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
`
`__________
`
`
`NOVARTIS PHARMA AG, NOVARTIS TECHNOLOGY LLC, AND
`NOVARTIS PHARMACEUTICALS CORPORATION’S
`PATENT OWNER SUR-REPLY
`
`
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`
`Page
`
`
`I.
`II.
`
`GENERAL PLASTIC SUPPORTS DENYING INSTITUTION. ................... 1
`THE BOARD SHOULD DENY INSTITUTION UNDER FINTIV. ............ 5
`
`
`
`
`
`-i-
`
`
`
`

`

`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Apple Inc. v. Uniloc 2017 LLC,
`IPR2020-00854, Paper 9 (PTAB Oct. 28, 2020) .................................................. 4
`Bentley Motors Limited v. Jaguar Land Rover Ltd.,
`IPR2019-01539, Paper 16 (PTAB Oct. 2, 2020) .................................................. 2
`Ivantis, Inc. v. Glaukos Corp.,
`No. IPR2019-00475, 2019 WL 3064909 (PTAB July 12, 2019) ......................... 4
`Kashiv Biosciences, LLC v. Amgen Inc.,
`IPR2019-00791, Paper 15 (PTAB Sept. 22, 2019)........................................... 3, 4
`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-00921, Paper 13 (PTAB Aug. 5, 2021) ................................................. 2
`Sand Revolution II, LLC v. Continental Intermodal Group,
`IPR2019-01393, Paper 24 (PTAB June 16, 2020) ........................................... 2, 3
`Other Authorities
`37 C.F.R. § 42.24(c) ................................................................................................... 7
`37 C.F.R. § 42.24(c)(2) .............................................................................................. 7
`
`
`
`
`
`
`
`-ii-
`
`
`
`

`

`
`
`Exhibit
`
`
`Patent Owner’s Exhibit List
`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)
`
`Ex. 2013
`
`IDS with Tack (9220631 File History)
`
`Ex. 2014
`
`European Patent Application No. EP 12189649 (EP '649)
`
`-iii-
`
`

`

`
`
`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
`
`Ex. 2025
`
`Ex. 2026
`
`
`
`
`
`Joseph Remington and Paul Beringer, Remington: The Science and
`Practice of Pharmacy, Philadelphia: Lippincott Williams & Wilkins,
`776-801 (21st Ed. 2006) (“Remington”)
`
`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
`-iv-
`
`
`

`

`
`
`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”)
`
`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
`
`
`
`
`
`-v-
`
`
`
`

`

`
`
`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)
`
`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-
`
`
`
`
`
`-vi-
`
`
`
`

