Paper No. 44
`Date Filed: July 14, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD.,
`SHANDONG LUYE PHARMACEUTICAL CO., LTD., and NANJING
`LUYE PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ EXHIBIT LIST 4
`
`1
`
`
`Date Filed: July 14, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD.,
`SHANDONG LUYE PHARMACEUTICAL CO., LTD., and NANJING
`LUYE PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ EXHIBIT LIST 4
`
`1
`
`
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`
`EXHIBIT LIST 4
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Alkermes Pharma Ireland
`
`Limited (“Alkermes”) respectfully submits the following current exhibit list.
`
`Alkermes
`Exhibit
`No.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`Description
`
`Patrick P. DeLuca & James C. Boylan, Chapter 5: Formulation of
`Small Volume Parenterals, in PHARMACEUTICAL DOSAGE FORMS:
`PARENTERAL MEDICATIONS 173-248 (Kenneth E. Avis et al. eds., 2nd
`ed. 1992).
`U.S. PHARMACOPEIA xxii-xxx (1995 ed.).
`
`EUROPEAN PHARMACOPEIA iii-vi, 1-10 (3rd ed. 1997).
`
`Intentionally Left Blank
`
`Intentionally Left Blank
`
`Intentionally Left Blank
`
`Intentionally Left Blank
`
`S.L. Phillips et al., Viscosity of NaCl and other solutions up to 350ºC
`and 50 MPa pressures, U.S. DEPT. ENERGY (1980).
`J. R. Nixon & B. P. S. Chawla, Viscosity and stability relations of the
`system ascorbic acid: water: polysorbate 20, 17 J. PHARMACY &
`PHARMACOLOGY 558-65 (1965).
`February 2, 2017 Declaration in Support of Patent Owners’ Motion for
`Pro Hac Vice Admission of Ha Kung Wong
`February 2, 2017 Declaration in Support of Patent Owners’ Motion for
`Pro Hac Vice Admission of Christina Schwarz
`February 2, 2017 Declaration in Support of Patent Owners’ Motion for
`Pro Hac Vice Admission of Melinda R. Roberts
`February 2, 2017 Declaration in Support of Patent Owners’ Motion for
`Pro Hac Vice Admission of Una Fan
`
`2
`
`
`
`Alkermes
`Exhibit
`No.
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`
`Description
`
`March 8, 2017 Declaration of Dr. Cory Berkland.
`
`Curriculum Vitae of Dr. Cory Berkland.
`
`February 22, 2017 Deposition Testimony of Dr. Patrick DeLuca.
`
`K.E. Avis, Chapter 21: Particle Phenomena and Coarse Dispersions,
`in REMINGTON’S PHARM. SCI. 301-329 (A.R. Gennaro et al. eds., 17th
`ed. 1985).
`K.E. Avis, Chapter 68: Particle Phenomena and Coarse Dispersions,
`in REMINGTON’S PHARM. SCI. 1306 (A.R. Gennaro et al. eds., 17th ed.
`1985).
`U.S. FOOD AND DRUG ADMIN., Medical Review, Risperdal® Consta®
`Long-Acting Injection NDA No. 21-346, approved Oct. 29, 2003.
`S. D’Souza, J.A. Faraj, S. Giovagnoli, & P.P. DeLuca, Dev. of
`Risperidone PLGA Microspheres, 2014 J. DRUG DELIVERY Art. ID
`420624 (2014).
`Y. Capan, G. Jiang, S. Giovagnoli, K.H. Na, & P.P. DeLuca,
`Preparation and Characterization of Poly(D,L-lactide-co-glycolide)
`Microspheres for Controlled Release of Human Growth Hormone,
`4(2) AAPS PHARMSCITECH Art. 28 (2003).
`K.W. Burton, M. Shameem, B.C. Thanoo, & P.P. DeLuca, Extended
`release peptide delivery systems through the use of PLGA microsphere
`combinations, 11(7) J. BIOMATERIALS SCI. POLYMER ED. 715-29
`(2000).
`H.B. Ravivarapu, H. Lee, & P.P. DeLuca, Enhancing Initial Release of
`Peptide from Poly(d,l-lactide-co-glycolide) (PLGA) Microspheres by
`Addition of a Porosigen and Increasing Drug Load, 5(2) PHARM. DEV.
`& TECH. 287-96 (2000).
`H.B. Ravivarapu, K. Burton, & P.P. DeLuca, Polymer and
`microsphere blending to alter the release of a peptide from PLGA
`microspheres, 50 EUR. J. PHARM. & BIOPHARM. 263-70 (2000).
`J.W. Kostanski, B.A. Dani, G.A. Reynolds, C.Y. Bowers, & P.P.
`DeLuca, Evaluation of Orntide Microspheres in a Rat Animal Model
`and Correlation to In Vitro Release Profiles, 1(4) AAPS
`PHARMSCITECH Art. 27 (2000).
