UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC. ,
`Patent Owners.
`
`
`U.S. Patent No. 9,326,945 to Patel et al.
`
`Inter Partes Review IPR2018-00892
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S
`UPDATED LIST OF EXHIBITS
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC. ,
`Patent Owners.
`
`
`U.S. Patent No. 9,326,945 to Patel et al.
`
`Inter Partes Review IPR2018-00892
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S
`UPDATED LIST OF EXHIBITS
`
`
`
`
`
`
`
`
`
`
`Exhibit
`No.
`1001
`1002
`1003
`1004
`
`1005
`
`1006
`1007
`1008
`1009
`
`1010
`
`1011
`
`1012
`
`
`
`
`
`
`LIST OF EXHIBITS
`
`Description
`
`U.S. Patent No. 9,326,945
`Declaration of Dr. Park
`Prosecution History of U.S. Patent No. 9,326,945
`Carreiro et al., “Apixaban, an oral direct Factor Xa inhibitor:
`awaiting the verdict,” Expert Opin. Investig. Drugs, 17(12):1937-
`1945 (2008)
`Pinto et al., “Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-
`oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahdyro-1H-pyrazolo[3,4-
`c]pyridine-3-carboxamide (Apixaban, BMS-562247), a highly
`potent, selective, efficacious, and orally bioavailable inhibitor of
`blood coagulation Factor Xa,” J. Med. Chem., 50:5339-5356 (2007)
`International Patent Publication WO 2010/147978 to Nause
`U.S. Patent No. 6,967,208 to Pinto et al.
`U.S. Patent Publication No. 2006/0160841 to Wei et al.
`Ashford, “Bioavailability: physicochemical and dosage form
`factors,” in Aulton’s Pharmaceutics: The Design and Manufacture
`of Medicines, 3rd ed., M. E. Aulton, ed., Churchill Livingstone
`Elsevier, pp. 286-291, 443-449 (2007)
`Rudnic et al., “Tablet Dosage Forms,” in Modern Pharmaceutics,
`4th ed., G.S. Banker and C.T. Rhodes, eds., Taylor & Francis
`Group, Boca Raton, FL, pp. 333-359 (2002)
`Stegemann, “When poor solubility becomes an issue: from early
`stage to proof of concept,” Eur. J. Sci., 31(5):249-261 (2007)
`International Patent Publication WO 2010/003811 to Hafner et al.
`
`2
`
`
`
`
`
`
`
`
`Exhibit
`No.
`1013
`
`1014
`1015
`
`1016
`
`1017
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`Description
`
`Augsburger et al., “Tablet Formulation,” in Encyclopedia of
`Pharmaceutical Technology, 2nd ed., Swarbrick et al., eds., pp.
`2701-2712 (2002)
`U.S. Patent No. 5,314,506
`Guidance for Industry: Dissolution Testing of Immediate Release
`Solid Oral Dosage Forms, U.S. Department of Health and Human
`Services, Food and Drug Administration, Center for Drug
`Evaluation and Research (CDER) (Aug. 1997)
`United States Pharmacopeia, 27th ed., General Notices and
`Requirements, United States Pharmacopeial Convention, Inc.,
`Rockville, MD, pp. 11-12 (2004)
`U.S. Provisional Application No. 61/308,056
`The Surgeon General’s Call to Action to Prevent Deep Vein
`Thrombosis and Pulmonary Embolism, U.S. Department of Health
`and Human Services (2008)
`Beckman, M.G., “Venous thromboembolism: a public health
`concern,” Am. J. Prev. Med., 38(4s):S495-S501 (2010)
`Cohen, “Venous thromboembolism (VTE) in Europe. The number
`of VTE events and associated morbidity and mortality,” Thromb.
`Haemost., 98(4):756-764 (2007)
`Remko, “Molecular structure, lipophilicity, solubility, absorption,
`and polar surface area of novel anticoagulant agents”, J. Mol.
`Structure, 916:76-85 (2009)
`Ungell et al., “Biopharmaceutical Support in Candidate Drug
`Selection,” in Pharmaceutical Preformulation and Formulation, M.
`Gibson, ed., 2nd Informa Healthcare, pp. 97-153 (2004)
`
`3
`
`
`
`
`
`
`
`
`Description
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`Exhibit
`No.
