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`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC. and
`DR. REDDY’S LABORATORIES, INC.
`Petitioners,
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO
`PHARMACEUTICALS (IRELAND) DESIGNATED
`ACTIVITY COMPANY
`Patent Owners.
`
`
`
`Case No. IPR2018-002721
`Patent No. 9,393,208
`
`
`
`
`
`
`
`PATENT OWNERS’ EXHIBIT LIST
`
`
`
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc. from IPR2018-01341, has been joined as
`a Petitioner to this proceeding.
`
`

`

`Exhibit
`No.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`2007-
`2011
`2012
`
`2013
`
`2014
`
`2015
`
`
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`
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`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`PATENT OWNERS’ EXHIBIT LIST
`Description of Document
`
`Gabriel, S.E., et al., “Risk for Serious Gastrointestinal Complications
`Related to Use of Nonsteroidal Anti-inflammatory Drugs,” Annals of
`Internal Medicine, Vol. 115, No. 10, pp. 787-796 (1991) (“Gabriel”)
`Cryer, B. and Feldman, M., “Effects of Nonsteroidal Anti-
`inflammatory Drugs on Endogenous Gastrointestinal Prostaglandins
`and Therapeutic Strategies for Prevention and Treatment of
`Nonsteroidal Anti-inflammatory Drug-Induced Damage,” Archives of
`Internal Medicine, Vol. 152, pp. 1145-1155 (1992) (“Cryer”)
`Fries, J.F., et al., “Nonsteroidal Anti-Inflammatory Drug-Associated
`Gastropathy: Incidence and Risk Factor Models,” The American
`Journal of Medicine, Vol. 91, pp. 213-222 (1991) (“Fries”)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Response to
`Final Office Action Mailed March 26, 2015 (Sept. 25, 2015)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Advisory
`Action (Oct. 9, 2015)
`Pozen Inc. Bankruptcy Petition dated August 10, 2018
`Exhibits Not Used
`
`Gabriel, S.E., et al., Risk for Serious Gastrointestinal Complications
`Related to Use of Nonsteroidal Anti-inflammatory Drugs, Annals of
`Internal Medicine, Vol. 115, No. 10, pp. 787-796 (1991) (with
`publication information)
`Cryer, B. and Feldman, M., Effects of Nonsteroidal Anti-
`inflammatory Drugs on Endogenous Gastrointestinal Prostaglandins
`and Therapeutic Strategies for Prevention and Treatment of
`Nonsteroidal Anti-inflammatory Drug-Induced Damage, Archives of
`Internal Medicine, Vol. 152, pp. 1145-1155 (1992) (with publication
`information)
`Fries, J.F., et al., Nonsteroidal Anti-Inflammatory Drug-Associated
`Gastropathy: Incidence and Risk Factor Models, The American
`Journal of Medicine, Vol. 91, pp. 213-222 (1991) (with publication
`information)
`Jan. 12, 2017 Trial Testimony of John R. Plachetka in the Horizon
`Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Case No. 3:11-cv-
`02317 (D.N.J.)
`
`1
`
`

`

`Exhibit
`No.
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`
`
`
`
`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`Description of Document
`
`Jan. 24, 2018 Deposition Testimony of Dr. John R. Plachetka in the
`Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Case No.
`3:15-cv-03324 (D.N.J.)
`PROTECTIVE ORDER MATERIAL
`PN400-104 Clinical Study Report
`PROTECTIVE ORDER MATERIAL
`Oct. 12, 2017 Deposition Testimony of Everardus Orlemans, Ph.D. in
`the Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Case No.
`3:15-cv-03324 (D.N.J.)
`Oct. 27, 2017 Deposition Testimony of Mark Sostek, MD in the
`Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Case No.
`3:15-cv-03324 (D.N.J.)
`PROTECTIVE ORDER MATERIAL
`Oct. 25, 2017 Deposition Testimony of Brian Ault, Ph.D. in the
`Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Case No.
`3:15-cv-03324 (D.N.J.)
`PROTECTIVE ORDER MATERIAL
`Norman, A. and Hawkey, C.J., What you need to know when you
`prescribe a proton pump inhibitor, Frontline Gastroenterology, Vol.
`2, pp. 199-205 (2011)
`Stollman, N. and Metz, D.C., Pathophysiology and prophylaxis of
`stress ulcer in intensive care unit patients, J. Critical Care, Vol. 20,
`pp. 35-45 (2005)
`Declaration of Michael Mayersohn, Ph.D. in Support of Defendants’
`Claim Construction Brief filed on April 24, 2014 in Par Pharm., Inc.
`v. Takeda Pharm. Co., Case No. 5:13-CV-1927 LHK (PSG)
`January 30, 2013 Amendment C and Response to Final Office Action,
`Application No. 12/553,107
`Declaration of David R. Taft PH.D. In Support of Patent Owner
`Response to Petition for Inter Partes Review of U.S. Patent No.
`9,393,208
`Declaration of David A. Johnson M.D. In Support of Patent Owner
`Response to Petition for Inter Partes Review of U.S. Patent No.
`9,393,208
`IPR2017-01995, May 25, 2018 Deposition Transcript of David C.
`Metz
`Redacted Amended Memorandum Opinion (D.I. 498), Case 3:11-cv-
`
`2
`
`

