AMP v. Myriad Genetics — Patents

The Supreme Court held that isolated human genes are unpatentable products of nature, while synthetic cDNA can be eligible because it is not naturally occurring.

When the Supreme Court decided Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), it answered a question that had hovered over the biotechnology industry for decades: can a company patent a human gene simply because it figured out where the gene is and pulled it out of the chromosome? Writing for a nearly unanimous Court on June 13, 2013, Justice Clarence Thomas said no for natural DNA but yes, in important part, for the synthetic version. The decision wiped out Myriad’s monopoly on the BRCA1 and BRCA2 breast- and ovarian-cancer genes while preserving room to patent genuinely man-made genetic constructs—a careful split that reshaped both clinical genetics and patent strategy.

At a glance

Case: Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, 569 U.S. 576 (U.S. June 13, 2013).
Court: Supreme Court of the United States; opinion by Justice Thomas, joined by all members of the Court, with Justice Scalia concurring in part and in the judgment.
Posture: On certiorari from the Federal Circuit, reviewing the eligibility under 35 U.S.C. 101 of Myriad’s claims to isolated BRCA genes and to cDNA.
Holding: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated; but cDNA is patent eligible because it is not naturally occurring (except short segments indistinguishable from natural DNA).
Significance: Confirmed and sharpened the product-of-nature exclusion for genetic material, ending broad gene patents while protecting synthetic constructs and downstream applications.

The BRCA discovery and the patents

Myriad Genetics identified the precise chromosomal location and nucleotide sequence of two genes, BRCA1 and BRCA2, whose mutations sharply raise a woman’s risk of breast and ovarian cancer. That knowledge let Myriad develop diagnostic tests, and the company obtained patents claiming the isolated genes themselves. Armed with those claims, Myriad asserted an exclusive right to isolate any individual’s BRCA1 and BRCA2 genes and effectively controlled BRCA testing in the United States. Researchers, clinicians, and patients—organized as the Association for Molecular Pathology and other petitioners—challenged the patents, arguing that genes are products of nature that no one may own. The case put 35 U.S.C. 101, which makes eligible any new and useful “composition of matter,” against the long-standing judicial exception that laws of nature, natural phenomena, and abstract ideas cannot be patented.

Isolation is discovery, not invention

The Court drew a sharp line between finding something in nature and creating something new. Myriad, Justice Thomas wrote, “did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes” and “did not create or alter the genetic structure of DNA.” Its principal contribution was locating and identifying the genes—an undeniably important scientific achievement, but a discovery rather than an act of invention. Separating a gene from its surrounding genetic material does not change the information it carries; the isolated DNA segment has the same sequence nature wrote. Because the claims focused on that genetic information rather than on any chemical change or new molecule, the isolated BRCA genes fell within the product-of-nature exclusion and were not eligible under Section 101. The Court rejected the argument that the act of breaking chemical bonds during isolation was enough to confer eligibility, because the claims were not expressed in terms of any such chemical alteration.

Why cDNA is different

The result flipped for complementary DNA. Scientists make cDNA in the laboratory by reverse-transcribing messenger RNA, producing a strand that contains only the protein-coding exons and omits the non-coding introns present in natural DNA. That exons-only sequence, the Court held, “is not naturally occurring.” A laboratory technician “unquestionably creates something new when cDNA is made,” and so cDNA is patent eligible under Section 101, with a narrow caveat: a very short cDNA segment may be indistinguishable from natural DNA and so might still fail. The distinction reflects the Court’s core principle—eligibility tracks human creation. Natural information, however hard-won its discovery, stays in the public domain; synthetic molecules that nature does not produce can be owned. Justice Scalia concurred in the judgment but declined to join the portions of the opinion describing the fine molecular biology, noting he could not affirm those details on his own knowledge.

The aftermath for genetics and patents

Myriad’s loss on the isolated-gene claims immediately opened the BRCA testing market to competitors and lower-cost diagnostics, a tangible public-health consequence of a patent ruling. For the biotechnology industry, the decision—read alongside Mayo Collaborative Services v. Prometheus Laboratories (2012)—signaled that the product-of-nature and law-of-nature exclusions had real teeth. Patent applicants shifted toward claiming engineered constructs, novel methods of use, vectors, primers in specific combinations, and applications rather than the natural sequences themselves. The Court was careful about what it did not decide: it expressly noted that method claims, new applications of knowledge about the genes, and claims to altered DNA were not before it. Myriad is thus a boundary-drawing case—it marks where natural information ends and human invention begins, leaving a wide field of genuinely engineered biotechnology still patentable.

Open questions

How short is too short? The Court allowed that very short cDNA segments might be indistinguishable from natural DNA, but left the cutoff undefined.
What about other isolated natural products? Myriad addressed DNA specifically; the eligibility of isolated proteins, antibodies, and other naturally derived molecules continues to be litigated.
How far do method and application claims reach? The Court reserved those questions, and the durability of diagnostic-method patents remains contested after Mayo and later Federal Circuit decisions.

Implications

For biotech patentees: Claim what you create—cDNA constructs, engineered sequences, vectors, and specific applications—rather than naturally occurring sequences, which are off-limits.
For diagnostics companies: Gene-sequence exclusivity is no longer available; competitive advantage must come from improved methods, instruments, or downstream uses that clear eligibility.
For researchers and clinicians: The ruling freed the underlying genetic information, expanding access to genetic testing and second-opinion diagnostics.
For patent counsel: Frame claims around human-made molecules and concrete chemical changes; reciting that DNA was merely isolated will not survive a Section 101 challenge.
For the broader life sciences: Myriad, together with Mayo, made eligibility a front-line battleground in biotech prosecution and litigation, requiring early strategic attention to what the invention actually contributes.

Frequently asked questions

Can you patent a human gene? No. In AMP v. Myriad Genetics the Supreme Court held that a naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated from the surrounding genome. The genetic information itself is a discovery, not an invention.

Why is cDNA patent eligible when isolated DNA is not? Complementary DNA, or cDNA, is synthesized in the lab from messenger RNA and omits the non-coding introns found in natural DNA. Because that exons-only sequence does not occur in nature, the Court held it is not a product of nature and can be patent eligible, except where the sequence is so short it is indistinguishable from natural DNA.

What did Myriad lose and keep? Myriad lost its claims to the isolated BRCA1 and BRCA2 genes themselves, opening the door to competing genetic testing. The Court left intact the eligibility of cDNA and noted it was not deciding the validity of method claims or claims to new applications of the genes.