Paper No. __
`Filed: March 16, 2015
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`
`ANTARES PHARMA, INC., LEO PHARMA A/S and LEO PHARMA INC.,
`
`
`Petitioners
`
`v.
`
`MEDAC GESELLSCHAFT FUER KLINISCHE SPEZIALPRÄPARATE MBH
`
`Patent Owner
`
`____________
`
`Case No.: IPR2014-01091
`Patent No. 8,664,231
`Title: Concentrated Methotrexate Solutions
`
`Before TONI R. SCHEINER, ERICA A. FRANKLIN, and
`JACQUELINE WIRGHT BONILLA
`
`
`PETITIONERS ANTARES PHARMA, INC., LEO PHARMA A/S and LEO
`PHARMA INC. LIST OF EXHIBITS
`
`
`
`
`Filed: March 16, 2015
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`
`ANTARES PHARMA, INC., LEO PHARMA A/S and LEO PHARMA INC.,
`
`
`Petitioners
`
`v.
`
`MEDAC GESELLSCHAFT FUER KLINISCHE SPEZIALPRÄPARATE MBH
`
`Patent Owner
`
`____________
`
`Case No.: IPR2014-01091
`Patent No. 8,664,231
`Title: Concentrated Methotrexate Solutions
`
`Before TONI R. SCHEINER, ERICA A. FRANKLIN, and
`JACQUELINE WIRGHT BONILLA
`
`
`PETITIONERS ANTARES PHARMA, INC., LEO PHARMA A/S and LEO
`PHARMA INC. LIST OF EXHIBITS
`
`
`
`
`
`Patent No. 8,664,231
`
`Further to 37 C.F.R. § 42.63(e), Petitioners Antares Pharma, Inc., Leo Pharma
`
`A/S and Leo Pharma Inc. hereby submit a current listing of Antares Exhibits to the
`
`Board and counsel for Patent Owner medac Pharma, Inc. and medac Gesellschaft für
`
`klinische Spezialpräparate mbH.
`
`Exhibit 1005
`
`DESCRIPTION
`FILED
`
`EXHIBITS
`Exhibit 1001 U.S. 8,664,231 to Heiner WILL, titled,
`“Concentrated Methotrexate Solutions,” filed on
`March 4, 2009, and issued on March 4, 2014 (“the
`’231 Patent”).
`Exhibit 1002 Excerpts from File History for U.S. Patent No.
`8,664,231.
`Exhibit 1003 U.S. 6,544,504 to Paul GRINT et al., titled,
`“Combined Use of Interleukin 10 and
`Methotrexate for Immunomodulatory Therapy,”
`filed on Jun. 26, 2000, and issued on April 8, 2003
`(“Grint”).
`Exhibit 1004 Hoekstra et al. (2004) J. Rheumatol 31(4):645-648
`(“Hoekstra”).
`Jørgensen et al. (1996) Ann Pharmacother 30:729-
`32 (“Jørgensen”).
`Exhibit 1006 Alsufyani et al. (2003) J. Rheumatol 31:179-82
`(“Alsufyani”).
`Exhibit 1007 1985 Ed. Physician’s Desk Reference for Mexate®
`(“the PDR for Mexate®”).
`Exhibit 1008 Brooks et al. (1990) Arthritis and Rheum.
`33(1):91-94 (“Brooks”).
`Exhibit 1009 Product Summary for the “Methotrexate 100
`mg/ml Injection” product by Hospira UK Ltd.,
`Date of First Authorization 13 March 1987, Date
`of Revision of the Text 22 November 2005 (“the
`Hospira reference”).
`Exhibit 1010 Zackheim (1992) J. Am. Acad. of Derm. 23(6) p.
`1008 (“Zackheim”).
`Exhibit 1011 Müller-Ladner (2010) The Open Rheumatology
`Journal 4:15-22. (“Müller-Ladner”).
`
`
`
`1
`
`PREVIOUSLY
`SUBMITTED
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`Patent No. 8,664,231
`
`Exhibit 1015
`
`DESCRIPTION
`FILED
`
`EXHIBITS
`Exhibit 1012 Weinblatt Declaration; Dated June 17, 2014
`(“Weinblatt Decl.”).
`Exhibit 1013 Gammon Declaration; Dated June 27, 2014
`(“Gammon Decl.”).
`Exhibit 1014 Pincus et al. (2003) Clin Exp Rheumatol (Suppl.
`31):S179-S185 (“Pincus”).
