United States: Factual Findings Required To Show "Apparent Reason To Combine"

Addressing issues of obviousness and anticipation in the context of an inter partes review, the US Court of Appeals for the Federal Circuit issued two decisions with respect to the same patent, vacating and remanding the Patent Trial and Appeal Board's (PTAB's) decision finding the claims invalid as obvious in the first case, and affirming the PTAB's finding that the claims were not anticipated in the second case. Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center v. Eli Lilly and Co., Case No. 16-1518 (Fed. Cir., Feb. 28, 2017) (Bryson, J) (Newman, J, concurring in part, dissenting from the judgment); Eli Lilly and Co. v. Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Case No. 16-1547 (Fed. Cir., Feb. 28, 2017) (Bryson, J). 

The patent at issue relates to a method of "arresting or regressing" a condition known as penile fibrosis by long-term daily administration of drugs known as type 5 phosphodiesterase (PDE5) inhibitors. Penile fibrosis includes two conditions, penile tunical fibrosis and corporal tissue fibrosis, each of which can cause erectile dysfunction, although they do not always do so. Los Angeles Biomedical Research Institute (LAB) sued Eli Lilly, alleging induced infringement of its patent by Eli Lilly's marketing of the drug Cialis, a PDE5 inhibitor. Eli Lilly subsequently filed a petition for inter partes review, contending that all claims of the patent were obvious in light of three prior art references. The PTAB ultimately concluded that the challenged claims were obvious because the combination of references satisfied each limitation of the challenged claims as construed and, further, because the combination provided a reasonable expectation of success in treating erectile dysfunction. LAB appealed.

The Federal Circuit agreed with LAB's contention that the PTAB's findings were insufficient to establish obviousness under the correct claim construction. Specifically, the Court found that, while the PTAB concluded that the prior art references rendered obvious the treatment of erectile dysfunction via the claimed method, it did not make factual findings to determine whether those references showed it would have been obvious to use long-term continuous treatment with a PDE5 inhibitor to treat individuals with penile fibrosis and to achieve the arrest or regression of that condition. The Court noted that the correct construction of the pertinent claim language required more than simply treating erectile dysfunction. The Court also noted that the PTAB failed to consider the possibility that, even if the combination of prior art references taught long-term treatment with a PDE inhibitor of individuals with some forms of erectile dysfunction, a person of skill in the art may not have been motivated to combine those same references to treat individuals with fibrosis-related erectile dysfunction, for whom, LAB argued, the results would have been expected to be detrimental. 

The Federal Circuit remanded the case back to the PTAB to make factual findings as to whether there was an apparent reason to combine the prior art references to treat penile fibrosis and whether a person of skill in the art would have had a reasonable expectation of success from such a combination. The Court also remanded for the PTAB to make factual findings bearing on the obviousness of the "arresting or regressing" limitation, including consideration of inventor statements during prosecution that administration for 45 days of an extremely high dose of sildenafil (PDE5 inhibitor) was required to achieve the arrest or regression of penile fibrosis.

Judge Newman dissented, stating that she would affirm the PTAB's decision. According to Newman, there was no reversible error in the PTAB's decision, and the PTAB's findings were supported by substantial evidence. With respect to the majority's remand back to the PTAB, Newman noted that "such further proceedings fail the policy and purpose of the America Invents Act, and should be invoked only when there are major defects in the PTAB proceeding requiring activity and redetermination that is not available on the appellate record." She also explained that, in this case, finality was available, and it was the Court's obligation to decide the merits because "the issues were fully developed, with eloquent argument all around, [along with] an extensive Board opinion."

In the companion case, the Federal Circuit affirmed the PTAB decision finding that the challenged claims were not anticipated. The companion case related to a separate inter partes review petition by Eli Lilly contending that all claims of the same patent were anticipated. The PTAB instituted on the petition but ultimately concluded that the prior art did not anticipate the claims because it did not disclose a limitation requiring administration of a PDE5 inhibitor "at a dosage up to 1.5 mg/kg/day for not less than 45 days." On appeal, Eli Lilly argued that the prior art's definition of "chronic administration" anticipated the claimed requirement of daily administration for 45 days or more because a person of skill in the art would understand that erectile dysfunction (in the absence of therapy) can last longer than 45 days. The Federal Circuit was not persuaded, noting that Lilly's argument was "at best, [ ] an obviousness argument." According to the Court, substantial evidence supported the PTAB's finding that the prior art did not disclose the claimed treatment regimen "with sufficient clarity to satisfy the demanding standard for anticipation."

Factual Findings Required To Show "Apparent Reason To Combine"

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
 
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

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