Association for Molecular Pathology v. Myriad Genetics, Inc.
The Court ruled that a company cannot patent a human gene merely by isolating it from the rest of the genome, because the gene itself is a product of nature. But the Court also ruled that synthetic DNA the company created in the lab, which strips out the non-coding parts of the gene, can be patented because it does not occur naturally.
The decision limits how much control biotech and pharmaceutical companies can claim over naturally occurring genetic material, while still allowing patents on human-made genetic tools built from that material.
“we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring”
The Court's core holding distinguishing isolated natural genes from lab-made synthetic DNA.
How it got here: A federal trial court invalidated the patents; the Federal Circuit reversed; the Supreme Court sent the case back for reconsideration under a new precedent, and after the Federal Circuit largely upheld the patents again, the Court agreed to hear the case.
The Case in Depth
What happened
Myriad Genetics discovered the location and sequence of the BRCA1 and BRCA2 genes, mutations that sharply raise breast and ovarian cancer risk, and patented isolated versions of those genes along with synthetic DNA copies. A researcher whose patients' samples were refused for testing because of Myriad's patents, along with other doctors, patients, and advocacy groups, sued to have the patents declared invalid so other labs could offer the same genetic testing.
The question before the Court
Could a biotech company patent human genes it discovered simply by isolating them, and could it also patent the synthetic DNA it made from those genes?
Why it matters
Diagnostic labs, hospitals, and researchers can now test for the BRCA1 and BRCA2 breast- and ovarian-cancer genes without needing a license from the company that first located them, potentially lowering testing costs and expanding access. Biotech companies still retain patent protection over lab-made synthetic DNA, so they can continue to profit from genetic tools they actually engineer.
What changes now
The ruling is final on the merits: Myriad's patent claims covering isolated, naturally occurring DNA are invalid, while its claims covering synthetic cDNA remain valid. Other labs are now free to test for BRCA mutations without licensing isolated-gene patents. The decision does not address method patents or patents on new uses of the genetic information, leaving those questions for future cases.
What this does not decide
The Court explicitly said it was not deciding the patentability of methods for manipulating genes, new applications of knowledge about the BRCA genes, or DNA whose natural nucleotide order has been deliberately altered. Those issues remain open for future cases.
Concurrences and dissents
Concurrence in part — Justice Scalia
Justice Scalia agreed with the Court's judgment and joined most of the opinion, but he declined to join the detailed scientific background section and other passages describing fine points of molecular biology. He explained he could not personally vouch for those technical details, though he accepted, based on the briefs and lower-court opinions, that isolated DNA matches its natural sequence while cDNA is a lab-made creation not normally found in nature.
How the Court got there
The legal reasoning, step by step
- The Court applied the patent law's long-standing rule that laws of nature, natural phenomena, and abstract ideas cannot be patented because they are basic tools of science that belong to everyone, while still allowing patents on genuinely new human-made compositions.
- Applying a 1980 case about a genetically modified, oil-eating bacterium, the Court asked whether Myriad's isolated genes had markedly different characteristics from anything found in nature — the bacterium there qualified because scientists had added new genetic material giving it a new function.
- Myriad had not changed the genetic sequence or structure of the BRCA1 and BRCA2 genes at all; it had only located and isolated them, so under a 1948 case involving a naturally occurring bacteria mixture, mere discovery and extraction — however difficult or valuable — is not itself an act of invention.
- Because Myriad's patent claims focused on the genetic information itself rather than any new chemical composition, breaking the chemical bonds to isolate the DNA did not create a patentable new substance.
- By contrast, the lab-made complementary DNA (cDNA) omits the non-coding portions found in natural DNA, so it is a molecule that does not exist in nature and therefore qualifies as a new, patent-eligible composition of matter.
Doctrinal impact
Cases affected by this decision
Reaffirms Diamond v. Chakrabarty (447 U. S. 303)
Reaffirms that a genuinely new, human-made composition with markedly different traits from nature can be patented.
Reaffirms Funk Brothers Seed Co. v. Kalo Inoculant Co. (333 U. S. 127)
Reaffirms that combining or discovering naturally occurring things, without altering them, is not patentable invention.
Distinguishes J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc. (534 U. S. 124)
Distinguished because Congress had endorsed the patent office's practice there but has not done so for gene patents.
Reaffirms Mayo Collaborative Services v. Prometheus Laboratories, Inc.
Applies Mayo's framework for deciding when a claim improperly covers a law of nature.