`

`
`
`
`
`cv-05502 (S.D.N.Y. January 25, 2021)
`cv-05502 (S.D.N.Y. January 25, 2021)
`
`
`
` Ex. 2062
`
`Ex. 2053
`Ex. 2053
`
`2020-01317 IPR, Paper No. 19, Petitioner’s Unopposed Motion to
`2020-01317 IPR, Paper No. 19, Petitioner’s Unopposed Motion to
`Withdraw its Request for Rehearing of the Board’s Decision Denying
`Withdraw its Request for Rehearing of the Board’s Decision Denying
`Inter Partes Review
`Inter Partes Review
`
`Ex. 2054
`Ex. 2054
`
`FDA Compliance Program Guidance Manual, Chapter 56 – Drug
`FDA Compliance Program Guidance Manual, Chapter 56 — Drug
`Quality Assurance, STERILE DRUG PROCESS INSPECTIONS
`Quality Assurance, STERILE DRUG PROCESS INSPECTIONS
`(Sept. 11, 2015)
`(Sept. 11, 2015)
`
`
`Ex. 2055
`Ex. 2055
`
`FDA Guidance for Industry, for the Submission Documentation for
`FDA Guidancefor Industry, for the Submission Documentation for
`Sterilization Process Validation in Applications for Human and
`Sterilization Process Validation in Applications for Human and
`Veterinary Drug Products (1994)
`Veterinary Drug Products (1994)
`
`Ex. 2056
`Ex. 2056
`
`European Medicines Agency, Macugen: European Public Assessment
`European Medicines Agency, Macugen: European Public Assessment
`Report – Scientific Discussion (May 31, 2007)
`Report — Scientific Discussion (May 31, 2007)
`
`
`Ex. 2057 Docket Text- Minute Entry for proceedings held before Magistrate
`Docket Text- Minute Entry for proceedings held before Magistrate
`Ex. 2057
`Judge Hummel: Status Conference held on 6/11/2021, Novartis
`Judge Hummel: Status Conference held on 6/11/2021, Novartis
`Pharma AG, et al. v. Regeneron Pharmaceuticals, Inc., 1:20-cv-
`Pharma AG,et al. v. Regeneron Pharmaceuticals, Inc., 1:20-cv-
`00690-TJM-CFH (N.D.N.Y. June 11, 2021)
`00690-TJM-CFH (N.D.N.Y. June 11, 2021)
`
`Ex. 2058
`Ex. 2058
`
`Letter from Jessica Falk to Novartis in Response to May 10 Letter
`Letter from Jessica Falk to Novartis in Response to May 10 Letter
`Redacted, dated May 14, 2021
`Redacted, dated May 14, 2021
`
`Ex. 2059
`Ex. 2059
`
`2020-01317 IPR, Ex. 3004, April 16, 2021 Email from Brian
`2020-01317 IPR, Ex. 3004, April 16, 2021 Email from Brian
`Ferguson to Board re Withdrawal of POP Consideration
`Ferguson to Board re Withdrawal of POP Consideration
`
`
`Ex. 2060 Uniform Pretrial Scheduling Order (DI67), Enthone Inc. v. Moses
`Uniform Pretrial Scheduling Order (DI67), EnthoneInc. v. Moses
`Ex. 2060
`Lake Industries, Inc., 1:13-CV-1054 (N.D.N.Y. August 14, 2014)
`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
`Uniform Pretrial Scheduling Order (DI22), Enthone Inc. v. BASF
`Ex. 2061
`Corporation, 1:15-CV-233 (N.D.N.Y. June 4 2015)
`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
`Declaration of Jeffrey Salling In Support of Novartis’s Patent Owner
`Preliminary Response
`Preliminary Response
`
`Ex. 2063
`Ex. 2063
`
`Lucentis Project Review_2011 10 05a.pptx [FILED UNDER SEAL]
`Lucentis Project Review_2011 10 05a.pptx [FILED UNDER SEAL]
`
`
`
`
`
`
`-vii-
`-vii-
`
`
`
`

