`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`
`v.
`
`
`POZEN INC. and HORIZON PHARMA USA, INC.,
`Patent Owners.
`
`___________
`
`
`Case IPR2017-01995
`Patent 9,220,698
`
`___________
`
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`
`
`
`
`
`
`

`

`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`PATENT OWNER EXHIBIT LIST
`
`DESCRIPTION
`
`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”)
`Second Amended Complaint for Patent Infringement, Horizon
`Pharma, Inc. v. Mylan Pharmaceuticals Inc., Civil Action No. 2:15-
`cv-03327 (D.N.J. Feb. 10, 2016)
`Answer to Second Amended Complaint, Separate Defenses, And
`Counterclaims by Defendants Mylan Pharmaceuticals Inc., Mylan
`Laboratories Limited and Mylan Inc. , Horizon Pharma, Inc. v. Mylan
`Pharmaceuticals Inc., Civil Action No. 2:15-cv-03327 (D.N.J. Feb.
`19, 2016)
`Plaintiffs’ Answer to Defendants’ Counterclaims to Second Amended
`Complaint, Horizon Pharma, Inc. v. Mylan Pharmaceuticals Inc.,
`Civil Action No. 2:15-cv-03327 (D.N.J. Mar. 7, 2016)
`157 Cong. Rec. S5429 (daily ed. Sept. 8, 2011) (statement of Sen.
`Kyl)
`Declaration of Jonathan G. Graves in Support of Pro Hac Vice Motion
`Declaration of Susan Krumplitsch in Support of Pro Hac Vice Motion
`Email string from Mylan’s counsel, Robert D. Swanson from February
`6, 2017 to February 15, 2017
`Declaration of Ellen Scordino in Support of Pro Hac Vice Motion
`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
`
`2
`
`
`
`
`
`
`
`EXHIBIT
`NO.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`2009
`2010
`
`2011
`2012
`
`
`
`

`

`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`DESCRIPTION
`
`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.)
`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)
`
`3
`
`
`EXHIBIT
`NO.
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`
`
`

`

`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`DESCRIPTION
`
`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.
`9,220,698
`Declaration of David A. Johnson. M.D. In Support of Patent Owner
`Response to Petition for Inter Partes Review of U.S. Patent No.
`9,220,698
`IPR2017-01995, May 25, 2018 Deposition Transcript of David C.
`Metz
`Redacted Amended Memorandum Opinion (D.I. 498), Case 3:11-cv-
`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)
`
`4
`
`
`EXHIBIT
`NO.
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
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`
`
`

`

`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`DESCRIPTION
`
`Leucuta et al., Pharmcokinetics and Metabolic Drug Interactions,
`CURRENT CLINICAL PHARMACOLOGY, 1:5-20 (2006)
`Meyer, Interaction of Proton Pump Inhibitors with Cytochromes
`P450: Consequences for Drug Interactions, YALE J. BIOL. MED.,
`69:203-209 (1996)
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`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
`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,
`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,
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`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
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`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)
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`management of acid-peptic disorders, Bioorganic & Medicinal
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`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
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`
`
`EXHIBIT
`NO.
`2036
`
`2037
`
`2038
`2039
`
`2040
`
`2041
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
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`2050
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`
`
`

`

`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`DESCRIPTION
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`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.
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`the practising physician, Best Prac. & Res. Clin. Gastroenterol.
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`induced Ulcers, Am. J. Gastroenterol., 93(11):2037–2046 (1998)
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`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`2058
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`
`
`

`

`
`EXHIBIT
`NO.
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
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`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`DESCRIPTION
`
`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)
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`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
`IPR2017-01995 Corrected Declaration of Bryan D. Beel in Support of
`Petitioner’s Evidence, June 1, 2018
`M. Hassan-Alin et al., Pharmacokinetics of esomeprazole after oral
`and intravenous administration of single and repeated doses to healthy
`subjects, Eur. J. Clin. Pharmacol., 56:665-670 (2000)
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`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
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`http://wayback.archive-
`it.org/7993/20161024015703/http://www.fda.gov/Drugs/DrugSafety/P
`ostmarketDrugSafetyInformationforPatientsandProviders/ucm150314.
`htm
`
`
`
`Date: June 22, 2018
`
`
`
`
`
`
`
`
`Respectfully submitted,
`/Thomas A. Blinka/
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
`
`
`BY:
`
`
`
`
`7
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`

`

`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`CERTIFICATION OF SERVICE UNDER 37 C.F.R. § 42.6(e)
`
`I, Thomas A. Blinka, hereby certify that on this 22nd day of June 2018, the
`
`
`
`
`
`foregoing Patent Owner Exhibit List was served electronically via email on the
`
`following:
`
`Brandon M. White
`bmwhite@perkinscoie.com
`700 13th St., NW Suite 600
`Washington, DC 20005
`
`Emily Greb
`egreb@perkinscoie.com
`One East Main St., Suite 201
`Madison, WI 53703
`
`EsoNaproxen@perkinscoie.com
`
`
`
`Date: June 22, 2018
`
`
`BY:
`
`
`/Thomas A. Blinka/
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
`
`
`
`8
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