United States: Non-Limiting Clauses And Written Description Based On Substantially Equivalent Disclosure

Last Updated: August 20 2019
Article by Daniel J. Pereira

Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion’s patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.

The opinion address questions of written description and obviousness of certain claims of the patents-in-suit. For the purpose here, I found the dispute centered on Claim 11 of U.S. patent no. 8,916,195 (‘the ‘195 patent) to be the most interesting. That claim is:

A method of treating overweight or obesity having reduced adverse effects comprising orally administering daily about 32 mg of naltrexone and about 360 mg of bupropion, or pharmaceutically acceptable salts thereof, to a person in need thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, and wherein said sustained release formulation of naltrexone has an in vitro naltrexone dissolution profile in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37° C. of:

a) between 39% and 70% of naltrexone released in one hour;

b) between 62% and 90% of naltrexone released in two hours; and

c) at least 99% in 8 hours;

wherein about 16 mg of said sustained release formulation of naltrexone or a pharmaceutically acceptable salt thereof is administered twice daily, and about 180

mg of said sustained release formulation of bupropion or a pharmaceutically

a cceptable salt thereof is administered twice daily.

The center of the written description dispute is the in vitro dissolution profile:

Actavis argued that claim 11 of the ’195 patent lacked adequate written description support because its claimed dissolution profile was achieved using the USP Apparatus 2 Paddle Method (“USP 2”), but the specification discloses data obtained using the different USP Apparatus 1 Basket Method (“USP 1”). The court was not persuaded that the use of a different method from what is prescribed in the claim presented a written description problem, holding that “whether the dissolution data reported in the specification was obtained using the basket method or the paddle method is not relevant to whether the inventors had possession of the invention.”

The majority and the dissent essentially disagreed as to what import to provide the dissolution profile

Judge Lourie opined:

But that dissolution profile for naltrexone as measured by USP 2 relates only to the measurement of resultant in vitro parameters, not to the operative steps to treat overweight or obesity. And the district court concluded, on the facts, that USP 1 and USP 2 would be “substantially equivalent,” Decision, 282 F. Supp. 3d at 801 (citation omitted). Thus, it found that, irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it. We conclude that this finding does not present clear error.

Judge Prost had a different take:

I part ways with the majority, however, for at least three reasons. First, the USP 2 clause is limiting. Second, the majority’s “substantially equivalent” rule is inconsistent with this court’s precedent. Third, the district court clearly erred in finding that the ’195 patent’s written description includes a disclosure “substantially equivalent” to USP 2.

The issue of written description is one of fact and such questions of fact are reviewed for clear error. How the majority reviewed that question and to what they give most importance is interesting. The majority opinion giving more credence to the expert testimony, as did the district court while Judge Prost’s view was that there was no evidence to support the notion that the two manners of determining the dissolution profiled were substantially equivalent and rather there was evidence that there were not.

The majority opinion relied on the district court’s analysis of the facts, while giving more credibility to Nalpropion’s expert over Actavis’s expert: “[t]he district court performed precisely its fact-finding function, weighing credibility of testimony.” Judge Prost was not so moved:

In finding that USP 1 and USP 2 are substantially equivalent, the majority overlooks the district court’s clear error. Not a shred of record evidence supports this fact-finding. And other record evidence refutes it. The record contains no evidence showing that the two methods produce the same results.

Instead, the record includes evidence that the two methods do not produce the same results. First, Dr. Soltero, one of the inventors named on the ’195 patent, testified that USP 1 and USP 2 results are not comparable. He confirmed that “just because you got a certain profile [using] a USP 1 method, you would not necessarily expect that you would get the same release profile [using] USP 2.” See J.A. 11319:17–11321:12. The trial court’s opinion does not even mention this testimony.

Second, Appellant’s expert, Dr. Mayersohn, opined that a skilled artisan would not have understood the two methods to yield the same results. J.A. 11356:22–11357:3. The district court discounted Dr. Mayersohn’s testimony, finding that his “theoretical opinion that the methods would yield different results is at odds with his reliance on a prior art reference using [USP 1] to argue that claim 11, which specifies [USP 2], was obvious.” See Majority Op. 11 (citing

Orexigen, 282 F. Supp. 3d at 801–02).

The standard for obviousness is not, however, the same as the standard for written description.

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.

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
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.


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