UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner
`
`___________________________
`
`Case No.: IPR2016-01104
`Patent No.: RE44,186
`
`___________________________
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`(as of June 3, 2016)
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Submitted Electronically via the Patent Review Processing System
`
`NY:1814157.1
`
`
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner
`
`___________________________
`
`Case No.: IPR2016-01104
`Patent No.: RE44,186
`
`___________________________
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`(as of June 3, 2016)
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Submitted Electronically via the Patent Review Processing System
`
`NY:1814157.1
`
`
`
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`Description
`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)
`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)
`WO Patent App. Pub. No. 99/38501 to Bachovchin et al. (pub’d
`Aug. 5, 1999)
`GLUCOPHAGE Label (available by FOIA Jan. 8, 1998)
`XENICAL Label (available by FOIA Aug. 9, 1999)
`MEVACOR Label (available by FOIA Sept. 15, 1994)
`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)
`Howard 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
`
`
`
`
`
`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`
`
`1008
`
`1009
`
`1010
`
`1011
`1012
`1013
`1014
`
`1015
`
`1016
`
`1017
`
`NY:1814157.1
`
`
`
`Description
`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 & Sons 1979)
`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, Optimalization 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)
`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. 60/188,555 to Robl
`Revised Certificate of Service
`Revised Certification Of Service
`
`
`
`
`
`
`
`
`Exhibit No.
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`
`1025
`
`1026
`
`1027
`1028
`1029
`
`NY:1814157.1
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§42.6(e) and 42.105(a), this is to certify that on June
`3, 2016, I caused to be served a true and correct copy of the foregoing “REVISED
`CERTIFICATE OF SERVICE, REVISED CERTIFICATION OF SERVICE
`PETITIONER’S UPDATED EXHIBIT LIST AS OF JUNE 3, 2016, Exhibits
`1028-1029”, by Express mail, on this 3rd day of June, 2016, on the following:
`
`
`Patent Owner’s
`correspondence
`address of record for U.S.
`Patent No. RE44,186 E
`Lead Counsel for Patent
`Owner:
`
`Back-Up Counsel for
`Patent Owner:
`
`Back-Up Counsel for
`Patent Owner:
`
`Back-Up Counsel for
`Patent Owner:
`
`NY:1814157.1
`
`Baker & Hostetler LLP
`Cira Centre 12th Floor
`2929 Arch Street
`Philadelphia, PA 19104-2891
`Charles E. Lipsey
`Reg. No. 28,165
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`11955 Freedom Drive
`Reston, VA 20190
`Email: charles.lipsey@finnegan.com
`Eric E. Grondahl
`Reg. No. 46,741
`McCarter & English LLP
`CityPlace I
`185 Asylum St.
`Hartford, CT 06103
`Email: egrondahl@mccarter.com
`John D. Livingstone
`Reg. No. 59,613
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`3500 SunTrust Plaza
`303 Peachtree Street, N.E.
`Atlanta, GA 30308
`Email:
`john.livingstone@finnegan.com
`Anthony A. Hartmann
`Reg. No. 43,662
`
`
`
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Email:
`anthony.hartmann@finnegan.com
`M. David Weingarten
`Reg. No. 54,533
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`3500 SunTrust Plaza
`303 Peachtree Street, N.E.
`Atlanta, GA 30308
`Email:
`david.weingarten@finnegan.com
`
`/s/ Samuel S. Park
`Samuel S. Park
`Registration No. 59,656
`
`Lead Counsel for Petitioners
`
`
`
`
`
`
`Back-Up Counsel for
`Patent Owner:
`
`
`
`Date: June 3, 2016
`
`35 West Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`Email: spark@winston.com
`
`
`
`
`
`NY:1814157.1
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