United States: District Court Excludes Reference To Presumption Of Validity To Avoid Jury Confusion

Last Updated: May 5 2017
Article by Zachary Miller

Addressing various evidentiary issues, US Court of Appeals for the Federal Circuit Judge Bryson (sitting by designation on the US District Court for the Eastern District of Texas) addressed a number of pre-trial motions, including granting a motion to preclude references to a patent's "presumption of validity" because that the phrase might be confusing to the jury in light of the court's instructions on the burden of proof for invalidity. Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., Case No. 2:15-CV-1202-WCB (ED Tex., Mar. 13, 2017; Mar. 17, 2017) (Bryson, J).

UroPep alleged that Eli Lilly's sale of Cialis infringed UroPep's method patent covering treatment of benign prostatic hyperplasia (BPH). Leading up to trial, the district court issued a number of orders related to the admissibility of evidence and expert testimony. Among them, the district court granted Eli Lilly's motion to prevent UroPep from referencing the "presumption of validity" of a patent because that phrase might confuse the jury by requiring it to consider both the presumption and the overall burden of proof that accompanies a validity challenge. At the very least, the Court would be required to give an additional jury instruction to explain the "presumption of validity." The district court ultimately determined that use of the phrase "presumption of validity" would not add to the jury's understanding of the burden of proof on validity issues, and thus excluded its use.

In the same order, the Court granted UroPep's motion to preclude Eli Lilly from offering evidence that UroPep was improperly taking advantage of the patent system. UroPep had sought to add specific claims to cover Cialis's treatment of BPH only after the US Food and Drug Administration approved Cialis for that purpose. Eli Lilly intended to elicit testimony that UroPep's application was therefore "opportunistic." The Court agreed that Eli Lilly should not be able to offer such evidence, explaining that a patentee is permitted to seek claims that specifically cover a product already on the market. Moreover, any evidence that UroPep's application was improper or untimely was inadmissible because Eli Lilly was not alleging inequitable conduct or unclean hands.

In a separate order, the Court addressed Eli Lilly's motions to exclude testimony of UroPep's experts. First, Eli Lilly argued that UroPep's infringement expert (Dr. Sliwinski, a urologist with experience prescribing Cialis) should be prevented from testifying about the nature of Eli Lilly's promotional material for Cialis and from estimating the number of Cialis prescriptions he has written for BPH. The Court agreed with Eli Lilly that Dr. Sliwinski was not a marketing expert and therefore could not testify about the overall impact of the marketing materials for Cialis. Because Dr. Sliwinski had personally received marketing materials, however, he was able to testify as to his personal experience and the impact those marketing materials had on his practice as a fact witness. Similarly, Dr. Sliwinski was permitted to estimate his practice of prescribing Cialis for BPH as a fact witness—not an expert.

Eli Lilly also sought to exclude testimony from UroPep's damages expert, arguing that the expert's damages calculation referenced and utilized profits from Cialis that were non-infringing. According to Eli Lilly, UroPep's expert first calculated the total profits from Cialis prior to 2011 (when it was approved for the treatment of BPH), then calculated incremental profits due only to the treatment of BPH by analyzing additional profits made after 2011. Finally, the expert subtracted profits from 2011 to 2014, which were made before Eli Lilly had knowledge of the patent and were therefore non-infringing. Eli Lilly argued that the non-infringing profits were unrelated to reasonable royalty damages and were prejudicial as they would only serve to improperly influence the jury to think that UroPep's damages model was reasonable. The Court rejected Eli Lilly's argument, finding that reference to these non-infringing profits was admissible because it was a necessary step in UroPep's damages calculation.

District Court Excludes Reference To Presumption Of Validity To Avoid Jury Confusion

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.

In association with
Related Topics
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