BUDD LARNER
`
`
`
`A PROFESSIONAL CORPORATION
`COUNSELLORS AT LAW
`
`150 JOHN F. KENNEDY PARKWAY
`SHORT HILLS, NJ 07078-2703
`973.379.4800
`FAX 973.379.7734
`www.buddlarner.com
`
`Direct Dial (973) 315-4439
`E-Mail: apollack@buddlarner.com
`
` February 24, 2015
`
`
`
`Electronically Filed
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`
`
`Inter Partes Review of U.S. Patent No. 8,557,285
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`
`Dear Patent Trial and Appeal Board:
`
`
`
`This transmittal letter identifies Exhibits 1001-1066, being filed concurrently
`with the present Petition for Inter Partes Review. Pursuant to 37 C.F.R. §
`42.6(e)(4)(ii), the Certificate of Service attached to the end of the Petition for Inter
`Partes Review filed herewith incorporates Exhibits 1001-1066, as listed below:
`
`
`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`
`Description
`United States Patent No. 8,557,285 B2
`United States Patent No. 8,852,636 B2
`United States Patent No. 8,858,996 B2
`United States Patent No. 6,926,907 B2
`Second Amended Complaint, Horizon Pharma. and Pozen
`Inc. v. Dr. Reddy’s Laboratories, Inc. & Dr. Reddy’s
`Laboratories, Ltd. District of New Jersey, Civil Action Nos.
`3-11-cv-02317, Docket Entry No. 226, February 25, 2014
`
`
`
`
`
`A PROFESSIONAL CORPORATION
`COUNSELLORS AT LAW
`
`150 JOHN F. KENNEDY PARKWAY
`SHORT HILLS, NJ 07078-2703
`973.379.4800
`FAX 973.379.7734
`www.buddlarner.com
`
`Direct Dial (973) 315-4439
`E-Mail: apollack@buddlarner.com
`
` February 24, 2015
`
`
`
`Electronically Filed
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`
`
`Inter Partes Review of U.S. Patent No. 8,557,285
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`
`Dear Patent Trial and Appeal Board:
`
`
`
`This transmittal letter identifies Exhibits 1001-1066, being filed concurrently
`with the present Petition for Inter Partes Review. Pursuant to 37 C.F.R. §
`42.6(e)(4)(ii), the Certificate of Service attached to the end of the Petition for Inter
`Partes Review filed herewith incorporates Exhibits 1001-1066, as listed below:
`
`
`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`
`Description
`United States Patent No. 8,557,285 B2
`United States Patent No. 8,852,636 B2
`United States Patent No. 8,858,996 B2
`United States Patent No. 6,926,907 B2
`Second Amended Complaint, Horizon Pharma. and Pozen
`Inc. v. Dr. Reddy’s Laboratories, Inc. & Dr. Reddy’s
`Laboratories, Ltd. District of New Jersey, Civil Action Nos.
`3-11-cv-02317, Docket Entry No. 226, February 25, 2014
`
`
`
`Patent Trial and Appeal Board
`February 24, 2015
`Page 2
`
`
`
`Exhibit No.
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`1011
`1012
`1013
`1014
`1015
`1016
`1017
`1018
`1019
`1020
`
`1021
`1022
`
`1023
`
`1024
`1025
`1026
`
`Description
`First Amended Complaint, Horizon Pharma. and Pozen Inc.
`v. Dr. Reddy’s Laboratories, Inc. & Dr. Reddy’s
`Laboratories, Ltd. District of New Jersey, Civil Action Nos.
`3-13-cv-00091, Docket Entry No. 62, February 25, 2014
`Print of ECF Docket of AstraZeneca AB, et. al. and Pozen
`Inc. v. Dr. Reddy’s Laboratories, Inc. & Dr. Reddy’s
`Laboratories, Ltd. District of New Jersey, Civil Action Nos.
`3-13-cv-06157
`Email correspondence between Alan H. Pollack and Ravin
`Patel, dated October 30 – 31, 2014
`Notice Of Voluntary Dismissal, AstraZeneca AB, et. al. and
`Pozen Inc. v. Dr. Reddy’s Laboratories, Inc. & Dr. Reddy’s
`Laboratories, Ltd. District of New Jersey, Civil Action No.
