Thursday, 13 June 2013

US Supreme Court Rules That Isolated DNA Is Not Patent-Eligible, But cDNA Is Eligible

In this morning's 9-0 decision written by Justice Clarence Thomas, the U.S. Supreme Court ruled that isolated human DNA is not eligible subject matter under 35 U.S.C. § 101. Assoc. for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013). The Court rejected the position articulated by Judge Lourie at the Federal Circuit that the isolation of the DNA molecule results in a physical change in the molecule, rendering it patentable, as it is chemically removed from its intracellular environment.  The Court noted:
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. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ’282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.
Slip op. at 14-15.

The Court ruled that complementary DNA (cDNA) molecules are eligible for patenting, as the Federal Circuit held. Justice Thomas wrote that although the cDNA contains the same genetic information as naturally-occurring DNA molecules, it is physically something that does not exist in nature (at least for longer cDNA fragments that do not span non-coding intron regions):
[The petitioners argue that] that cDNA is not patent eligible because “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” That may be so, but 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. In that situation, a short strand of cDNA may be indistinguishable from natural DNA. 
Slip op. at 17 (citation ommitted). Jusitice Scalia filed a concurring opinion, stating essentially that he did not claim to understand all the science, but generally agreed with the Court's result.

The opinions are available HERE.

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