UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner
`
`__________
`
`Case IPR2021-00816
`Patent 9,220,631
`
`__________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner
`
`__________
`
`Case IPR2021-00816
`Patent 9,220,631
`
`__________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owners Novartis Pharma AG,
`
`Novartis Technology LLC, and Novartis Pharmaceuticals Corporation
`
`(collectively “Novartis”) hereby submit a current listing of Patent Owners’
`
`Exhibits.
`
`Exhibit
`
`Description
`
`Ex. 2001 Declaration of Karl R. Leinsing, PE
`
`Ex. 2002 Declaration of Marie Picci [Filed Under Seal]
`
`Ex. 2003 October 29, 2020 Telephonic Hearing Transcript, Regeneron
`Pharmaceuticals, Inc. v. Novartis Pharma AG et al., IPR2020-01317
`
`Ex. 2004 Redline comparison of Koller Declarations submitted in IPR2020-
`01317 and IPR2021-00816
`Ex. 2005 Court Notice setting Rule 16 Scheduling Conference (DI45), Novartis
`Pharma AG, et al. v. Regeneron Pharmaceuticals, Inc., 1:20-cv-
`00690-TJM-CFH (N.D.N.Y. June 22, 2021)
`
`Ex. 2006 Regeneron Pharmaceuticals, Inc.’s Partial Answer to Complaint
`(DI55), Novartis Pharma AG, et al. v. Regeneron Pharmaceuticals,
`Inc., 1:20-cv-00690-TJM-CFH (N.D.N.Y. July 11, 2021)
`
`Ex. 2007 Regeneron Pharmaceuticals, Inc.’s Complaint (DI01), Regeneron
`Pharmaceuticals, Inc. v. Novartis Pharma AG et al., 1:20-cv-005502
`(S.D.N.Y. July 17, 2020)
`
`Ex. 2008
`
`9220631 File History (Examiner's Search)
`
`Ex. 2009 WO 2007/084765 (Deschatelets)
`
`Ex. 2010 WO 1997/44068 (Tack)
`
`Ex. 2011
`
`English Translation of WO 1997/44068 (Tack)
`
`Ex. 2012
`
`IDS with Deschatelets (9220631 File History)
`
`1
`
`
`
`
`
`Exhibit
`
`Description
`
`Ex. 2013
`
`IDS with Tack (9220631 File History)
`
`Ex. 2014
`
`European Patent Application No. EP 12189649 (EP '649)
`
`Ex. 2015
`
`Screen capture of Genentech Press Release, “FDA Approves
`Genentech’s Lucentis (Ranibizumab Injection) Prefilled Syringe”
`(Oct. 14, 2016)
`Ex. 2016 Roche Finance Report 2018
`
`Ex. 2017
`
`Ex. 2018
`
`Eric Souied, Ranibizumab prefilled syringes: benefits of reduced
`syringe preparation times and less complex preparation procedures,
`EUR. J. OPHTHALMOL. 25(6): 529-34 (2015) (“Souied”)
`
`Thérèse M Sassalos and Yannis M Paulus, Prefilled syringes for
`intravitreal drug delivery, CLINICAL OPHTHALMOLOGY 13:701-
`06 (2019) (“Sassalos”)
`
`Ex. 2019 Gholam A. Peyman, Eleonora M. Lad and Darius M. Moshfeghi,
`Intravitreal Injection Of Therapeutic Agents, RETINA 29:875–912
`(2009) (“Peyman”)
`
`Ex. 2020
`
`Lloyd Aiello, et al., Evolving guidelines for intravitreous injections,
`RETINA (2004) (“Aiello”)
`
`Ex. 2021 Bruno Reuter and Claudia Petersen, Syringe Siliconisation Trends ,
`Methods, Analysis Procedures.” (2012) (“Reuter”)
`
`Ex. 2022
`
`Edwin Chan, et al., Syringe Siliconization Process Investigation and
`Optimization, PDA JOURNAL OF PHARMACEUTICAL SCIENCE
`AND TECHNOLOGY, 136-158 (2012) (“Chan”)
`
`Ex. 2023 Anita Leys, et al., Neovascular growth following photodynamic
`therapy for choroidal hemangioma and neovascular regression after
`intravitreous injection of triamcinolone, RETINA (2006) ul-Aug;
`
`Ex. 2024
`
`Joseph Remington and Paul Beringer, Remington: The Science and
`Practice of Pharmacy, Philadelphia: Lippincott Williams & Wilkins,
`776-801 (21st Ed. 2006) (“Remington”)
`
`2
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Ex. 2025
`
`Ex. 2026
`
`Pearse Keane and Srinivas Sadda, Development of Anti-VEGF
`Therapies for Intraocular Use: A Guide for Clinicians, J
`OPTHAMOL. (2012) (“Keane”)
`
`FDA Alerts Health Care Professionals of Injection Risk from
