UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`ROSELLINI SCIENTIFIC, LLC,
`Petitioner
`
`v.
`
`GRÜNENTHAL GMBH,
`Patent Owner
`____________________________________________
`
`
`Case: IPR2016-00471
`U.S. Patent No. 7,994,364
`____________________________________________
`
`
`
`PATENT OWNER’S EXHIBIT LIST
`(as of April 27, 2016)
`
`
`
`
`
`
`
`
`
`
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`ROSELLINI SCIENTIFIC, LLC,
`Petitioner
`
`v.
`
`GRÜNENTHAL GMBH,
`Patent Owner
`____________________________________________
`
`
`Case: IPR2016-00471
`U.S. Patent No. 7,994,364
`____________________________________________
`
`
`
`PATENT OWNER’S EXHIBIT LIST
`(as of April 27, 2016)
`
`
`
`
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`
`
`Exhibits
`
`Description
`
`Exhibit 2001
`
`Marc Afilalo et al., Tapentadol immediate release: a new
`treatment option for acute pain management, 3 J. PAIN
`RESEARCH, 1-9 (2010)
`
`Exhibit 2002
`
`Craig T. Hartrick, Tapentadol immediate release for the relief
`of moderate-to-severe acute pain, 10 EXPERT OPIN.
`PHARMACOTHER. 2687-2696 (2009)
`
`Exhibit 2003 Excerpts of JOEL BERNSTEIN, POLYMORPHISM IN MOLECULAR
`CRYSTALS (2002)
`
`Exhibit 2004 Valeant Int’l (Barbados) SRL v. Watson Pharm., Inc., No. 10-
`20526-CIV, 2011 WL 6792653 (S.D. Fla. Nov. 8, 2011)
`
`Exhibit 2005 Valeant Int’l Bermuda v. Actavis, Inc., 534 F. App’x 999 (Fed.
`Cir. 2013)
`
`Exhibit 2006
`
`Expert Declaration in support of claim construction from Dr.
`Joel Bernstein executed on August 8, 2014, in In re Depomed
`Patent Litig., 2:13-cv-04507-CCC-MF, 2:13-cv-06929-CCC-
`MF, 2:13-cv-07803-CCC-MF, 2:14-cv-03941-CCC-MF, 2:14-
`cv-04617-CCC-MF, 2:15-cv-06797-CCC-MF (D.N.J.)
`
`Exhibit 2007
`
`D.-K. Bučar, R. W. Lancaster and J. Bernstein, Disappearing
`Polymorphs Revisited, 54 ANGEW. CHEM. INT’L. ED. ENG.
`6972-6993 (2015)
`
`Exhibit 2008
`
`J. D. Dunitz & J. Bernstein, Disappearing Polymorphs, 28 ACC.
`CHEM. RES. 193-200 (1995)
`
`
`
`2
`
`
`
`
`
`Exhibits
`
`Description
`
`Exhibit 2009
`
`J. Bernstein & J.-O. Henck, Disappearing and Reappearing
`Polymorphs‒An Anathema to Crystal Engineering?, 1 CRYST.
`ENG. 119-128 (1998)
`
`Exhibit 2010
`
`J.-O. Henck et al., Disappearing and Reappearing Polymorphs.
`The Benzocaine: Picric Acid System, 123 J. AM. CHEM. SOC.
`1834-1841 (2001)
`
`Exhibit 2011 Grünenthal’s Written Responses to Select 30(b)(6) Topics
`(Excerpted from Defendants’ Deposition Exhibit 150)
`
`Exhibit 2012 Manufacturing Record for IMEG77 (previously produced as
`GRT-NUC00056662-56663)
`
`Exhibit 2013
`
`Certified English translation of Manufacturing Record for
`IMEG77
`(including Translator Certification)
`(previously
`produced as GRT-NUC00056662T-56663T and marked as
`Defendants’ Deposition Exhibit Bernstein 108)
`
`Exhibit 2014 Korsch EK-0 Operating Manual (previously produced as GRT-
`NUC00206796-206827)
`
`Exhibit 2015
`
`XRPD pattern of IMEG77 compared to Tablet Standard Form
`A and Tablet Standard Form B (previously produced as GRT-
`NUC00056665)
`
`Exhibit 2016 Deposition Transcript of Marita Mueller, April 10, 2015, and
`errata.
