United States: What Amounts To Significantly More?

The two-part Alice/Mayo test includes an analysis involving three questions, one of which is: "Does the claim recite additional elements that amount to significantly more than the judicial exception?" This question is asked in Step 2B in a flow chart published by the USPTO in the Federal Register, 79(241), 74618-74633 (2014). Courts have been left to grapple with what constitutes "significantly more," creating uncertainty about what is patentable and what is not. Since the Alice/Mayo decisions, challenges and defenses claiming invalidity of claims under 35 U.S.C. § 101 have increased and patent examiners have not hesitated to reject claims under Section 101. Some recent district court decisions provide a few more guideposts in our journey of discovering what "significantly more" means.

In Oxford Immunotec Ltd. v. Qiagen, Inc. et al., 15-cv-13124-NMG (Mass. Dist. Ct. 2015), Oxford filed a claim of infringement against Qiagen asserting a number of patents related to tuberculosis (TB) tests. On August 31, 2016, the magistrate judge allowed in part and denied in part Qiagen's motion to dismiss. Qiagen argued that Oxford's claims in the asserted patents are invalid as directed to patent ineligible subject matter. The claims in question may be represented by claim 7 of U.S. Patent No. 7,632,646 and claim 1 of U.S Patent No. 8,507,211.

Claim 7 of the '646 patent recites a kit for diagnosing infection in a human host by, or exposure of a human host to, a mycobacterium that expresses ESAT-6, comprising a panel of eight peptides represented by SEQ ID NOS: 1 to 8. The eight peptides recited in claim 7 occur naturally but were synthesized in the lab. Oxford argued that the peptides functioned differently than the naturally-occurring peptides. However, the court found that the kit claims are directed to a product of nature and that the peptides had not been modified beyond the naturally-occurring peptides. Although the peptides were synthesized in the lab and the peptides perform differently than their naturally-occurring counterparts, the court concluded that the kit claims are invalid under Section 101.

Claim 1 of the '211 patent recites a method for identifying Mycobacterium tuberculosis-specific immediate effector T cells in a subject. The method includes providing a sample from a patient, exposing the sample to peptides, and determining if the T-cells in the sample are activated by measuring cytokine production. The court determined that the method claims were directed to a law of nature and continued to Step 2B of the Alice/Mayo test. Pursuant to Step 2B, the court found that claim 1 contained enough to qualify as "significantly more." The court pointed out that "the patented invention improves on existing methods for diagnosing TB by making diagnosis more convenient, less dependent on a physician's subjective interpretation of results, and more accurate." Oxford Immunotec Ltd. v. Qiagen, Inc. et al., 15-cv-13124-NMG, pages 11-12, (Mass. Dist. Ct. 2015).

In Vanda Pharmaceuticals Inc. v. Roxane Laboratories, Inc., 13-cv-01973 (D. Del. 2013), Vanda Pharmaceuticals Inc. and Aventisub LLC alleged infringement by Roxane of several U.S. patents. Roxane is seeking to make and sell the drug iloperidone - an antipsychotic drug. Vanda sells FANAPT® (iloperidone), which is approved for treating patients with schizophrenia. Roxane contended that the claims in asserted U.S. Patent No. 8,586,610 are invalid under Section 101.

Claim 1 of the '610 patent is directed to a method of treating a patient with iloperidone by adjusting the dosage based on whether the patient has a CYP2D6 poor metabolizer genotype. Roxane argued that the relationship between the patient genotype and the drug's metabolism is a natural law and that adjusting the dosage of iloperidone to reduce adverse effects amounted to "routine and conventional" activities. Vanda conversely argued that the tests to determine the claimed dosage adjustments were not routine, noting Novartis's attempted clinical trial of iloperidone that failed to determine a relationship between adverse effects and CYP2D6 metabolism. The court concluded that the asserted claims amount to significantly more than just a natural law in view of Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., No. 2015-1570, 2016 WL 3606624 (Fed. Cir. July 5, 2016) (valid claims may depend upon a natural relationship if the claims contain a particular combination of steps.)

The USPTO, in its 2014 Interim Guidance to Examiners, advised that valid claims may contain a specific limitation that is not routine or conventional that limits the claim without pre-empting the use of the natural law or natural product. In Vanda, the patent owners successfully showed that the claim contained "significantly more" by arguing that using a genotyping assay to determine dosage was not routine or conventional as evidenced by the failure of others to do so. In Oxford, the court found that, in relation to the asserted method claims, the in vitro aspect of the TB test is an "inventive concept" because it improves on existing methods for diagnosing TB by making diagnosis more convenient, reducing diagnostic error, and increasing accuracy.

In light of recent court decisions, claims must be carefully evaluated to ensure that the claimed invention amounts to "significantly more" than just a natural law or a natural productto withstand anticipated Section 101 challenges.

This article is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. Brinks Gilson & Lione does not intend to create an attorney-client relationship by offering this information and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Brinks Gilson & Lione lawyer.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
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
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.


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.


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