Supreme Court Limits Patentability of Human Gene Sequences

The Supreme Court today issued a decision in Association for Molecular Pathology v. Myriad Genetics, which reduced the ability to patent human gene sequences. 

In a departure from established Federal Circuit law, the Supreme Court determined that isolated gene sequences found in nature are natural phenomena and not patent eligible.  Myriad’s patents covered gene sequences removed from a cell, referenced by Myriad as isolated DNA.  The gene sequences are identical to those found in the body except that they are isolated from the remainder of the strand of DNA. The Supreme Court found that these isolated gene sequences are a “product of nature and not patent eligible merely because it has been isolated.”  The Court found that “Myriad did not create or alter either the genetic information encoded in the [isolated] genes or the genetic structure of the DNA.”  In particular, Justice Thomas, writing for the Court stated “[t]he claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the [isolated] genes.” 

The Supreme Court did, however, specifically hold that complementary DNA (“cDNA”) was patentable because it is not found in nature and something new is created when portions of the DNA are removed to make the end product.  

The Court was explicit in noting that this decision did not cover “method claims, patents on new applications of knowledge about the [isolated] genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.” 

Patent owners with issued patents related to gene sequences and patent applications with currently pending or unfiled applications should carefully review their portfolios to determine how this decision will affect the value and enforceability of their applications, and determine if there are strategies to create value around this decision. 

A copy of the decision may be found here.