`3:13-cv-06157
`Pozen’s Responses to DRL’s Invalidity Contentions
`US Provisional Patent Application No. 60/294,588
`US Application No. 10/158,216
`US Application No. 11/129,320
`US Application No. 12/553,804
`US Application No. 13/215,855
`US Application No. 14/045,156
`US Application No. 14/244,471
`Letter of Pozen’s counsel dated 5/2/14
`Claim Construction Opinion of Judge Pisano dated 5/1/13
`Prosecution History of ‘855 Application (issued as ‘285
`patent)
`US 2003/0069255 A1, Published April 10, 2003
`Prosecution History of ‘156 Application (issued as ‘636
`patent)
`Prosecution History of ‘471 Application (issued as ‘996
`patent)
`Horizon’s Citizen Petition, dated February 4, 2014
`FDA Response to Horizon’s Citizen Petition
`Morrison & Boyd, Organic Chemistry, (Prentice-Hall, Inc.,
`Englewood Cliffs, New Jersey, 3d ed. 1992), p. 49
`
`
`
`Patent Trial and Appeal Board
`February 24, 2015
`Page 3
`
`
`
`Exhibit No.
`1027
`
`1028
`
`1029
`
`1030
`1031
`1032
`1033
`1034
`1035
`
`1036
`
`1037
`
`1038
`1039
`1040
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`Description
`The Random House Dictionary of the English Language, p.
`732 (Random House, Inc., N.Y. 1966)
`The Oxford Encyclopedic English Dictionary (Oxford Univ,
`Press, N.Y., 1991). p. 730
`Clissold et al., “Omeprazole: A Preliminary Review of Its
`Pharmacodynamic and Pharmacokinetic Properties, and
`Therapeutic Potential in Peptic Ulcer Disease and Zollinger-
`Ellison Syndrome,” Drugs, 32, 15-47 (1986)
`WO 97/25064 published July 17, 1997 (“Depui”)
`WO 00/78293 published December 28, 2000 (“Lundberg”)
`WO 00/26185 published May 11, 2000 (“Phillips”)
`Nexium® Package Insert, February 2001
`Vimovo® Package Insert
`The Random House College Dictionary, p. 1035 (Random
`House, Inc., N.Y. 1988)
`Declaration of Arthur H. Kibbe, Ph.D. in Support of Inter
`Partes Review
`United States Patent No. 5,601,843 issued February 11,
`1997 (“’843 patent”)
`www.merriam-webster.com/dictionary/inhibit
`Zegerid® Package Insert
`Curriculum Vitae of Arthur Kibbe
`Provisional Application No. 60/294,588 (“’588
`provisional”)
`Brown and Yeomans, “Prevention of Gastrointestinal
`Adverse Effects of Nonsteroidal Anti-Inflammatory Drugs,”
`Drug Safety, Dec. 21 (6):503-512 (1999) (“Brown”)
`Bjorkman, “Nonsteroidal Anti-Inflammatory Drug-Induced
`Gastrointestinal Injury,” Am. J. Med, 101(Suppl. 1A) 25S-
`32S (1996) (“Bjorkman”)
`Wallace, “How do NSAIDs cause ulcer disease?” Bailliere’s
`Clinical Gastroenterology,14(1):147-159 (2000)
`(“Wallace”)
`Scarpignato et al., “Prevention and Treatment of Non-
`Steroidal Anti-Inflammatory Drug-Induced Gastro-
`
`
`
`Patent Trial and Appeal Board
`February 24, 2015
`Page 4
`
`
`
`Exhibit No.
`
`1046
`
`1047
`
`1048
`
`1049
`1050
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`1057
`
`Description
`Duodenal Damage: Rational for the Use of Antisecretory
`Compounds,” Ital. J. Gastroenterol. Hepatol., 31 (Suppl.
`I):S63-72 (1999), PZ00096216-PZ00096225
`(“Scarpignato”)
`Daneshmend et al., “Abolition by Omeprazole of Aspirin
`Induced Gastric Mucosal Injury in Man,” Gut, v. 31, 514-
`517 (1990) (“Daneshmend”)
`Sachs et al., “Review Article: The Control of Gastric Acid
`and Helicobacter Pylori Eradication,” Aliment Pharmacol.
