Evidence: historical governance case. Imported from the supplied 65-Case Master Edition, dated September 19, 2026. Source links and classifications are retained as an attributed case account; import is not an independent source review.
Case at a glance
- Case number
- 061
- Date / range
- 2013
- Sector
- Consent, ownership, and biospecimens
- Genetic asset
- Human DNA patent claims and genetic-testing access
- Security principle
- Ownership Boundaries Around Genetic Information
Event summary
The U.S. Supreme Court unanimously held that a naturally occurring DNA segment is not patent eligible merely because it was isolated, while distinguishing laboratory-created cDNA.
Source: Court opinion — Association For Molecular Pathology v. Myriad.
The case in context
The Myriad decision distinguished naturally occurring DNA from the claimed laboratory-created cDNA at issue. It concerned patent eligibility, not a finding that every genetic invention, method, or application is outside patent protection.
The case belongs in this collection because control over genetic information can affect access to testing and the use of knowledge. It is not a cybersecurity incident. Describing the challenged claims and the Court's limits makes that access question clearer than a universal slogan about whether anyone can own genes.
Acquisition and processing
gene discovery → patent claims → exclusive testing/control → legal challenge → narrowed patent boundary
The sequence of events
- gene discovery
- patent claims
- exclusive testing/control
- legal challenge
- narrowed patent boundary
What became inferable or exposed
Human DNA patent claims and genetic-testing access
The U.S. Supreme Court unanimously held that a naturally occurring DNA segment is not patent eligible merely because it was isolated, while distinguishing laboratory-created cDNA.
Affected parties and consent
- Direct parties
- Parties challenging and defending the patent claims
- Indirect parties
- Relatives and connected participants may be relevant where the asset contains relationship information.
- Direct count
- Unknown / not assigned
- Indirect count
- Unknown / not assigned
- Consent status
- Collection, custody, research purpose, transfer, withdrawal, and commercial use are separate permissions. The case concerns how those boundaries are interpreted or enforced.
Security dimensions
Confidentiality
The confidentiality question concerns human dna patent claims and genetic-testing access. Exposure and further inference must be distinguished from the fact of collection or availability.
Integrity
The integrity question is whether the described material, permissions, processing, or interpretation can be relied upon. Ownership Boundaries Around Genetic Information identifies the particular boundary examined here.
Availability
Access and continuity are assessed for the described event; potential effects are not presented as confirmed outages or losses.
Provenance
The relevant chain follows human dna patent claims and genetic-testing access through the stages shown below. Missing public detail is not proof that internal records did not exist.
Consent, persistence, and relational exposure
Consent
Collection, custody, research purpose, transfer, withdrawal, and commercial use are separate permissions. The case concerns how those boundaries are interpreted or enforced.
Persistence
Later reuse depends on the actual asset and links to other records; no future misuse is asserted.
Relational exposure
Relatives and connected participants may be relevant where the asset contains relationship information.
Case-specific assessment
confidentiality secondary; availability/access critical; provenance and intellectual control high; consent indirect.
GeneticSecurity.org analysis
Genetic Exposure Radius
No single level is assigned where the supplied dossier gives a range, conditional outcome, or broad institutional consequence. The affected parties and proposed assessment are shown separately.
Confidence: not assigned. Classification: GeneticSecurity.org analysis.
Genetic Persistence Risk
Persistence depends on the specific biological material or information retained. A potential effect is not treated as an observed genomic disclosure.
Confidence: not assigned. Classification: GeneticSecurity.org analysis.
Genetic Provenance Integrity
A numeric provenance level is not inferred from the existence of a source or court record. It requires evidence of the relevant custody and processing controls.
Confidence: not assigned. Classification: GeneticSecurity.org analysis.
Proposed classification and its limits
Suggested GER: GER-4 because affected testing populations are broad. GPR: not the main analytical axis. GPI: relevant to variant evidence databases, not the holding itself.
These are proposed classifications from the supplied case dossier. Conditional scores describe an assumed exposure; they are not evidence that it occurred. A single numeric value is left unassigned when the asset or outcome is not sufficiently bounded.
What this case does not prove
It did not make every genetic invention unpatentable, decide methods, or prohibit patents on altered sequences and applications.
Mitigations and lessons
- Public variant databases
- Transparent evidence sharing
- Licensing review
- Interoperability
- Clear separation of natural sequence from engineered application
Primary sources
Secondary sources
No additional source listed. See the evidence notes for limitations.
Policy and standards
Genetic Security Policy and StandardsReview and correction history
Source edition: September 19, 2026. Imported case account; no substantive corrections recorded.
Correction policy and logCite this case
GS-CASE-061. Myriad: Can a Naturally Occurring Human Gene Be Patented?. GeneticSecurity.org. https://geneticsecurity.org/cases/061-myriad-human-gene-patents/