Can Genes Be Patented? What the Supreme Court Ruled
Can genes be patented in the United States? The answer depends on what the invention is. In 2013, the Supreme Court ruled that naturally occurring DNA does not become patent-eligible simply because it has been isolated from the body. The same decision treated certain laboratory-created DNA differently. The ruling reshaped gene patent law, especially for genetic testing, but it did not make every invention involving genes unpatentable. Understanding the distinction between natural DNA, cDNA, and other biotechnology inventions helps clarify what the Court decided—and what it left unresolved.
The Supreme Court’s Gene Patent Ruling
The central case was Association for Molecular Pathology v. Myriad Genetics, Inc., decided on June 13, 2013. Myriad had identified the locations and sequences of the BRCA1 and BRCA2 genes and developed tests related to mutations associated with increased risks of breast and ovarian cancer. It held patents covering certain DNA sequences and methods.
Medical organizations, researchers, patients, and others challenged the patents. They argued that genes are products of nature and should not be owned through patents. The Supreme Court agreed in part, holding that a naturally occurring DNA segment is not patent eligible under federal patent law merely because it has been isolated from the rest of the genome.
The decision was unanimous. Justice Clarence Thomas wrote the opinion. The Court distinguished between finding and identifying something that already exists in nature, and creating something with a structure that does not occur naturally in the same form.
In brief: Naturally occurring DNA sequences are not patentable just because they have been isolated. Laboratory-created DNA, such as certain complementary DNA, may be eligible, subject to other patent-law requirements.
Why the Court Said Naturally Occurring DNA Cannot Be Patented
U.S. patent law allows patents for a “new and useful process, machine, manufacture, or composition of matter,” subject to limits and other requirements. But longstanding Supreme Court decisions exclude laws of nature, natural phenomena, and abstract ideas from patent eligibility. Those exclusions preserve basic building blocks of science for public use.
Myriad argued that isolating DNA from a chromosome created a patentable molecule. The Court rejected that reasoning. Although isolation can require technical skill and may produce a molecule separated from its surroundings, the genetic information in the claimed DNA remained the same as the information in the corresponding natural sequence. Myriad had discovered the location and sequence; it had not created the sequence itself.
The decision therefore rejected the idea that a naturally occurring gene becomes patent eligible simply by being removed from the body or chromosome. A company cannot claim exclusive rights to a human gene sequence based only on discovering it and isolating it.
This does not mean that everything found in nature is automatically outside the patent system. A natural product may be relevant to a patentable invention if the claimed subject matter includes an inventive application or a distinct, man-made composition. Each claim must be evaluated according to its wording and the facts.
What the Court Said About cDNA
The Court treated complementary DNA, commonly called cDNA, differently from genomic DNA. Cells use RNA to carry a working copy of genetic instructions. In many genes, the original genomic sequence includes both coding sections, called exons, and noncoding sections, called introns. When RNA is processed, introns are generally removed. Scientists can use the processed RNA as a template to make cDNA, which typically contains the coding sequence without those introns.
Because cDNA is created in a laboratory and generally has a structure that differs from naturally occurring genomic DNA, the Court held that cDNA is not a product of nature in the same way as the genomic sequence. It may therefore be patent eligible. The Court noted an important qualification: when a DNA sequence is too short to contain introns, the cDNA may be identical to a naturally occurring DNA segment. In that situation, the reasoning against patenting natural DNA may still apply.
The ruling did not automatically grant patents on all cDNA. Patent eligibility is only one part of the analysis. A cDNA claim must also satisfy other legal requirements, including novelty, nonobviousness, usefulness, and adequate disclosure.
What the Ruling Did—and Did Not—Decide
The Supreme Court’s holding focused on claims to DNA molecules. It did not issue a broad ruling that all gene-related inventions are unpatentable. Instead, the opinion drew a boundary between naturally occurring genetic material and certain laboratory-created molecules.
Several method claims were not before the Court because the parties did not ask it to review those claims. The Court also did not decide whether specific scientific research tools, diagnostic methods, or other biotechnology inventions would qualify for patents in different cases. Such claims must be assessed on their own terms under the applicable patent rules.
That distinction matters. A claim to a natural gene sequence is not the same as a claim to a particular laboratory process, a specially engineered molecule, a drug, or a diagnostic technique. A method that uses genetic information may still face eligibility challenges, especially if it amounts to observing a natural relationship and applying routine steps. The outcome depends on the claimed invention and the law governing it.
