`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner
`
`__________
`
`Case IPR2020-01317
`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 .................... 5
`The Fintiv Factors Compel Denial of Institution Based on
`Concurrent ITC Proceedings. ................................................................ 6
`Factor 1 (stay of proceedings) ..................................................... 8
`
`Factor 2 (proximity of trial date to projected deadline for
`final written decision) ................................................................. 9
`Factor 3 (investment in the ITC proceeding) ............................11
`
`Factor 4 (overlap of issues) .......................................................12
`
`Factor 5 (same parties) ..............................................................14
`
`Factor 6 (other circumstances) ..................................................14
`
`The Board Should Exercise Its Discretion Under Section 325(d)
`and Decline Institution Because the Art and Arguments Relied
`on in the Petition are Substantially the Same as What Was
`Addressed During Prosecution. ...........................................................15
`The Asserted Art is not Materially Different from Art
`
`Evaluated by the Examiner During Prosecution (Becton
`Dickinson Factors (a) and (b)). .................................................17
`The Examiner Evaluated and Rejected Arguments that
`Essentially Overlap with Those Presented by Petitioner
`(Becton Dickinson Factor (d)). ..................................................22
`The Examiner Extensively Evaluated Art and Arguments
`Essentially Similar to Those Asserted by Petitioner, and
`Developed a Thorough Record (Becton Dickinson Factor
`(c)). ............................................................................................25
`Petitioner Has Neither Pointed Out How the Examiner
`Erred in Her Evaluation of the Prior Art nor Identified
`Additional Evidence or Facts That Warrant
`Reconsideration of the Prior Art or Arguments (Becton
`Dickinson Factors (e) and (f)). ..................................................27
`
`
`
`
`
`
`
`i
`
`
`
`Person of Ordinary Skill and Claim Construction .........................................28
` Petitioner Has Failed to Carry Its Burden of Proving that there is a
`Likelihood that any CHallenged Claim is Unpatentable ...............................28
`The Claims of the ’631 Patent Would Not Have Been Obvious
`Over The Combination of Sigg and Boulange (Ground 1). ................28
`Petitioner Ignores Key Disclosures in Sigg. .............................29
`
`Petitioner Ignores Key Disclosures of Boulange. .....................33
`
`Petitioner Fails to Show Why a POSA Would Have Been
`
`Motivated To Combine Sigg and Boulange to Make the
`Claimed Invention. ....................................................................35
`Petitioner Ignores Prior Art Teachings and Fails to
`Demonstrate that A POSA Would Have had a
`Reasonable Expectation of Success in Combining Sigg
`and Boulange. ............................................................................39
`The Petition Fails to Address Secondary Considerations
`Supporting the Non-obviousness of the Claimed Inventions. ............42
`Claims 1–26 of the ’631 Patent would not have been obvious
`over the combination of Sigg and Boulange (Grounds 1–5). .............45
`Conclusion .....................................................................................................47
`
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`
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`
`
`ii
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`
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Advanced Bionics, LLC. V. Med-El Elektromedizinishce Gerate
`GMBH,
`No. IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) ......................... 6, 17, 25, 28
`Apple Inc. v. Fintiv Inc.,
`IPR2020-00019, Paper 11 (PTAB, March 20, 2020) ..................................passim
`Apple Inc. v. Fintiv Inc.,
`IPR2020-00019, Paper 15 (PTAB, May 13, 2020) ........................................ 9, 15
`Apple Inc. v. Maxell, Ltd.,
`IPR2020-00203, Paper 12 (PTAB July 6, 2020) ................................................ 10
`Becton, Dickinson and Co. v. B. Braun Melsungen AG,
`No. IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) .................................passim
`Cisco Sys., Inc. v. Ramot at Tel Aviv University Ltd.,
`IPR2020-00122, Paper 15 (PTAB May 15, 2020) ................................... 9, 14, 15
`Crocs, Inc. v. Int’l Trade Comm.,
`598 F.3d 1294 (Fed. Cir. 2010) .................................................................... 42, 43
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 5
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig.,
