and therapeutic applications rather than raw sequence discovery.
- Laboratory Supply Procurement: Molecular diagnostics facilities transitioned from single-vendor proprietary testing agreements toward competitive, open-market sequencing reagents and analytical platforms.
Common misunderstandings
Several misconceptions surround the scope of the Myriad ruling:
- Misunderstanding: All gene patents were banned globally. The ruling is binding only in U.S. jurisdiction under 35 U.S.C. § 101. Other jurisdictions, such as the European Patent Office under EU Directive 98/44/EC, permit patents on isolated biological elements if industrial application is disclosed.
- Misunderstanding: cDNA is patentable in every conceivable form. The Court noted that for very short sequences lacking natural introns, synthetic cDNA may be identical to native DNA and thus ineligible.
- Misunderstanding: Molecular diagnostic tests cannot be patented. While correlating natural sequence variations with disease risk is unpatentable, novel assay chemistry, modified primer tags, and inventive analytical platforms remain patent-eligible.
- Misunderstanding: The decision removed regulatory oversight for genetic tests. Patent eligibility under Section 101 is distinct from regulatory oversight. Diagnostic tests remain subject to CLIA validation standards and FDA regulatory oversight.
Frequently asked questions
Can you patent genes under current U.S. law?
No, naturally occurring genes cannot be patented. The Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that isolating genomic DNA from cellular material does not create an eligible invention under 35 U.S.C. § 101.
What did the Myriad Genetics Supreme Court decision hold regarding cDNA?
The Court held that complementary DNA (cDNA) is patent-eligible. Because cDNA is synthetically engineered by transcribing mRNA without non-coding introns, its continuous exon structure does not exist naturally in chromatin.
How did gene patents change for academic research after 2013?
The ruling eliminated patent barriers that prevented university laboratories from freely sequencing, analyzing, and reporting native genetic sequences. Academic TTOs shifted focus from isolated genes toward synthetic constructs, therapeutic targets, and delivery platforms.
What is the difference between Diamond v. Chakrabarty and AMP v. Myriad Genetics?
In Diamond v. Chakrabarty (1980), the Supreme Court upheld patent eligibility for a genetically altered bacterium displaying markedly different characteristics from nature. In AMP v. Myriad Genetics (2013), the Court held that isolating natural genomic DNA does not create markedly different characteristics because the informational code remains identical to nature.
Sources
- Supreme Court of the United States. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). Decided June 13, 2013. Available at: https://supreme.justia.com/cases/federal/us/569/576/ (Date read: 2026-11-07).
- Supreme Court of the United States. Diamond v. Chakrabarty, 447 U.S. 303 (1980). Decided June 16, 1980. Available at: https://supreme.justia.com/cases/federal/us/447/303/ (Date read: 2026-11-07).
- Cook-Deegan, R., & Heaney, C. (2014). Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics. Journal of Law and the Biosciences, 1(3), 332–338. DOI: 10.1093/jlb/lsu020. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5033540/ (Date read: 2026-11-07).
- Evans, B. J. (2014). Mining the human genome after Association for Molecular Pathology v. Myriad Genetics. Genetics in Medicine, 16(7), 504–509. DOI: 10.1038/gim.2013.186. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4063888/ (Date read: 2026-11-07).
