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 PRELIMINARY RESPONSE
`
`
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`
`
` 
`
` 
`
` 
`
`Introduction ...................................................................................................... 1 
`The Board Should Exercise Its Discretion and Deny Institution .................... 6 
`The Board Should Deny Institution of Regeneron’s Third
`Petition Under General Plastic. ............................................................ 6 
`Factors 1 & 2: Petitioner challenges the same claims of
` 
`the same patents using the same prior art. ................................ 10 
`Factor 3: Petitioner received two POPRs, the Board’s
`decision denying institution, and extensive discovery in
`related proceedings. .................................................................. 11 
`Factors 4 & 5: Petitioner fails to justify the significant
`time gap between petitions. ....................................................... 14 
`Factors 6 & 7: Institution would be a waste of the
`Board’s finite resources. ........................................................... 16 
`The Board Should Deny Institution Under Fintiv. .............................. 16 
`The Board Should Exercise Its Discretion Under Section 325(d)
`and Decline Institution. ....................................................................... 22 
`The asserted art is not materially different from art
` 
`evaluated during prosecution (Factors (a) and (b)). .................. 22 
`The Examiner evaluated and rejected arguments that
`overlap with those presented here (Factor (d)). ........................ 26 
`The Examiner evaluated art and arguments similar to
`those asserted here (Factor (c)). ................................................ 28 
`Petitioner has not identified any error by the Examiner
`(Factors (e) and (f)). .................................................................. 29 
`Petitioner Has Not Shown There Is A Likelihood That Any
`Challenged Claim Is Unpatentable ................................................................ 30 
`The Claims of the ’631 Patent Would Not Have Been Obvious
`Over The Combination of Sigg and Boulange (Ground 1). ................ 30 
`Petitioner has failed to show that Sigg enables a
` 
`sterilization method for a PFS................................................... 31 
`
` 
`
` 
`
` 
`
` 
`
` 
`
` 
`
` 
`
` 
`
`3. 
`
` 
`
`i
`
`

`

` 
`
` 
`
` 
`
`A POSA would not have been motivated to use
`Boulange. .................................................................................. 37 
`Petitioner fails to show that a POSA would have had a
`reasonable expectation of success in combining Sigg and
`Boulange. .................................................................................. 49 
`The Claims of the ’631 Patent Would Not Have Been Obvious
`Over The Combination of Lam and Boulange (Ground 2). ................ 53 
`The Petition’s Cursory Treatment of Secondary Considerations
`Further Undermines Petitioner’s Obviousness Argument. ................. 55 
`Long-felt Need and Failure of Others ....................................... 56 
` 
`Commercial Success, Licensing, and Industry Praise .............. 58 
`Unexpected Results ................................................................... 60 
` 
`Claims 1–26 of the ’631 Patent Would Not Have Been Obvious
`Over any of the Combinations of Grounds 1–10. ............................... 61 
`  Conclusion ..................................................................................................... 62 
`
` 
`
` 
`
` 
`
`
` 
`
` 
`
`
`
`
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Advanced Bionics,
`No. IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) ..............................................................30
`
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (Mar. 20, 2020)...................................................................... passim
`
`Apple Inc. v. Pinn, Inc.,
`IPR2020-00999, Paper 15 (PTAB Dec. 8, 2020) .....................................................................17
`
`Apple Inc. v. Uniloc 2017 LLC,
`IPR2020-00854, Paper 9 (PTAB Oct. 28, 2020) ...............................................................11, 14
`
`Arctic Cat Inc. v. GEP Power Prod., Inc.,
`919 F.3d 1320 (Fed. Cir. 2019)................................................................................................48
`
`Becton, Dickinson and Co. v. B. Braun Melsungen AG,
`No. IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ..................................................22, 26, 28
`
`Chengdu Kanghong Biotech. Co., Ltd. v. Regeneron Pharms, Inc.,
`PGR2021-00035, Paper 6 (PTAB Apr. 15, 2021) .............................................................32, 33
`
`Conopco, Inc. v. The Procter & Gamble Co.,
`IPR2014-00506, Paper 25 (PTAB Dec. 10, 2014) .............................................................11, 15
`
`Crocs, Inc. v. Int’l Trade Comm’n,
`598 F.3d 1294 (Fed. Cir. 2010)................................................................................................55
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012)................................................................................................57
`
`Envtl. Designs v. Union Oil Co. of Cal.,
`713 F.2d 693 (Fed. Cir. 1983)..................................................................................................56
`
`In re Fritch,
`972 F.2d 1260 (Fed. Cir. 1992)................................................................................................31
`
`General Plastic Industrial Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) ............................................................ passim
`
`Google LLC v. Personalized Median Comm’cns, LLC,
`IPR2020-00719, Paper 16 (PTAB Aug. 31, 2020) ..................................................................21
`
`iii
`
`