`

` Ex. 2064|RFB002, RPO1030A,Risk assessment: Changesin starting material
`
`Ex. 2065 Metadata Report for Ex. 2063
`Ex. 2065|Metadata Report for Ex. 2063
`
`
`Ex. 2066
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 11, 2011)
`Ex. 2066|Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 11, 2011)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`Ex. 2067
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 27, 2011)
`Ex. 2067|Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 27, 2011)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`
`Ex. 2068
`Lucentis® PFS TRD SubTeam Meeting Minutes (Nov. 11, 2011 and
`Ex. 2068|Lucentis® PFS TRD SubTeam Meeting Minutes (Nov. 11, 2011 and
`Nov. 21, 2011) [FILED UNDER SEAL]
`Nov.21, 2011) [FILED UNDER SEAL]
`
`Ex. 2069
`Lucentis® PFS TRD SubTeam Meeting Minutes (Dec. 5, 2011)
`Ex. 2069|Lucentis® PFS TRD SubTeam Meeting Minutes (Dec. 5, 2011)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`Ex. 2070
`Lucentis® PFS TRD SubTeam Meeting Minutes (Dec. 20, 2011)
`Ex. 2070|Lucentis® PFS TRD SubTeam Meeting Minutes (Dec. 20, 2011)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`Ex. 2071
`Lucentis® PFS TRD SubTeam Meeting Minutes (Jan. 9, 2012)
`Ex. 2071|Lucentis® PFS TRD SubTeam Meeting Minutes (Jan. 9, 2012)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`Ex. 2072
`Lucentis® PFS TRD SubTeam Meeting Minutes (Jan. 23, 2012)
`Ex. 2072|Lucentis® PFS TRD SubTeam Meeting Minutes (Jan. 23, 2012)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`
`Ex. 2073
`Lucentis® PFS TRD SubTeam Meeting Minutes (Feb. 20, 2012 and
`Ex. 2073|Lucentis® PFS TRD SubTeam Meeting Minutes (Feb. 20, 2012 and
`Mar. 6, 2012) [FILED UNDER SEAL]
`Mar. 6, 2012) [FILED UNDER SEAL]
`
`Ex. 2074
`Lucentis® PFS TRD SubTeam Meeting Minutes (Mar. 19, 2012)
`Ex. 2074|Lucentis® PFS TRD SubTeam Meeting Minutes (Mar. 19, 2012)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`Ex. 2075
`Lucentis® PFS TRD SubTeam Meeting Minutes (Apr. 2, 2012)
`Ex. 2075|Lucentis® PFS TRD SubTeam Meeting Minutes (Apr. 2, 2012)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`Ex. 2076
`Lucentis® PFS TRD SubTeam Meeting Minutes (Apr. 16, 2012)
`Ex. 2076|Lucentis® PFS TRD SubTeam Meeting Minutes (Apr. 16, 2012)
`[FILED UNDER SEAL]
`[FILED UNDER SEAL]
`
`
`
`
`
`Ex. 2064 RFB002, RP01030A, Risk assessment: Changes in starting material
`and manufacturing process between registration stability and process
`and manufacturing process betweenregistration stability and process
`validation campaigns [FILED UNDER SEAL]
`validation campaigns [FILED UNDER SEAL]
`
`
`
`
`
`
`
`-viii-
`-vill-
`
`
`
`

`

`
`
`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]
`
`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
`-ix-
`
`
`

`

`
`
`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)
`
`
`
`
`
`
`-x-
`
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`

`

`
`
`After ignoring General Plastic in its Petition, Petitioner now concedes the
`
`General Plastic factors apply because “Regeneron previously filed two IPRs
`
`against the 631 Patent.” Reply at 2. Petitioner’s assertion that those factors
`
`nonetheless favor institution rewrites several of the factors, mischaracterizes Board
`
`procedures, and improperly discounts Petitioner’s gamesmanship in using Patent
`
`Owner’s two previous POPRs and the extensive ITC discovery as a roadmap for
`
`this third Petition. With the General Plastic factors all pointing against institution,
`
`Petitioner resorts to distraction by trumpeting the pretrial brief by an ITC staff
`
`attorney. Id. at 1, 4. But neither the preliminary arguments of one ITC attorney
`
`nor Patent Owner’s decision to pursue the alternative relief available in district
`
`court for Petitioner’s infringement are relevant to General Plastic.
`
`
`
`Institution should also be denied under Fintiv. Petitioner’s contrary
`
`arguments ignore the NDNY court’s instructions that it would move “th[e] matter
`
`forward in an expeditious … fashion” and not let the parties “reinvent the wheel or
`
`redo all of th[e] discovery” already completed. Ex. 2093 at 4; see also Ex. 2094.
`
` GENERAL PLASTIC SUPPORTS DENYING INSTITUTION.
`Factors 1 and 2 clearly weigh against institution: as Petitioner concedes, it
`
`“previously filed two IPRs against the 631 Patent” (Factor 1) and knew of the prior
`
`art as of its first petition (Factor 2) because those references appeared in “the
`
`original IPRs.” Reply at 2. Petitioner’s conclusory assertion that these facts
`
`1
`
`