`Repackaged Avastin Intravitreal Injections, U.S. Food and Drug
`Administration (Sep. 1, 2011),
`https://web.archive.org/web/20110901180651/https://www.fda.gov/Dr
`ugs/DrugSafety/ucm270296.htm (last accessed Nov. 10, 2020) (“FDA
`Alert”)
`
`Ex. 2027
`
`FDA Guidance for Industry – Q1A (R2) Stability Testing of New
`Drug Substances and Products (2003)
`
`Ex. 2028 Hultman, et al., The Physical Chemistry of Decontamination with
`Gaseous Hydrogen Peroxide, Pharmaceutical Engineering,
`January/February 2007, 27(1):1-6 (“Hultman”)
`
`Ex. 2029 Nitin Rathore, et al., Characterization of Protein Rheology and
`Delivery Forces for Combination Products, JOURNAL OF
`PHARMACEUTICAL SCIENCES, 101(12):4472-80 (Dec. 2012)
`(“Rathore 2012”)
`
`Ex. 2030
`
`Tracy Chang, et al., Cell and Protein Compatibility of Parylene-C
`Surfaces, Langmuir (2007) (“Chang”)
`
`Ex. 2031 Marta Kaminska, et al., Interaction of parylene C with biological
`objects, Acta Bioeng Biomech. (2009) (“Kaminska”)
`
`Ex. 2032 United States Patent Publication 2014/0012227A1
`
`Ex. 2033
`
`Joseph Remington and Paul Beringer, Remington: The Science and
`Practice of Pharmacy, Philadelphia: Lippincott Williams & Wilkins,
`1025-1036 (21st Ed. 2006) (“Remington”)
`
`Ex. 2034
`
`Sandeep Nema, et al., Antibody Structure, Instability, and
`Formulation, Wiley InterScience. (2006) (“Nema”)
`
`3
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Ex. 2035 Gregory Sacha, et al., Practical fundamentals of glass, rubber, and
`plastic sterile packaging systems, PHARM DEV TECHNOL. (2010)
`(“Sacha”)
`
`Ex. 2036 MiniVision, Eylea Pre-Filled Syringe PBS Listed, Indication
`Expanded (Dec. 1, 2020)
`
`Ex. 2037
`
`Intentionally Omitted
`
`Ex. 2038
`
`Intentionally Omitted
`
`Ex. 2039
`
`Intentionally Omitted
`
`Ex. 2040
`
`Intentionally Omitted
`
`Ex. 2041
`
`Ingrid Markovic, Regulatory Perspective on Safety Qualification of
`Extractables and Leachables, (2011)
`
`Ex. 2042
`
`International Standard, Biological Evolution of medical devices – Part
`1: Evaluation and Testing Within a Risk Management Process, (2009)
`
`Ex. 2043
`
`Intentionally Omitted
`
`Ex. 2044 U.S. Lucentis® PFS Administration Flashcard (dated April 2018)
`
`Ex. 2045
`
`IPR2020-01317, Petition for Inter Partes Review
`
`Ex. 2046
`
`IPR2020-01318, Petition for Inter Partes Review
`
`Ex. 2047
`
`Ex. 2048
`
`IPR2020-01318 Novartis Pharma AG, Novartis Technology LLC, and
`Novartis Pharmaceuticals Corporation’s Patent Owner Preliminary
`Response
`
`International Conference on Harmonisation of Technical
`Requirements for Registration of Pharmaceuticals for Human Use,
`STABILITY TESTING OF NEW DRUG SUBSTANCES AND
`PRODUCTS Q1A(R2) GUIDELINE (Feb. 6, 2003)
`
`4
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Ex. 2049 Glen Petrie, The Need for Specificity in Accelerated Aging, Medical
`Device & Diagnostic Industry (2006) (“Petrie”)
`
`Ex. 2050
`
`2020-01318 IPR, Paper No. 16, Petitioner’s Unopposed Motion to
`Terminate the Proceeding
`
`Ex. 2051
`
`2020-01317 IPR, Paper No. 13, Petitioner’s Reply Regarding 35
`U.S.C. §§ 314(a), 325(d)
`
`Ex. 2052 Regeneron Pharmaceuticals, Inc.’s First Amended Complaint (DI87),
`Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG et al., 1:20-
`cv-05502 (S.D.N.Y. January 25, 2021)
`
`Ex. 2053
`
`Ex. 2054
`
`Ex. 2055
`
`2020-01317 IPR, Paper No. 19, Petitioner’s Unopposed Motion to
`Withdraw its Request for Rehearing of the Board’s Decision Denying
`Inter Partes Review
`
`FDA Compliance Program Guidance Manual, Chapter 56 – Drug
`Quality Assurance, STERILE DRUG PROCESS INSPECTIONS
`(Sept. 11, 2015)
