Gene patenting is the practice of claiming exclusive legal rights over genetic material, genetic tests, or biotechnology methods that result from human invention rather than from simply finding something that already exists in nature. Under current U.S. law, a naturally occurring human gene cannot be patented, even if a scientist spent years locating it. Synthetic or modified genetic material, genetically engineered organisms, and genuinely novel methods that use genetic material can be. The line between discovery and invention is what every gene patent dispute turns on, and three Supreme Court decisions have drawn and redrawn it over the past four decades.
Where Gene Patents Come From in the Law
Gene patents rest on the same statute as any other U.S. patent. Section 101 of the Patent Act allows a patent on “any new and useful process, machine, manufacture, or composition of matter.”1Office of the Law Revision Counsel. 35 USC 101 – Inventions Patentable Courts read “composition of matter” broadly enough to cover biological material, but only when that material is the product of human ingenuity. A patent, once granted, lets its holder stop others from making, using, selling, or importing the invention. For genetic material, that can mean controlling who performs a particular test, who manufactures a protein using a given sequence, or who produces an engineered organism.
What Kinds of Genetic Material Can Be Patented
The clearest example is complementary DNA, or cDNA. A technician makes cDNA from messenger RNA, producing a version of a gene that contains only the protein-coding regions and strips out the non-coding segments (introns) found in natural DNA. Because cDNA in that form does not exist in nature, the Supreme Court has confirmed it is eligible for patent protection.2Justia U.S. Supreme Court Center. Association for Molecular Pathology v. Myriad Genetics, Inc.
Several other categories qualify as well:
- Synthetic DNA sequences built from scratch in a lab rather than copied from a living organism.
- Genetically engineered bacteria, plants, or animals with “markedly different characteristics from any found in nature.”3Justia U.S. Supreme Court Center. Diamond v. Chakrabarty
- Novel methods for detecting a mutation, analyzing gene expression, or using a genetic sequence in therapy, provided the method goes beyond routine, well-known techniques.4MedlinePlus. Can Genes Be Patented
- Chemically modified nucleic acids, such as sequences altered for better stability in tools like CRISPR guide RNAs, treated as human-made inventions (though they can still be challenged on grounds like obviousness).
The common thread: human intervention has to produce something that does not occur naturally. Finding a gene, no matter how hard the search, does not qualify.
What Cannot Be Patented
Naturally occurring DNA sequences are off-limits, regardless of how difficult or expensive they were to locate. The Supreme Court treats natural phenomena and laws of nature as “the basic tools of scientific and technological work,” and allowing patents on them would block further discovery rather than promote it.5United States Patent and Trademark Office. MPEP 2106.04(b) – Laws of Nature, Natural Phenomena and Products of Nature
Isolating a gene from the surrounding DNA does not change that answer. Before 2013, patent holders argued that cutting a gene free from a chromosome created something new by breaking chemical bonds. The Supreme Court rejected the argument, holding that the patent claims were really about genetic information, and that information is the same whether the gene sits in a chromosome or in a test tube.2Justia U.S. Supreme Court Center. Association for Molecular Pathology v. Myriad Genetics, Inc.
Diagnostic methods can run into the same wall. If a test simply observes a natural correlation and tells a doctor to act on it using standard laboratory techniques, it is likely unpatentable. Adding routine, well-known steps to a natural law does not turn it into an invention. This matters for genetic testing, because many tests detect naturally occurring mutations using conventional methods.
The Three Supreme Court Decisions That Set the Rules
Diamond v. Chakrabarty (1980)
The modern era of biotechnology patents started with a genetically engineered bacterium designed to break down crude oil. The Patent and Trademark Office refused the application on the view that living things could not be patented. The Supreme Court disagreed, holding that “the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.” Because the bacterium had “markedly different characteristics from any found in nature,” it was a patentable composition of matter.3Justia U.S. Supreme Court Center. Diamond v. Chakrabarty That ruling opened the door to decades of biotechnology patents, including patents on isolated human genes.
