US Supreme Court Holds Isolated Naturally-Occurring DNA Segments Are Products of Nature and Not Patent Eligible

US Supreme Court Holds Isolated Naturally-Occurring DNA Segments Are Products of Nature and Not Patent Eligible

Association for Molecular Pathology v Myriad Genetics Inc, US SC No 12–398 (2013)

Myriad Genetics discovered the precise location and sequence of two human genes, BRCA1 and BRCA2, mutations of which can substantially increase the risks of breast and ovarian cancer. Myriad obtained a number of patents based upon its discovery. In this case the Court must resolve whether a naturally occurring segment of DNA is patent eligible under 35 U.S.C. §101 by virtue of its isolation from the rest of the human genome. The Court also must address the patent eligibility of synthetically created DNA known as complementary DNA (cDNA), which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins.

A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.

cDNA is patent eligible because it is not naturally occurring.

A representative claim asserts a patent on “[a]n isolated DNA coding for a BRCA1 polypeptide,” which has “the amino acid sequence set forth in SEQ ID NO:2.” SEQ ID NO:2 sets forth a list of 1,863 amino acids that the typical BRCA1 gene encodes. Put differently, claim 1 asserts a patent claim on the DNA code that tells a cell to produce the string of BRCA1 amino acids listed in SEQ ID NO:2.

Another representative claim directed at cDNA claims “[t]he isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.” Like SEQ ID NO:2, SEQ ID NO:1 sets forth a long list of data, in this instance the sequence of cDNA that codes for the BRCA1 amino acids listed in claim 1. Importantly, SEQ ID NO:1 lists only the cDNA exons in the BRCA1 gene, rather than a full DNA sequence containing both exons and introns.

Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome. The patents would also give Myriad the exclusive right to synthetically create BRCA cDNA.

Isolated Naturally-Occurring DNA

Isolated naturally-occurring DNA is not patent eligible.

Myriad found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.

Myriad found the location of the BRCA1 andBRCA2 genes, but that discovery, by itself, does not render the BRCA genes “new . . . composition[s] of matter,” §101, that are patent eligible.

Myriad sought to import its extensive research efforts into the §101 patent eligibility inquiry. But extensive effort alone is insufficient to satisfy the demands of §101.

Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule.

Myriad’s patent claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

Finally, Myriad argued that the PTO’s past practice of awarding gene patents is entitled to deference. In this case, however, Congress has not endorsed the views of the PTO in subsequent legislation. Further undercutting the PTO’s practice, the United States argued in the Federal Circuit and in this Court that isolated DNA was not patent eligible under §101.


cDNA is patent eligible because it is not naturally occurring.

The lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature”.