`

`Immunex Corp. v. Sandoz Inc.,
`964 F.3d 1049 (Fed. Cir. 2020)................................................................................................59
`
`Impax Labs. Inc. v. Lannett Holdings Inc.,
`893 F.3d 1372 (Fed. Cir. 2018)................................................................................................58
`
`Mylan Pharm. Inc. v. Research Corp. Techs., Inc.,
`914 F.3d 1366 (Fed. Cir. 2019)................................................................................................61
`
`Novartis Pharma AG et al. v. Regeneron Pharms., Inc.,
`No. 20-cv-690 (N.D.N.Y.) (filed Jun. 19, 2020) .....................................................................17
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`711 F.3d 1348 (Fed. Cir. 2013)................................................................................................59
`
`Raytheon Techs. Corp. v. General Elec. Co.,
`993 F.3d 1374 (Fed. Cir. 2021)..........................................................................................32, 54
`
`Regeneron Pharms., Inc. v. Novartis Pharma AG et al.,
`No. 20-cv-5502 (S.D.N.Y.) (filed July 17, 2020) ....................................................................17
`
`Regents of Univ. of Cal. v. Broad Inst., Inc.,
`903 F.3d 1286 (Fed. Cir. 2018)................................................................................................49
`
`Samsung Elecs. Co. v. Elm 3DS Innovations, LLC,
`IPR2017-01305, Paper 11 (PTAB Oct. 17, 2017) .................................................10, 11, 14, 15
`
`Seko S.P.A. v. CM2W JSC,
`IPR2020-01636, Paper 8 (PTAB Dec. 2, 2020).........................................................................8
`
`Shenzhen Silver Star Intelligent Tech. Co. v. iRobot Corp.,
`IPR2018-00880, Paper 8 (PTAB Sept. 19, 2018) ......................................................................8
`
`Sotera Wireless, Inc. v. Masimo Corp.,
`IPR2020-01019, Paper 12 (Dec. 1, 2020) ................................................................................20
`
`Storer v. Clark,
`860 F.3d 1340 (Fed. Cir. 2017)................................................................................................34
`
`Stryker Corp. v. KFX Medical, LLC,
`IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019) ..................................................................55
`
`Symbol Techs., Inc. v. Opticon, Inc.,
`935 F.2d 1569 (Fed. Cir. 1991)................................................................................................58
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016)..........................................................................................56, 59
`
`
`
`iv
`
`

`

`Wyeth & Cordis Corp. v. Abbott Labs.,
`720 F.3d 1380 (Fed. Cir. 2013)................................................................................................37
`
`
`
`Statutes
`
`28 U.S.C. § 1659 ......................................................................................................................17, 19
`
`35 U.S.C. § 102(e) .........................................................................................................................48
`
`35 U.S.C. § 313 ................................................................................................................................1
`
`35 U.S.C. § 314(a) ...........................................................................................................................6
`
`35 U.S.C. § 315(b) ...................................................................................................................15, 20
`
`35 U.S.C. § 316(a)(11) .....................................................................................................................9
`
`35 U.S.C. § 325(d) .................................................................................................................4, 6, 22
`
`
`
`Other Authorities
`
`37 C.F.R. § 42.24 .............................................................................................................................1
`
`37 C.F.R. § 42.107 ...........................................................................................................................1
`
`H.R. Rep. No. 103-826(I) reprinted in 1994 U.S.C.C.A.N. 3773 .................................................19
`
`
`
`v
`
`