`

`
`
`somehow “favor institution,” id., turns Factors 1 and 2 on their head.
`
`As to the remaining factors, Petitioner tries to explain away its serial filings,
`
`and the delay between its petitions (Factors 4 and 5), by insisting that its “only
`
`choice was to file this petition” because it had no way to argue that the ITC
`
`termination supported reconsideration of the 1317 Petition, even though it still had
`
`a rehearing petition pending at the time. Reply at 1–2. That is wrong. To begin,
`
`the Board entertains requests to reconsider institution denials under Fintiv based on
`
`post-decision developments. E.g., Philip Morris Products, S.A. v. RAI Strategic
`
`Holdings, Inc., IPR2020-00921, Paper 13 (PTAB Aug. 5, 2021) (granting
`
`rehearing and instituting based on post-decision stay in district court); Sand
`
`Revolution II, LLC v. Continental Intermodal Group, IPR2019-01393, Paper 24
`
`(PTAB June 16, 2020) (similar). Petitioner’s assertion that it could not inform the
`
`Board of the ITC termination is not credible. Parties often apprise the Board of
`
`developments and request leave to submit further briefing—indeed, that is exactly
`
`what Petitioner did here in seeking leave to reply to the POPR. Ex. 2095. And in
`
`cases involving Fintiv denials, the Board has repeatedly allowed supplemental
`
`briefing on a pending rehearing request. See Bentley Motors Limited v. Jaguar
`
`Land Rover Ltd., IPR2019-01539, Paper 16 at 3–4 (PTAB Oct. 2, 2020) (noting
`
`that “Petitioner’s email” informed the Board of a change in the district court
`
`schedule, prompting the Board to order “supplemental briefing on the Request for
`
`2
`
`

`

`
`
`Rehearing”); Sand Revolution II, IPR2019-01393, Paper 24 at 7 (similar).
`
`Yet Petitioner never tried to bring the ITC termination to the Board’s
`
`attention or bothered to ask Patent Owner whether it would consent to
`
`supplemental briefing. Nor did Petitioner simply refile the 1317 Petition. The
`
`reason behind these choices is self-evident: Petitioner wanted to file a third petition
`
`to refashion its arguments after receiving the two POPRs and ITC discovery.
`
`Contrary to Petitioner’s efforts at minimization (Reply at 3–4), its shifts are
`
`significant. The Petition relies on a new prior-art combination (Lam and
`
`Boulange), which responds to Patent Owner’s earlier POPR swearing behind
`
`Reuter. Petitioner likewise does not dispute that it introduced new evidence and
`
`arguments in response to the POPRs and ITC discovery. POPR at 11–13. Indeed,
`
`its expert repeatedly invoked Patent Owner’s submissions. Id. at 12.
`
`Instead, Petitioner asserts that it “gained no advantage” from the earlier
`
`proceedings, and it insists that efforts to leverage ITC discovery are “wholly
`
`irrelevant.” Reply at 3. That position has no basis in Board precedent1 or logic: it
`
`
`1 Petitioner cites Kashiv Biosciences, LLC v. Amgen Inc., IPR2019-00791, Paper
`
`15 (PTAB Sept. 11, 2019), but the petition there was “the first filed in the PTAB”
`
`challenging the patent and the Patent Owner admitted that “‘the General Plastic
`
`factors themselves are not all directly applicable.’” Id. at 30 (emphasis added).
`
`3
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`is no less burdensome to file serial petitions in order to use discovery from parallel
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`litigation than it is to use materials from related IPR proceedings. Cf. Ivantis, Inc.
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`v. Glaukos Corp., IPR2019-00475, Paper 8 at 11–12 (PTAB July 12, 2019)
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`(Factor 3 weighed against institution where, inter alia, the petitioner updated claim
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`construction arguments based on a pending district litigation). In any event, the
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`“third General Plastic factor addresses whether [Petitioner] had access to a Board
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`decision or preliminary response concerning its first petition.” Apple Inc. v.
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`Uniloc 2017 LLC, IPR2020-00854, Paper 9 at 10 (PTAB Oct. 28, 2020) (emphasis
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`added). Petitioner received two POPRs, which it used to guide the new Petition.
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`Finally, Petitioner asserts (Reply at 4) that any advantage it gained “from
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`receiving Novartis’s POPR and ITC arguments” is not unfair because Patent
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`Owner chose to terminate the ITC investigation. Petitioner’s insinuation that
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`Patent Owner sought to avoid an adverse invalidity ruling is baseless: the
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`prehearing brief of a staff attorney is not meaningfully predictive of how an
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`administrative law judge will rule after hearing the evidence, much less of what the
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`Commission will ultimately decide. Regardless, Petitioner’s remedy for any
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`supposed “forum shopping” (Reply at 4 n.1), was to apprise the Board of the ITC
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`termination and to urge reconsideration of the institution denial. Its strategic
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`decision to file a third petition instead should not be rewarded, as all of the
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`General Plastic factors favor denial of institution.
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`4
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` THE BOARD SHOULD DENY INSTITUTION UNDER FINTIV.
`Petitioner’s reply ignores most of the Fintiv factors, and guidance from the
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`recent NDNY Rule 16 conference confirms several of Patent Owner’s Fintiv
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`arguments. For example, Patent Owner explained that the parties have completed
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`much of the relevant discovery in the parallel ITC and SDNY proceedings,
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`allowing the NDNY matter to move quickly to trial. POPR at 17–19. The NDNY
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`magistrate judge endorsed that position, agreeing to “shorten the deadlines” in the
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`local patent rules, and admonishing Petitioner that it would not be allowed to
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`“reinvent the wheel.” Ex. 2093 at 4. The parties investment in parallel litigation
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`is considerable—indeed greater than when the Board denied the 1317 Petition.
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`Thus, contrary to Petitioner, it remains likely that the NDNY Patent
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`Litigation will proceed to trial around the time of a FWD here, making institution a
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`poor use of Board resources. Petitioner’s spin on the conference is misleading. It
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`incorrectly asserts that the NDNY “rejected Novartis’s request” on trial scheduling
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`(Reply at 5), when the magistrate judge simply left the issue unresolved because
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`the district judge “sets his own trial dates.” Ex. 2093 at 12. Petitioner’s argument
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`that discovery deadlines have not yet been set also ignores the magistrate judge’s
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`instruction for the parties to coordinate discovery with the SDNY Antitrust
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`Litigation. Ex. 2093 at 15. Fact discovery in SDNY closes in December 2021 and
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`expert discovery in May 2022—well before a FWD. Ex. 2096.
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`5
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`Date: August 27, 2021
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`Respectfully submitted,
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` 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
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`CERTIFICATE OF COMPLIANCE
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`The undersigned certifies that this brief complies with the type-volume
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`limitations of 37 CFR § 42.24(c). This brief contains no more than 5 pages, as
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`permitted by the Board’s email authorization dated August 12, 2021.
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`The undersigned further certifies that this brief complies with the typeface
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`requirements of 37 CFR § 42.6(a)(2)(ii) and typestyle requirements of 37 CFR §
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`42.6(a)(2)(iii). This brief has been prepared in a proportionally spaced typeface
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`using Microsoft Word 2010 in Times New Roman 14 point font.
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`Date: August 27, 2021
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`Respectfully submitted,
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`/Elizabeth J. Holland/
`By:
`Elizabeth J. Holland
`Registration. No. 47,657
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`7
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that this Novartis Pharma AG, Novartis Technology LLC,
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`and Novartis Pharmaceuticals Corporation’s Patent Owner Sur-Reply and all
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`Patent Owner exhibits cited therein were served via electronic mail, as agreed to by
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`counsel, upon the following counsel of record for the Petitioner:
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`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
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`Counsel for Petitioner Regeneron Pharmaceuticals, Inc.
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`Dated: August 27, 2021 By:
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`/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
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`8
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