Bass Biogen

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Bass Biogen

Text of Bass Biogen

  • For the Patent Owner Paper No. __ Backup counsel: Robert W. Hahl, Reg. No. 33,893 Backup counsel: Robert Mihail, Reg. No. 66,021 Neifeld IP Law, PC

    UNITED STATES PATENT AND TRADEMARK OFFICE ____________

    BEFORE THE PATENT TRIAL AND APPEAL BOARD

    ____________

    Coalition For Affordable Drugs V LLC Petitioner

    v.

    Biogen IDEC International GmbH Patent Owner

    ____________

    Case IPR Unassigned Patent 8,759,393

    Title: UTILIZATION OF DIALKYLFUMARATES

    ____________

    PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,759,393

    UNDER 35 U.S.C. 312 AND 37 C.F.R. 42.104

    Mail Stop PATENT BOARD U.S. Patent Trial & Trademark Office P.O. Box 1450 Alexandria, VA 22313-14

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    TABLE OF CONTENTS

    I. INTRODUCTION ............................................................................................. 1

    II. MANDATORY NOTICES ............................................................................ 2

    A. Real Party-In-Interest 37 C.F.R. 42.8(b)(1) ............................................... 2

    B. Related Matters 37 C.F.R. 42.8(b)(2)......................................................... 3

    C. Designation of Lead and Backup Counsel 37 C.F.R. 42.8(b)(3) ............... 3

    D. Notice of Service Information (37 C.F.R. 42.8(b)(4)) ............................... 4

    III. FEES 37 C.F.R. 42.15(a) ............................................................................. 4

    IV. REQUIREMENTS UNDER 37 C.F.R. 42.104 .......................................... 4

    A. Grounds for Standing 37 C.F.R. 42.104(a) ................................................ 4

    B. Identification of Challenge and Precise Relief Requested 37 C.F.R.

    42.104(b) ................................................................................................................. 4

    2. Specific Statutory Grounds for Challenge 42.104(b)(2) .................................. 5

    V. UNPATENTABILITY OF THE 393 PATENT ......................................... 6

    A. Brief History of dimethyl fumarate therapy .................................................. 6

    B. Prosecution History of the 393 Patent ......................................................... 8

    C. Person of Ordinary Skill in the Art ............................................................. 10

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    D. Claim Construction ...................................................................................... 11

    VI. DETAILED EXPLANATION OF THE CHALLENGES ........................ 22

    A. Ground 1: Claims 1, 2, and 8 are anticipated by Nieboer ........................... 22

    B. Ground 2: Claims 1-13 are obvious over Nieboer in view of Kolter .......... 26

    VII. CONCLUSION .......................................................................................... 52

  • iii

    TABLE OF AUTHORITIES Cases

    In re Cuozzo Speed Technologies, LLC, 2014-1301 (Fed. Cir. 2015) ..................... 18

    KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) ........................... 31, 32

    Titaniium Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985) ...... 38, 40, 48, 57

    Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628 (Fed. Cir. 1987) .... 21

    Statutes

    35 U.S.C. 102 ............................................................................................... 5, 6, 23

    35 U.S.C. 103 ................................................................................................... 6, 26

    Rules

    37 C.F.R. 42.82, 3, 8

    37 C.F.R. 42.15..4

    37 C.F.R. 42.22..6

    37 C.F.R. 42.100..11

    37 C.F.R. 42.104....4, 5

  • iv

    LIST OF EXHIBITS

    Exhibit 1001 U.S. Patent No. 8,759,393, titled Utilization of

    Dialkylfumarates to Joshi et al. (393 patent)

    Exhibit 1002 C. Nieboer, et al., Systemic therapy with fumaric acid

    derivatives: New possibilities in the treatment of psoriasis,

    Journal of the American Academy of Dermatology, April 1989

    Vol. 20, Number 4, pg. 601-608 (Nieboer)

    Exhibit 1003 U.S. Patent No. 5,681,588, titled Delayed Release Microtablet

    of -Phenylpropiophenone Derivatives to Kolter et al. (Kolter) Exhibit 1004 Declaration of Dr. James E. Polli

    Exhibit 1005 Prosecution history of the 393 patent as contained in the Image

    File Wrapper on PAIR

    Exhibit 1006 Assignment record of the 393 patent as contained in USPTOs

    Assignments on The Web at

    http://assignment.uspto.gov/#/search?adv=patNum%3A875939

    3&q=&sort=patAssignorEarliestExDate%20desc%2C%20id%2

    0desc&synonyms=false

    Exhibit 1007 Julian H. Fincher, Dictionary of Pharmacy, University of South

    Carolina Press, 1986

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    Exhibit 1008 PubChem entry for Dimethyl Fumarate, U.S. National Library

