IPR2017-00200
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`MYLAN TECHNOLOGIES, INC.,
`Petitioner
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner
`_______________
`
`Case: IPR2017-00200
`
`Patent 8,603,514
`_______________
`
`PATENT OWNER MONOSOL RX, LLC’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`MYLAN TECHNOLOGIES, INC.,
`Petitioner
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner
`_______________
`
`Case: IPR2017-00200
`
`Patent 8,603,514
`_______________
`
`PATENT OWNER MONOSOL RX, LLC’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`IPR2017-00200
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`DESCRIPTION
`
`Trial Transcript, Reckitt Benckiser Pharms
`Inc. v. Watson Laboratories, Inc. et al., CA
`No. 14-1574-RGA (Nov. 3-4, 2015) (“Trial
`Tr.”)
`Reckitt Benckiser Pharmaceuticals Inc. v.
`Watson Laboratories, Inc. et al., Civil Case
`No. 1:13-1674, slip opinion (D. Del. June 3,
`2016) (Richard G. Andrews, J.) (Reckitt v.
`Watson)
`J. O. Morales and J. T. McConville,
`Manufacture and Characterization of
`Mucoadhesive Buccal Films, European
`Journal of Pharmaceutics and v
`Biopharmaceutics 77, pp. 187-99 (2011)
`A. F. Borges et al., Oral Films: Current Status
`and Future Perspectives II – Intellectual
`Property, Technologies and Market Needs,
`Journal of Controlled Release 206, pp. 108–21
`V.A. Perumal et al., Investigating a New
`Approach to Film Casting for Enhanced Drug
`Content Uniformity in Polymeric Films, Drug
`Dev. & Indust. Pharm. 34, pp. 1036-47 (2008)
`H. Kathpalia and A. Gupte, An Introduction to
`Fast Dissolving Oral Thin Film Drug Delivery
`Systems: A Review, Drug Delivery &
`Formulation 10, pp. 667-84 (2013)
`Declaration of Dr. Robert Langer
`Deposition Transcript of Dr. Graham Buckton
`V. A. Perumal, “Multipolymeric Monolayered Mucoadhesive
`Films for Drug Therapy,” Master’s Thesis (2007)
`Morales et al., “The Influence of Recrystallized Caffeine on
`Water-Swellable Polymethacrylate Mucoadhesive Bucca
`Films,” AAPS PharmSciTech, Vol. 14, No. 2, 475–484
`(2013)
`U.S. Provisional App. Ser. No. 60/443,741
`
`EXHIBIT
`
`*2001
`
`*2002
`
`*2003
`
`*2004
`
`*2005
`
`*2006
`
`*2007
`*2008
`*2009
`
`*2010
`
`*2011
`
`
`
`*2012
`*2013
`*2014
`
`*2015
`
`*2016
`
`*2017
`
`*2018
`
`*2019
`
`*2020
`
`*2021
`
`*2022
`
`*2023
`
`*2024
`
`*2025
`*2026
`
`IPR2017-00200
`
`Curriculum Vitae of Dr. Robert Langer
`C.A. No. 1:14-cv-01451-RGA, Trial Tr.
`Lachman, L. et al., The Theory and Practice of Industrial
`Pharmacy (3d ed. 1986)
`S. Puttipipatkhachorn et al., “Drug physical state and
`drugpolymer interaction on drug release from chitosan
`matrix films” (2001)
`J. Siepmann and N. Peppas entitled “Modeling of drug
`release from delivery systems based on hydroxypropyl
`methylcellulose” (2001)
`Compos-Aldrete et al., “Influence of the viscosity grade and
`the particle size of HPMC on metronidazole release from
`matrix tablets”, European Journal of Pharmaceutics and
`Biopharmaceutics, 43:173–178 (1997)
`James E. De Muth, Basic Statistics and Pharmaceutical
`Statistical Applications (2d ed. 2006)
`Staniforth, J.N., “Particle size analysis,” Pharmaceutics –
`The Science of Dosage Form Design (Aulton ed.), Ch. 33 at
`p. 578 (1988)
`P. Perugini et al., “Periodontal delivery of ipriflavone: new
`chitosan/PLGA film delivery system for a lipophilic drug,”
`Int’l J. of Pharmaceutics, 252:1–9 (2003)
`J. Yoo et al., “The physicodynamic properties of
`mucoadhesive polymeric films developed as female
`controlled drug delivery system,” Int’l J. of Pharmaceutics,
`309:139–145 (2006)
`A. Dhanikula et al., “Development and Characterization of
`Biodegradable Chitosan Films for Local Delivery of
`Paclitaxel,” The AAPS Journal, 6(3):1–12 (2004)
`A. Ahmed et al., “Penciclovir solubility in Eudragit films: a
`comparison of X-ray, thermal, microscopic and release rate
`techniques,” J. Pharm. & Biomedical Analysis, 34:945–956
`(2004)
`C. Amnuaikit et al., “Skin permeation of propranolol from
`polymeric film containing terpene enhancers for transdermal
`use,” Int’l J. of Pharmaceutics, 289:167–178 (2005)
`U.S. Patent No. 7,425,292 to Yang et al.
`Sigma-Aldrich Product Information Sheet re Caffeine
`(Anhydrous)
`
`
`
`*2027
`
`*2028
`*2029
`
`*2030
`
`*2031
`2032
`
`IPR2017-00200
`
`Shakeel et al., “Thermodynamics-based mathematical model
`for solubility prediction of glibenclamide in ethanol–water
`mixtures,” Pharm. Dev. Technol., 2014; 19(6): 702–707
`USP 905 (2002)
`Donald J. Wheeler, Advanced Topics in Statistical Process
`Control (1st ed. 1995)
`James E. De Muth, Basic Statistics and Pharmaceutical
`Statistical Applications (1st ed. 1999)
`David S. Jones, Pharmaceutical Statistics (2002)
`Transcript of Patent Trial and Appeal Board Hearing on
`October 4, 2017
`
`
`
`*Patent Owner’s exhibits 2001-2031 were previously filed and are listed here again
`
`pursuant to 37 C.F.R. § 42.63.
`
`
`
`Date: October 10, 2017
`
`Steptoe & Johnson LLP
`1330 Connecticut Avenue, N.W.
`Washington, DC 20036-1795
`Telephone: (202) 429-3000
`Facsimile: (202) 429-3902
`
`Respectfully submitted,
`
`/Harold H. Fox/
`
`
`
`
`
`Harold H. Fox
`Reg. No. 41,498
`Counsel for MonoSol Rx, LLC
`
`
`
`IPR2017-00200
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 10th day of
`
`October 2017, the foregoing PATENT OWNER MONOSOL RX, LLC’S
`
`UPDATED EXHIBIT LIST were served by filing this document through the
`
`Patent Trial Appeal Board End To End system as well as by delivering a copy via
`
`electronic mail, by agreement of the parties, on the following counsel of record for
`
`Petitioner.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`
`
`
`Date: October 10, 2017
`
`
`
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
`
`/Harold H. Fox/
`Harold H. Fox
`Reg. No. 41,498
`
`
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