Mayo Collaborative Services v. Prometheus Laboratories (2012)
Prometheus held patents on a method for adjusting drug dosages based on metabolite levels in a patient’s blood. The relationship between those levels and drug effectiveness was a natural phenomenon, and doctors had long used the drugs involved. The Supreme Court unanimously held the patents invalid.6Justia U.S. Supreme Court Center. Mayo Collaborative Services v. Prometheus Laboratories, Inc. A claim built on a law of nature has to add an “inventive concept,” meaning something significantly more than the natural law itself. Routine steps like “administer the drug” and “measure the metabolite” did not clear that bar, and the ruling made it substantially harder to patent diagnostic methods that depend on observing natural biological processes.
Association for Molecular Pathology v. Myriad Genetics (2013)
This is the decision that directly answered the gene patenting question. Myriad Genetics had identified the BRCA1 and BRCA2 genes, mutations in which sharply raise breast and ovarian cancer risk. Myriad patented the isolated genes and used those patents to keep exclusive control over BRCA diagnostic testing.2Justia U.S. Supreme Court Center. Association for Molecular Pathology v. Myriad Genetics, Inc.
The Supreme Court ruled unanimously that naturally occurring DNA segments are not patent eligible simply because someone isolated them. Myriad’s work in locating and sequencing the genes was a scientific breakthrough, but the company “did not create or alter either the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA.” Discovery is not invention.
The Court kept cDNA on the patentable side of the line. Because making cDNA requires removing introns to produce an exons-only molecule that does not exist in nature, a technician “unquestionably creates something new.”7Library of Congress. Association for Molecular Pathology v. Myriad Genetics, Inc.
What Changed After Myriad
The effects showed up fast. On the day of the ruling, competing laboratories announced they would begin offering BRCA testing, and within months multiple companies were providing the tests at different price points. Academic medical centers that Myriad had previously forced out of the market returned to it.8PubMed Central. After Myriad: Genetic Testing in the Wake of Recent Supreme Court Decisions Myriad’s comprehensive BRCA test had cost roughly $4,000. Competitors introduced comparable tests for around $2,200, and some targeted panels for less.
The ruling also freed researchers to study any naturally occurring gene without licensing it from a patent holder, and it made multi-gene panel testing commercially possible. A panel that screens for dozens of cancer-related genes at once would have been unworkable if each gene required a separate license from a different company.
Other Requirements a Gene Patent Must Meet
Eligibility under Section 101 is only the first hurdle. A gene-related patent application has to clear the same requirements as any other patent. The invention must be novel, meaning no one has previously described it. It must be non-obvious, meaning a scientist skilled in the relevant field would not see it as a straightforward step from what is already known.9Office of the Law Revision Counsel. 35 US Code 103 – Conditions for Patentability; Non-Obvious Subject Matter And the application must include a written description detailed enough that another scientist could reproduce the invention; vague descriptions of sequences or methods that work only under undisclosed conditions do not survive examination.10Office of the Law Revision Counsel. 35 USC 112 – Specification
Pending Legislation That Could Reshape the Rules
The current framework rests on Supreme Court decisions rather than a statute written for genetics. That may change. The Patent Eligibility Restoration Act of 2025 has been introduced in both chambers of Congress with the stated goal of eliminating judicially created exceptions to patent eligibility and replacing them with narrower, defined exclusions.11Congress.gov. S.1546 – Patent Eligibility Restoration Act of 2025
Under the bill, “an unmodified human gene, as that gene exists in the human body” would still be unpatentable. But a gene would not count as “unmodified” if it has been purified, enriched, or otherwise altered by human activity, or if it is “employed in a useful invention or discovery.” That language could effectively undo part of the Myriad ruling by making isolated or purified genes patent-eligible again. The bill would also remove the abstract-idea and natural-phenomenon exceptions that currently limit diagnostic method patents under the Mayo framework.11Congress.gov. S.1546 – Patent Eligibility Restoration Act of 2025 As of early 2026, the bill has not been enacted, and the Myriad and Mayo rules remain the law.