Cleveland Clinic Decision Highlights Catch-22 Of Personalized Medicine Patents

by Foley & Lardner LLP
Contact

The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized medicine patents. The court affirmed the invalidity of claims related to a blood test for atherosclerotic cardiovascular disease, and agreed with the district court that diagnostic company True Health was not liable for contributory or induced infringement of claims directed to treating patients diagnosed by the blood test.

The Diagnostic Patents — Ineligible

The diagnostic patents at issue were U.S. Patent No. 7,223,552, U.S. Patent No. 7,459,286, and U.S. Patent No. 8,349,581. Claim 14 of the ‘552 patent illustrates the claimed methods:

14. A method of assessing a test subject’s risk of developing a complication of atherosclerotic cardiovascular disease comprising:
determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample of the test subject, said bodily sample being blood … ;
wherein elevated levels of MPO activity or MPO mass or both in the test subject’s bodily sample as compared to levels of MPO activity, MPO mass, or both, respectively in comparable bodily samples obtained from control subjects diagnosed as not having the disease indicates that the test subject is at risk of developing a complication of atherosclerotic cardiovascular disease.

Cleveland Clinic asserted the patents in the U.S. District Court for the Northern District of Ohio, which denied its motions for a temporary restraining order and preliminary injunction, and instead granted True Health’s motion to dismiss on the grounds that the patents are directed to ineligible subject matter.

The Federal Circuit upheld the district court’s findings on these patents, approving its treatment of the issues at the motion to dismiss stage, and agreeing with its determinations on the merits.

Applying step one of the Alice analysis, the Federal Circuit found:

[J]ust like Ariosa, the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between—the presence of MPO in a bodily sample is correlated to its relationship to cardiovascular disease. The claims are therefore directed to a natural law.

Applying step two of the Alice analysis, the Federal Circuit noted that the claims do not recite the use of any new detection or analytical techniques, and found:

The claims, whether considered limitation-by-limitation or as a whole, do not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention. The process steps here merely tell those “interested in the subject about the correlations that the researchers discovered.” Mayo, 566 U.S. at 78.

Thus, the court “affirm[ed] the district court’s determination that the testing patents are directed to patent-ineligible subject matter.”

The Treatment Patent — Not Infringed

The method of treatment patent at issue was U.S. Patent No. 9,170,260. Independent claim 1 recites:

1. A method for administering a lipid lowering agent to a human patient based on elevated levels of myeloperoxidase (MPO) mass and/or activity comprising:
(a) performing an enzyme linked immunosorbent assay (ELISA) comprising contacting a serum or plasma sample with an anti-MPO antibody and a peroxidase activity assay to determine MPO activity in the serum or plasma sample;
(b) selecting a patient who has elevated levels of MPO mass and/or activity compared to levels of MPO mass and/or activity in apparently healthy control subjects; and
(c) administering a lipid lowering agent to the selected human patient.

The district court granted True Health’s motion to dismiss as to this patent on non-infringement grounds, finding no basis to support claims of contributory infringement or induced infringement.

The Federal Circuit upheld the district court’s treatment of this patent, agreeing that Cleveland Clinic had failed to assert facts that could support True Health’s liability for contributory infringement or induced infringement.

As to contributory infringement, the Federal Circuit agreed that True Health’s lab reports do not qualify as a “material or apparatus” that could support liability under 35 USC § 271(c).

As to induced infringement, the Federal Circuit noted

Cleveland Clinic alleges no facts that suggest any connection between True Health and doctors that may prescribe lipid lowering drugs.

Thus, the Federal Circuit agreed that Cleveland Clinic “falls short of showing ‘specific intent and action’ on behalf of True Health to induce infringement of the ’260 patent.”

Can Personalized Medicine Methods Be Protected?

Given the difficulty of patenting diagnostic methods after Mayo, many stakeholders are focusing on personalized medicine patents similar to the ‘260 patent at issue here. This case highlights challenges that may be faced when enforcing such patents–who is liable for infringement when different entities may perform the diagnosing and treating steps?

While Akamai provides some avenues for establishing liability for divided infringement, it may be difficult to establish that diagnostic companies are liable for treatment steps they do not perform. Diagnostic companies are not likely to condition their services on another party’s performance of a treatment step, or to establish the manner or timing of that performance. Thus, they may not be liable under the Akamai paradigm.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Foley & Lardner LLP | Attorney Advertising

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.