Gene Patent Eligibility Is Not the Same as Getting a Patent
When someone asks, “Can genes be patented?”, the word “patented” can blur several separate legal questions. A claim must first be eligible subject matter under Section 101 of the Patent Act. It must also meet other statutory requirements before a patent can issue or withstand a challenge.
| Patent Requirement | What It Generally Asks |
|---|---|
| Eligibility | Is the claimed subject matter within the categories allowed by patent law, rather than an excluded natural phenomenon or other ineligible subject matter? |
| Novelty | Was the claimed invention already known or publicly available before the relevant filing date? |
| Nonobviousness | Would the invention have been obvious to a person skilled in the relevant field, considering earlier knowledge? |
| Utility | Does the invention have a specific, substantial, and credible use? |
| Disclosure | Does the patent application describe the invention clearly and provide enough information to support the claims? |
For example, a DNA sequence might be eligible because it was engineered rather than found in nature, yet still fail because it was already known or would have been obvious. Conversely, a useful scientific discovery is not necessarily patentable if the claim seeks exclusive rights to a natural phenomenon itself.
How the Ruling Affected Genetic Testing
Before the decision, Myriad’s patents were associated with its exclusive control over certain BRCA-related testing in the United States. The Supreme Court ruling removed a major legal barrier to other laboratories offering tests based on naturally occurring BRCA sequences, provided those laboratories complied with other applicable laws and did not infringe any valid remaining patents.
That change expanded the possibility of competition in genetic testing. Additional providers could offer testing, and researchers gained greater freedom to study the natural sequences at issue. The ruling also influenced how biotechnology companies and patent applicants frame claims: a claim based on an engineered product or a specific invention may be treated differently from one that simply covers a natural gene.
However, the decision did not guarantee that every genetic test would be inexpensive, available, or covered by insurance. Testing costs and access can depend on laboratory capacity, clinical guidelines, insurance policies, regulatory obligations, and other factors. Nor did the ruling resolve every dispute over diagnostic methods or technology used in testing.
Patients should not interpret the case as medical guidance about whether to seek genetic testing. A health care professional or genetic counselor can explain what a test may reveal, its limitations, and how the results could affect medical decisions.
What Gene Patents Can Still Cover
Although naturally occurring human gene sequences cannot be patented simply because they have been isolated, some inventions involving genes may remain eligible. Depending on the claims and evidence, these may include:
- Engineered DNA: A sequence or construct deliberately modified so that it is meaningfully different from a naturally occurring molecule.
- Some cDNA: Laboratory-created complementary DNA that is not identical to a naturally occurring DNA segment.
- Biotechnology products: A specifically engineered molecule or other invention that satisfies eligibility and the remaining patent requirements.
- Processes and applications: A sufficiently inventive method involving genetic material, rather than a claim that merely captures a natural relationship or routine activity.
These categories are not automatic guarantees of patent protection. Patentability depends on the precise claim language, the invention’s features, prior art, and current law. A patent on a particular engineered construct, for example, would not give its owner ownership of every naturally occurring version of the gene.
How Long a Patent Lasts and What Rights It Provides
A U.S. patent generally gives its owner the right to exclude others from making, using, selling, offering to sell, or importing the claimed invention in the United States, subject to statutory rules and exceptions. It does not confer ownership of a person’s genes or grant unlimited control over every activity involving similar genetic information.
For many U.S. patents filed on or after June 8, 1995, the standard term is generally 20 years from the relevant filing date, subject to adjustments and other rules. The clock does not necessarily begin on the date a patent is granted. Patent rights can also be affected by maintenance fees, expiration, licensing, litigation, and the scope of the claims.
The Myriad decision did not cancel every patent involving DNA. It addressed the eligibility of particular claims and established a rule for naturally occurring DNA. Other claims must be evaluated separately, and the status of a specific patent requires checking its claims, prosecution history, and legal status.
Why the Decision Still Matters
The Supreme Court’s answer to “Can genes be patented?” is not an unqualified yes or no. A naturally occurring human gene cannot be patented merely because a company discovered and isolated it. Some DNA created in a laboratory may be eligible, and other inventions involving genes may also qualify if they meet all applicable requirements.
The distinction matters to researchers, diagnostic laboratories, biotechnology companies, and patients because it affects who can study and use genetic information. The decision also reinforces a broader principle of patent law: discoveries of natural facts can support innovation, but the facts themselves generally remain available as building blocks for further work.