    of Medicine, National Center for Biotechnology Information,

    the National Institute of Health at

    https://pubchem.ncbi.nlm.nih.gov/compound/637568

    Exhibit 1009 Dean E. Snyder, The Interpharm International Dictionary of

    Biotechnology and Pharmaceutical Manufacturing, Interpharm

    Press, Inc., 1992

    Exhibit 1010 Friedrick Moll et al., Biodegradable Microtablets Made of Low

    Molecular Weight Polyglycolic Acid, 1991

    Exhibit 1011 Unassigned

    Exhibit 1012 Curriculum Vitae of Dr. James E. Polli

    Exhibit 1013 Nieboer et al., Fumaric Acid Therapy in Psoriasis: A Double-

    Blind Comparison between Fumaric Acid Compound Therapy

    and Monotherapy with Dimethylfumaric Acid Ester

    Dermatologica 1990; 181:33- 37

    Exhibit 1014 Kokelj et al., Fumaric Acid and Its Derivatives in the Treatment

    of Psoriasis Vulgaris: Our Experience in Forty-One Patients,

    Acta Dermatovenerol Croat, 2009; 17(3):170-175

    Exhibit 1015 FDA News Release, FDA approves new multiple sclerosis

    treatment: Tecfidera, available at

  • vi

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnounceme

    nts/ucm345528.htm

    Exhibit 1016 Follonier et al., Various ways of modulating the release of

    diltiazem hydrochloride from hot-melt extruded sustained

    release pellets prepared using polymeric materials., Journal of

    Controlled Release 36 (1995) 243-250

    Exhibit 1017 Conine et al., Special Tablets, Pharmaceutical Dosage Forms,

    Marcel Dekker, Inc., 1989, 329-366

  • 1

    I. INTRODUCTION The 393 patent, entitled Utilization of Dialkylfumarates and filed on

    March 4, 2011 is a continuation of application no. 12/405,665 (now US 7,915,310)

    filed on March 17, 2009, which is a continuation of application no. 11/765,578

    (now US 7,619,001) filed on June 20, 2007, which is a continuation of application

    no. 10/197,077 (now US 7,320,999) filed on July 17, 2002 which is a division of

    application no. 09/831,620 (now US 6,509,376) filed on May 10, 2001 which is the

    National Stage Entry of PCT/EP99/08215 filed on October 29, 1999 and published

    in German on June 2, 2000, which claims priority to German application no.

    19853487 filed on November 19, 1998. (Ex. 1005). The 393 patent was originally

    assigned to Fumapharm AG. Fumapharm AG was acquired by Biogen IDEC

    International AG in 2006 and the 393 patent was assigned to Biogen IDEC

    International AG on May 15, 2007. (Ex. 1006). Biogen IDEC International AG

    changed its name to Biogen IDEC International GMBH on May 15, 2007. (Ex.

    1006).

    In accordance with 35 U.S.C. 311-319 and 37 C.F.R. 42.1-.80 &

    42.100-123, inter partes review is respectfully requested for claims 1-13 of U.S.

    Patent No. 8,759,393 to Joshi et al., titled Utilization of Dialkylfumarates (393

    patent) (Ex. 1001). This petition demonstrates that there is a reasonable likelihood

    that the petitioner will prevail on at least one of the claims challenged in the

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    petition based on one or more prior art references. For the reasons provided herein,

    claims 1-13 of the 393 patent should be canceled as unpatentable.

    II. MANDATORY NOTICES

    A. Real Party-In-Interest 37 C.F.R. 42.8(b)(1)

    Pursuant to 37 C.F.R. 42.8(b)(1), Petitioner certifies that Coalition For

    Affordable Drugs V LLC (CFAD), Hayman Credes Master Fund, L.P.

    (Credes), Hayman Orange Fund SPC Portfolio A (HOF), Hayman Capital

    Master Fund, L.P. (HCMF), Hayman Capital Management, L.P. (HCM),

    Hayman Offshore Management, Inc. (HOM), Hayman Investments, L.L.C.

    (HI), nXn Partners, LLC (nXnP), IP Navigation Group, LLC (IPNav), J

    Kyle Bass, and Erich Spangenberg are the real parties in interest (collectively,

    RPI). The RPI hereby certify the following information: CFAD is a wholly

    owned subsidiary of Credes. Credes is a limited partnership. HOF is a segregated

    portfolio company. HCMF is a limited partnership. HCM is the general partner

    and investment manager of Credes and HCMF. HCM is the investment manager of

    HOF. HOM is the administrative general partner of Credes and HCMF. HI is the

    general partner of HCM. J Kyle Bass is the sole member of HI and sole

    shareholder of HOM. CFAD, Credes, HOF and HCMF act, directly or indirectly,

    through HCM as the general partner and/or investment manager of Credes, HOF

    and HCMF. nXnP is a paid consultant to HCM. Erich Spangenberg is 98.5%

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    member of nXnP. IPNav is a paid consultant to nXnP. Erich Spangenberg is the

    98.5% member of IPNav. Other than HCM and J Kyle Bass in his capacity as th