United States: Federal Circuit Applies "Alice" To Biotechnology In Striking Down Myriad Method Of Screening Claims, Leaves Door Open For Narrower Method Claims

On December 17, 2014, a three judge panel of the Federal Circuit issued a ruling that may significantly narrow the scope of patent eligible subject matter with respect to method claims in the biotechnology field. The unanimous decision, authored by Judge Dyk, held that claims to isolated short primers derived from genomic DNA and certain diagnostic method claims utilizing those primers recited patent ineligible subject matter. Following the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, which held that Myriad’s patent claims directed to the BRCA1 and BRCA2 genes were directed towards natural products and accordingly were not eligible for patent protection, Myriad filed suit on different BRCA1 and BRCA2 patents against Ambry Genetics. In the decision issued by the Federal Circuit yesterday, captioned University of Utah Research Foundation et al. v. Ambry Genetics Corp, the appellate court applied the Supreme Court’s reasoning in Myriad and in Alice Corp v. CLS Bank Int’l to hold that claims directed towards primers derived from naturally-occurring DNA and methods of diagnosing an alteration in the BRCA1 gene using those primers are ineligible for patent protection. 

The patents at issue involved two separate sets of claims. The first set comprised a number of composition of matter claims directed towards short, synthetic, single-stranded DNA molecules known as primers. Such primers serve as a starting point for DNA synthesis. The primers were derived from genomic DNA. Also at issue was a pair of method claims involving the comparison of a portion of a patient’s genome at a particular location (specifically the BRCA1 gene) to the sequence most typically at that location in the human genome (known as the “wild-type” sequence). The method claims were not limited to identifying specific mutations or to diagnosing a predisposition to specific diseases or even specific cancers.

In holding that the composition of matter claims were patent ineligible, the Court relied on the Myriad decision, stating that DNA “can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature,” and thus cannot be based on naturally-occurring nucleotide sequences. The Court rejected the patentee’s argument that the primers were patentable because they were synthetically replicated, as were the cDNAs upheld as patentable in Myriad. The Court distinguished the claims at issue from the Myriad cDNA claims, noting that the structures of the claimed cDNAs were altered to exclude introns, those portions of naturally occurring DNA that do not code for amino acids. Because isolated DNA is “routinely synthetically created,” the Court held that the proper inquiry when assessing patentability is whether the DNA has a structure that can be “found” in nature. 

The Court also rejected the patentee’s argument that the primers were patentable because single-stranded DNA molecules are not found in the human body as directly contravened by Myriad. Quoting the Myriad decision, the Court held that separating DNA from its surrounding genetic material “is not an act of invention,” and thus not amenable to patentability even if the molecule in question is not found in nature as a single isolated unit. The Court was also not convinced by Myriad’s argument that its primers had a different function than natural DNA.

Turning to the method claims, the Court did not decide if they were patent ineligible under the “law of nature” reasoning of the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, which also involved diagnostic claims. Instead, the Court held that the claims failed as reciting “abstract ideas.” In reaching its decision, the Court applied the two-step analysis used by the Supreme Court in Alice Corp v. CLS Bank Int’l. First, the Court held that the comparison of a sequence of a patient’s genome to a particular reference sequence was nothing more than “the abstract mental steps necessary to compare two nucleotide sequences,” and thus directed toward patent ineligible subject matter. The Court expressed particular concerns that allowing a patent on a comparison between a gene sequence taken from a human subject and a reference sequence would allow “basic building blocks of scientific research to be monopolized,” and that the resulting monopoly could seriously impede future research relating to the BRCA genes.

Next, the Court considered whether the claim elements in addition to the comparison step, either in isolation or in combination with the comparison step, contained a sufficient “inventive concept” to render the claims patent eligible. Here the Court relied on the district court’s unchallenged finding that the subsequent elements “set forth well-understood, routine and conventional activity engaged in by scientists at the time of Myriad’s patent applications,” and that “any scientist engaged in obtaining the sequence of a gene in a patient sample would rely on these techniques.” Myriad argued that the method claims at issue were sufficiently similar to a method claim that Judge Bryson had suggested was patentable in a separate opinion in the Federal Circuit’s original decision in the Myriad case. That claim also involved a method of comparing a patient’s BRCA1 gene to a reference sequence, but it limited the application of the method to detecting specific mutations in the patient’s genes that are known to predispose the patient to specific forms of cancer. The Supreme Court in its Myriad decision had also referred to that claim and Judge Bryson’s opinion, but had not ruled on its patent eligibility.

The Court was not convinced by Myriad’s argument. Rather, it held that the claims at issue here were “qualitatively different” than those that Judge Bryson and the Supreme Court had addressed. Significantly, the Court did not take up the question of whether the limitation of the claims to detecting specific mutations that predispose a subject to specific cancers was sufficient to establish that the claims were directed to patent eligible subject matter. Furthermore, the Court found that the lack of such limitations in the rejected claims rendered them “significantly broader and more abstract.” As such, the Federal Circuit may have read the enablement standards of 35 U.S.C. § 112 into its § 101 analysis. However, the Court may have left the door open for method claims directed towards diagnosing genetic predisposition to specific diseases, provided that those claims are also limited to the detection of particular mutations. 

The effects of this decision remain to be seen. Method claims directed towards diagnosis of predisposition to specific diseases may still be viable if sufficiently limited in scope, but the extent of the necessary limitations remain unclear. This ruling also suggests that the “significantly more” analysis outlined in the December 16, 2014 Interim Guidance of the U.S. Patent and Trademark Office may need to be reconsidered to take into account the breadth of the claim at issue. 

A copy of the Federal Circuit’s University of Utah Research Foundation v. Ambry Genetics Corporation decision is available here.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions