UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: June 8, 2018
`
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`POZEN INC. and HORIZON PHARMA USA, INC.
`
`Patent Owners
`____________________________
`
`Case No. IPR2017-01995
`U.S. Patent No. 9,220,698
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNERS’ EVIDENCE
`
`
`
`
`
`Filed: June 8, 2018
`
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`POZEN INC. and HORIZON PHARMA USA, INC.
`
`Patent Owners
`____________________________
`
`Case No. IPR2017-01995
`U.S. Patent No. 9,220,698
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNERS’ EVIDENCE
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Mylan Pharmaceuticals Inc.
`
`(“Petitioner”) objects to the admissibility of the following exhibits filed by Patent
`
`Owners Pozen Inc. and Horizon Pharma USA, Inc. (“Patent Owners”) in the Patent
`
`Owners’ Response in the above-captioned inter partes review.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because they
`
`are being filed and served within five business days. Petitioner’s objections provide
`
`notice to Patent Owners that Petitioner may move to exclude these exhibits under 37
`
`C.F.R. § 42.64(c).
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’698 patent”
`
`means U.S. Patent No. 9,220,698. All objections under FRE 801-803 (hearsay)
`
`apply to the extent Patent Owners rely on the exhibits identified in connection with
`
`that objection for the truth of the matter asserted therein.
`
`Exhibit descriptions provided in this table are taken from Patent Owners’
`
`exhibit list and are used for identification purposes only. The use of the description
`
`does not indicate that Petitioner agrees with the descriptions or characterizations of
`
`the documents.
`
`Exhibit
`2012
`
`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) (with publication information)
`
`Objection
`A, D, F, G,
`H, M, N, O
`
`- 1 -
`
`
`
`Exhibit
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`Description
`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
`
`Objection
`A, D, F, G,
`H, M, N, O
`
`A, D, F, G,
`H, M, N, O
`
`A, B, C, D, E,
`F, G, H, I, J,
`M, N, O, W
`
`A, B, C, D, E,
`F, G, H, I, J,
`M, N, O, W
`
`A, B, C, D, E,
`F, I, M, N, O
`A, B, C, D, E,
`F, G, H, I, J,
`M, N, O, W
`
`A, B, C, D, E,
`F, G, H, I, J,
`M, N, O, W
`
`A, B, C, D, E,
`F, G, H, I, J,
`M, N, O, W
`
`- 2 -
`
`
`
`Exhibit
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`Description
`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. 9,220,698
`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
`
`Objection
`A, C, D, E,
`F, G, H, M,
`N, O
`
`A, D, F, G,
`H, M, N, O
`
`A, B, C, D, E,
`F, G, H, I, M,
`N, O
`
`A, I, M, N,
`O
`A, D, F, G,
`H, I, N, O, Q,
`S, T, U
`A, D, F, G,
`H, I, N, O, Q,
`S, T, U
`
`A, B, D, F, G,
`H, I, K, L, M,
`N, O, Q, S, T,
`U
`A, C, E, I, M,
`N, O
`
`A, B, D, F, G,
`H, I, K, L, M,
`N, O, Q, S, T,
`U
`A, B, C, D, E,
`F, G, H, I, J,
`M, N, O, W
`
`- 3 -
`
`
`
`Exhibit
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`Description
`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)
`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
`
`Objection
`A, B, C, D, E,
`F, G, H, I, J,
`M, N, O, W
`
`A, B, D, F, I,
`J, K, M, N,
`O, R
`A, D, F, G,
`H, M, N, O
`
`A, D, F, G,
`H, M, N, O
`
`A, D, F, G,
`H, M, N, O
`
`A, D, F, G,
`H, M, N, O
`
`A, D, F, G,
`H, M, N, O
`
`A, C, E, M,
`N, O
`A, D, F, G,
`H, M, N, O
`
`A, D, F, G,
`H, M, N, O
`
`A, B, C, D, E,
`F, H, M, N, O
`
`- 4 -
`
`
`
`Exhibit
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`2051
`
`Description
`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,
`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)
`
`Objection
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`
`A, B, C, D, E,
`F, I, K, M, N,
`O
`
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`
`P
`A, D, F, G,
`M, N, O
`
`- 5 -
`
`
`
`Exhibit
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`Description
`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, 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)
`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)
`Wolfe et al., Gastroprotective therapy and risk of
`gastrointestinal ulcers: risk reduction by COX-2
`therapy, J. Rheumatol. 29(3):467-473 (2002)
`
`Objection
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`
`A, B, C, D,
`E, F, G, M,
`N, O
`
`A, D, F, G,
`M, N, O
`
`A, B, C, D, E,
`F, M, N, O
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`
`A, D, F, G,
`M, N, O
`A, D, F, G,
`M, N, O
`
`- 6 -
`
`
`
`Exhibit
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`
`
`Description
`FDA Public Health Advisory, April 7, 2005,
`available at
`http://www.fda.gov/drugs/drugsafety/postmarketdr
`ugsafetyinformatio
`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
`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)
`
`Objection
`A, B, C, D, E,
`F, I, K, M, N,
`O
`
`A, D, F, G,
`M, N, O
`
`A, B, D, F,
`G, M, N, O
`
`A, D, F, G,
`M, N, O
`
`A, B, C, D,
`E, F, G, M,
`N, O
`
`A, B, C, D, E,
`F, I, K, M, N,
`O
`A, C, D, E, F,
`G, H, N, O, S
`
`A, B, D, F,
`G, M, N, O
`
`- 7 -
`
`
`
`Petitioner objects to paragraphs in the Patent Owners’ Response that rely on
`
`exhibits objected to in this Petitioner’s Objection to Evidence.
