`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ACTAVIS, INC., ACTAVIS LABORATORIES FL, INC.,
`ACTAVIS PHARMA, INC., AMNEAL PHARMACEUTICALS, LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`AUROBINDO PHARMA LTD., AUROBINDO PHARMA USA, INC.,
`BRECKENRIDGE PHARMACEUTICAL, INC., VENNOOT
`PHARMACEUTICALS, LLC, SANDOZ INC., SUN PHARMA GLOBAL FZE,
`and SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`Petitioners
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner
`
`
`
`Case: IPR2014-01126
`Patent RE 38,551
`
`
`
`PETITIONERS’ EXHIBIT LIST
`(as of August 19, 2014)
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313–1450
`Submitted Electronically via the Patent Review Processing System
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioners Actavis, Inc., Actavis
`
`Laboratories FL, Inc. (f/k/a Watson Laboratories, Inc. – Florida), Actavis Pharma,
`
`Inc. (f/k/a Watson Pharma, Inc.), Amneal Pharmaceuticals, LLC, Amneal
`
`Pharmaceuticals of New York, LLC, Aurobindo Pharma Ltd., Aurobindo Pharma
`
`USA, Inc., Breckenridge Pharmaceutical, Inc., Vennoot Pharmaceuticals, LLC,
`
`Sandoz Inc., Sun Pharma Global FZE, and Sun Pharmaceutical Industries, Ltd.
`
`submit the following Exhibit List identifying the exhibit number and a brief
`
`description of each exhibit filed in connection with the above-captioned petition
`
`for inter partes review.
`
`EXHIBITS
`
`Description
`
`U.S. Patent No. RE 38,551 to Kohn (“’551 patent”)
`(reissue of U.S. Patent No. 5,773,475 (“’475 patent”))
`
`Declaration of Clayton H. Heathcock, Ph.D.
`
`U.S. Patent No. 5,654,301 to Kohn and Watson
`(“’301 patent”)
`
`Jan. 28, 1998 Notice of Allowability
`(excerpt from prosecution history of ’475 patent)
`
`Philippe LeGall, 2-Substituted-2-acetamido-N-
`benzylacetamides. Synthesis, Spectroscopic and
`Anticonvulsant Properties (Dec. 1987) (“LeGall thesis”)
`
`Apr. 10, 1998 Amendment Under 37 C.F.R. § 1.312
`(excerpt from prosecution history of ’475 patent)
`
`
`
`Exhibit
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`
`
`
`
`
`
`Exhibit
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`Description
`
`Dec. 23, 2008 Application for Extension of Patent Term
`Under 35 U.S.C. § 156
`(excerpt from prosecution history of ’301 patent)
`
`U.S. Patent No. 5,378,729 to Kohn and Watson
`(“’729 patent”)
`
`Sergio Cortes et al., Effect of Structural Modification of the
`Hydantoin Ring on Anticonvulsant Activity, 28 J. Med.
`Chem. 601 (1985) (“Cortes”)
`
`Harold Kohn et al., Preparation and Anticonvulsant Activity
`of a Series of Functionalized α-Heteroatom-Substituted
`Amino Acids, 34 J. Med. Chem. 2444 (1991) (“Kohn 1991”)
`
`U.S. Food and Drug Administration, Approved Drug
`Products With Therapeutic Equivalence Evaluations 3-202,
`ADA 101 (34th ed. 2014) (“Orange Book”)
`
`U.S. Provisional Patent Application No. 60/013,522
`(“’522 prov. app.”)
`
`Apr. 14, 2014 Plaintiffs’ Response to Defendants’ Joint Set
`of Interrogatories (UCB, Inc., et al. v. Accord Healthcare,
`Inc., et al., C.A. No. 13-1206-LPS (D. Del.))
`
`Phillipe LeGall et al., Synthesis of Functionalized Non-
`Natural Amino Acid Derivatives via Amidoalkylation
`Transformations, 32 Int’l J. Peptide Protein Res. 279 (1988)
`
`R. L. M. Synge, CCXXXIX. Experiments On Amino Acids.
`IV. The Methyl Ethers Of Some N-Acetyl-Hydroxyamino-
`Acids, 33 Biochem. J. 1931 (1939)
`
`M. Jaeger et al., Enzymatic Resolution of O-Methyl-N-
`acetyl-DL-serine. Amino Acids. XXXII., 28 Croat. Chem.