`1023 W-Q Tong., “Practical aspects of solubility determination in
`pharmaceutical preformulation, in Solvent Systems and Their
`Selection,” in Pharmaceutics and Biopharmaceutics, P. Augustijns
`and M. Brewster (eds.), Springer, New York, pp. 137-149 (2007)
`Yu et al., “Biopharmaceutics classification system: the scientific
`basisf for biowaiver extensions,” Pharm Res., 19(7): 921-925,
`(2002)
`Brown, C.K., “Dissolution method development: an industry
`perspective,” in Pharmaceutical Dissolution Testing, J. Dressman
`and J. Krämer (eds.), Taylor & Francis, New York, pp. 351-372
`(2005)
`Gong et al., “Principles of solubility,” in Solvent Systems and Their
`Selection in Pharmaceutics and Biopharmaceutics,” P. Augustijns
`and M. Brewster (eds.), Springer, New York, pp. 1-27 (2007)
`United States Pharmacopeia XX, 20th Revision, Description and
`solubility, United States Pharmacopeil Convention, Inc., Rockville,
`MD, p. 1121 (1980)
`Diebold, S.M., “Physiological parameters relevant to dissolution
`testing: hydrodynamic considerations,” in Pharmaceutical
`Dissolution Testing, J. Dressman and J. Kramer (eds.), Taylor &
`Francis, New York, pp. 127-191 (2005)
`Dahan et al., “Prediction of solubility and permeability class
`membership: Provisional BCS classification of the world’s top oral
`drugs,” AAPS J., 11(4):740-746 (2009)
`Shah, V.P., “The role of dissolution testing in the regulation of
`pharmaceuticals. The FDA perspective.” in Pharmaceutical
`Dissolution Testing, J. Dressman and J. Krämer (eds.), Taylor &
`Francis, New York, pp. 81-96 (2005)
`
`1029
`
`1030
`
`4
`
`
`
`Exhibit
`No.
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`1038
`1039
`
`1040
`
`1041
`1042
`1043
`1044
`
`
`
`
`
`
`Description
`
`Dressman, “The BCS: Where do we go from here?,” Pharma.
`Tech., 68-76 (2001)
`Krämer, J. et al., “Dissolution method development with a view to
`quality control,” in Pharmaceutical Dissolution Testing, J.
`Dressman and J. Krämer (eds.), Taylor & Francis, New York, pp.
`1-37 (2005)
`Handbook of Pharmaceutical Excipients, 6th ed., R. Rowe, P.
`Shesky, and M.E. Quinn (eds.), Pharmaceutical Press, Grayslake,
`IL, pp. 1-888 at p. 651 (2009)
`Hom et al., “Oral dosage form design and its influence in
`dissolution rates for a series of drugs,” J. Pharm. Sci., 59(6): 827-
`830 (1970)
`Remington’s Pharmaceutical Sciences, 18th ed., A.R. Gennaro (ed.),
`Mack Publishing Co., Easton, PA, pp. 1615-1632 (1990)
`Transcript of August 30, 2018 Telephonic Hearing in
`IPR2018-00892
`Declaration of James L. Mullins, Ph.D. and Attachments
`Supplemental Declaration of Kinam Park, Ph.D.
`Carreiro publication from Taylor and Francis Online website,
`available at
`https://www.tandfonline.com/doi/full/10.1517/13543780802528625
`Carreiro publication from Expert Opinion on Investigational Drugs
`obtained from National Library of Medicine
`Federal Register, Vol. 62, No. 164 (Aug.25, 1997) at 44974-44975
`Rudnic publication from Modern Pharmaceutics, Third Edition
`Rudnic publication from Modern Pharmaceutics, Fourth Edition
`Second Supplemental Declaration of Kinam Park, Ph.D.
`
`5
`
`
`
`
`
`
`
`
`
`
`
`Exhibit
`No.
`1045
`1046
`
`Description
`
`Declaration of Karen L. Carroll
`Transcript of November 16, 2018 Telephonic Hearing in
`IPR2018-00892
`
`6
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Updated List of Exhibits and
`
`Exhibit 1046 by email on this 29th day of November, 2018 on the following
`
`attorneys of record:
`
`Heather M. Petruzzi
`Michael E. Nelson
`Amy K. Wigmore
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Ave, NW
`Washington, DC 20006
`E-mail: Heather.Petruzzi@wilmerhale.com
`E-mail: Michael.Nelson@wilmerhale.com
`E-mail: Amy.Wigmore@wilmerhale.com
`
`Timothy A. Cook
`Kevin M. Yurkerwich
`Kevin S. Prussia
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`E-mail: Tim.Cook@wilmerhale.com
`E-mail: Kevin.Yurkerwich@wilmerhale.com
`E-mail: Kevin.Prussia@wilmerhale.com
`
`Jason M. Okun
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`E-mail: JOkun@fchs.com
`
`
`Respectfully submitted,
`
`
`
`/ Robert L. Florence /
`Robert L. Florence, Lead Counsel
`Registration No. 54,933
`
`
`Dated: November 29, 2018
`
`
`
`
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