UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG, TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A. INC., and SUN PHARMACEUTICAL
`INDUSTRIES, LTD., SUN PHARMA GLOBAL FZE
`and AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`_____________________________
`
`Case IPR2015-01340
`Patent RE44,186 E1
`_____________________________
`
`
`
`PETITIONERS’ EXHIBIT LIST AND
`NOTICE SUBMITTING EXHIBITS 1060B & 1062B
`37 CFR §§42.6(c) & 42.63(e)
`
`
`
`1 Wockhardt from IPR2016-01029, Teva from IPR2016-01122, Aurobindo from
`
`IPR2016-01117, and Sun/Amneal from IPR2016-01104 has each been joined as a
`
`Petitioner to this proceeding.
`
`
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG, TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A. INC., and SUN PHARMACEUTICAL
`INDUSTRIES, LTD., SUN PHARMA GLOBAL FZE
`and AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`_____________________________
`
`Case IPR2015-01340
`Patent RE44,186 E1
`_____________________________
`
`
`
`PETITIONERS’ EXHIBIT LIST AND
`NOTICE SUBMITTING EXHIBITS 1060B & 1062B
`37 CFR §§42.6(c) & 42.63(e)
`
`
`
`1 Wockhardt from IPR2016-01029, Teva from IPR2016-01122, Aurobindo from
`
`IPR2016-01117, and Sun/Amneal from IPR2016-01104 has each been joined as a
`
`Petitioner to this proceeding.
`
`
`
`On 10 January 2017, AstraZeneca electronically requested authorization for
`
`the parties to submit less-redacted versions of specified exhibits, including exhibits
`
`1060A and 1062A. On the same day, the Board granted the request, specifying that
`
`these exhibits be submitted as exhibits 1060B and 1062B, respectively.
`
`
`
`Mylan (on behalf of Petitioners) submits less-redacted exhibits 1060B and
`
`1062B, along with the following updated exhibit list.
`
`Description
`
`Exhibit
`No.
`1001
`1002
`1003
`1004
`1005
`1006
`
`1007
`
`U.S. Reissue Patent 44,186 E to Robl et al. (reissued Apr. 30, 2013)
`U.S. Patent No. 6,395,767 to Robl et al. (issued May 28, 2002)
`Declaration of David P. Rotella, Ph.D.
`Curriculum Vitae of David P. Rotella, Ph.D.
`File History of U.S. Patent No. 6,395,767 to Robl et al.
`File History of U.S. Reissued Patent 44,186 E to Robl et al.
`
`Doreen M. Ashworth et al., 2-cyanopyrrolidides as potent, stable
`inhibitors of dipeptidyl peptidase IV, 6 BIOORG. & MED. CHEM.
`LTRS. 1163 (1996)
`1008 WO Patent App. Pub. No. 98/19998 to Villhauer (pub’d May
`14,1998)
`Reetta Raag & Thomas L. Poulos, Crystal Structure of Cytochrome
`P-450CAM Complexed with Camphane, Thiocamphor, and
`Adamantane: Factors Controlling P-450 Substrate
`Hydroxylation, 30 BIOCHEMISTRY 2674 (1991)
`Stephen Hanessian et al., The Synthesis of Enantiopure ω-
`Methanoprolines and ω-Methanopipecolic Acids by a Novel
`Cyclopropanation Reaction: The “Flattening” of Proline,
`36 ANGEW. CHEM. ED. ENGL. 1881 (1997)
`1011 WO Patent App. Pub. No. 99/38501 to Bachovchin et al. (pub’d
`Aug. 5, 1999)
`1012
`GLUCOPHAGE Label (available by FOIA Jan. 8, 1998)
`1013
`XENICAL Label (available by FOIA Aug. 9, 1999)
`1014 MEVACOR Label (available by FOIA Sept. 15, 1994)
`
`1009
`
`1010
`
`-1-
`
`
`
`Exhibit
`No.
`
`Description
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`Jian Lin et al., Inhibition of dipeptidyl peptidase IV by fluoroolefin-
`containing N-peptidyl-O-hydroxylamine peptidomimetics, 95
`PROC. NATL. ACAD. SCI. USA 14020 (1998)
`Howared E. Hoffman et al., Pharmacokinetics and Metabolism of
`Rimantadine Hydrochloride in Mice and Dogs, 32(11)
`ANTIMICROBIAL AGENTS AND CHEMOTHERAPY 1699 (1988)
`Christopher A. Lipinski et al., Experimental and computational
`approaches to estimate solubility and permeability in drug
`discovery and development settings, 23 ADV. DRUG DELIV. REV.
`3 (1996)
`Hansch et al., Cluster Analysis and the Design of Congener Sets, in
`SUBSTITUENT CONSTANTS FOR CORRELATION ANALYSIS IN
`CHEMISTRY AND BIOLOGY 48 (John Wiley & Sons1979)
`Lindley A. Cates, Calculation of Drug Solubilities by Pharmacy
`Students, 45 AM. J. PHARM. EDUC. 11 (1981)
`Walter A. Korfmacher et al., HPLC-API/MS/MS: a powerful tool
`for integrating drug metabolism into the drug discovery process,
`2 DRUG DISC. TODAY 532 (1997)
`C. Y. Chiou et al., The Cholinergic Effects and Rates of Hydrolysis
`of Conformationally Rigid Analogs of Acetylcholine, 166 J.