`Acta 5 (1956)
`
`2
`
`
`
`
`
`Exhibit
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`Description
`
`Judith D. Conley & Harold Kohn, Functionalized DL-
`Amino Acid Derivatives. Potent New Agents for the
`Treatment of Epilepsy, 30 J. Med. Chem. 567 (1987)
`
`Judith D. Conley, Functionalized Amino Acid Derivatives –
`Potent New Agents for the Treatment of Epilepsy: Synthesis,
`and Spectroscopic and Pharmacological Properties (May
`1986)
`
`Harold Kohn & Judith D. Conley, New Antiepileptic Agents,
`24 Chemistry in Britain 231 (March 1988)
`
`European Patent Application No. 0 194 464
`(“’464 application”)
`
`Harold Kohn et al., Marked Stereospecificity in a New Class
`of Anticonvulsants, 457 Brain Res. 371 (1988)
`
`Harold Kohn et al., Preparation and Anticonvulsant Activity
`of a Series of Functionalized α-Aromatic and α-
`Heteroaromatic Amino Acids, 33 J. Med. Chem. 919 (1990)
`
`European Patent Application No. 0 263 506
`(“’506 application”)
`
`European Patent Application No. 0 400 440
`(“’440 application”)
`
`Harold Kohn et al., Synthesis and Anticonvulsant Activities
`of α-Heterocyclic α-Acetamido-N-Benzylacetamide
`Derivatives, 36 J. Med. Chem. 3350 (1993)
`
`Harold Kohn et al., Anticonvulsant Properties of N-
`Substituted α,α-Diamino Acid Derivatives, 83 J.
`Pharmaceutical Sci. 689 (May 1994)
`
`C.W. Thornber, Isosterism and Molecular Modification in
`Drug Design, 8 Chemical Soc’y Revs. 563 (1979)
`
`3
`
`
`
`
`
`Exhibit
`
`Description
`
`(“Thornber 1979”)
`
`1028
`
`1029
`
`1030
`
`1031
`
`
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`Wilson & Gisvold’s Textbook of Organic Medicinal and
`Pharmaceutical Chemistry, Ch. 2 (Delgado & Remers eds.
`1991) (“W&G 1991”)
`
`Richard B. Silverman, The Organic Chemistry of Drug
`Design and Drug Action, Ch. 2 (1992) (“Silverman 1992”)
`
`Rosa Amoroso et al., A New Route to the Synthesis of Amino
`Acids Through the Mercury Cyclization of Chiral Amidals,
`57 J. Org. Chem. 1082 (1992)
`
`S. Cerrini et al., Serine-Containing 10-Membered
`Cyclodepsipeptides, 41 Int’l J. Peptide Protein Res. 282
`(1993)
`
`Svante Axelsson et al., Versatile Synthesis of
`Stereospecifically Labelled D-Amino Acids via Labelled
`Aziridines, J. Chem. Soc. Perkin Trans. 1 (1994)
`
`Oliver Keil et al., New Hydantoinases from Thermophilic
`Microorganisms – Synthesis of Enantiomerically Pure D-
`Amino Acids, 6 Tetrahedron: Asymmetry 1257 (1995)
`
`Patrick Bardel et al., Synthesis and Anticonvulsant Activities
`of α-Acetamido-N-Benzylacetamide Derivatives Containing
`an Electron-Deficient α-Heteroaromatic Substituent, 37 J.
`Med. Chem. 4567 (1994)
`
`FDA, Guideline for Industry: Dose-Response Information to
`Support Drug Registration (Nov. 1994)
`
`R. Schmidt, Dose-Finding Studies in Clinical Drug
`Development, 34 Eur. J. Clin. Pharmacol. 15-19 (1988)
`
`Declaration of James F. Hurst in Support of Motion for Pro
`Hac Vice Admission
`
`4
`
`
`
`Description
`
`Declaration of Charles B. Klein in Support of Motion for
`Pro Hac Vice Admission
`
`Declaration of Maureen L. Rurka in Support of Motion for
`Pro Hac Vice Admission
`
`
`
`Exhibit
`
`1038
`
`1039
`
`
`
`Respectfully submitted,
`
`
`
` /Samuel S. Park/
`Samuel S. Park
`Reg. No. 59,656
`Lead Counsel for Petitioners Actavis,
`Inc., Actavis Laboratories FL, Inc.,
`Actavis Pharma, Inc., Amneal
`Pharmaceuticals, LLC, Amneal
`Pharmaceuticals of New York, LLC,
`Aurobindo Pharma Ltd., Aurobindo
`Pharma USA, Inc., Breckenridge
`Pharmaceutical, Inc., Vennoot
`Pharmaceuticals, LLC, Sandoz Inc.,
`Sun Pharma Global FZE, and Sun
`Pharmaceutical Industries, Ltd.
`
`Dated: August 19, 2014
`
`
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`Email: spark@winston.com
`
`
`5
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), I certify that, on August 19,
`
`2014, I caused to be served true and correct copies of the foregoing
`
`“PETITIONERS’ EXHIBIT LIST (as of August 19, 2014)” by electronic mail on
`
`the following attorneys:
`
`
`
`Andrea G. Reister (Reg. No. 36,253)
`COVINGTON & BURLING LLP
`1201 Pennsylvania Ave., NW
`Washington, DC 20004
`areister@cov.com
`
`Lead Counsel for Patent Owner
`
`Enrique D. Longton (Reg. No. 47,304)
`Gregory S. Discher (Reg No. 42,488)
`COVINGTON & BURLING LLP
`1201 Pennsylvania Ave., NW
`Washington, DC 20004
`rlongton@cov.com
`gidscher@cov.com
`
`Backup Counsel for Patent Owner
`
`Respectfully submitted,
`
` /Samuel S. Park/
`Samuel S. Park
`Reg. No. 59,656
`
`Lead Counsel for Petitioners
`
`
`
`
`
`Dated: August 19, 2014
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`Email: spark@winston.com