`3
`
`
`
`Alkermes
`Exhibit
`No.
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`
`Description
`
`B.H. Woo, J.W. Kostanski, S. Gebrekidan, B.A. Dani, B.C. Thanoo, &
`P.P. DeLuca, Preparation, characterization and in vivo evaluation of
`120-day poly(D,L-lactide) leuprolide microspheres, 75 J. CONTROLLED
`RELEASE 307-15 (2001).
`B.A. Dani & P.P. DeLuca, Preparation, Characterization, and In Vivo
`Evaluation of Salmon Calcitonin Microspheres, 2(4) AAPS
`PHARMSCITECH Art. 22 (2001).
`B.H. Woo, K.H. Na, B.A. Dani, G. Jiang, B.C. Thanoo, & P.P.
`DeLuca, In Vitro Characterization and in Vivo Testosterone
`Suppression of 6-Month Release Poly(D,L-Lactide) Leuprolide
`Microspheres, 19(4) PHARM. RES. 546-50 (2002).
`G. Jiang, W. Qiu, & P.P. DeLuca, Preparation and in Vitro/in Vivo
`Evaluation of Insulin-Loaded Poly(Acryloyl-Hydroxyethyl Starch)-
`PLGA Composite Microspheres, 20(3) PHARM. RES. 452-59 (2003).
`P.P. DeLuca et al., Patent App. Pub. No. US 2007/0122487.
`
`S. Duggirala & P.P. DeLuca, Rheological Characterization of
`Cellulosic and Alginate Polymers, PDA J. PHARM. SCI. & TECH. 50(5):
`290-96 (1996).
`A.R. Hurwitz, P.P. DeLuca, & H.B. Kostenbauder, Binding of Organic
`Electrolytes by a Nonionic Surface-Active Agent, J. PHARM. SCI. 52(9):
`893-97 (1963).
`P.P. DeLuca, Chapter 32: Parenteral Products: Design and
`Optimization, Including Freeze Drying, in TOPICS IN PHARM. SCI. 471-
`91 (D.J.A. Crommelin et al. eds., 1994).
`Aqualon Sodium Carboxymethylcelluose: Physical and Chemical
`Properties, AQUALON (1999).
`X.H. Yang & W.L. Zhu, Viscosity properties of sodium
`carboxymethylcellulose solutions, CELLULOSE 14(5):409-17 (2007).
`Carboxymethylcellulose, DOW CHEMICAL, available at
`http://www.dow.com/dowwolff/en/industrial_solutions/polymers/carb
`oxymethylcellulose/ (last visited March 1, 2017).
`U. Florjancic et al., Rheological Characterization of Aqueous
`Polysaccharide Mixtures Undergoing Shear, CHEM. BIOCHEM. ENG. Q.
`16(3): 105-18 (2002).
`
`4
`
`
`
`Alkermes
`Exhibit
`No.
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`
`Description
`
`Performance Specialties Reference Guide, ASHLAND, available at
`http://www.brenntag.com/media/documents/bsi/product_data_sheets/
`material_science/ashland_polymers/performance_specialties_reference
`_guide.pdf (last visited Mar. 1, 2017).
`Specification Sheet-Sodium carboxymethyl cellulose-ultra low
`viscosity, SIGMA-ALDRICH, available at
`http://www.sigmaaldrich.com/catalog/DataSheetPage.do?brandKey=A
`LDRICH&symbol=360384 (last visited March 1, 2017).
`Specification Sheet-Carboxymethylcellulose sodium-low viscosity,
`SPECTRUM CHEMICAL, available at
`https://www.spectrumchemical.com/MSDS/CA193-AGHS.pdf (last
`visited March 1, 2017).
`U.S. FOOD AND DRUG ADMIN., Clinical Pharm. and Biopharm. Review,
`Risperdal® Consta® Long-Acting Injection NDA No. 21-346, approved
`Oct. 29, 2003.
`A. Benchabane & K. Bekkour, Rheological properties of
`carboxymethyl cellulose (CMC) solutions, 286 COLLOID POLYMER SCI.
`1173-80 (2008).
`J.H. Guo et al., Pharmaceutical applications of naturally occurring
`water-soluble polymers, PHARM. SCI. & TECH. TODAY 1(6): 254-61
`(1998).
`S.I. Conceicao et al., Influence of deagglomeration and carboxymethyl
`cellulose binders on rheological behaviour of kaolin suspensions,
`APPLIED CLAY SCI. 23: 257-64 (2003).
`M. Bonferoni et al., Influence of medium on dissolution-erosion
`behavior of Na carboxymethylcellulose and on viscoelastic properties
`of gels, INT’L J. PHARM. 117: 41-48 (1995).
`P. Sebert et al., Gamma irradiation of carboxymethylcellulose:
`technological and pharmaceutical aspects, INT’L J. PHARM. 106: 103-
`08 (1994).