`

`
`
`Patent Owner’s Exhibit List
`
`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)
`
`Ex. 2013
`
`IDS with Tack (9220631 File History)
`
`Ex. 2014
`
`European Patent Application No. EP 12189649 (EP ʼ649)
`
`vi
`
`

`

`Exhibit
`
`Description
`
`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
`
`
`
`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”)
`
`vii
`
`

`

`Exhibit
`
`Ex. 2026
`
`Description
`
`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”)
`
`Ex. 2035 Gregory Sacha, et al., Practical fundamentals of glass, rubber, and
`plastic sterile packaging systems, PHARM DEV TECHNOL. (2010)
`(“Sacha”)
`
`
`
`viii
`
`

`

`Exhibit
`
`Description
`
`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)
`
`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
`
`
`
`ix
`
`

`

`Exhibit
`
`Description
`
`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 Redacted Letter from Jessica Falk to Novartis in Response to May 10
`Letter, 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
`
`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)
`
`
`
`x
`
`

`

`Exhibit
`
`Description
`
`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]
`
`Ex. 2073
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Feb. 20, 2012 and
`Mar. 6, 2012) [FILED UNDER SEAL]
`
`
`
`xi
`
`

`

`Exhibit
`
`Ex. 2074
`
`Description
`
`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]
`
`Ex. 2086
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct.15, 2012)
`[FILED UNDER SEAL]
`
`
`
`xii
`
`

`

`Exhibit
`
`Ex. 2087
`
`Description
`
`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
`
`
`
`xiii
`
`

`

`
`
`
`
`INTRODUCTION
`Pursuant to 35 U.S.C. § 313 and 37 C.F.R. § 42.107, Novartis Pharma AG,
`
`Novartis Technology LLC and Novartis Pharmaceuticals Corp. (together “Patent
`
`Owner” or “Novartis”) submit this Patent Owner Preliminary Response to the
`
`Petition of Regeneron Pharmaceuticals, Inc. (“Petitioner” or “Regeneron”)
`
`challenging all claims of U.S. Patent No. 9,220,631 (“the ’631 patent”) (Ex. 1001).
`
`This is the third time that the same Petitioner has filed a petition challenging
`
`the same claims of the ’631 patent with the same art. See Ex. 2045 (IPR2020-
`
`01317 or “1317 IPR”, Pet.); Ex. 2046 (IPR2020-01318 or “1318 IPR”, Pet.). The
`
`Board granted Petitioner’s motion to terminate one of those petitions (Ex. 2050
`
`(1318 IPR, Paper 16)) and denied institution in the other (Ex. 1064 (1317 IPR,
`
`Paper 15)). Petitioner then withdrew its motion for reconsideration (Ex. 2053
`
`(1317 IPR, Paper 19)), even though the events that it now relies upon to justify this
`
`new Petition had already occurred. Under the Board’s precedent, successive
`
`petitions are disfavored, because they “are an inefficient use of the inter partes
`
`review process and the Board’s resources” and because they carry “the potential
`
`for abuse of the review process by repeated attacks on patents.” General Plastic
`
`Industrial Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 17, 21
`
`(PTAB Sept. 6, 2017) (precedential as to § II.B.4.i) (“General Plastic”). General
`
`Plastic provides a set of factors guiding the Board’s discretion on whether to grant
`
`IPR2021-00816 Page 1 of 63
`
`