`

`Exhibit
`No.
`
`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`Description of Document
`
`02317-MLC-DEA (D.N.J. July 12, 2017)
`IPR2017-01995, May 24, 2018 Deposition Transcript of Dr. Michael
`Mayersohn
`Oct. 16, 2014 Deposition Testimony of Brian Ault, Ph.D. in the
`Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Case No.
`3:11-cv-02317 (D.N.J.)
`PROTECTIVE ORDER MATERIAL
`Oct. 10, 2014 Deposition Testimony of Dr. Mark Sostek in the
`Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Case No.
`3:11-cv-02317 (D.N.J.)
`PROTECTIVE ORDER MATERIAL
`Email string from Tore Lind to Richard Leff, Doug Levine, David
`Magner, and Mark Sostek, dated May 27, 2006 to May 31, 2006
`Andersson et al., Pharmacokinetic Studies with Esomeprazole, the
`(S)-Isomer of Omeprazole, CLIN. PHARMACOKINET., 40(6):411-426
`(2001)
`Tolman et al., The Effects of Oral Doses of Lansoprazole and
`Omeprazole on Gastric pH, J. CLIN. GASTROENTEROL., 24(2):65-70
`(1997)
`Hartmann et al., Twenty-four-hour intragastric pH profiles and
`pharmacokinetics following single and repeated oral administration
`of the proton pump inhibitor pantoprazole in comparison to
`omeprazole, ALIMENT PHARMACOL. THER., 10:359-366 (1996)
`Leucuta et al., Pharmcokinetics and Metabolic Drug Interactions,
`CURRENT CLINICAL PHARMACOLOGY, 1:5-20 (2006)
`2037 Meyer, Interaction of Proton Pump Inhibitors with Cytochromes
`P450: Consequences for Drug Interactions, YALE J. BIOL. MED.,
`69:203-209 (1996)
`Prilosec Label
`Vanderhoff et al., Proton Pump Inhibitors: An Update, AMERICAN
`FAMILY PHYSICIAN, 66:273-280 (2002)
`Arnold, Safety of proton pump inhibitors-an overview, Aliment
`Pharmacol. Ther., 8(Suppl. 1):65-70 (1994)
`VIMOVO Prescribing Information
`2041
`2042 M.M. Wolfe et al., Gastrointestinal toxicity of nonsteroidal
`antiinflammatory drugs, N. Engl. J. Med., 340(24):1888-1899 (1999)
`L. Laine, Nonsteroidal anti-inflammatory drug gastropathy,
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2038
`2039
`
`2040
`
`2043
`
`3
`
`
`
`
`
`