`PHARM. EXP. THER. 243 (1969)
`Daniel E. Koshland, Jr., The Key-Lock Theory and the Induced Fit
`Theory, 33 ANGEW. CHEM. ED. ENGL. 2375 (1994)
`E.J. Ariëns & A. M. Simonis, Optimization of Pharmacokinetics –
`An Essential Aspect of Drug Development – by Metabolic
`Stabilization, Pharmacochem. Lib., in 4 PHARMACOCHEM. LIB.
`165 (1982)
`R. Scott Obach, Prediction of Human Clearance of Twenty-nine
`Drugs from Hepatic Microsomal Intrinsic Clearance Data: An
`Examination of In Vitro Half-life Approach and Nonspecific
`Binding to Microsomes, 27 DRUG METAB. DISPOS. 1350 (1999)
`Yung-chi Cheng & William H. Prusoff, Relationship Between the
`Inhibition Constant (KI) and the Concentration of Inhibitor which
`Causes 50 Per Cent Inhibition (I50) of an Enzymatic Reaction, 22
`BIOCHEM. PHARMACOL. 3099 (1973)
`
`-2-
`
`
`
`Exhibit
`No.
`
`Description
`
`1026
`
`1027
`
`1028
`
`Debnath Pal & Pinak Chakrabarti, Cis Peptide Bonds in Proteins:
`Residues Involved, their Conformations, Interactions and
`Location, 294 J. OF MOL. BIOL. 271 (1999)
`US Provisional Patent Application No. 60/1888,555 to Robl
`Cross-Examination of Dr. James Lenhard, Excerpts from Transcript
`of Day 2 of Bench Trial in 14-664-GMS, 14-666-GMS, and 14-
`667-GMS (September 20, 2016)
`Cross-Examination of Dr. Christine Meyer, Excerpts from
`Transcript of Day 3 of Bench Trial in 14-664-GMS, 14-666-
`GMS, and 14-667-GMS (September 20, 2016)
`What is JANUVIA® (sitagliptin) tablets?, obtained from
`http://www.januvia.com/sitagliptin/what-is-januvia/ (September
`20, 2016)
`1031 Why Tradjenta® (linagliptin) Tablets?, obtained from
`https://www.tadjenta.com/about (September 20, 2016)
`(JTX-146) FDA Drug Safety Communication: FDA adds warnings
`about heart failure risk to labels of type 2 diabetes medicines
`containing saxagliptin and alogliptin (2016).
`
`1029
`
`1030
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`
`(JTX-196) ONGLYZA Label (2016).
`Demonstrative Exhibits Referenced During Cross-Examination of
`Christine S. Meyer, Ph.D. in 14-664-GMS, 14-666-GMS, and 14-
`667-GMS (2016)
`(PTX-2344) Reply Expert Report of Ivan T. Hofmann, CPA/CFF,
`CLP in 14-cv-00664-GMS (Consolidated) (PROTECTIVE
`ORDER MATERIAL).
`ADVAIR Label (2008)
`CYMBALTA Label (2010)
`Mushtaq et al., A Study of the Current Prescribing Patterns of
`Dipeptidyl Peptidase 4 Inhibitors in a Multi Speciality Hospital
`Outpatient Setting, 7 ASIAN J. PHARM. CLIN. RES. 134 (2014)
`Long-term Trends in Diabetes, CDC’s Division of Diabetes
`Translation (April 2016)
`Kabadi, Sulfonylurea Glimepiride: A Proven Cost Effective, Safe
`and Reliable War Horse in Combating Hyperglycemia in Type 2
`Diabetes, 5 JOURNAL OF DIABETES MELLITUS 211 (2015)
`Declaration of Robert J. Tanenberg, M.D., FACP
`
`-3-
`
`
`
`Description
`
`Exhibit
`No.
`1042
`Curriculum Vitae of Robert J. Tanenberg, M.D., FACP
`1043 World Health Organization List of Essential Medicines for the
`Treatment of Diabetes, 19th Edition
`1044
`2008 Novartis Annual Report
`1045
`2009 Novartis Annual Report
`1046
`2010 Novartis Annual Report
`1047
`2011 Novartis Annual Report
`1048
`2012 Novartis Annual Report
`1049
`2013 Novartis Annual Report
`1050
`2014 Novartis Annual Report
`1051
`2015 Novartis Annual Report
`1052
`2008 Merck Annual Report
`1053
`2009 Merck Annual Report
`1054
`2010 Merck Annual Report
`1055
`2011 Merck Annual Report
`1056
`2012 Merck Annual Report
`1057
`2013 Merck Annual Report
`1058
`2014 Merck Annual Report
`1059
`2015 Merck Annual Report
`1060
`Redacted Declaration of DeForest McDuff, Ph.D.
`Declaration of DeForest McDuff, Ph.D. (PROTECTIVE ORDER
`MATERIAL).
