United States: Federal Circuit Denies En Banc Review Of Ariosa v. Sequenom

Last Updated: December 11 2015
Article by Ronald C. Kern

On December 2, 2015, an almost unanimous Federal Circuit decision was issued denying the en banc rehearing of Ariosa v. Sequenom, a case having significant consequences for diagnostic patents and Section 101 case law in general.1 The concurrences and dissent in the Ariosa case offer insight into how the various judges perceive the existing Section 101 case law and attempt to offer applicants guidance in obtaining patent-eligible claims in the diagnostic arena.

The patent at issue

Sequenom is the exclusive licensee of U.S. Patent No. 6,258,540 (the '540 patent), which claims a "method of detecting paternally inherited nucleic acid of fetal origin performed on the maternal serum or plasma sample from a pregnant female." '540 patent at 23:61-63. According to the '540 patent, the invention enables noninvasive prenatal diagnosis (id. at Abstract) and differs from previous noninvasive tests that detected fetal cells in a mother's bloodstream. Id. 1:18-36. The independent claims of the '540 patent recite:

  1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
  1. A method of performing a prenatal diagnosis, which method comprises the steps of:

    1. providing a maternal blood sample;
    2. separating the sample into a cellular and a non-cellular fraction;
    3. detecting the presence of a nucleic acid of foetal origin in the non-cellular fraction according to the method of claim 1;
    4. providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid.
  1. A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises: removing all or substantially all nucleated and anucleated cell populations from the blood sample, amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the Paternally inherited fetal nucleic acid.
  2. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises obtaining a non-cellular fraction of the blood sample amplifying a paternally inherited nucleic acid from the non-cellular fraction and performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid.

The district court action

On December 19, 2011, Ariosa filed suit against Sequenom, seeking a declaration that Ariosa's noninvasive prenatal test did not infringe the '540 patent. Sequenom counterclaimed, alleging infringement of the '540 patent. Both parties filed motions for summary judgment regarding invalidity under Section 101. The district court concluded that the only inventive part of the '540 patent is the application of well-understood, routine, and conventional steps of fractionation, amplification, and detection to a natural phenomenon, i.e., cffDNA.2 Ariosa Diagnostic, Inc. v. Sequenom, Inc., 19 F.Supp.3d 938 at 953 (N.D. Cal. 2013). Because fractionation, amplification, and detection techniques were previously engaged in by those in the field, albeit on DNA, and because cffDNA is itself not patentable, the district court ruled that the claims of the '540 patent are directed to patent-ineligible subject matter. Id. at 952-953.

The Federal Circuit affirms the lack of patent-eligible subject matter

The initial Federal Circuit panel (Judge Reyna joined by Judge Linn) applied the two-part test set forth in Mayo and affirmed the district court's ruling.3 Ariosa Diagnostic, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). Under the first part of the test (whether the claims are directed to a patent-ineligible concept), the court concluded that the claims "begin[] and end[] with a natural phenomenon" and are thus "directed to matter that is naturally occurring." Id. at 1376. Under the second part of the test (whether the claim elements individually and as a whole contain an inventive concept to transform the claim into patent-eligible subject matter), the court concluded that "the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention." Id. at 1376. In reaching its decision, the court analyzed the evidence of record, including the specification, expert testimony, and arguments raised by the applicant during prosecution, which, according to the court, established that the process steps did not contain additional features that are new and useful. Id. at 1377. The court held that "[w]here claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent-eligible subject matter if the methods themselves are conventional, routine, and well understood applications in the art." Id. at 1378.

Judge Linn concurred, but only because he was "bound by the sweeping language of the test set out in Mayo." Id. at 1380. Judge Linn's concern for the overly broad test set forth in Mayo is clear from his following statement:

[T]he breadth of the second part of the test was unnecessary to the decision reached in Mayo. This case represents the consequence – perhaps unintended – of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.

Ariosa, 788 F.3d at 1380.