`Insulin Administration, Diabetes Care, 26:1 S121-
`124 (2003) (“Insulin Admin”)
`Exhibit 1016 Complaint in Medac Pharma, Inc. v. Antares
`Pharma, Inc., Nos. 1:14-cv-01498-JBS-KMW
`Exhibit 1017 Portion of EPO prosecution for EP Application
`No.
` 07 786 239.9 and Certified English Translation of
`the same.
`Exhibit 1018 Weinblatt (1993) “Methotrexate,” in Textbook of
`Rheumatology, 4th Edition, Chapter 47, (Kelley et
`al., eds. 1993) (“Weinblatt 1993”)
`Exhibit 1019 Hoffmeister (1983) “Methotrexate therapy in
`rheumatoid arthritis: 15 years experience,” Am J
`Med 75:69-73 (1993)
`Exhibit 1020 Weinblatt (1995) Efficacy of Methotrexate in
`Rheumatoid Arthritis, Br. J. Rheum. 34(suppl.
`2):43-48 (“Weinblatt 1995”)
`Exhibit 1021 Weinblatt et al. (1985) “Efficacy of Low-Dose
`Methotrexate in Rheumatoid Arthritis,” New
`England J. Med. 312:818-822 (“Weinblatt 1985”)
`Exhibit 1022 Hoffmeister (1972) Methotrexate in rheumatoid
`arthritis. Arthritis rheum. 15 (Suppl.): S114
`(abstract) (“Hoffmeister 1972”)
`Exhibit 1023 Weinblatt et al. (1994) Methotrexate in
`Rheumatoid Arthritis: a 5 Year Prospective
`Multicenter Study, Arth. Rheum. 37(10):1492-
`1498 (“Weinblatt 1994”)
`Exhibit 1024 Weinblatt et al. (1992) Long-Term Prospective
`Study of Methotrexate the Treatment of
`Rheumatoid Arthritis: 84-Month Update, Arth.
`Rheum. 35(2):129-137 (“Weinblatt 1992”)
`
`
`
`2
`
`PREVIOUSLY
`SUBMITTED
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`Patent No. 8,664,231
`
`DESCRIPTION
`FILED
`
`EXHIBITS
`Exhibit 1025 Gubner et al. (1951) Therapeutic suppression of
`tissue reactivity. II. Effect of aminopterin in
`rheumatoid arthritis and psoriasis. Am J Med Sci.,
`22:176-82 (“Gubner”)
`Exhibit 1026 Black et al. (1964) Methotrexate therapy in
`psoriatic arthritis. Double-blind study on 21
`patients. J Am Med Assoc 189:743-7 (“Black”)
`Exhibit 1027 Feagan et al. (1995) Methotrexate for the
`Treatment of Crohn’s Disease, New England J.
`Med. 332(5):292-297 (“Feagan”)
`Exhibit 1028 Furst et al. (1989) Increasing Methotrexate Effect
`with Increasing Dose in the Treatment of
`Resistant Rheumatoid Arthritis, J. Rheum
`16(3):313-20 (“Furst”)
`Exhibit 1029 Giannini, et al. (1992) Methotrexate in resistant
`juvenile rheumatoid arthritis—results of the
`U.S.A.-U.S.S.R. double-blind, placebo-controlled
`trial. N. Engl.. Med. 326:1043 (“Giannini”)
`Exhibit 1030 Michaels, et al. (1992) Weekly Intravenous
`Methotrexate in the Treatment of Rheumatoid
`Arthritis, Arthritis and Rheumatism 25(3):339-341
`(“Michaels”)
`Exhibit 1031 Weinblatt Curriculum Vitae
`Exhibit 1032 Gammon Curriculum Vitae
`Exhibit 1033 Transcript of January 21, 2015, Conference Call
`
`
`PREVIOUSLY
`SUBMITTED
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`x
`
`
`
`
`
`
`
`
`March 16, 2015
`
`
`
`
`
`
`
`
`
`3
`
`Respectfully submitted,
`
`/S/ Sanya Sukduang
`By:Sanya Sukduang (Lead Counsel)
`Reg. No. 46,390
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Patent No. 8,664,231
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), I, john W. Kozikowski,
`
`certify that on this 16th day of March, 2015, a copy of PETITIONERS
`
`ANTARES PHARMA, INC., LEO PHARMA A/S and LEO PHARMA INC.
`
`LIST OF EXHIBITS was served by electronic mail upon the following:
`
`James F. Haley, Jr. (james.haley@ropesgray.corn)
`
`Ching—Lee Fukuda (Ching—lee.fukuda@ropesgray.Corn)
`
`Date: March 16, 2015
`
`j<l*-W' WM“
`
`John W. Kozikowski
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
