In the United States, DNA can be patented only when human effort has created something that doesn’t exist in nature. Naturally occurring DNA sequences are not patentable, even if a researcher is the first to isolate and identify them. Engineered sequences like complementary DNA (cDNA), genetically modified organisms, and certain methods that apply genetic knowledge in novel ways can qualify. The dividing line is invention versus discovery.
Why Natural DNA Is Off-Limits
The Supreme Court settled this in Association for Molecular Pathology v. Myriad Genetics, Inc. in 2013. Myriad had located and sequenced the BRCA1 and BRCA2 genes, mutations of which sharply increase the risk of breast and ovarian cancer. It obtained patents on those genes and used them to maintain exclusive control over BRCA testing in the United States.1Justia. Association for Molecular Pathology v Myriad Genetics Inc, 569 US 576 (2013)
The Court ruled unanimously that a naturally occurring DNA segment is a product of nature and not patent eligible simply because someone isolated it. Myriad did not create or alter the genetic information encoded in BRCA1 and BRCA2. It found and sequenced genes that already existed in the human body. No matter how significant the scientific achievement, that is a discovery, not an invention.2Library of Congress. Association for Molecular Pathology v Myriad Genetics Inc
The reasoning traces back to a broader rule in patent law. Federal statute allows anyone who “invents or discovers any new and useful process, machine, manufacture, or composition of matter” to seek a patent.3Office of the Law Revision Counsel. 35 USC 101 – Inventions Patentable But courts have long recognized three exceptions that fall outside that language: laws of nature, natural phenomena, and abstract ideas.4United States Patent and Trademark Office. Manual of Patent Examining Procedure – 2106 Patent Subject Matter Eligibility A gene sequence as it exists in a living cell is a natural phenomenon, and isolating it doesn’t change that.
What Engineered DNA Qualifies
The same Myriad decision drew the other side of the line. Complementary DNA is patent eligible. cDNA is built in a laboratory by synthesizing a DNA strand from messenger RNA, a process that strips out the non-coding portions of the gene (called introns) and leaves only the protein-coding segments. The result is a molecule that does not appear anywhere in nature.1Justia. Association for Molecular Pathology v Myriad Genetics Inc, 569 US 576 (2013)
The Court acknowledged that cDNA carries the same protein-coding information as natural DNA and that the order of its components is dictated by nature. Still, a lab technician “unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.”2Library of Congress. Association for Molecular Pathology v Myriad Genetics Inc That structural departure from any naturally occurring molecule is what turns discovery into invention.
The principle reaches further than cDNA. In 1980, the Supreme Court held in Diamond v. Chakrabarty that a genetically engineered bacterium capable of breaking down crude oil could be patented, describing patentable subject matter as “anything under the sun that is made by man.”5Justia. Diamond v Chakrabarty, 447 US 303 (1980) That ruling opened the door to patents on genetically modified organisms and synthetic gene constructs, so long as human effort produces something with characteristics not found in nature.
Methods That Use DNA
Even though natural DNA is unpatentable, methods that apply genetic knowledge in inventive ways can be. A gene-editing technique, a process for synthesizing a novel protein, or a method for creating a genetically modified organism can qualify if the steps themselves are new and non-obvious. The patent covers the process, not the underlying genetic information.
Diagnostic methods are the difficult case. The Supreme Court’s 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. invalidated patents on a method for adjusting drug dosages by measuring metabolite levels in a patient’s blood. The Court found the claimed method amounted to observing a natural correlation between metabolite levels and drug effectiveness and then telling a doctor to think about it. The additional steps beyond the natural law were routine and conventional, not inventive.6Justia. Mayo Collaborative Services v Prometheus Laboratories Inc, 566 US 66 (2012)
Under the framework that emerged from Mayo, a method claim that relies on a natural phenomenon must contain an “inventive concept” beyond simply observing that phenomenon using standard techniques. In practice, this has made it very hard to patent diagnostic tests that identify genetic markers for disease. A claim that reduces to “test for gene X and correlate the result with condition Y” almost certainly fails. A genetics method patent needs a genuinely new technical step in how the testing is performed, not just in what it reveals.
Human Organisms Are Barred by Statute
One boundary sits outside the product-of-nature doctrine. Federal law explicitly prohibits any patent on a claim directed to or encompassing a human organism.3Office of the Law Revision Counsel. 35 USC 101 – Inventions Patentable Congress added that restriction through the Leahy-Smith America Invents Act in 2011.7United States Patent and Trademark Office. Manual of Patent Examining Procedure – 2105 Patent Eligible Subject Matter – Living Subject Matter
The bar applies to the organism itself. It does not stop patents on specific engineered genetic sequences, tools, or methods used in human gene therapy, as long as the claims don’t cover a human being as a whole.
How CRISPR Illustrates the Rules
The CRISPR-Cas9 gene-editing system is the most visible example of these rules playing out. Two groups have contested foundational U.S. patents for over a decade: a team led by the Broad Institute (with MIT and Harvard) and a group representing UC Berkeley, the University of Vienna, and Umeå University, collectively known as CVC.
The dispute is who first invented the use of CRISPR-Cas9 in eukaryotic cells, meaning the plant, animal, and human cells that matter most commercially. In March 2026, the U.S. Patent Trial and Appeal Board reaffirmed its earlier finding that the Broad Institute team first achieved that breakthrough, denying CVC’s motion for priority and blocking 14 CVC patent applications at the USPTO.8Berkeley News. PTAB Sides With Broad Institute Over University of California on Patent Priority for Use of CRISPR in Eukaryotic Cells
CVC still holds more than 60 U.S. patents and over 40 non-U.S. patents covering CRISPR-Cas9 compositions and methods across all cell types, including human cells. Those existing patents were unaffected by the ruling. The result is a fragmented landscape in which different institutions control different applications of the same underlying technology, and anyone commercializing CRISPR-based therapies or agricultural products likely needs licenses from more than one patent holder.
U.S. Rules Do Not Travel
Myriad applies only in the United States. The European Union takes a different approach under its Biotechnology Directive. European law allows an element isolated from the human body, including a gene sequence, to be patented even if its structure is identical to a naturally occurring element, as long as the application discloses an industrial use for that sequence. A bare DNA sequence with no identified function still cannot be patented in Europe, but an isolated gene with a demonstrated purpose can qualify.
The practical effect matters for anyone operating across jurisdictions. A company that isolates a gene linked to a disease and shows its diagnostic or therapeutic use may be able to patent that isolated gene in Europe while being unable to do so in the United States. European law treats the act of isolating and characterizing a gene as sufficient technical intervention. U.S. law treats it as finding what nature already made.