`
`FDA Guidance for Industry, for the Submission Documentation for
`Sterilization Process Validation in Applications for Human and
`Veterinary Drug Products (1994)
`
`Ex. 2056
`
`European Medicines Agency, Macugen: European Public Assessment
`Report – Scientific Discussion (May 31, 2007)
`
`Ex. 2057 Docket Text- Minute Entry for proceedings held before Magistrate
`Judge Hummel: Status Conference held on 6/11/2021, Novartis
`Pharma AG, et al. v. Regeneron Pharmaceuticals, Inc., 1:20-cv-
`00690-TJM-CFH (N.D.N.Y. June 11, 2021)
`
`Ex. 2058
`
`Letter from Jessica Falk to Novartis in Response to May 10 Letter
`Redacted, dated May 14, 2021
`
`Ex. 2059
`
`2020-01317 IPR, Ex. 3004, April 16, 2021 Email from Brian
`Ferguson to Board re Withdrawal of POP Consideration
`
`5
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Ex. 2060 Uniform Pretrial Scheduling Order (DI67), Enthone Inc. v. Moses
`Lake Industries, Inc., 1:13-CV-1054 (N.D.N.Y. August 14, 2014)
`
`Ex. 2061 Uniform Pretrial Scheduling Order (DI22), Enthone Inc. v. BASF
`Corporation, 1:15-CV-233 (N.D.N.Y. June 4 2015)
`
`Ex. 2062 Declaration of Jeffrey Salling In Support of Novartis’s Patent Owner
`Preliminary Response
`
`Ex. 2063
`
`Lucentis Project Review_2011 10 05a.pptx [FILED UNDER SEAL]
`
`Ex. 2064 RFB002, RP01030A, Risk assessment: Changes in starting material
`and manufacturing process between registration stability and process
`validation campaigns [FILED UNDER SEAL]
`
`Ex. 2065 Metadata Report for Ex. 2063
`
`Ex. 2066
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 11, 2011)
`[FILED UNDER SEAL]
`
`Ex. 2067
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 27, 2011)
`[FILED UNDER SEAL]
`
`Ex. 2068
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Nov. 11, 2011 and
`Nov. 21, 2011) [FILED UNDER SEAL]
`
`Ex. 2069
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Dec. 5, 2011)
`[FILED UNDER SEAL]
`
`Ex. 2070
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Dec. 20, 2011)
`[FILED UNDER SEAL]
`
`Ex. 2071
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Jan. 9, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2072
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Jan. 23, 2012)
`[FILED UNDER SEAL]
`
`6
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Ex. 2073
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Feb. 20, 2012 and
`Mar. 6, 2012) [FILED UNDER SEAL]
`
`Ex. 2074
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Mar. 19, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2075
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Apr. 2, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2076
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Apr. 16, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2077
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (May 3, 2012 and
`May 14, 2012) [FILED UNDER SEAL]
`
`Ex. 2078
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (May 31, 2012 and
`June 11, 2012) [FILED UNDER SEAL]
`
`Ex. 2079
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (June 25, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2080
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (July 9, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2081
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (July 23, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2082
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Aug. 6, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2083
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Aug. 20, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2084