`

`Exhibit
`No.
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`
`
`
`
`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`Description of Document
`
`Gastrointest. Endosc. Clin. North Am., 6(3):489–504 (1996)
`F.E. Silverstein et al., Gastrointestinal toxicity with celecoxib vs.
`nonsteroidal anti-inflammatory drugs for osteoarthritis and
`rheumatoid arthritis: the CLASS study: A randomized controlled
`trial, JAMA, 284(10):1247–1255 (2000)
`C. Bombardier et al., Comparison of upper gastrointestinal toxicity of
`rofecoxib and naproxen in patients with rheumatoid arthritis, N.
`Engl. J. Med., 343(21):1520–1528 (2000)
`G. Singh, Gastrointestinal complications of prescription and over-
`the-counter nonsteroidal anti-inflammatory drugs: a view from the
`ARAMIS database, Am. J. Ther., 7:115–121 (2000)
`NIH, National Institute of Diabetes and Digestive and Kidney
`Diseases, Bleeding in the Digestive Tract, available at
`http://www.niddk.nih.gov/health-information/health-topics/digestive-
`diseases/bleeding-in-the-digestive-tract/Pages/facts.aspx (last
`accessed March 23, 2015)
`K.S. Jain, et al., Recent advances in proton pump inhibitors and
`management of acid-peptic disorders, Bioorganic & Medicinal
`Chemistry 15:1181-1205 (2007)
`N. Hudson et al., Famotidine for healing and maintenance in
`nonsteroidal anti-inflammatory drug-associated gastroduodenal
`ulceration, Gastroenterology, 112:1817-1822 (1997)
`Exhibit Not Used
`L. Olbe et al., Reviews: A Proton-pump inhibitor expedition: The case
`histories of omeprazole and esomeprazole, Nature 2:132-139 (2003)
`C.W. Howden, Clinical pharmacology of omeprazole, Clin.
`Pharmacokinet 20(1):38-49 (1991)).
`J.Q. Huang & R.H. Hunt, Pharmacological and pharmacodynamic
`essentials of H2-receptor antagonists and proton pump inhibitors for
`the practising physician, Best Prac. & Res. Clin. Gastroenterol.
`15(3):355-370 (2001)
`H. Koop, Review article: metabolic consequences of long-term
`inhibition of acid secretion by omeprazole, Aliment. Pharmacol. Ther.
`6:399–406 (1992)
`Donnellan C., Preston C., Moayyedi P., Sharma N., Medical
`treatments for the maintenance therapy of reflux oesophagitis and
`endoscopic negative reflux disease (Review), The Cochrane Library,
`
`4
`
`

`

`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`Description of Document
`
`Exhibit
`No.
`
`2056
`
`2057
`2058
`
`2060
`
`Issue 4, at 14 (2004)
`D.A. Johnson, Review of esomeprazole in the treatment of acid
`disorders, Expert Opin. Pharmacother. 4(2):253-264 (2003)
`Nexium label
`S.H. Roth, NSAID gastropathy: A new understanding, Arch. Intern.
`Med. 156:1623–1628 (1996)
`2059 W. Bensen & A. Zizzo, Newer, safer nonsteroidal anti-inflammatory
`drugs. Rational NSAID selection for arthritis, Can. Fam. Physician
`44:101-102, 105-107 (1998)
`R.J. Flower, Reviews: The development of COX2 inhibitors, Nature
`2:179-191 (2003)
`2061 Wolfe et al., Gastroprotective therapy and risk of gastrointestinal
`ulcers: risk reduction by COX-2 therapy, J. Rheumatol. 29(3):467-
`473 (2002)
`FDA Public Health Advisory, April 7, 2005, available at
`http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformatio
`nforpatientsandproviders/ucm150314.htm (last accessed March 23,
`2015)).
`J.L. Wallace et al., Gastrointestinal-sparing anti-inflammatory drugs:
`the development of nitric oxide-releasing NSAIDs, Drug Dev Res
`42:144-149 (1997)
`F.L. Lanza, A guideline for the treatment and prevention of NSAID-
`induced Ulcers, Am. J. Gastroenterol., 93(11):2037–2046 (1998)
`J.L. Goldstein et al., Impact of adherence to concomitant
`gastroprotective therapy on nonsteroidal-related gastroduodenal
`ulcer complications, Clin. Gastroenterol. & Hepatology, 4:1337-1345
`(2006)
`J.L. Goldstein et al., Clinical trial: the incidence of NSAID-associated
`endoscopic gastric ulcers in patients treated with PN 400 (naproxen
`plus esomeprazole magnesium) vs. enteric-coated naproxen alone,
`Aliment Pharmacol. Ther., 32:401-413 (2010)
`AstraZeneca/Pozen Collaboration and License Agreement (August 1,
`2006)
`PROTECTIVE ORDER MATERIAL
`Exhibit Not Used
`2068
`2069 M. Hassan-Alin et al., Pharmacokinetics of esomeprazole after oral
`and intravenous administration of single and repeated doses to
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`5
`
`
`
`
`
`

