Isolated DNA

The United States Supreme Court has ruled that isolated DNA is not patentable subject matter but cDNA is patentable in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al.

In the unanimous decision (PDF), the Supreme Court reversed-in-part and affirmed-in-part the CAFC decision, in which a majority had held that uphol isolated DNA were patentable but denying the patentability of certain method claims.

Representative claims at issued were directed to isolated DNA sequences (claims 1 and 2 of US5,747,282):

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. [where SEQ ID NO:2 was a list of 1,863 amino acids that the typical BRCA1 gene encodes]

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1. [where SEQ ID NO:1 lists only the cDNA exons in the BRCA1 gene, rather than a full DNA sequence containing both exons and introns.]

In today’s decision, the Court stated that merely isolating DNA was not patentable:

In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.

Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.

On the other hand, complementary DNA (cDNA):

… 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” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA.

The Court concludes its decision by cautioning that a) no method claims were before the Court; b) the claims did not relate to new applications of the genes; and c) the Court does not address modified genes in the decision.

This decision and its implications will likely be widely discussed. Some early reaction is in the NY Times and Patently-O.