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Sept. 3, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2085
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 1, 2012)
`[FILED UNDER SEAL]
`
`7
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Ex. 2086
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct.15, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2087
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Nov. 12, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2088
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Dec. 10, 2012)
`[FILED UNDER SEAL]
`
`Ex. 2089
`
`Letter from Jessica Falk to Novartis in Response to June 9 Letter,
`dated June 11, 2021
`
`Ex. 2090
`
`Initial Determination Granting Complainants’ Motion for Summary
`Determination as to Direct Infringement and the Economic and
`Technical Prongs of the Domestic Industry Requirement, Certain Pre-
`Filled Syringes for Intravitreal Injection and Components Thereof,
`Inv. No. 337-TA-1207 (April 7, 2021)
`
`Ex. 2091 Modified Default Protective Order
`
`Ex. 2092 Redline of Modified Default Protective Order
`
`Ex. 2093
`
`Transcript of Proceedings Novartis Pharma AG, et al. v. Regeneron
`Pharmaceuticals, Inc., 1:20-cv-00690-TJM-CFH (N.D.N.Y. Aug. 18,
`2021)
`
`Ex. 2094 Uniform Pre-Trial Scheduling Order (DI 82), Novartis Pharma AG, et
`al. v. Regeneron Pharmaceuticals, Inc., 1:20-cv-00690-TJM-CFH
`(N.D.N.Y. Aug. 24, 2021)
`
`E-mail from Christopher Pepe to the PTAB, Re: IPR2021-00816 –
`Request for Authorization (Aug. 6, 2021)
`
`Ex. 2095
`
`Ex. 2096
`
`Stipulation and Order Modifying Case Schedule (DI 133), Regeneron
`Pharmaceuticals, Inc. v. Novartis Pharma AG et al., 1:20-
`cv-05502-AJN (S.D.N.Y. June 23, 2021)
`
`
`8
`
`
`
`
`Exhibit
`
`Description
`
`Ex. 2097 Declaration of Martina Athanas In Support of Novartis’s Second
`Motion to Seal
`
`Respectfully submitted,
`
`
`
`Date: November 19, 2021
`
`
`
` By: /Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Linnea Cipriano (Reg. No. 67,729)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`eholland@goodwinlaw.com
`lcipriano@goodwinlaw.com
`
`William G. James (Reg. No. 55,931)
`GOODWIN PROCTER LLP
`1900 N Street, N.W.
`Washington, D.C. 20036
`Tel: (202) 346-4000
`Fax: (202) 346-4444
`wjames@goodwinlaw.com
`
`Joshua Weinger
`(Reg. No. 73,198)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston MA 02210-1980
`Tel: 617-570-1000
`Fax: 617-523-1231
`jweinger@goodwinlaw.com
`
`
`Attorneys for Patent Owner
`
`9
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.8(b)(4), I hereby certify that this
`
`Patent Owner’s Updated Exhibit List and Exhibit 2097, as well as redacted
`
`versions of Exhibits 2063, 2064, and 2066-2088 were served via electronic mail, as
`
`agreed to by counsel, upon the following counsel of record for the Petitioner:
`
`Elizabeth S. Weiswasser (Reg. No. 55,721)
`Anish R. Desai (Reg. No. 73,760)
`Natalie Kennedy (Reg. No. 68,511)
`Andrew Gesior (Reg. No. 76,588)
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8000
`E: Regeneron.IPR.Service@weil.com
`
`Brian E. Ferguson (Reg. No. 36,801)
`Christopher Pepe (Reg. No. 73,851)
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street NW, Suite 600
`Washington, DC 20036
`T: 202-682-7000
`E: Regeneron.IPR.Service@weil.com
`
`Counsel for Petitioner Regeneron Pharmaceuticals, Inc.
`
`Dated: November 19, 2021
`
`By:
`
`
`
`
`
`
`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owner
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`EHolland@goodwinlaw.com
`
`10
`
`
`
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