`676 F.3d 1062 (Fed. Cir. 2012) .......................................................................... 44
`Ecolochem, Inc. v. S. California Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000) .......................................................................... 39
`Fitbit, Inc. v. Koninklijke Philips N.V.,
`IPR2020-00772, Paper 14 (P.T.A.B. Oct. 19, 2020) ...................................passim
`In re Fritch,
`972 F.2d 1260 (Fed. Cir. 1992) .......................................................................... 29
`
`i
`
`
`
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) ............................................................................ 5
`Impax Labs. Inc. v. Lannett Holdings Inc.,
`893 F.3d 1372 (Fed. Cir. 2018) .......................................................................... 44
`Intel Corp. v. VLSI Tech. LLC,
`IPR2020-00106, Paper 17 (PTAB May 5, 2020) ............................................... 10
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .......................................................................... 39
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ...................................................................................... 35, 36
`Mylan Pharm. Inc. v. Research Corp. Techs., Inc.,
`914 F.3d 1366 (Fed. Cir. 2019) .......................................................................... 46
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ........................................... 6, 10
`Novartis Pharma AG, et al. v. Regeneron Pharmaceuticals, Inc.,
`1:20-cv-690 (S.D.N.Y. July 30, 2020) ................................................................. xi
`Novartis Pharma AG v. Regeneron Pharm. Inc.,
`1:20-cv-00690 (N.D.N.Y.) .................................................................................... 8
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) .......................................................................... 38
`Regents of Univ. of Cal. v. Broad Inst., Inc.,
`903 F.3d 1286 (Fed. Cir. 2018) .......................................................................... 39
`Samsung Electronics America, Inc. v. Uniloc 2017 LLC,
`IPR2019-01218, Paper 7 (PTAB Jan. 7, 2020) .................................................. 10
`Stryker Corp. v. KFX Medical, LLC,
`IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019)............................................. 43
`Supercell Oy v. Gree, Inc.,
`IPR2020-00310, Paper 13 (PTAB June 18, 2020) ............................................. 10
`
`
`
`ii
`
`
`
`Tec Air, Inc. v. Denso Mf’g. Michigan, Inc.,
`192 F.3d 1353 (Fed. Cir. 1999) .......................................................................... 39
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .......................................................................... 36
`VIZIO, Inc. v. Polaris PowerLED Tech.,
`IPR2020-00043, Paper 30 (PTAB May 4, 2020) ............................................... 10
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) .......................................................................... 44
`Statutes
`28 U.S.C. § 1659 ................................................................................................... xi, 8
`35 U.S.C. § 313 .......................................................................................................... 1
`35 U.S.C. § 314(a) ................................................................................................. 2, 5
`35 U.S.C. § 316(b) ..................................................................................................... 7
`35 U.S.C. § 325(d) ............................................................................................passim
`Other Authorities
`37 C.F.R. § 42.24 ....................................................................................................... 1
`37 C.F.R. § 42.107 ..................................................................................................... 1
`37 C.F.R. § 42.108(c) ......................................................................................... 15, 47
`
`
`
`iii
`
`
`
`
`
`Patent Owner’s Exhibit List
`
`
`
`Exhibit
`
`Description
`
`Ex. 2001 Declaration of Karl R. Leinsing, PE
`
`Ex. 2002 Order No. 8: Procedural Schedule, ITC Inv. No. 337-TA-1207
`
`Ex. 2003 Regeneron’s Initial Invalidity Contentions in ITC Inv. No. 337-TA-
`1207, Exhibit A: Invalidity of U.S. Patent No. 9,220,631 Under 35
`U.S.C. §§ 102-103
`
`Ex. 2004 Regeneron’s Initial Invalidity Contentions in ITC Inv. No. 337-TA-
`1207, Exhibit A1: Invalidity Claim Chart of Sigg, alone or in
`combination with any of Boulange, Lam, Reuter, Scypinski, Metzner,
`Shah, Fries, Schoenknecht, Chacornac, Nema, D’Souza, Furfine,
`Badkar, Macugen, Eylea, Lucentis, Stewart, USP789, Liu, Hioki,
`DC365, Hagen, Khandke, Wittland, Shams, Dixon, and/or Cormier
`against U.S. Patent No. 9,220,631.
