Legal Alert: Isolated Genes No Longer Patentable: Supreme Court Reverses Federal Circuit in Myriad Case

In a thinly worded unanimous decision in Assn. for Molecular Pathology v. Myriad Genetics, Inc. on June 13, 2013, the U.S. Supreme Court held that patent claims directed to genes are not patent eligible despite being claimed in an isolated form. The Court indicated that in order to qualify for patentability, a composition must be not only non-naturally occurring, but also have markedly different characteristics from any found in nature. An isolated naturally occurring DNA gene sequence, or amplification fragment, though made useful to provide a diagnosis for disease propensity, is apparently not modified sufficiently through isolation from its chromosomal environment to meet the standard for patentability.

The Court distinguished the patent eligibility of cDNA molecules, which are copies of RNA molecules encoding for a protein, but having certain non-useful corresponding original DNA (introns) removed. The Court also distinguished the patent eligibility of novel DNA sequences that are not found in nature but are instead engineered. Therefore, despite the surprising nature of this decision, there remains numerous ways in which patent eligible DNA claims can be drafted and protected, such as by claiming cDNA or including the native DNA in association with other components.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

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.

© Sutherland Asbill & Brennan LLP | 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.