`Ther., 14:1383-1401 (2000), AZV00293734-AZV00293752
`(“Sachs”)
`Warren and Marshall, “Unidentified Curved Bacilli on
`Gastric Epithelium in Active Chronic Gastritis,” Lancet,
`I:1273-1275 (1983) (“Warren”)
`Prilosec® PDR 2000
`Nexium® Package Insert, February 2001
`U.S. Patent No. 5,877,192 issued March 2, 1999 (“’192
`patent”)
`U.S. Patent No. 5,714,504 issued February 3, 1998 (“’504
`patent”)
`Chandramouli et al., “Prevention and Management of
`NSAID-Induced Gastropathy,” Journal of Pharmaceutical
`Care in Pain and Symptom Control, v. 8(4) 27-40 (2000)
`(“Chandramouli”)
`U.S. Patent No. 6,319,519 issued November 20, 2001 (“’519
`patent”)
`Howden et al., “Effects of Single and Repeated Doses of
`Omeprazole in Gastric Acid and Pepsin Secretion in Man,”
`Gut, 25, 707-710 (1984) (“Howden”)
`Prichard et al., “Omeprazole: A Study of Its Inhibition of
`Gastric pH and Oral Pharmacokinetics After Morning or
`Evening Dosage,” Gastroenterol., 88:64-69 (1985)
`(“Prichard”)
`Tolman et al., “The Effects of Oral Doses of Lansoprazole
`and Omeprazole on Gastric pH,” J. Clin. Gastroenterol,
`
`
`
`Patent TTrial and AAppeal Boaard
`
`
`
`
`
`
`Februarry 24, 20155
`Page 5
`
`DDescriptionn
`
`. (1985), 1
`
`9, 9-12
`
`
`
`Akdaamar et al., Am. J. of f Gastroenteerology, 19982, v. 77,, No.
`
`
`
`Naproocyn Physiicians’ Dessk Referennce (2000),, p. 2631-332
`
` 0
`
`
`
`mg:
`
`)
`
`Non-cconfidentiaal excerptss from the ddepositionn transcript t of
`
`
`
`24(2)
`
`
`:65-70 (19997) (“Tolmman”)
`
`
`
`Ramaage et al., BBr. J. Clin.. Pharmac
`
`(“Rammage”)
`
`
`
`
`
`
`
`12, 9002-904 (“AAkdamar”))
`
`
`
`
`
`
`Wilsoon et al., “EEffects of MMisoprostool on Gastrric Acid annd
`
`Mucuus Secretion in Man,”” Dig. Dis.
`
`
` Sci., 31(SSuppl. 2):1226S-
`
`
`
`
`129S (1986) (“WWilson”)
`
`
`
`
`
`Reminngton’s Phharmaceutiical Sciencces, 17th edd., (1985).
`
`
`
`
`
`
`
`Kibbee A.H., Edd., “Handboook of Phaarmaceuticaal Excipiennts,”
`
`3rd Edd., 2000.
`
`
`
`
`
`
`
`
`
`
`
`Pilbraant and Cederberg, “DDevelopmment of an OOral
`
`
`
`Formmulation of Omeprazoole,” Scandd. J. Gastrooenterol.,
`
`
`
`
`
`
`20(Suuppl. 108):113-120 (11985) (“Piilbrant”)
`
`
`
`
`
`Minerr et al., “CClinical Triaal: Evaluaation of Gaastric Acid
`
`
`
`
`
`Supprression witth Three DDoses of Immmediate-RRelease
`
`
`
`
`
`Esommeprazole inn the Fixedd-Dose Coombinationn of PN 400
`
`
`(Naprroxen/Esommeprazole
`
`
`Magnesiuum) Compaared with
`
`
`
`
`
`Naprooxen 500 mmg and Entteric-Coateed Esomepprazole 20
`Healthy
`
`
`
`A Ranndomized, Open-Labbel, Phase
`I Study in
`
`
`
`
`
`Volunnteers,” Allim. Pharmmacol. Therr., 32:414-4424 (2010
`
`(“Minner”)
`
`
`
`
`
`
`
`
`
`
`
`Jeff SSherman MMD, Horizoon Pharma’’s 30(b)(6)) witness
`
`
`
`EExhibit Noo.
`
`
`
`1058
`
`1059
`
`1060
`
`1061
`1062
`
`1063
`1064
`
`1065
`
`1066
`
`
`
`
`
`Resspectfully ssubmitted,
`
`
`
`
`
`
`
`BUUDD LARNNER, P.C.
`
`
`
`
`
`_____________________
`
`
`Alaan H. Pollaack
`
`
`
`Reggistration NNo. 39,8022
`
`
`
`Leaad Counsell for Petitiooner
`Dr.
`
`
`Reddy’s LLaboratoriees, Inc.
`
`
`
`
`
`
`
`
`
`
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`
`1015500
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