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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`QUALICAPS CO., LTD,
`Patent Owner
`
`Case IPR2017-00203
`Patent 6,649,180
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`DC: 6428538-5
`
`
`
`
`
`
`
`IPR2017-00203
`
`LIST OF EXHIBITS
`
`Ex. 2004
`
`DESCRIPTION
`EXHIBIT
`Ex. 2001 HARD CAPSULES (K. Ridgway ed., 1987)
`Ex. 2002 Toshihiro Ogura, Yoshihiro Furuya, & Seinosuke Matsuura, HPMC
`Capsules — An Alternative to Gelatin, 20(11) J. PHARM. TECH.
`EUROPE 32 (November 1998)
`Ex. 2003 THE HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (“HPE”) Second
`Edition 229–32 (Ainley Wade and Paul J. Weller, eds., 1994)
`Jae-Hwang Lee, et al., Specific PCR assays to determine bovine,
`porcine, fish and plant origin of gelatin capsules of dietary
`supplements, 211 FOOD CHEMISTRY 253 (2016)
`Ex. 2005 Federal Standard No. 285A, Capsules (For Medicinal Purposes)
`(October 19, 1976)
`Ex. 2006 E. Bradbury & C. Martin, The effect of temperature of preparation
`on the mechanical properties and structure of gelatin films, 214
`PROC. R. SOC. LONDON SERIES A 183 (1952)
`Ex. 2007 U.S. Pat. No. 2,526,683 (issued Oct. 24, 1950 to Murphy)
`Ex. 2008 U.S. Pat. No. 2,810,659 (issued Oct. 22, 1957 to Greminger, et al.)
`Ex. 2009
`intentionally left blank
`Ex. 2010
`J. C. Stone, Objective Visual Evaluation of the Relative Content of
`Major and Minor Defects in Tablets and Capsules, 59(9) J. PHARM.
`SCI. 1364 (1970)
`I. H. Coopes, Structure Formation in Gelatin Films, PHOTOGRAPHIC
`GELATIN II, PROCEEDINGS OF THE ROYAL PHOTOGRAPHIC SOCIETY
`SYMPOSIUM 121 (R. J. Cox, ed., 1974)
`J. E. Jolley, The Microstructure of Photographic Gelatin Binders,
`14(3) PHOTOGR. SCI. ENG’G 169 (1970)
`Ex. 2013 George A. Digenis, Thomas B. Gold, & Vinod P. Shah, Cross-
`Linking of Gelatin Capsules and Its Relevance to Their In Vitro-In
`Vivo Performance, 83(7) J. PHARM. SCI. 915 (1994)
`
`Ex. 2011
`
`Ex. 2012
`
`- 1 -
`
`
`
`IPR2017-00203
`
`Ex. 2018
`
`EXHIBIT
`Ex. 2014
`
`DESCRIPTION
`James Hogan, et al., Investigations into the Relationship Between
`Drug Properties, Filling, and the Release of Drugs from Hard
`Gelatin Capsules Using Multivariate Statistical Analysis, 13(6)
`PHARM. RES. 944 (1996)
`Ex. 2015 THE UNITED STATES PHARMACOPOEIA, at 774– 76 (1994)
`Ex. 2016 THE JAPANESE PHARMACOPOEIA, at i–vii; 750–51, 800–804 (13th ed.
`1996)
`Ex. 2017 DOW METHOCEL CELLULOSE ETHERS HANDBOOK (1978) [sp.
`corrected]
`Jaime Curtis-Fisk, et al., Effect of Formulation Conditions on
`Hypromellose Performance Properties in Films Used for Capsules
`and Tablet Coatings, 13(4) AAPS PHARMSCITECH 1170 (December
`2012)
`Ex. 2019 Linda Felton, Film Coating of Oral Solid Dosage Forms, in
`ENCYCLOPEDIA OF PHARMACEUTICAL TECHNOLOGY, at 1729–47 (J.
`Swabrick ed., 3rd ed., 2007)
`Ex. 2020 U.S. Pat. No. 4,001,211 (issued Jan. 4, 1977 to Sarkar)
`Ex. 2021 Document comparison by Workshare Compare software: comparison
`of Petition and Declaration of Arthur H. Kibbe
`Ex. 2022 U.S. Pat. No. 5,431,917 (issued Jul. 11, 1995 to Yamamoto, et al.)
`Ex. 2023 U.S. Pat. No. 6,326,026 (issued Dec. 4, 2001 to Parekh, et al.)
`Ex. 2024 U.S. Pat. No. 6,228,416 (issued May 8, 2001 to Reibert, et al.)
`Ex. 2025 U.S. Pat. No. 4,365,060 (issued Dec. 21, 1982 to Onda, et al.)