`

`
`
`review of “follow-on petitions after the Board’s denial of one or more first-filed
`
`petitions on the same patent.” See id. at 15–16. When those factors are applied
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`here, as they must be, they overwhelmingly favor denying institution.
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`Petitioner fails to address General Plastic, disregarding the Board’s
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`instruction that petitioners should always “justify multiple petitions in the first
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`instance.” Patent Trial and Appeal Board Consolidated Trial Practice Guide
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`November 2019 at 61 n.4; see also id. at 56–61. Instead, Petitioner tries to
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`rationalize its follow-on Petition by noting that its 1317 IPR was denied in light of
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`a parallel ITC Investigation (“the ITC Investigation”) that has since been
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`terminated by Patent Owner to pursue other remedies. Pet. at 6, 8–9. But
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`Petitioner’s motion for reconsideration in the 1317 IPR was still pending when
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`Patent Owner moved to terminate the ITC Investigation in order to continue
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`pursuing its already filed district court infringement action instead.
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`Petitioner thus had ample opportunity to raise the ITC termination with the
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`Board as part of the previously filed and still pending 1317 IPR. Instead,
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`Petitioner withdrew its motion, closed the 1317 IPR, and filed this Petition. Doing
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`so allowed Petitioner to refashion its arguments in response to the deficiencies
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`identified by Patent Owner—by, for example, swapping out a reference (Reuter)
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`that Patent Owner had successfully sworn behind, and offering completely
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`revamped arguments on one of its lead references (Boulange). That type of
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`gamesmanship is exactly what the Board’s General Plastic test guards against.
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`General Plastic, IPR2016-01357, Paper 19 at 17–18. Petitioner’s silence on this
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`key issue underscores the indefensibility of its strategy.
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`Even leaving General Plastic aside, institution should be denied because
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`granting this successive Petition would be a poor use of this Board’s resources.
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`First, the Board should deny institution under Apple Inc. v. Fintiv, Inc.,
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`IPR2020-00019, Paper 11 (Mar. 20, 2020) (precedential) (“Fintiv”), as it did in the
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`1317 IPR. Petitioner tries to distinguish the 1317 IPR decision based on
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`termination of the ITC Investigation, but that development is offset by other events
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`over the last seven months. Once Patent Owner dismissed the ITC Investigation,
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`the district court lifted the stay in Patent Owner’s infringement action against
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`Petitioner in the Northern District of New York (“NDNY Patent Litigation”). Ex.
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`2057. Much of the discovery in that action is done, since discovery from the
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`nearly completed ITC Investigation is cross-designated for use in district court.
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`Ex. 2058.003; Ex. 2089.001. Moreover, Petitioner “also chose to pursue complex
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`antitrust claims” in separate district court action, which also “implicate many of the
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`same issues” pressed to the Board. Ex. 1064.023 (1317 IPR, Paper 15)). That
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`litigation (“the SDNY Antitrust Litigation”) has continued forward, with fact and
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`expert discovery closing well before a final written decision would issue. And the
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`parties have agreed that such discovery be cross-designated in the NDNY Patent
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`Litigation. Ex. 2058.003; Ex. 2089.001.
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`Second, institution should be denied under 35 U.S.C. § 325(d) because the
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`Petition relies on substantially the same art and arguments that were before the
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`Examiner during prosecution.
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`Finally, institution should be denied because the Petition fails to establish a
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`reasonable likelihood of success as to any claim. Petitioner relies on a
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`combination of Sigg (Ex. 1007) or Lam (Ex. 1029) (abandoned patent applications
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`that purport to disclose methods for terminally sterilizing a prefilled syringe) and
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`Boulange (Ex. 1008) (which discloses a syringe with stoppers coated with the
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`chemical Parylene C). But Petitioner fails to show that Sigg or Lam are enabled,
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`since they provide no guidance on which syringe designs are compatible with their
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`proposed methods—indeed, Sigg teaches that “very few” packaging material
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`combinations work. Ex. 1007.004. Boulange not only fails to fill these gaps, but
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`has its own significant limitations. The syringe disclosed in Boulange requires
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`Parylene C coating to function properly, but a POSA would not have considered
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`this unproven chemical acceptable for a PFS intended for injecting a VEGF