`Declaration of DeForest McDuff, Ph.D. (PROTECTIVE ORDER
`1060B
`MATERIAL).
`1061 McDuff Attachment A (McDuff CV)
`1062
`Redacted McDuff Attachments B-1a through B-10b
`McDuff Attachments B-1a through B-10b (PROTECTIVE ORDER
`MATERIAL).
`McDuff Attachments B-1a through B-10b (PROTECTIVE ORDER
`MATERIAL).
`Mestre-Ferrandiz, Jorge, Jon Sussex, and Adrian Towse , The R&D
`Cost of a New Medicine, OFFICE OF HEALTH ECONOMICS, London
`UK, 1–86 (2012)
`DiMasi, Joseph, Henry Grabowski, and Ronald Hansen , Innovation
`in the pharmaceutical industry: New estimates of R&D costs,
`JOURNAL OF HEALTH ECONOMICS 47: 20–33 (2016)
`
`1060A
`
`1062A
`
`1062B
`
`1063
`
`1064
`
`-4-
`
`
`
`Exhibit
`No.
`
`Description
`
`David, Jesse and Marion B. Stewart, Commercial Success:
`Economic Principles Applied to Patent Litigation, in Gregory K.
`Leonard and Lauren J. Stiroh, ed., ECONOMIC APPROACHES TO
`INTELLECTUAL PROPERTY POLICY, LITIGATION, AND
`MANAGEMENT, White Plains, NY: National Economic Research
`Associates, Inc., at 196 (2005)
`Scala, Steve, et al., Cowen & Co Pharmaceutical Industry Pulse
`(January 2010) (PROTECTIVE ORDER MATERIAL).
`Scala, Steve, et al., Cowen & Co Pharmaceutical Industry Pulse
`(June 2010) (PROTECTIVE ORDER MATERIAL).
`Credit Suisse, AstraZeneca: FDA Panel Supports Saxagliptin CV
`Safety (April 2, 2009) (PROTECTIVE ORDER MATERIAL).
`J.P. Morgan, Merck & Co., Inc.: Playing the Januvia and Gardasil
`Product Cycle (June 24, 2008) (PROTECTIVE ORDER
`MATERIAL).
`Piper Jaffray, Forest Laboratories, Inc. – Victim of its Own Success
`(December 15, 2008) (PROTECTIVE ORDER MATERIAL).
`Barclays Capital, Bristol Myers Squibb Co. – Low Tax Rate Drives
`EPS Beat (January 28, 2010) (PROTECTIVE ORDER
`MATERIAL).
`T.A. Kelly, et al. Immunosuppressive Boronic Acid Dipeptides:
`Correlation between Conformation and Activity, 115 J. AM.
`CHEM. SOC. 12637 (1993)
`Transcript of Deposition of Ann E. Weber, Ph.D. (October 27,
`2016)
`Second Declaration of David P. Rotella, Ph.D.
`[Supplemental evidence, not filed]
`[Supplemental evidence, not filed]
`[Supplemental evidence, not filed]
`[Supplemental evidence, not filed]
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`1074
`1075
`1076
`1077
`1078
`
`
`
`
`
`
`Date: 13 January 2017
`
`
`
`
`
`Respectfully,
`
`
`
`/ Richard Torczon /
`Richard Torczon, Reg. No. 34,448
`Backup counsel for Mylan
`
`-5-
`
`
`
`CERTIFICATE OF SERVICE
`37 CFR §42.6(e)(i)
`
`
`I certify that, on 13 January 2017, this PETITIONERS’ NOTICE
`
`SUBMITTING EXHIBITS 1060B & 1062B was served on AstraZeneca at the
`
`following electronic service addresses:
`
`
`
`Charles E. Lipsey
`
`charles.lipsey@finnegan.com
`
`Eric E. Grondahl
`
`egrondahl@mccarter.com
`
`John D. Livingstone
`
`john.livingstone@finnegan.com
`
`Anthony A. Hartmann
`
`anthony.hartmann@finnegan.com
`
`M. David Weingarten
`
`david.weingarten@finnegan.com
`
`
`
`on Wockhardt at the following electronic service addresses:
`
`Frederick R. Ball
`
`FRBall@duanemorris.com
`
`Patrick C. Gallagher
`
`PCGallagher@duanemorris.com
`
`
`
`on Teva at the following electronic service addresses:
`
`Iain A. McIntyre
`
`IMcIntyre@carlsoncaspers.com
`
`Gary J. Speier
`
`GSpeier@carlsoncaspers.com
`
`
`
`-i-
`
`
`
`on Aurobindo at the following electronic service addresses:
`
`Sailesh K. Patel
`
`SPatel@schiffhardin.com
`
`Joel Wallace
`
`JWallace@schiffhardin.com
`
`George Yu
`
`GYu@schiffhardin.com
`
`
`
`and on Sun/Amneal at the following electronic service addresses:
`
`Samuel Park
`
`spark@winston.com
`
`Andrew Sommer
`
`asommer@winston.com
`
`
`
`Dated: 13 January 2017
`
`
`
`
`/ Richard Torczon /
` Richard Torczon, Reg. No. 34,448
`
`-ii-
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