`
`Ex. 2005 Regeneron’s Initial Invalidity Contentions in ITC Inv. No. 337-1207,
`Exhibit A2: Invalidity Claim Chart of Boulange, alone or in
`combination with any of Sigg, Lam, Reuter, Scypinski, Metzner,
`Shah, Fries, Schoenknecht, Chacornac, Nema, D’Souza, Furfine,
`Badkar, Macugen, Eylea, Lucentis, Stewart, USP789, Liu, Hioki,
`DC365, Hagen, Khandke, Wittland, Shams, Dixon, and/or Cormier
`against U.S. Patent No. 9,220,631.
`
`Ex. 2006
`
`Ex. 2007
`
`Edwin Chan, et al., Syringe Siliconization Process Investigation and
`Optimization, PDA JOURNAL OF PHARMACEUTICAL SCIENCE AND
`TECHNOLOGY, 136-158 (2012) (“Chan”)
`
`Sophie J. Bakri, M.D. and Noha S. Ekdawi, M.D., Intravitreal
`Silicone Oil Droplets After Intravitreal Drug Injections, RETINA
`28:996-1001 (2008) (“Bakri”)
`
`Ex. 2008 Mehmet Selim Kocabora, Kemal Turgay Ozbilen and Kubra
`Serefoglu, Letter to the Editor: Intravitreal silicone oil droplets
`following pegaptanib injection, ACTA OPHTHALMOLOGICA e44-e45
`
`iv
`
`
`
`Exhibit
`
`Description
`
`(2010) (“Kocabora”)
`
`Ex. 2009 Gholam A. Peyman, Eleonora M. Lad and Darius M. Moshfeghi,
`Intravitreal Injection Of Therapeutic Agents, RETINA 29:875–912
`(2009) (“Peyman”)
`
`Ex. 2010 Randall V. Wong, Ocular Drug Delivery Systems, RETINA TODAY 48-
`49 (Jan./Feb. 2016) (“Wong”)
`
`Ex. 2011 Rohan Merani and Alex P. Hunyor, Endophthalmitis following
`intravitreal anti‑vascular endothelial growth factor (VEGF) injection:
`a comprehensive review, INT. J. RETIN. VITR. 1:9 (2015) (“Merani”)
`
`Ex. 2012 U.S. Patent No. 6,884,879 to Baca, et al. (2005) (“Baca”)
`
`Ex. 2013
`
`Ex. 2014
`
`Ex. 2015
`
`Philip J. Rosenfeld, et al., Ranibizumab for Neovascular Age-Related
`Macular Degeneration, NEJM 355(14): 1419-31 (2005)
`(“Rosenfeld”)
`
`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. 2016 Michael Colucciello, Prefilled Syringe Delivery of Intravitreal Anti-
`VEGF Medications, RETINAL PHYSICIAN 16: 50-52 (Mar. 2019)
`(“Colucciello”)
`
`Ex. 2017 Masabumi Shibuya, Vascular Endothelial Growth Factor (VEGF) and
`Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target
`forAnti- and Pro-Angiogenic Therapies, GENES & CANCER 2(12):
`1097–1105 (2011) (“Shibuya”)
`
`Ex. 2018 Manish Nagpal, Kamal Nagpal and P.N. Nagpal, A comparative
`debate on the various anti-vascular endothelial growth factor drugs:
`Pegaptanib sodium (Macugen), ranibizumab (Lucentis) and
`v
`
`
`
`
`
`Exhibit
`
`Description
`
`bevacizumab (Avastin), INDIAN J. OPHTHALMOL. 255:437-39 (2007)
`
`Ex. 2019
`
`Ingrid U. Scott, et al., SCORE Study Report 7: Incidence of
`Intravitreal Silicone Oil Droplets Associated With Staked-on Versus
`Luer Cone Syringe Design, AM. J. OPHTHALMOL. 48(5):725-32 (Nov.