`

`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`Description of Document
`
`healthy subjects, Eur. J. Clin. Pharmacol., 56:665-670 (2000)
`Exhibits Not Used
`
`Exhibit
`No.
`
`2070-
`2072
`2073
`
`2075
`
`2076
`
`2077
`
`2078
`
`2079
`
`Opinion & Order, filed on November 14, 2017 in Horizon Pharma,
`Inc. v. Dr. Reddy’s Laboratories, Inc., Civ. A. No. 2:15-cv-03324-
`SRC-CLW (SRC)
`2074 Memorandum of Mylan and DRL in Support of Their Motion for
`Summary Judgment of Invalidity of U.S. Patent Nos. 9,220,698 and
`9,393,208, filed on November 12, 2018 in Horizon Pharma, Inc. v.
`Dr. Reddy’s Laboratories, Inc., Civ. A. No. 2:15-cv-03324-SRC-
`CLW (SRC)
`Opinion, filed on November 19, 2018 in Horizon Pharma, Inc. v. Dr.
`Reddy’s Laboratories, Inc., Civ. A. No. 2:15-cv-03324-SRC-CLW
`(SRC)
`Final Judgment Under Rule 54(b), signed and filed January 22, 2019
`in Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Civ. A.
`No. 2:15-cv-03324-SRC-CLW (SRC)
`Final Judgment Under Rule 54(b), signed and filed January 22, 2019
`in Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., Civ. A.
`No. 2:15-cv-03324-SRC-CLW (SRC)
`Declaration of Susan M. Krumplitsch in Support of Patent Owners’
`Evidence (not filed)
`NIH, National Institute of Diabetes and Digestive and Kidney
`Diseases, Bleeding in the Digestive Tract webpage,
`https://web.archive.org/web/20150405005309/http://www.niddk.nih.g
`ov/health-information/health-topics/digestive-diseases/bleeding-in-
`the-digestive-tract/Pages/facts.aspx (not filed)
`Archived FDA Public Health Advisory webpage,
`http://wayback.archive-
`it.org/7993/20161024015703/http://www.fda.gov/Drugs/DrugSafety/
`PostmarketDrugSafetyInformationforPatientsandProviders/ucm15031
`4.htm (not filed)
`2081 Motion for Ellen Scordino to Appear Pro Hac Vice on Behalf of
`Patent Owner Horizon Pharma USA, Inc.
`IPR2018-00272, May 16, 2019 Rough Deposition Transcript of
`Michael Mayersohn
`
`
`2080
`
`2082
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`6
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`
`Exhibit
`No.
`2083
`
`2084
`
`
`
`
`
`Date: June 4, 2019
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue,
`N.W Suite 700
`Washington, DC 20004-2400
`Tel: 720-566-4119
`Fax: 720-566-4099
`
`
`
`
`
`
`
`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`Description of Document
`
`IPR2018-00272, May 10, 2019 Deposition Transcript of David C.
`Metz, MD
`Declaration of Susan Krumplitsch in Support of Motion to Appear
`Pro Hac Vice on Behalf of Patent Owner Horizon
`
`Respectfully submitted,
`
`By: /Thomas A. Blinka/
`Thomas A. Blinka
`Reg. No. 44,541
`Counsel for Patent Owner
`
`7
`
`

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`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`CERTIFICATE OF SERVICE UNDER 37 C.F.R. § 42.6(e)
`
`I, Thomas A. Blinka, hereby certify that on this 4th day of June 2019, the
`
`foregoing Patent Owners’ Exhibit List was served electronically via email on the
`
`following:
`
`
`
`Counsel for MYLAN
`
`Counsel for DR. REDDY'S
`
`
`
`
`
`Brandon M. White
`Emily J. Greb
`Autumn N. Nero
`Bryan D. Beel
`Maria A. Stubbings
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`egreb@perkinscoie.com
`anero@perkinscoie.com
`bbeel@perkinscoie.com
`mstubbings@perkinscoie.com
`EsoNaproxen@perkinscoie.com
`
`Alan H. Pollack
`Stuart D. Sender
`Louis H. Weinstein
`WINDELS MARX LANE &
`MITTENDORF, LLP
`apollack@windelsmarx.com
`ssender@windelsmarx.com
`lweinstein@windelsmarx.com
`
`
`
`
`Date: June 4, 2019
`
`
`
`By: /Thomas A. Blinka/
`Thomas A. Blinka
`Reg. No. 44,541
`Counsel for Patent Owner
`
`
`
`
`
`8
`
`