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.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

    Disclaimer

    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

    Registration

    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

    Cookies

    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

    Links

    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

    Mail-A-Friend

    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

    Emails

    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

    Security

    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

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