`2009) (“Scott”)
`
`Ex. 2020 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”)
`
`Ex. 2021
`
`Prefilled syringes: the container of choice for today’s injectables,
`ONDRUGDELIVERY LTD. (June 2008) (“ONdrugDelivery”)
`
`Ex. 2022 Miki Honda, et al., Liposomes and nanotechnology in drug
`development: focus on ocular targets, INTERNATIONAL JOURNAL OF
`NANOMEDICINE 8:495-504 (2013) (“Honda”)
`
`Ex. 2023
`
`European Patent Application No. 12189649 to Novartis AG
`
`Ex. 2024
`
`Zai-Quin Wen, et al., Distribution of Silicone Oil in Prefilled Glass
`Syringes Probed with Optical and Spectroscopic Methods, PDA
`JOURNAL OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY 63(2):149-
`58 (Mar.–April 2009) (“Wen”)
`
`Ex. 2025 Andrea Wagner, Advances in Prefilled Syringe Technology,
`INNOVATIONS IN PHARMACEUTICAL TECHNOLOGY 73-75 (2007)
`(“Wagner”)
`
`Ex. 2026 Roche Finance Report 2015
`
`Ex. 2027 Roche Finance Report 2016
`
`Ex. 2028 Roche Finance Report 2018
`
`Ex. 2029 Roche Finance Report 2019
`
`
`
`vi
`
`
`
`Exhibit
`
`Description
`
`Ex. 2030
`
`Intentionally Omitted
`
`Ex. 2031
`
`Intentionally Omitted
`
`Ex. 2032
`
`Intentionally Omitted
`
`Ex. 2033
`
`Intentionally Omitted
`
`Ex. 2034
`
`Intentionally Omitted
`
`Ex. 2035
`
`Intentionally Omitted
`
`Ex. 2036
`
`Intentionally Omitted
`
`Ex. 2037
`
`Intentionally Omitted
`
`Ex. 2038
`
`Intentionally Omitted
`
`Ex. 2039
`
`Intentionally Omitted
`
`Ex. 2040
`
`Jared S. Bee, Effects of Surfaces and Leachables on the Stability of
`Biopharmaceuticals, PHARM SCI 100:4158-70 (2011) (“Bee”)
`
`Ex. 2041
`
`Screen capture of Genentech Press Release, “FDA Approves
`Genentech’s Lucentis (Ranibizumab Injection) Prefilled Syringe”
`(Oct. 14, 2016)
`
`Ex. 2042 Unopposed Motion to Stay Pursuant to 28 U.S.C. § 1659 (ECF 24),
`Novartis Pharma AG, et al. v. Regeneron Pharmaceuticals, Inc., 1:20-
`cv-690 (S.D.N.Y., July 28, 2020)
`
`Ex. 2043
`
`Text Order granting Motion to Stay the Case (ECF 25), Novartis
`Pharma AG, et al. v. Regeneron Pharmaceuticals, Inc., 1:20-cv-690
`(S.D.N.Y. July 30, 2020)
`
`Ex. 2044 U.S. Patent Application Publication No. 2014/0012227 to Sigg, et al.
`
`Ex. 2045 Regeneron’s Initial Invalidity Contentions in ITC Inv. No. 337-TA-
`1207, Exhibit A3: Invalidity Claim Chart of Lam, alone or in
`
`
`
`vii
`
`
`
`Exhibit
`
`Description
`
`combination with any of Sigg, Boulange, Reuter, Scypinski, Fries,
`Chacornac, Nema, D’Souza, Furfine, Badkar, Macugen, Eylea,
`Lucentis, Stewart, USP789, Liu, Hioki, DC365, Khandke, and/or
`Dixon against U.S. Patent No. 9,220,631.