`J. Wang & P. Somasundaran, Adsorption and conformation of
`carboxymethylcellulose at solid-liquid interfaces using spectroscopic,
`AFM and allied techniques, J. COLLOID & INTERFACE SCI. 291: 75-83
`(2005).
`Y.C.J. Wang, Chapter 7: Parenteral Products of Peptides and
`Proteins, in 1 PHARM. DOSAGE FORMS: PARENTERAL MEDICATIONS
`
`5
`
`
`
`Alkermes
`Exhibit
`No.
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`
`Description
`
`283-319 (K. Avis et al. eds., 2d ed. rev. 1992).
`Johnson & Johnson Reports 2016 Fourth-Quarter Results, JOHNSON &
`JOHNSON (Jan. 24, 2017), available at
`http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=1008867.
`M.K. Rainer, Risperidone long-acting injection: a review of its long
`term safety and efficacy, 4(5) NEUROPSYCHIATRIC DISEASE &
`TREATMENT: 919-27 (2008).
`Y.S. Rhee, C.W. Park, P.P. DeLuca, H.M. Mansour, Sustained-
`Release Injectable Drug Delivery, 2010 supp.(6) PHARM. TECH. (Nov.
`1, 2010).
`Ashland to Acquire Hercules, ASHLAND (July 11, 2008),
`http://investor.ashland.com/releasedetail.cfm?releaseid=333633.
`U.S. Patent Application No. 09/577,875.
`
`March 6, 2017 Declaration of Dr. Robson Storey.
`
`U.S. Patent No. 5,792,477.
`
`About Spectrum Chemical: The USA’s Leading Chemical
`Manufacturing Company, SPECTRUM CHEM., available at
`https://www.spectrumchemical.com/OA_HTML/About-Spectrum-
`Chemical.jsp?minisite=10020&respid=22372 (last visited Mar. 8,
`2017).
`Dow’s Growth Story, DOW CHEM., available at
`http://www.dow.com/en-us/about-dow/dows-growth-story (last visited
`Mar. 8, 2017).
`Our History, SIGMA-ALDRICH, available at
`http://www.sigmaaldrich.com/customer-service/about-us/sigma-
`aldrich-history.html (last visited Mar. 8, 2017).
`March 8, 2017 Declaration of Dr. Stevin Gehrke.
`
`Intentionally Left Blank
`
`March 6, 2017 Quick Courier Chain of Custody Form.
`
`6
`
`
`
`Alkermes
`Exhibit
`No.
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`2071
`
`2072
`
`2073
`
`2074
`
`2075
`
`2076
`
`2077
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`
`Description
`
`Blanose CMC 7ULC Certificate of Analysis, ASHLAND (Apr. 29,
`2016).
`Blanose CMC 7ELC1 Certificate of Analysis, ASHLAND (Oct. 31,
`2014).
`Sodium Chloride Certificate of Analysis, FISHER SCI. (Jun. 26, 2015).
`
`Tween® 20 Certificate of Analysis, SIGMA-ALDRICH (Jul. 6, 2016).
`
`Deionized Ultra-filtered Water Certificate of Analysis, FISHER SCI.
`(Feb. 20, 2016).
`Procedure for Preparing CMC Water Solution, NIPPON PAPER INDUS.
`(2013).
`Brookfield DV-II+ Pro Progammable Viscometer: Operating
`Instructions, Manual No. M/03-165-C0508, BROOKFIELD ENG. LAB.
`Millex-GV Syringe Filter Unit, EMD MILLIPORE, available at
`http://www.emdmillipore.com/US/en/product/Millex-GV-Syringe-
`Filter-Unit%2C-0.22%C2%A0%C2%B5m%2C-PVDF%2C-
`33%C2%A0mm%2C-gamma-sterilized,MM_NF-
`SLGV033RS?ReferrerURL=https%3A%2F%2Fwww.google.com%2F
`(last visited Mar. 8, 2017).
`Intentionally Left Blank
`
`Risperdal® Consta® Drug Label, JANSSEN PHARM. (Feb. 2017).
`
`March 8, 2017 Declaration of Scott Spears Regarding Chain of
`Custody.
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`7
`
`
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`
`Description
`
`Reserved
`
`Reserved
`
`June 30, 2017 Transcript of the Proceedings
`
`Alkermes
`Exhibit
`No.
`2078
`
`2079
`
`2080
`
`July 14, 2017
`
`Respectfully submitted,
`
`/Scott K. Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`8
`
`
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNERS’ EXHIBIT LIST 4 was served on July 14, 2017 by causing it
`
`to be sent by email to counsel for Petitioner at the following email addresses:
`
`wmentlik.ipr@lernerdavid.com
`
`pkochanski@lernerdavid.com
`
`tvanbuskirk@lernerdavid.com
`
`nvaleyko@lernerdavid.com
`
`July 14, 2017
`
`Respectfully submitted,
`
`/Scott K. Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`9
`
`
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