En banc review denied

In an almost unanimous decision (11-1), the active judges of the Federal Circuit denied the petition for rehearing en banc. Ariosa Diagnostic, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), reh'g denied, Nos. 2014-1139, 2014-1144 at 4-5 (Fed. Cir., Dec. 2, 2015). Three opinions were filed with the denial: concurring opinions by Judge Lourie (joined by Judge Moore) and Judge Dyk and a dissent by Judge Newman. Both Judge Lourie and Judge Dyk concurred because they were bound by Supreme Court precedent. According to Judge Lourie, "neither of the traditional preclusions of laws of nature or of abstract ideas ought to prohibit patenting of the subject matter of this case" (Lourie, J., concurring in denial of rehearing en banc at pp. 2-3), but "[a]pplying 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." Id. at p. 6. Similarly, Judge Dyk noted that the court is bound to follow the Mayo decision, and that the court "cannot confine Mayo to its facts or otherwise cabin a clear statement from the Supreme Court." Dyk, J., concurring in denial of rehearing en banc at p. 1. Judge Newman, on the other hand, dissented, arguing that this case "diverge[s] significantly" from Mayo. Newman, J., dissenting in denial of rehearing en banc at pp. 1-2. According to Judge Newman, whereas the Mayo claims recited a previously known medicinal product and its metabolites, the Sequenom claims recite a "new diagnostic method [that] is novel and unforeseen." Id. at p. 3.

Guidance offered by the Federal Circuit?

As the diagnostic and life science communities eagerly wait to see whether or not Ariosa will petition the Supreme Court to review this case, the Federal Circuit may have begun to offer applicants guidance on pursuing patentable claims in the diagnostic arena. For example, the original panel decision states that "[f]or process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful." Ariosa, 788 F.3d at 1377. Therefore, when the claims include a law of nature, the focus of the claims should be on the process steps, with the inclusion of some new process limitation, as opposed to simply reciting amplifying or sequencing. Furthermore, the Federal Circuit and the district court both focused on the specification and arguments raised by the applicants during prosecution, which established that the method steps can be formed using conventional, well-known techniques. Thus, applicants are advised, depending on the facts of the case, to avoid including broad language regarding well-known or common techniques in the specification.

Judge Lourie suggests drafting the claims as Jepsen claims, i.e., reciting what is in the prior art and the improvement over the prior art. Judge Lourie offers the following example:

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.

Lourie, J., concurring in denial of rehearing en banc at pp. 2-3. It is unclear whether this uncommonly used claim strategy will overcome the issues facing diagnostic claims.

Judge Dyk suggests that claims might be patentable if the claims are "both narrow in scope and actually reduced to practice" (Dyk, J., concurring in denial of rehearing en banc at p. 9), such that the claim is "narrowly tailored to the particular application of the law [of nature] that has been developed." Id. at p. 10. Both Judge Lourie and Judge Dyk offer concerns about the broad scope of the claims in the '540 patent. Judge Lourie states that "[t]he claims in this case perhaps should be in jeopardy, not because they recite natural laws or abstract ideas, but because they may be indefinite or too broad." Lourie, J., concurring in denial of rehearing en banc at p. 4. Similarly, Judge Dyk states that "the major defect is not that the claims lack inventive concept but rather that they are overbroad." Dyk, J., concurring in denial of rehearing en banc at p. 13.

Although there is still a chance that Ariosa will petition the Supreme Court to review the case, the Ariosa decisions continue to narrow the scope of what constitutes patentable subject matter in the diagnostic area. Time will tell whether or not the guidance offered by the Federal Circuit will assist applicants in drafting claims that withstand Section 101 scrutiny going forward.

Footnotes

[1] Ariosa Diagnostic, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), reh'g denied, Nos. 2014-1139, 2014-1144 at 4-5 (Fed. Cir., Dec. 2, 2015).

[2] The evidence before the court established that fractionation, amplification, and detection techniques, including fractionating, amplifying, and detecting DNA from plasma and serum, were well understood, routine, and conventional. Id. at 949-950. Sequenom acknowledged that the claims of the '540 patent are directed to applying these "conventional techniques" to the newly discovered cffDNA. Id. at 950.

[3] Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012).

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
Similar Articles
Relevancy Powered by MondaqAI
Stroock & Stroock & Lavan LLP
Foley & Lardner
Kramer Levin Naftalis & Frankel LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Stroock & Stroock & Lavan LLP
Foley & Lardner
Kramer Levin Naftalis & Frankel LLP
Related Articles
 
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 (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.

Disclaimer

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.

General

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