`
`Ex. 2046 Regeneron’s Initial Invalidity Contentions in ITC Inv. No. 337-TA-
`1207, Exhibit A4: Invalidity Claim Chart of Reuter, alone or in
`combination with any of Sigg, Boulange, Lam, Scypinski, Metzner,
`Shah, Fries, Schoenknecht, Chacornac, Nema, D’Souza, Furfine,
`Badkar, Macugen, Eylea, Lucentis, Stewart, USP789, Liu, Hioki,
`DC365, Hagen, Khandke, Wittland, Shams, Dixon, and/or Cormier
`against U.S. Patent No. 9,220,631.
`
`
`
`viii
`
`
`
`
`
`
`
`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. (“Patent Owner”
`
`or “Novartis”) submits 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”).
`
`Petitioner asks the Board to expend its time and resources duplicating the
`
`efforts that are already well underway in a parallel proceeding between the same
`
`parties before the International Trade Commission (the “ITC Investigation”). In
`
`the ITC Investigation, Petitioner is making the exact same obviousness arguments,
`
`based on the exact same prior art combinations, that appear in its Petition.
`
`Significantly, the ITC Investigation will be tried approximately nine months, and
`
`decided approximately six months, before any potential final written decision here.
`
`Moreover, the parties, the ITC Administrative Law Judge (“ALJ”), and the staff
`
`attorneys at the Office of Unfair Import Investigation (“OUII”) have already
`
`expended significant resources on the case, and by the time an institution decision
`
`is due, both fact discovery and claim construction will have concluded, and the
`
`parties will be in the thick of expert discovery. In short, all the Fintiv factors
`
`weigh heavily against institution. Apple Inc. v. Fintiv Inc., IPR2020-00019, Paper
`
`11 (PTAB, March 20, 2020) (“Fintiv I”) (precedential). Accordingly, the Board
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`IPR2020-01317
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`Page 1 of 49
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`should decline to engage in the inefficiencies, duplication of efforts and potential
`
`for inconsistent decisions that would result from institution, and exercise its
`
`discretion under § 314(a) to deny the Petition.
`
`Even setting aside the parallel, advanced ITC Investigation, Regeneron has
`
`engaged in efforts to pile-on and have the Board engage in needlessly duplicative
`
`proceedings. Not only has Regeneron filed two separate Petitions with the Board
`
`that make essentially the same arguments (see IPR2020-01318), both Petitions rely
`
`on substantially the same art and arguments that were before the Examiner during
`
`prosecution. In this Petition, Regeneron relies on Sigg for its teaching of terminal
`
`sterilization and Boulange for its teaching of baked-on siliconization. But the
`
`specification itself explicitly acknowledges that terminal sterilization was taught in
`
`the prior art, and the Badkar reference, among other references that were of record
`
`during prosecution, discloses baked-on siliconization. The Board should not have
`
`to expend its time and energy rehashing what was already considered and decided
`
`during prosecution, and, accordingly, should exercise its discretion to deny the
`
`Petition under 35 U.S.C. § 325(d).
`
`Finally, the Petition fails to establish a reasonable likelihood of success as to
`
`any claim. Petitioner has failed to demonstrate that a person of ordinary skill in the
`
`art (“POSA”) would have been motivated to combine Sigg and Boulange. Among
`
`other things, Petitioner completely ignores that Boulange expressly teaches away
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`IPR2020-01317
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`Page 2 of 49
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`
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`from the claimed invention because it discloses that its syringe will not function
`
`properly unless the stopper is coated with the unproven chemical Parylene C, but
`
`provides no teaching or even a suggestion that a POSA would find Parylene C to
`
`be acceptable for a prefilled syringe (“PFS”) used for injecting sensitive VEGF
`
`antagonists into the eye. And Petitioner fails to demonstrate why a POSA would
`
`have had any reason to believe that the Parylene C-coated PFS of Boulange would
`
`coincidentally be among the “few” syringes that Sigg says would be compatible
`
`with its terminal sterilization technique. Since the Petition does not provide any
`
`reason why a POSA would want to combine the references when all their teachings
`
`are taken into consideration, Petitioner has not demonstrated a motivation to
`
`combine.