`Ex. 2026 Declaration of Megan P. Keane in Support of Patent Owner’s Motion
`for Admission Pro Hac Vice of Megan P. Keane Under 37 C.F.R. §
`42.10
`Ex. 2027 Declaration of Michael N. Kennedy in Support of Patent Owner’s
`Motion for Admission Pro Hac Vice of Michael N. Kennedy Under
`37 C.F.R. § 42.10
`Ex. 2028 Declaration of Jason T. McConville, Ph.D. with cv and list of prior
`consulting work
`Ex. 2029 Transcript, Deposition of Arthur H. Kibbe, Ph.D. (June 16, 2017)
`
`- 2 -
`
`
`
`IPR2017-00203
`
`DESCRIPTION
`EXHIBIT
`Ex. 2030 Torrent Pharm. Ltd v. Novartis AG, IPR2014-00784, Ex. 1028
`(Transcript, Deposition of Arthur H. Kibbe, Ph.D. (March 25, 2015))
`Ex. 2031 Torrent Pharm. Ltd v. Novartis AG, IPR2014-00784, Ex. 2058
`(comparison between declarations of Dr. Kibbe and Dr. Kent)
`Ex. 2032 Torrent Pharm. Ltd v. Novartis AG, IPR2014-00784, Paper 112
`(Final Written Decision (Sept. 24, 2015))
`Ex. 2033 Gray Square Pharm, LLC v. Pozen, Inc., IPR2016-00191, Paper 10
`(Decision Denying Institution (May 6, 2016))
`Ex. 2034 Dr. Reddy’s Labs., Inc. v. Pozen Inc., IPR2015-00802, Paper 28
`(Decision Denying Institution (Oct. 9, 2015))
`Ex. 2035 DOW METHOCEL CELLULOSE ETHERS TECHNICAL HANDBOOK
`(1991)
`Ex. 2036 R.C. Rowe, The adhesion of film coatings to table surfaces - the
`effect of some direct compression excipients and lubricants, 29 J.
`PHARM. PHARMAC. 723-26 (1977)
`Ex. 2037 R.C. Rowe, The molecular weight and molecular weight distribution
`of hydroxypropyl methylcellulose used in the film coating of tablets,
`32 J. PHARM. PHARMACOL. 116-19 (1980)
`Ex. 2038 Gilbert Banker, et al., Evaluation of hydroxypropyl cellulose and
`hydroxypopyl methyl cellulose as aqueous based film coatings, 7(6)
`DRUG DEV. IND. PHARM. 693-716 (1981)
`Ex. 2039 A.O. Okhamafe, et al., Moisture permeation mechanism of some
`aqueous-based film coats, 34(Suppl) J. PHARM. PHARMACOL 53P
`(1982)
`Ex. 2040 U.S. Pat. No. 4,816,298 (iss. Mar. 28, 1989 to Alderman, et al.)
`Ex. 2041 U.S. Pat. No. 4,916,161 (iss. Apr. 10, 1990 to Patell)
`Ex. 2042 R.C. Rowe, Materials used in the film coating of oral dosage forms,
`in MATERIALS USED IN PHARMACEUTICAL FORMULATION, at 1-36
`(A.T. Florence, ed. 1984)
`Ex. 2043 M.C. Bonferoni, et al., A characterization of the three HPMC
`substitution grades: rheological properties and dissolution
`behaviour, 13TH PHARMACEUTICAL TECHNOL. CONFERENCE, VOL. 1
`(Strasbourg, France Apr. 12, 1994)
`
`- 3 -
`
`
`
`IPR2017-00203
`
`Ex. 2048
`
`DESCRIPTION
`EXHIBIT
`Ex. 2044 ASHP guidelines for selecting pharmaceutical manufacturers and
`suppliers, 48(3) AM. J. HOSP. PHARM. 523-24 (1993)
`Ex. 2045 Karen Mitchell, et al., The influence of additives on the cloud point,
`disintegration and dissolution of hydroxypropylmethylcellulose gels
`and matrix tablets, 66 INT’L J. PHARM. 233-42 (1990)
`Ex. 2046 U.S. Pat. No. 5,756,036 (iss. May 26, 1998 to Grosswald, et al.)
`Ex. 2047 U.S. Pharmacopoeia, Ch. 1151, 4433–4440 (rev. 23d, 8th Supp.
