Association for Molecular Pathology v. Myriad Genetics, Inc.
The Court ruled that a company could not patent naturally occurring human genes just because it isolated them from the rest of a chromosome, but it could patent the synthetic, lab-created version of those genes known as cDNA.
The decision limits how far biotech and pharmaceutical companies can go in patenting the human genome, while still allowing patents on genetic material that scientists create rather than simply find.
How it got here: A trial court invalidated the gene patents as products of nature; the Federal Circuit reversed and, after a remand from the Supreme Court, found both isolated DNA and cDNA patent eligible, leading to this appeal.
The Case in Depth
What happened
A biotechnology company found the exact location and sequence of the BRCA1 and BRCA2 genes, whose mutations sharply raise breast- and ovarian-cancer risk, and patented that discovery along with a synthetic version of the gene's coding sequence called cDNA. Doctors, patients, and medical groups who wanted to test for these mutations without the company's permission sued, arguing the patents covered products of nature and were therefore invalid.
The question before the Court
Could a company patent human genes it discovered, and could it patent a lab-made version of that gene's coding sequence?
Why it matters
Other laboratories and researchers can now offer genetic testing for the BRCA1 and BRCA2 breast- and ovarian-cancer genes without paying royalties or facing infringement suits from the company that isolated them, likely lowering testing costs. Biotech companies must now look to inventive methods or synthetic products, rather than mere discovery of natural genes, to obtain patent protection.
What changes now
The judgment of the Federal Circuit is affirmed as to the naturally occurring, isolated DNA claims (which are invalid) and reversed as to the cDNA claims (which remain patentable). This is a final merits decision, not a remand for further factfinding. Other companies and researchers can now perform genetic testing on the isolated BRCA1 and BRCA2 genes without infringing the company's patents, though its cDNA-based patents remain enforceable.
What this does not decide
The Court stressed it was not deciding whether the company's method for isolating DNA could be patented, whether new medical or diagnostic uses discovered from the genes could be patented, or whether DNA with an altered nucleotide sequence would be patent eligible. Those questions remain open for future cases.
Concurrences and dissents
Concurrence — Justice Scalia
Justice Scalia joined the Court's judgment and legal reasoning but declined to join Part I-A and other passages detailing molecular biology, saying he could not personally vouch for those scientific details. He said it was enough for him to accept, based on the lower-court opinions and expert briefs, that isolated DNA matches its natural counterpart while cDNA is a synthetic creation not found in nature.
How the Court got there
The legal reasoning, step by step
- The Court applied the longstanding rule that laws of nature, natural phenomena, and abstract ideas cannot be patented because they are basic tools of science that everyone must remain free to use, while balancing this against patent law's goal of rewarding invention.
- Relying on its 1980 ruling in Diamond v. Chakrabarty, which allowed a patent on a bacterium modified to have new capabilities not found in nature, the Court asked whether the company's genetic material had markedly different characteristics from anything occurring naturally.
- The Court found that isolating the BRCA1 and BRCA2 genes did not create anything new: the company merely located and copied information that already existed in the human genome, so its claims fell within the unpatentable products-of-nature category.
- The Court explained that even a groundbreaking, difficult discovery does not by itself satisfy the patent law's requirement of a 'new and useful' invention, citing a 1948 case rejecting a patent on a naturally occurring bacteria mixture for the same reason.
- By contrast, the Court found that cDNA -- a synthetic, exons-only strand of genetic material that a lab technician creates by removing non-coding portions -- is not naturally occurring, because it does not exist in that exact form inside the human body, and is therefore eligible for a patent.
- The Court also noted that its ruling did not address method patents, new uses of the discovered genetic information, or DNA whose natural nucleotide order has been altered, leaving those questions for another case.
Doctrinal impact
Cases affected by this decision
Reaffirms Diamond v. Chakrabarty (447 U. S. 303)
Used its test for markedly different characteristics from nature to decide genes were not patentable while cDNA was.
Reaffirms Funk Brothers Seed Co. v. Kalo Inoculant Co. (333 U. S. 127)
Relied on its rule that combining natural materials without altering them is not a patentable invention.
Distinguishes J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc. (534 U. S. 124)
Found this case did not apply because Congress never endorsed the Patent Office's gene-patenting practice as it had for plant patents.