United States: Method-of-Treatment Claims, Comprising Excluding Certain Patients From Treatment, Found To Be Patent-Ineligible Under 35 U.S.C. § 101

Last Updated: September 20 2019
Article by Matthew E. Barnet

On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.

Claim 1 of U.S. Patent No. 8,795,741 is representative:

1. A method of treating patients who are candidates for inhaled nitric oxide ["iNO"] treatment...comprising:

(a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment;

(b) determining that a first patient of the plurality does not have left ventricular dysfunction ["LVD"];

(c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide;

(d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and

(e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.

The majority of the Federal Circuit panel noted that "[i]t is undisputed that treatment of infants experiencing hypoxic respiratory failure with iNO gas has existed for decades" (slip op. at page 8). The majority acknowledged that "[t]he inventors observed an adverse event [pulmonary edema] that iNO gas causes for certain patients" (Id. at pages 8-9).

The majority focused on step (e) of the claim, reciting the exclusion of such patients from treatment with iNO. The majority characterized this step as "simply an instruction not to act" (Id. at page 10). The majority stated that "[i]n effect, the claim is directed to detecting the presence of LVD in a patient and then doing nothing but leaving the natural processes taking place in the body alone for the group of LVD patients. Accordingly, the claim is directed to the natural phenomenon" (Id.).

The majority distinguished the claims in INO from method-of-treatment claims recently found to be patent-eligible in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018). The majority in INO noted that in Vanda,

[a]fter the risk of QT prolongation was identified for certain metabolizers, the claims did not simply instruct doctors to stop treating those patients with iloperidone based on that information. Instead, the claims leveraged the natural phenomenon to improve treatment for schizophrenia. The claims required the doctor to treat a patient with a specific low-dose range if she had a "poor metabolizer genotype" or a specific high-dose range if she did not have the genotype. (slip op. at page 12).

In contrast, the majority noted that in INO, "the invention is not focused on changing the physiological state of the patient to treat the disease. The claimed invention is focused on screening for a natural law" (Id. at pages 14-15). "Claim 1 does not recite a set of dosages that offer some relief to LVD infants while minimizing the risk of an adverse event. It simply sets out an observation of the adverse event, and then instructs the physician to withhold iNO treatment" (Id. at pages 15-16).

Interestingly, the majority acknowledged that step (d) of claim 1 positively recites administering iNO to a patient who does not have LVD. That is, step (d) requires administering iNO to a certain patient, as opposed to step (e)'s withholding of iNO treatment from a different patient (to let nature take its course). However, the majority found that step (d) "is plainly not the focus of the claimed invention. [Plaintiff-Appellant] concedes this step is not innovative" (Id. at page 11). This is similar to the district court's analysis, which found that steps (a), (b), (c) and (d) of claim 1 were "routine and conventional in the art" and therefore unable to "transform a patient's natural risk of developing pulmonary edema, given preexisting LVD and treatment with iNO, into a patentable invention."

Thus, the majority of the Federal Circuit panel continued the trend, from most cases in the Mayo/Alice line, of considering "inventiveness" in the § 101 inquiry, rather than leaving inventiveness for an inquiry under § 103.

The majority expressed caution about the breadth of its holding, in particular about concerns that the holding could harm the nascent field of personalized medicine. The majority explained that "[w]hile § 101 precludes bare monopolies on natural phenomena, new and inventive methods of treatment in personalized medicine remain patent eligible. We conclude that the specific claims here are ineligible. But we emphasize the narrowness of our holding today, which is limited to the particular claims at issue and is driven by the particular circumstances here" (slip op. at page 22).

Judge Newman dissented from the majority's opinion on patent-eligibility under § 101. She explained that "[t]he claims are for a method of medical treatment—a class of subject matter whose eligibility under section 101 is established by precedent" (slip op. at page 1). She criticized the majority's opinion for "not acknowledg[ing] that the claimed multi-step method of treatment of hypoxic respiratory failure does not occur in nature. The majority improperly separates the claims into old and new steps, describes some claim steps as a 'natural phenomenon' and some steps as 'well-understood, routine, and conventional steps,' and avoids the requirement that a claimed invention is considered as a whole" (Id. at page 2).

Judge Newman acknowledged that the claimed "method of treatment may or may not pass the tests of sections 102 or 103" (Id. at page 2). However, she expressed concern that the majority's opinion "adds to the inconsistency and unpredictability of this area of patent-supported innovation" (Id. at page 3).

The majority's opinion in INO suggests that method-of-treatment claims are not per se eligible under § 101. That is, method-of-treatment claims still can face scrutiny under § 101 as being "directed to" natural phenomena, especially when certain method steps are considered to be "routine and conventional in the art." This contrasts with the clarity some hoped for after the decision in Vanda. As is usually the case with patent claims, the devil is in the details.

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
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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