United States: Agreeing To Disagree With The Supreme Court: Mayo Is Wrong, Would You Please Fix It?

Three strikes and you're out? The Federal Circuit's per curiam denial of en banc rehearing of Ariosa v. Sequenom, is the third time that Sequenom has seen its diagnostic methods denied patent protection. But the company is likely to continue trying to change this outcome, particularly in view of the Federal Circuit's tortured acknowledgment that its hands are tied by Supreme Court precedent. Since "it ain't over until it's over," until the Supreme Court rules, there is hope for Sequenom's patent and many other diagnostic patent applications currently being denied by the U.S. Patent and Trademark Office (USPTO). Hope has never been so justified, in view of some experienced judges explicitly agreeing to disagree with the Supreme Court.

The Federal Circuit has not accepted responsibility for the state of diagnostic patents and personalized medicine, instead attributing it to the Supreme Court because "applying Mayo, we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process" (Judge Lourie) or because "we are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court" (Judge Dyk). But is that so—even if, as Judge Dyk stated, the "panel's decision to withhold access to patenting . . . is devoid of support" and the "subject matter is not ineligible under Section 101 . . ."? (emphasis added).

Not necessarily. "I do not share their view that this incorrect decision is required by Supreme Court precedent," wrote Judge Newman (emphasis added). The court is not bound by Mayo because "[t]he facts of this case diverge significantly from the facts and rulings in" that case. Judge Newman specifically points to the difference between Sequenom's situation, where the natural law was newly discovered and at least the step involving the starting material was new, and the facts in Mayo, where "both the medicinal product and its metabolites were previously known, leaving sparse room for innovative advance in using this information as a diagnostic dosage tool." In Judge Dyk's view, however, the Supreme Court has spoken:

The Mayo Court found that prior Supreme Court decisions "insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."

On the other hand, Judges Lourie and Moore share the view that Sequenom's claims do not "merely recite a law of nature, a natural phenomenon, or an abstract idea." They agree that "[t]he claims rely on or operate by, but do not recite, a natural phenomenon or law" and instead recite steps that "are all physical, and not insignificant, steps requiring human intervention." They agree that the claims "recite innovative and practical uses for [cffDNA]" and that "it is undisputed that before [Sequenom's] invention, the ... use of these methods for prenatal diagnosis were not routine and conventional" (emphasis in original). Yet in spite of this view, Judges Lourie and Moore found "no principled basis to distinguish this case from Mayo."

One unexpected item in this decision was Judge Lourie's proposal for a different way of claiming the invention through an improvement-based "Jepson claim," such as:

In a method of performing a prenatal diagnosis using techniques of fractionation and amplification, the improvement consisting of using the non-cellular fraction of a maternal blood sample.

The Judge saw Sequenom's invention as an "improvement in the method of determining fetal genetic characteristics or diagnosing abnormalities of fetal DNA, consisting of use of the non-cellular fraction of fetal DNA obtained from a maternal blood sample." A claim of this general format may have been sufficient to protect Sequenom's invention, but it is not clear whether this format would be applicable to all types of diagnostic inventions. Nevertheless, it is refreshing that a Federal Circuit judge would propose an alternative claim strategy in the face of "the accusation that such a claim to the invention might be considered mere draftsmanship and thus still ineligible under the seemingly expansive holding of Mayo . . . ." It is also inspirational to have two judges consider that "claim drafting is a laudable professional skill, not necessarily a devious device for avoiding prohibitions," encouraging practitioners to creatively revisit their claim strategies for alternative ways of claiming their Applicants' diagnostic inventions.

But it is Judge Dyk's opinion that offers the most helpful insight into how to meet the elusive "inventive concept" requirement of the Mayo framework. In fact, it would seem that at least some of Sequenom's claims, untouched, might already meet this requirement. As Judge Dyk "see[s] it,"

[T]here is a problem with Mayo insofar as it concludes that inventive step cannot come from discovering something new in nature—e.g., identification of a previously unknown natural relationship or property. In my view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself.