`1998)
`Joseph Grover, Methylcellulose and Its Derivatives, Chap. 18 in
`INDUSTRIAL GUMS: POLYSACCHARIDES AND THEIR DERIVATIVES, at
`475-504 (Roy Whistler & James BeMiller, eds. 3d ed. 1993)
`Ex. 2049 A.C. Shah, et al., Gel-matrix systems exhibiting bimodal controlled
`release for oral drug delivery, 9 J. CONTROL. RELEASE 169-75 (1989)
`Ex. 2050 T.C. Dahl, et al., Influence of physico-chemical properties of
`hydroxypropyl methylcellulose on naproxen release from sustained
`release matrix tablets, 14 J. CONTROL. RELEASE 1-10 (1990)
`J.E. Hogan, Hydroxypropylmethylcellulose sustained release
`technology, 15(6&7) DRUG. DEV. IND. PHARM. 975-99 (1989)
`Ex. 2052 Front Matter for Ex. 2036, R.C. Rowe, The adhesion of film coatings
`to table surfaces - the effect of some direct compression excipients
`and lubricants, 29 J. PHARM. PHARMAC. 723-26 (1977) (served, but
`not filed, August 11, 2017)
`Ex. 2053 Front Matter for Ex. 2037, R.C. Rowe, The molecular weight and
`molecular weight distribution of hydroxypropyl methylcellulose used
`in the film coating of tablets, 32 J. PHARM. PHARMACOL. 116-19
`(1980) (served, but not filed, August 11, 2017)
`Ex. 2054 Front Matter for Ex. 2038, Gilbert Banker, et al., Evaluation of
`hydroxypropyl cellulose and hydroxypopyl methyl cellulose as
`aqueous based film coatings, 7(6) DRUG DEV. IND. PHARM. 693-716
`(1981) (served, but not filed, August 11, 2017)
`
`Ex. 2051
`
`- 4 -
`
`
`
`IPR2017-00203
`
`DESCRIPTION
`EXHIBIT
`Ex. 2055 Front Matter for Ex. 2039, A.O. Okhamafe, et al., Moisture
`permeation mechanism of some aqueous-based film coats, 34(Suppl)
`J. PHARM. PHARMACOL 53P (1982) (served, but not filed, August 11,
`2017)
`Ex. 2056 Front Matter for Ex. 2042, R.C. Rowe, Materials used in the film
`coating of oral dosage forms, in MATERIALS USED IN
`PHARMACEUTICAL FORMULATION, at 1-36 (A.T. Florence, ed. 1984)
`(served, but not filed, August 11, 2017)
`Ex. 2057 Front Matter for Ex. 2049, A.C. Shah, et al., Gel-matrix systems
`exhibiting bimodal controlled release for oral drug delivery, 9 J.
`CONTROL. RELEASE 169-75 (1989) (served, but not filed, August 11,
`2017)
`Ex. 2058 Front Matter for Ex. 2050, T.C. Dahl, et al., Influence of physico-
`chemical properties of hydroxypropyl methylcellulose on naproxen
`release from sustained release matrix tablets, 14 J. CONTROL.
`RELEASE 1-10 (1990) (served, but not filed, August 11, 2017)
`Ex. 2059 Front Matter for Ex. 2051, J.E. Hogan,
`Hydroxypropylmethylcellulose sustained release technology,
`15(6&7) DRUG. DEV. IND. PHARM. 975-99 (1989) (served, but not
`filed, August 11, 2017)
`Ex. 2060 Declaration of Scott Bennett, Ph.D. with Appendix A and
`Attachments (served, but not filed, August 11, 2017)
`Ex. 2061 Email exchange between Counsel and PTAB, Aug. 3, 2017
`Ex. 2062 Email exchange between Counsel, July-Aug. 2017
`
`
`
`- 5 -
`
`
`
`Date: August 18, 2017
`
`Respectfuliy submitted,
`
`IPR2017-00203
`
`
`
`
`
`
`
`Warez. (Reg. N . 50,8 )
`Jssica
`Andrea GE
`eister (Reg. No. 36,253)
`Scott E. Kamhoiz (Reg. No. 48,543)
`Michael N. Kennedy (pro hac vice)
`Megan P. Keane (pro hac vice)
`COVENGTON & BURLING LLP
`
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`MaryAnne Armstrong (Reg. No. 40,069)
`Lynde F. Herzbach (Reg. No. 74,886)
`BIRCH, STEWART, KOLASCH & BIRCH, LLP
`8110 Gatehouse Road, Suite 100 East
`Falis Church, VA 22042
`(703) 205—8000
`
`Attorneys for Patent Owner
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CPR. § 42.6, I hereby certify that on this 18th day of August
`
`2017, the foregoing Patent Owner’s Updated Exhibit List and Exhibits 2061-2062
`
`were served by electronic mail, by agreement of the parties, on the following counsel
`
`of record for Petitioner.
`
`Mitchell (3. Stockwell
`
`David C. Holloway
`Jonathan D. Olinger
`Miranda C. Rogers
`Mylan~WC—IPR@kilpatricktownsendxom
`KILPATRICK TOWNSEND & STOCKTON LLP
`
`Date: August 18, 2017
`
`Reg. No: 50,286
`
`
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