Intellectual Property Rights

Association for Molecular Pathology v. Myriad Genetics, Inc.

569 U.S. 576 (2013)

Facts

Myriad Genetics discovered the precise location and sequence of the BRCA1 and BRCA2 genes.
Certain mutations in those genes substantially increase the risk of breast and ovarian cancer.
Myriad obtained patents claiming:
isolated DNA containing BRCA sequences;
complementary DNA, or cDNA;
related methods and applications.
The patents allowed Myriad to control important forms of genetic testing involving those sequences.
Medical organisations, researchers and patients challenged the claims.
They argued that human genes are naturally occurring information and cannot become inventions merely through isolation.
Myriad responded that isolated DNA was chemically separated from the chromosome and therefore human-made.
The dispute reached the United States Supreme Court.

Whether naturally occurring DNA becomes patentable when isolated from the human genome.
Whether cDNA is patentable.
How the product-of-nature doctrine applies to genetic material.

Laws of nature, natural phenomena and products of nature are excluded from patent eligibility.
Discovering the location or significance of a naturally existing substance does not by itself create a patentable invention.
Isolation alone is insufficient where the claimed genetic information and sequence remain naturally occurring.
A molecule created in the laboratory may be patent eligible where it is not naturally occurring.
Patent eligibility is distinct from novelty, non-obviousness and sufficient disclosure.
The decision concerned product claims and did not broadly decide:
new genetic-testing methods;
altered DNA sequences;
applications of genetic knowledge.

Myriad made an important scientific discovery by locating the BRCA genes and identifying their medical significance.
Scientific importance, however, is not the same as invention.
The nucleotide sequence claimed in isolated genomic DNA was created by nature.
Removing the gene from surrounding chromosomal material did not change the genetic information that Myriad sought to control.
Myriad did not create or alter the order of nucleotides in the naturally occurring BRCA sequence.
The Court therefore held that isolated genomic DNA remained a product of nature.
cDNA was different.
It is produced by using messenger RNA as a template and generally removes non-coding regions called introns.
The resulting molecule is ordinarily not found in that exact form in nature.
A laboratory technician therefore creates something structurally distinct from the naturally occurring gene.
cDNA was generally patent eligible.
The Court added an important qualification:
very short DNA sequences may contain no introns;
in such cases, the cDNA sequence may be identical to natural DNA and therefore remain unpatentable.
The decision did not prevent patents on:
genuinely altered genetic material;
innovative applications;
new technical methods satisfying the remaining patent requirements.
It only prevented ownership of the naturally occurring genetic information itself.

The Supreme Court unanimously held that naturally occurring BRCA DNA is not patentable merely because it has been isolated.
cDNA is generally patent eligible because it is not naturally occurring, subject to the qualification concerning identical short sequences.
Use this case for: discovering and isolating a natural gene does not create patentable subject matter, while laboratory-created cDNA may qualify because it is structurally distinct from natural DNA.