`
`
`
`- 8 -
`
`
`
`Objection Key:
`
`A:
`B:
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`
`I:
`
`J:
`
`K:
`L:
`M:
`N:
`
`O:
`
`P:
`Q:
`
`FRE 801/802/803 (hearsay)
`FRE 901/902 (lacking authentication)
`FRE 402 (relevance) the document is not relevant to any issue in this IPR
`proceeding because the purported date of the document is after the filing
`date of the ’698 patent or the prior art status is not clear
`FRE 402 (relevance) to the extent the document is relied upon for secondary
`considerations of nonobviousness, there is no nexus to the claimed
`compositions and methods
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding because the purported date of the document is
`after the filing date of the ’698 patent or the prior art status is not clear
`FRE 403 (confusing, waste of time) to the extent the document is relied
`upon for secondary considerations of nonobviousness, there is no nexus to
`the claimed compositions and methods
`FRE 702 (improper expert testimony) expert testimony that relies on the
`document is not based on sufficient facts or data and/or is not the product of
`reliable principles and methods
`FRE 703 (bases of expert opinion) expert testimony that relies on the
`document is unreliable because the document is not of a type reasonably
`relied upon by experts in the field
`FRE 106 (completeness) the document is incomplete and includes only a
`select portion of a larger document that in fairness should be considered
`along with this document
`FRE 701, 702 (improper expert testimony) improper expert testimony by a
`lay witness
`FRE 1001-1003 (best evidence)
`FRE 403, 901 (improper compilation)
`FRE 403 (cumulative)
`FRE 402 (relevance) the document is not relevant to any issue in the IPR
`proceeding
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in the IPR proceeding
`No exhibit filed.
`Expert testimony fails to identify with particularity the underlying facts or
`data on which the opinion is based, violating 37 C.F.R. § 42.65(a)
`
`- 9 -
`
`
`
`R:
`S:
`
`T:
`U:
`
`V:
`
`W:
`
`FRE 602 (lack of personal knowledge)
`FRE 702/703 to the extent that the expert declarant relies on an exhibit
`objected to under grounds G and H, the testimony is (i) not based on
`sufficient facts or data and/or is not the product of reliable principles and
`methods and/or is (ii) is unreliable because the exhibit is not of a type
`reasonably relied upon by experts in the field
`FRE 1006 (improper summary)
`37 C.F.R. § 42.65 (fails to provide underlying facts or data on which opinion
`is based)
`Exhibit is improper new evidence untimely filed with a request for
`rehearing, in violation of 37 C.F.R. § 42.71
`Improper uncompelled direct testimony (not submitted as an affidavit),
`contrary to 37 C.F.R. § 42.53.
`
`June 8, 2018
`
`
`
`
`
`Respectfully submitted,
`
`/Brandon M. White/
`Brandon M. White, Esq.
`Reg. No. 52,354
`Perkins Coie LLP
`700 13th Street, NW
`Suite 600
`Washington, D.C. 20005
`bmwhite@perkinscoie.com
`Tel: 202-654-6204
`Fax: 202-654-6211
`
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`- 10 -
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: PETITIONER’S OBJECTIONS TO PATENT
`
`OWNERS’ EVIDENCE by email to the electronic service addresses for Patent
`
`Owner:
`
`Thomas A. Blinka
`Jonathan G. Graves
`Susan Krumplitsch
`Lauren Krickl
`Cooley LLP
`zIPR2017-01995@cooley.com
`
`Margaret J. Sampson
`Stephen M. Hash
`Jeffrey S. Gritton
`Baker Botts LLP
`pozen-vimovoBB@bakerbotts.com
`
`Dated: June 8, 2018
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`
`
`
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
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