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
Expiration
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.

Authors
Similar Articles
Relevancy Powered by MondaqAI
Jones Day
Akin Gump Strauss Hauer & Feld LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Jones Day
Akin Gump Strauss Hauer & Feld LLP
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