Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

by Foley & Lardner LLP
Contact

On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's decision shows the sweeping impact of the Supreme Court's decision in Mayo v. Prometheus, and the Federal Circuit’s rigid interpretation of the Mayo framework for determining patent eligibility of diagnostic methods. While the Federal Circuit acknowledged the real-world contribution of the Sequenom methods, it cited the Supreme Court’s decision in Myriad for the proposition that “[groundbreaking], innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ariosa, slip op. at 16.

The Claims at Issue

The Sequenom patent at issue was U.S. Patent 6,258,540. The claimed technology relates to diagnostic methods for determining certain fetal characteristics such as gender and genetic defects, based on paternally inherited cell-free fetal DNA (cffDNA) found in maternal plasma and serum.

The independent claims at issue in this appeal 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.

24. 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 [sic] inherited fetal nucleic acid.

25. 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.

Ariosa, slip op. at 4-5.

The Procedural History

This case dates back to 2011, when Ariosa brought a declaratory judgment action seeking a declaration that its “Harmony” test did not infringe the ’540 patent. Sequenom brought an infringement counterclaim and sought a preliminary injunction. The district court construed the claims, found a substantial question of non-infringement, considered the other factors pertinent to a preliminary injunction inquiry, and denied the preliminary injunction. Sequenom appealed to the Federal Circuit, which vacated and remanded based on a different claim construction. In that decision, the Federal Circuit also directed the district court to consider the patent eligibility issues in view of the Supreme Court's Myriad decision. (Read more about the first Federal Circuit decision here.) On remand, the district court granted summary judgment of invalidity under 35 USC § 101. It is Sequenom's appeal of that decision that the Federal Circuit has now decided.

The Patent Eligibility Problem

The Federal Circuit decision was authored by Judge Reyna and joined by Judges Linn and Wallach. Judge Linn also filed a concurring opinion.

The court applied Mayo’s two-step framework for determining patent eligibility, considering first whether the claims are directed to a patent-ineligible concept, and, if they are, determining whether the additional claim elements “transform the nature of the claim” into a patent-eligible application of the natural phenomenon. Ariosa, slip op. at 8. With regard to the first step, the Federal Circuit noted that the claims recite “a multistep method that starts with cffDNA taken from a sample of maternal plasma or serum . . . [and] ends with paternally inherited cffDNA, which is also a natural phenomenon.” Ariosa, slip op. at 8-9. Having found that “[t]he method begins and ends with a natural phenomenon,” Ariosa, slip op. at 9, the Federal Circuit moved on to the second step of the Mayo framework.

For the second step, the Federal Circuit explained that “for process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful.” The court followed a methodical approach, studying the individual active steps within the body of the claims, and determining that each were “well-understood, conventional and routine.” Ariosa, slip op. at 11. Instead of focusing on the undisputed novelty of amplifying and detecting a paternally inherited nucleic acid in a serum sample from a pregnant female, the court’s analysis centered on the laboratory techniques used to perform those steps. For example, the court noted that the specification taught that the preparation, amplification and detection “of DNA sequences in a plasma or serum sample were well-understood, routine, conventional activities,” Ariosa, slip op. at 11, even though the specific type of DNA recited in the claims had not been amplified or detected in the specific type of sample recited in the claims. The court also considered several dependent claims, but found none to add anything “inventive” to the claimed methods. Ariosa, slip op. at 12. The court’s conclusion indicates how it may analyze other diagnostic method claims for patent eligibility:

Where 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.

Ariosa, slip op at 13.

Responding to Sequenom's other arguments, the Federal Circuit indicated that the preemption aspect of the subject matter eligibility analysis was more useful as a sword than a shield, noting that “[w]hile preemption may signal patent ineligible subject matter, the absence of preemption does not result in a determination of patent eligibility.” Ariosa, slip op. at 14.

Thus, the Federal Circuit affirmed the district court's grant of summary judgment of invalidity.

Judge Linn’s Concurrence

Judge Linn’s concurring opinion places blame for the result here squarely on the shoulders of the Supreme Court and its decision in Mayo. Although Judge Linn finds that Sequenom's claims are distinguished from the claims at issue in Mayo, he feels bound by the language of Mayo to hold the Sequenom claims ineligible. Judge Linn urges the Supreme Court to reconsider the Mayo framework, and at least permit the consideration of “post-solution activity” when that activity is novel.

What’s Next for Diagnostic Medicine Patents?

This decision is going to have a ripple effect across the diagnostic and personalized medicine industry. While the contours of this decision have yet to be determined, it at least appears to leave room for patent eligibility where method claims recite novel laboratory techniques or reagents. However, it may make it more difficult to obtain patents related to diagnostic methods, personalized medicine, and other method claims that involve a “natural phenomenon.”

Judge Linn’s concurrence offers one possible solution to this problem, but if the Supreme Court grants certiorari, it will be another year before we could have a different decision. Various groups are working on possible legislative solutions to the patent eligibility problem, but it will take time to negotiate statutory language that is agreeable to all stakeholders, and even longer for any proposed legislation to make is way through Congress.

Written by:

Foley & Lardner LLP
Contact
more
less

Foley & Lardner LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*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. Or, sign up using your email address.