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.

Written by:

Published In:


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Squire Patton Boggs | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.