United States: Patents Nominally Directed To Method Of Treatment Held Invalid As Claiming Law Of Nature

Charles A. Weiss is a Partner in our New York office.

Most of the Section 101 cases discussed on this blog concern patents in the technology arts, which are commonly challenged on the ground that the claims are invalid because they are directed to an "abstract idea." This post concerns a pharmaceutical case, in which the Section 101 challenge was based on the argument that the claims were directed to a "law of nature."

By way of background, patents claiming methods of treating patients by administering pharmaceuticals have generally survived challenges under Section 101. For example, patents that direct treating patients with lower doses of a particular drug when lab tests show that those patients will be more sensitive than typical—for example because of a specific genetic variation that results in slow metabolism, or impaired renal function that results in slow elimination—were held by the Federal Circuit to claim patent-eligible subject matter. Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018); Endo Pharm. Inc. v. Teva Pharm. USA, Inc., 919 F.3d 1347 (Fed. Cir. 2019).

In a recent case, the Federal Circuit held that claims which were written in method-of-treatment format, but instructed to not treat patients with a drug that might cause them harm, were invalid as claiming laws of nature. INO Therapeutics LLC v. Praxair Distribution Inc., No. 2018-1019 (Fed. Cir. Aug. 27, 2019).

This case arose from the defendants' submission of an abbreviated new drug application (ANDA) seeking FDA approval to sell a generic formulation of the plaintiffs' inhaled nitric oxide (iNO) medical gas. For those who don't remember their chemistry, the formula for nitric acid is NO, while that for nitrous oxide (laughing gas) is N2O. They are distinct compounds with different physiological effects.

Nitric oxide is a vasodilator that can be useful for treatment of pulmonary hypertension, including in certain neonates with respiratory problems. However, giving it to infants with compromised heart function, specifically left ventricular dysfunction, was found to increase the risk of pulmonary edema. The patents at issue were directed to "solving" this problem by withholding iNO from neonates with the heart condition, although some of the claims were drafted more creatively by further reciting the step of administering iNO to those patients without the heart problem. The Federal Circuit quoted this claim as representative:

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

(a) identifying a plurality of term or near-term neonatal patients who . . . are candidates for . . . 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 . . . pulmonary edema upon treatment with inhaled nitric oxide;

(d) administering . . . 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 . . . pulmonary edema upon treatment with inhaled nitric oxide.

U.S. Patent No. 8,795,741 (the '741 patent).

Translated from patentese, the claimed method was to determine which infants with breathing problems had LVD, and only treat infants without LVD with iNO.

Because the use of iNO for breathing problems was conventional, the only potentially inventive feature of the claims was to determine if an infant with respiratory problems also had LVD, and if so to refrain from treating that infant with iNO. This feature is even clearer in claims of some of the other asserted patents, such as this one:

  1. A method of reducing the risk of occurrence of pulmonary edema associated with . . . inhalation of 20 ppm nitric oxide gas, said method comprising: (a) performing echocardiography to identify a child in need of 20 ppm inhaled nitric oxide treatment for pulmonary hypertension . . .; (b) determining that the child . . . has left ventricular dysfunction, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide; and (c) excluding the child from inhaled nitric oxide treatment based on the determination that the child has left ventricular dysfunction and so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide.

U.S. Patent No. 8,282,966 (the '966 patent).

The district court held the method claims invalid as being directed to unpatentable subject matter, and the Federal Circuit affirmed in a fully elaborated, but nonprecedential, opinion authored by Chief Judge Prost in which Judge Dyk joined. Judge Newman dissented.

The Federal Circuit opinion repeatedly noted that the claims were not directed to a method of giving a drug to treat a disease, but to an instruction to not give it. For example:

It is undisputed that treatment of infants experiencing hypoxic respiratory failure with iNO gas has existed for decades. The inventors observed an adverse event that iNO gas causes for certain patients. The patent claim does no more than add an instruction to withhold iNO treatment from the identified patients; it does not recite giving any affirmative treatment for the iNO-excluded group, and so it covers a method in which, for the iNO-excluded patients, the body's natural processes are simply allowed to take place. Consequently, the claim here is directed to the natural phenomenon.

Slip op. at 8-9. The court rejected the patentees' argument that the above-quoted claim of the '741 patent was directed to a "protocol" for "selective administration" of iNO, with the new step of not giving the drug to infants with LVD:

Properly understood, this added step is simply an instruction not to act. In 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. at 10.

The Federal Circuit distinguished the result of the discovery at issue here—which is to refrain from giving the drug to patients in whom it may do more harm than good—with other method-of-treatment claims that were held to pass muster under Section 101. Specifically, the court explained that in each of the Vanda and Endo cases, the focus of the claims was treating the patient by administering the drug at issue in a different way, which used the law of nature underlying the discoveries "to produce a change in the natural state of the patient to treat a condition." Slip op. at 13.

Similarly, the claims at issue in a case involving nutritional supplements required administering sufficient amounts of a particular compound that was said to promote the endogenous production of creatine, thereby improving the user's athletic performance. Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019). In that case, explained the INO Therapeutics opinion, "the claim used a particular dose of a substance to obtain a specific benefit by altering the subject's natural state."Slip op. at 14 (internal citation omitted).

Although not mentioned by the Federal Circuit, another way to understand the outcome here is to note the similarity between the claims at issue and claims of diagnostic patents held invalid under Section 101. Specifically, while the preamble of the exemplary claim of the '741 patent recited that it was drawn to a "method of treating patients," the discovery behind the claim was associating the presence of LVD with the undesirability of administering iNO, i.e., not administering the identified treatment. Despite the preamble, then, the claim can be characterized as a method of acting on a diagnosis. This is more apparent from the above-quoted claim of the '966 patent, which unlike the exemplary claim of the '741 patent did not even require the step, albeit the conventional step, of administering iNO to infants with breathing problems who were not also diagnosed with LVD.

Understood in this manner, the claims at issue here are not too different for Section 101 purposes from those held invalid in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, 915 F.3d 742 (Fed. Cir. 2019), which concerned a method of diagnosing certain neurological diseases by detecting in the blood specific antibodies associated with them. In that case, the Federal Circuit distinguished Vanda by noting that Vanda concerned claims to a method of treatment:

Claiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself [Athena]. But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law [Vanda].  

Athena, 915 F.3d at 752-53.

More simply, perhaps, the INO Therapeutics decision can also be understood as standing for the unremarkable proposition that applicants cannot rely merely on clever drafting—such as including the step of treating patients without LVD with the standard dose of iNO—to satisfy the demands of Section 101. Had the inventors' come up with an unconventional way of using iNO in patients with LVD, such as giving a reduced dose of iNO or coadministering it another drug that avoided the risk of pulmonary edema while preserving the benefits of iNO, claims directed to such methods would likely have fit comfortably within the Vanda/Endo line of cases holding that methods of treatment that change the body's natural state do not impermissibly claim a law of nature.

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