`
`Exhibit 2017 Synthesis of GB-Bu322-1-1 and GB-Bu322-1-3 (previously
`
`
`
`3
`
`
`
`
`
`Exhibits
`
`Description
`produced as GRT-NUC00021278-21293 and marked as
`Defendants’ Deposition Exhibit 48)
`
`Exhibit 2018
`
`Certified English translation of Excerpts of Synthesis of GB-
`Bu322-1-1
`and GB-Bu322-1-3
`(including Translator
`Certification) (previously produced as GRT-NUC00021278_T-
`21291_T, 21293_T and marked as Defendants’ Deposition
`Exhibit 48T)
`
`Exhibit 2019
`
`Laboratory Notebook, Including Synthesis of GB-Bu322-1-1
`and GB-Bu322-1-3
`(previously
`produced
`as GRT-
`NUC00110737-110844 and marked as Defendants’ Deposition
`Exhibit 46)
`
`Exhibit 2020
`
`Certified English translation of Excerpts Laboratory Notebook,
`Including Synthesis of GB-Bu322-1-1 and GB-Bu322-1-3
`(including Translator Certification) (previously produced as
`GRT-NUC000110737-110844
`(excerpts) and marked as
`Defendants’ Deposition Exhibit 47)
`
`Exhibit 2021
`
`Proton NMR Spectrum of GB-Bu322-1-1 (previously produced
`as GRT-NUC000205078-205079 and marked as Deposition
`Exhibit Mueller 1)
`
`Exhibit 2022
`
`Proton NMR Spectrum of GB-Bu322-1-3 (previously produced
`as GRT-NUC00205082-205083 and marked as Deposition
`Exhibit Mueller 2)
`
`Exhibit 2023
`
`XRPD pattern of GB-BN200/Patent (GB-Bu322-1-1) compared
`to Form B (calculated) (5-65° 2-theta scale) (previously
`produced as GRT-NUC00056667 and included within
`Defendants’ Deposition Exhibit 32)
`
`
`
`4
`
`
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`
`
`Exhibits
`
`Description
`
`Exhibit 2024
`
`XRPD pattern of GB-Bu322-1-3 compared to Form A
`(calculated) (0-50° 2-theta scale) (previously produced as
`GRT-NUC00056668 and included, in black and white, within
`Defendants’ Deposition Exhibit 32)
`
`Exhibit 2025
`
`XRPD pattern of GB-BN200/Patent (GB-Bu322-1-1) compared
`to Form A (calculated) (2-40° 2-theta scale) (previously
`produced as GRT-NUC00056669 and included, in black and
`white, within Defendants’ Deposition Exhibit 32)
`
`Exhibit 2026
`
`XRPD pattern of GB-BN200/Patent (GB-Bu322-1-1) compared
`to Form B (calculated) (2-40° 2-theta scale) (previously
`produced as GRT-NUC00056670 and included, in black and
`white, within Defendants’ Deposition Exhibit 32)
`
`Exhibit 2027
`
`XRPD pattern of GB-Bu322-1-3 compared to GB-
`BN200/Patent (GB-Bu322-1-1) (2-40° 2-theta scale)
`(previously produced as GRT-NUC00056671 and included, in
`black and white, within Defendants’ Deposition Exhibit 32)
`
`Exhibit 2028
`
`XRPD pattern of GB-Bu322-1-3 compared to Form B
`(calculated) (2-40° 2-theta scale) (previously produced as GRT-
`NUC00056672 and included, in black and white, within
`Defendants’ Deposition Exhibit 32)
`
`Exhibit 2029
`
`Excerpts of KENNETH D. M. HARRIS et al., POWDER
`DIFFRACTION IN STRUCTURE FROM DIFFRACTION METHODS
`(Duncan W. Bruce et al. eds., 2014)
`
`Exhibit 2030 Synthesis of PG1026-001 (previously produced as GRT-
`NUC00056648-56658 and marked as Defendants’ Deposition
`
`
`
`5
`
`
`
`
`
`Exhibits
`
`Description
`Exhibit 51)
`
`Exhibit 2031
`
`Certified English translation of Synthesis of PG1026-001
`(including Translator Certification) (previously produced as
`GRT-NUC00056648_T-56658_T and marked as Defendants’
`Deposition Exhibit 51T)
