United States: PTAB Institutes Kyle Bass IPRs Against Juxtapid Patents

The USPTO Patent Trial and Appeal Board (PTAB) decided to institute inter partes review (IPR) proceedings filed by Kyle Bass against two of the five Juxtapid patents listed in the Orange Book. Two of the cited references may qualify as § 102(b) prior art because the provisional application was found not to support certain aspects of the claims.

The Juxtapid® Patents At Issue

The patents at issue were U.S. Patent Nos. 7,932,268 and 8,618,135, licensed by Aegerion from the Trustees of the University of Pennsylvania. Juxtapid® is an oral capsule containing the active ingredient lomitapide mesylate for treating high cholesterol. Both the '135 patent and the'268 patent claim methods of administering at least three step-wise increasing doses of lomitapide mesylate. Claim 1 of the '135 patent is representative and recites:

1. A method of treating a subject suffering from hyperlipidemia or hypercholesterolemia, the method comprising administering to the subject an effective amount of an MTP inhibitor, wherein said administration comprises at least three step-wise, increasing dose levels of the MTP inhibitor wherein a first dose level is from about 2 to about 13 mg/day, a second dose level is from about 5 to about 30 mg/day, and a third dose level is from about 10 to about 50 mg/day,
and wherein the MTP inhibitor is represented by:

or a pharmaceutically acceptable salt thereof or the piperidine N-oxide thereof,
wherein each dose level is administered to the subject for about 1 to about 5 weeks.

Claim 1 of the '268 patent is nearly identical but recites that each dose level is administered to the subject for about 1 to 4 weeks.

Challenging The Priority Date

The Petitioner contended that the challenged claims were not entitled to the March 5, 2004 priority date of Provisional Application No. 60/550,915, asserting that the provisional application did not support the claimed piperidine N-oxide derivatives or the claimed dose ranges.

With regard to "piperidine N-oxide derivatives," Petitioner argued that the closest disclsoure in the provisional application was the statement "[i]n some embodiments the MTP inhibitors are piperidine, pyrrolidine or azetidine compounds," but that did not disclose piperidine N-oxides. The Patent Owner argued that a person of ordinary skill in the art would have understood "piperidine .... compounds" to include piperidine N-oxides. The PTAB sided with Petitioner, noting that "Patent Owner's arguments ... do not explain why the ordinary artisan would realize, upon reading the provisional application, that the invention relates to a piperidine N-oxide of the illustrated compound, lomitapide."

With regard to the claimed dose ranges, Petitioner argued that the provisional application focused on different dose ranges. Patent Owner argued support as follows:

For example, the first claimed dosage level "from about 2 to about 13 mg/day," is supported by Paragraph 0047 of the provisional application, which discloses that "[i]n some embodiments, the first dose level is from about 0.02 to about 0.59 mg/kg/day. In some embodiments, [the] second dose level is from about 0.06 to about 0.19 mg/kg/day." Ex. 1006 at 14. The skilled artisan would see that exemplary embodiments reference a 70 kg person, and would use this weight to calculate a range between 1.4 mg/day to 13.3 mg/day, which supports "about 2 to about 13 mg/day." Id. at 23.

The PTAB was not convinced by the Patent Owner's arguments. For example, the PTAB explained:

When we look at the second two calculations for the second two dose levels, the claimed ranges are even more difficult to discern. Thus, again assuming a 70 kg man, a range of 4.2 mg per day to 41.3 mg per day is calculated for the second dose level, whereas the claims require a dose level from about 5 to about 30 mg/day. .... Finally, making the same assumption as to the patient being treated, a range of 14 mg per day to 41.3 mg per day is calculated for the third dose level, whereas the claims require a dose level from about 10 to about 50 mg/day.

Thus, the patents were accorded the March 7, 2005 filing date of the PCT application from which they both claim priority.

The Grounds of Institution

Because the challenged claims were not entitled to the March 7, 2004 priority date, two of the references cited by Petitioner may qualify as prior art under 35 U.S.C. §102(b):

  • Bayer/PPD Implitapide Development Follows Zetia Model As Statin Add-On, 66 THE PINK SHEET 17 (Feb. 16, 2004) ("Pink Sheet")
  • Evan Stein, Microsomal Triglygeride [sic] Transfer Protein (MTP) Inhibitor (implitapide) program (Feb. 5, 2004) ("Stein")

Patent Owner challenges whether the February 5, 2004 Stein webinar qualifies as a printed publication. If not, Petitioner contends that the slides qualify as prior art at least as of April 15, 2004, when they were available for download. If the Patent Owner attempts to antedate Stein, the PTAB will have to decided this issue.

The PTAB instituted IPR proceedings on the following grounds:

  • Claims 1-8 of the '268 patent and claims 1-10 of the '135 patent would have been obvious over Pink Sheet and George Chang et al., "Microsomal triglyceride transfer protein (MTP) inhibitors: Discovery of clinically active inhibitors using high-throughput screening and parallel synthesis paradigms," Curr. Op. Drug Discovery & Devel. 5: 562 (2002) ("Chang").
  • Claims 1-8 of the '268 patent and claims 1-10 of the '135 patent would have been obvious over Stein and Chang.

Grasping at Section 325(d)

In its Patent Owner Preliminary Response to the IPR Petition filed against the '135 patent, the Patent Owner urged the PTAB to exercise discretion under 35 USC 325(d) and deny the Petition because the asserted references were considered by the Examiner during the prosecution. The PTAB declined under "the facts and circumstances of the instant proceeding." Indeed, the references were submitted in a supplemental Information Disclosure Statement filed after allowance, and not discussed during examination.

The PTAB has until March 7, 2017 to render its final decisions.

Other Juxtapid® Patents 

The challenged patents include two of the latest-expiring Orange Book-listed Juxtapid® patent.

Proprietary Name Patent No Patent
Drug Substance Claim and Drug Product Claim Applicant
JUXTAPID 5712279 Feb 21, 2020 Yes AEGERION
JUXTAPID 6492365 Dec 10, 2019 No AEGERION
JUXTAPID 7932268 Aug 19, 2027 No AEGERION
JUXTAPID 8618135 Mar 7, 2025 No AEGERION
JUXTAPID 9265758 Mar 7, 2025 No AEGERION

U.S. Patent 9,265,758, which has the same March 7, 2025 expiration date as the '135 patent, just granted on February 23, 2016, with similar method claims. It will be interesting to see whether Kyle Bass challenges that patent as well.

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 Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.