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`antagonist into the eye—a highly specialized use with unique safety concerns.
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`Recognizing this problem, Petitioner now argues that a POSA would have used
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`alternative syringes described in Boulange that were not coated with Parylene C.
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`But that new argument, in addition to flouting General Plastic, is contradicted by
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`Boulange itself, which describes the alternative syringes as “not… acceptable for a
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`medical device” and “markedly inferior.” Ex. 1008.021, .023.
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`In short, a POSA would not have been motivated to combine either Sigg or
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`Lam with Boulange, nor would a POSA have reasonably expected such a
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`combination to succeed. This conclusion is reinforced by objective evidence of
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`non-obviousness—evidence that Petitioner ignored in its first two petitions and
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`still only addresses in cursory fashion here, despite having taken discovery on the
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`issue in the ITC Investigation. Among other things, there was a long-felt unmet
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`need for a terminally-sterilized prefilled syringe (“PFS”) suitable for intravitreal
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`injection of a VEGF antagonist with low silicone oil amounts and low injection
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`forces. But despite market demand, sophisticated pharmaceutical companies tried
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`and failed to develop a PFS with this combination of features. Rather than engage
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`with this real-world evidence of non-obviousness, Petitioner relies heavily on the
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`prehearing brief submitted by a staff attorney in the ITC Investigation. See Pet. at
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`5, 7–9. But as Petitioner previously observed, the Board owes no deference even
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`to final Commission decisions. Ex. 2051.0017–.0018 (1317 IPR, Paper 13). The
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`Board should not give weight to a preliminary brief filed by a staff attorney before
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`evidence was presented at an ITC trial.
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`For the foregoing reasons, the Board should deny institution.
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` THE BOARD SHOULD EXERCISE ITS DISCRETION AND DENY
`INSTITUTION
`The question whether to institute inter partes review is committed to the
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`Board’s discretion. See 35 U.S.C. § 314(a). Here, there are three independent
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`reasons to exercise that discretion to deny institution. First, because Petitioner has
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`already filed two petitions challenging the same patent claims based on the same
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`prior art, the Board should deny institution under General Plastic. Second, the
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`Board should deny institution under Fintiv in view of the parallel, advanced district
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`court proceedings in which the ’631 patent’s validity will be adjudicated. Third,
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`the Board should deny institution under 35 U.S.C. § 325(d), because the Petition
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`revisits arguments that were considered and rejected during prosecution.
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` The Board Should Deny Institution of Regeneron’s Third Petition
`Under General Plastic.
`As the Board has recognized, “[m]ultiple, staggered petitions challenging the
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`same patent and same claims raise the potential for abuse.” General Plastic,
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`IPR2016-01357, Paper 19 at 17. Here, Petitioner files its third petition (through
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`the same counsel of record) challenging the same claims of the same patent based
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`on the same prior art as two earlier petitions:
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`IPR2021-00816 Page 6 of 63
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`Case
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`1317 IPR
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`1318 IPR
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`816 IPR
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`
`
`Claims
`challenged
`Claims 1–26
`of ’631 patent
`
`Primary
`references
`Sigg and
`Boulange
`
`Claims 1–26
`of ’631 patent
`
`Lam and
`Reuter
`
`Claims 1–26
`of ’631 patent
`
`Sigg or Lam
`and Boulange
`
`Procedural history
`
`Filed: Jul. 16, 2020
`Institution denied: Jan. 15, 2021
`Mot. for reconsid.: Feb. 12, 2021
`Mot. to withdraw: Apr. 27, 2021
`Filed: Jul. 16, 2020
`Vol. Mot. to Terminate: Dec. 2, 2020
`Dismissed: Dec. 7, 2020
`Filed: Apr. 16, 2021
`
`The only apparent difference in this Petition is that Petitioner has reframed several
`
`of its arguments in view of Patent Owner’s two prior preliminary responses and the
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`arguments and discovery put forward in litigation on the same patent claims. But
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`that is precisely what General Plastic forbids, making this Petition improper. Nor,
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`as discussed further below, can Petitioner justify its repetitive filing on the timing
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`of Patent Owner’s dismissal of the ITC Investigation.
`
`Contrary to Petitioner’s speculation (Pet. at 7–9), Patent Owner did not
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`dismiss the ITC Investigation to avoid an adverse merits ruling. Rather, as Patent
`
`Owner explained in its motion to terminate, it “strongly believe[d] it would prevail
`
`on the merits” (Ex. 1006.002) and had already won partial summary
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`determinations on key issues, including direct infringement of the ’631 patent (Ex.
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`2090). But Patent Owner recognized that it might prove unable to secure a
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`meaningful