`
`Exhibit 2032
`
`Laboratory Notebook, Including Synthesis of PG1026-001
`(previously produced as GRT-NUC00074243-74250 and
`marked as Defendants’ Deposition Exhibit 50)
`
`Exhibit 2033
`
`Certified English translation of Laboratory Notebook, Including
`Synthesis of PG1026-001 (including Translator Certification)
`(previously produced as GRT-NUC00074243_T-74250_T and
`marked as Defendants’ Deposition Exhibit 50T)
`
`Exhibit 2034
`
`XRPD pattern of PG1026-001-1-1 compared to Form B
`(reference) (5-50° 2-theta scale) (previously produced as GRT-
`NUC00056659)
`
`Exhibit 2035
`
`S. R. Chemburkar et al., Dealing with the Impact of Ritonavir
`Polymorphs on the Late Stages of Bulk Drug Process
`Development, 4 ORGANIC PROCESS RESEARCH & DEV. 413-17
`(2000)
`
`Exhibit 2036
`
`Sodium bicarbonate, SIGMA-ALDRICH (April 18, 2016, 4:30
`PM),
`http://www.sigmaaldrich.com/catalog/product/sial/s6014?lang=
`en®ion=US
`
`Exhibit 2037
`
`J. Rojas et al., Evaluation of several microcrystalline celluloses
`obtained from agricultural by-products, 2(3) J. ADV. PHARM.
`
`
`
`6
`
`
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`
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`Exhibits
`
`Description
`TECH. & RES. 144-50 (2011).
`
`Exhibit 2038 April 18, 2008 correspondence from Grünenthal GmbH to EPO
`
`Exhibit 2039
`
`M. Levin, Tablet Press Instrumentation, Encyclopedia of
`Pharmaceutical Technology, Marcel Dekker, Inc. New York
`(2002)
`
`Exhibit 2040 M. Tousey, Optimal Tablet Press Operation – Machine versus
`Granulation, Pharmaceutical Technology, (January 2002)
`
`Exhibit 2041
`
`Excerpts of HARRY G. BRITTAIN & EUGENE F. FIESE, EFFECTS
`OF PHARMACEUTICAL PROCESSING ON DRUG POLYMORPHS AND
`SOLVATES, IN POLYMORPHISM IN PHARMACEUTICAL SOLIDS
`(Harry G. Brittain ed. 1999)
`
`
`Respectfully submitted,
`
`
`
`
`
`By: /Anthony C. Tridico/
`Anthony C. Tridico, Reg. No. 45,958
`Kristi L. McIntyre, Reg. No. 74,377
`Amanda K. Murphy, Reg. No. 59,387
`Finnegan, Henderson, Farabow, Garrett
`& Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
`IPR2016-00471
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`Dated: April 27, 2016
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`
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`7
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that copies of the foregoing PATENT
`
`OWNER’S EXHIBIT LIST and Exhibits 2001-2041 were served on April 27,
`
`2016, via electronic mail directed to counsel of record for the Petitioner at the
`
`following:
`
`Sarah E. Spires
`
`
`
`Reg. No.: 61,501
`
`
`Skiermont Derby LLP
`
`2200 Ross Ave. Ste. 4800W
`
`Dallas, TX 75201
`
`364Rosellini@skiermontderby.com
`
`Dr. Parvathi Kota
`Reg. No.: 65,122
`
`
`Skiermont Derby LLP
`
`2200 Ross Ave. Ste. 4800W
`
`Dallas, TX 75201
`
`364Rosellini@skiermontderby.com
`
`Paul J. Skiermont
`(pro hac vice requested)
`
`
`Skiermont Derby LLP
`
`2200 Ross Ave. Ste. 4800W
`
`Dallas, TX 75201
`
`364Rosellini@skiermontderby.com
`
`Petitioner has agreed to electronic service.
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`Dated: April 27, 2016
`
`
`By: /Anthony C. Tridico/
` Anthony C. Tridico
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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