Supreme Court Holds That a Law of Nature Applied Using Known and Obvious Steps Is Not Patent Eligible

by Sheppard Mullin Richter & Hampton LLP
Contact

[author: Kevin Capps]

On March 20, 2012, the Supreme Court issued its much-anticipated decision in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., with potentially far-reaching ramifications for pharmaceutical and biotechnology companies, particularly those developing diagnostic methods and assays.

At issue was the patent eligibility of certain diagnostic methods under 35 U.S.C. § 101. 35 U.S.C. § 101 provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter…may obtain a patent therefor, subject to the [other conditions for patentability under the Patent Act].” Given the broad language of § 101, it was long considered a relatively low barrier to patentability. However, more recent cases, particularly relating to business and computer-software-implemented methods, have curtailed and arguably defined new legal standards for patent eligibility.

Prometheus Laboratories, Inc. (“Prometheus”) was the exclusive licensee of the two patents-in-suit, which claim methods of optimizing therapeutic efficacy for the treatment of immune-mediated gastrointestinal disorders. The claims recite the steps of administering a thiopurine drug to a patient having such a disorder and determining the level of the thiopurine in the patient, along with a statement that the level of the thiopurine drug subsequently administered to the patient should be increased or decreased depending on the concentration of the drug in the patient’s system.

The Court began by noting the primary recognized exceptions to patent eligibility, namely that “laws of nature, natural phenomena, and abstract ideas are not patentable.” The Court did “recognize[], however, that too broad an interpretation of this exclusionary principle could eviscerate patent law[,…f]or all inventions at some level embody, use reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”

After characterizing the “relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm” as a “law of nature,” the Court considered each of the steps recited in Prometheus’s patent claims, and concluded that the patents were invalid because “the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” The Court further stated that the decision is consistent with earlier Supreme Court cases, particularly Diamond v. Diehr and Parker v. Flook, because “post-solution activity that is purely conventional or obvious…cannot transform an unpatentable principle into a patentable process” (internal quotations omitted).

This case may present more questions to pharmaceutical and biotechnology companies than it resolves. While the Court concluded that Prometheus’s patent claims were not patent eligible because “any additional steps [beyond informing a relevant audience about certain laws of nature] consist of well-understood, routine, conventional activity already engaged in by the scientific community,” the Court set forth no standard for determining what further steps would be required to transform the method into patentable subject matter.

The decision is also noteworthy in that it appears to conflate the novelty and non-obviousness requirements for patentability under 35 U.S.C. §§ 102 and 103 with the issue of patent eligibility under 35 U.S.C. § 101. Indeed, the Court even “recognize[d] that, in evaluating the significance of additional steps, the §101 patent-eligibility inquiry and, say, the §102 novelty inquiry might sometimes overlap.” However, the Court did not enunciate the level of novelty and non-obviousness that a claimed diagnostic method must possess before it would be considered patent eligible under 35 U.S.C. § 101.

Finally, the Court dismissed the Federal Circuit’s rationale for upholding the validity of Prometheus’s patents because “[w]hile it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes.” It remains to be seen how or whether the Court would distinguish purely therapeutic methods, particularly those that involve new uses of known compounds, since the pharmacological activities of the compounds “is a consequence of the ways in which [the drugs] are metabolized by the body—entirely natural processes.”

 

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.

© Sheppard Mullin Richter & Hampton LLP | Attorney Advertising

Written by:

Sheppard Mullin Richter & Hampton LLP
Contact
more
less

Sheppard Mullin Richter & Hampton 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.
Feedback? Tell us what you think of the new jdsupra.com!