Judge Dyk's reasoning is consonant with the Supreme Court statement in Myriad that "an inventive concept can sometimes come from discovery of an unknown natural phenomenon, not just from unconventional application of a phenomenon." As Judge Dyk points out, it is very important to note that Myriad suggested that "'new applications of knowledge about the BRCA1 and BRCA2 [newly discovered genes]' could generally be eligible, with reference to claim 21 of U.S. Patent No. 5,753,441."

The difference between Myriad's claim 21 (which, unfortunately, was not part of the case before the Supreme Court) and the claims that were found to be patent ineligible is that it is directed to detecting specific, newly discovered gene mutations (38 of them). Judge Dyk suggests that the Supreme Court's implication that Myriad's claim 21 is patent eligible is due to the fact that it "is narrowly tailored to what the patent applicant has actually invented and reduced to practice." (emphasis added). In effect, Judge Dyk set forth a new "more permissive" measure of "inventive concept," one that renders patent eligible claims that are "both narrow in scope and actually reduced to practice, not merely 'constructively' reduced to practice by filing of a patent application replete with prophetic examples."

Judge Dyk describes his proposed approach as supported by Morse, a seminal patent eligibility case. This coalescence between claim scope and novelty of the discovery for purposes of establishing "inventive concept" is not only creative but perhaps workable. As Judge Dyk states:

The approach would, I think, ensure that only diagnostic and therapeutic method patents limited in their claim scope would survive. These patents would provide the world with disclosure and useful applications of previously unknown natural laws, and the opportunity to obtain such patents would help to restore the incentive to make those discoveries that the patent system has historically provided.

That might be so. From a pragmatic standpoint, this approach also provides a more exact test for patent eligibility than anything the courts have said so far, making it much more useful to practitioners, investors, and the industry in general. But it is likely that this approach would not always serve the needs of the community developing diagnostic tests for personalized medicine. First, as Judge Dyk warns, this test "could [still] present difficulties of definition and line drawing." Second, "representative examples" of the invention possessed by the inventor would no longer suffice. And it would be difficult, for example, to reduce to practice prior to filing all applications of the discovery of a natural correlation linking a certain marker to cancer. It is more likely that only a subset of cancers would have been actually tested prior to filing the application. And limiting the claims to that subset would leave unprotected obvious variations of the method, even when the subset of cancers disclosed is clearly representative and predictive of others.

Although at least some judges have taken positive steps by recognizing that "discoveries" are patent eligible (which many consider to be mandated by statute), the fact of the matter is that the per curiam denial rules. And, right or wrong, "method claims that apply newly discovered laws and phenomena in somewhat conventional ways are screened out by the Mayo test." (Judge Dyk). Even Judges Lourie and Moore recognize that, unfortunately, "a crisis of patent law and medical innovation may be upon us."

Will the Supreme Court take this case and provide the final (and hopefully more instructive) word on the patent eligibility of diagnostic-related claims? Sequenom has until early next year to petition for certiorari. If granted, the case would be argued in the Fall of 2016. Thus, the ball is in Sequenom's court.

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.

Events from this Firm
15 Nov 2017, Conference, California, United States

Finnegan is a Gold sponsor of the second annual Digital Media & IP Forum, hosted by World Congress.

15 Nov 2017, Conference, London, UK

Finnegan partner Leythem Wall will consider European claim drafting strategy and will lead the Chemical Workshop during a two-day course, hosted by Management Forum.

15 Nov 2017, Seminar, Amsterdam, Netherlands

Finnegan partner Anthony Tridico will lead Forum Institute for Management’s course comparing patent law in the United States and Europe.

In association with
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
Check to state you have read and
agree to our Terms and Conditions

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.


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.


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 by clicking here .

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.


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.


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.


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.


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.