`
`Moreover, even if a POSA were to have combined Sigg and Boulange, there
`
`would have been no reason to expect the combination to be successful. As set
`
`forth above, Petitioner provides no reason why a POSA would have used (let alone
`
`have been confident in using) the unproven Parylene C stopper coating required by
`
`Boulange; and Boulange teaches that without the coating, a low-silicone oil
`
`syringe would not work. Among other things, Petitioner does not explain why a
`
`POSA would have reasonably expected that Parylene C could be used without
`
`damaging a sensitive VEGF antagonist formulation; would not lead to harmful
`
`effects after injection into the eye; and would maintain its lubricating ability upon
`
`IPR2020-01317
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`Page 3 of 49
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`exposure to the gases in Sigg’s terminal sterilization method. Petitioner also does
`
`not explain why a POSA would have had reason to expect that the amount of
`
`silicone oil taught in Boulange would be sufficient to ensure smooth, controlled
`
`use of the syringe by a physician.
`
`In short, Petitioner’s attempt to portray the claimed inventions as an obvious
`
`combination of prior art elements is based on nothing more than hindsight, as can
`
`be seen from real-world evidence. Regeneron acknowledges the “well-known
`
`advantages” of a pre-filled syringe (“PFS”) over a vial for intravitreal
`
`administration of VEGF antagonists (Pet. at 5), but ignores the fact that no
`
`pharmaceutical company was able to put a PFS with the claimed elements on the
`
`market before the priority date of the ’631 patent. For example, Genentech had
`
`tried for years to develop a PFS that could be used to administer its VEGF-
`
`antagonist drug Lucentis®, but ultimately abandoned the project after its efforts
`
`failed. Genentech was only able to get Lucentis® to market in a PFS format after
`
`taking a license to the ’631 patent and adopting Novartis’s PFS technology. The
`
`Lucentis® PFS, which practices the inventions of the ’631 patent, has been a
`
`commercial success and has generated industry acclaim. Petitioner simply ignores
`
`such evidence.
`
`In sum, based on the Petition’s failure to demonstrate either motivation to
`
`combine Sigg and Boulange or a reasonable expectation of success even if a POSA
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`IPR2020-01317
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`Page 4 of 49
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`were to do so, combined with its failure to address any secondary considerations of
`
`nonobviousness, including Genentech’s licensing of the ’631 patent (which
`
`Regeneron was aware of), the Board should decline to institute the Petition for this
`
`additional reason.
`
` THE BOARD SHOULD EXERCISE ITS DISCRETION AND DENY
`INSTITUTION
`Institution of an inter partes review is in the Board’s discretion. 35 U.S.C.
`
`§ 314(a); see also Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (2016)
`
`(“[T]he agency’s decision to deny a petition is a matter committed to the Patent
`
`Office’s discretion.”); Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367
`
`(Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR
`
`proceeding.”).
`
`Here, there are two independent reasons for the Board to exercise its
`
`discretion and deny institution. First, institution should be denied under 35 U.S.C.
`
`§ 314(a) and the Board’s precedential decision in Fintiv because Petitioner and
`
`Patent Owner are litigating the identical issues raised in the Petition in the parallel
`
`ITC Investigation; a decision is set to issue in the ITC Investigation six months
`
`before any final written decision here; the parties, ALJ and OUII staff have already
`
`expended, and continue to expend, significant resources in the ITC Investigation;
`
`and the arguments in the Petition are weak. See generally Fintiv I.
`
`IPR2020-01317
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`Page 5 of 49
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`Second, Becton Dickinson and Advanced Bionics compel denial of
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`institution under 35 U.S.C. § 325(d) because the art and arguments in the Petition
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`are substantially the same as what the Examiner considered during prosecution,
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`and Petitioner fails to establish any error by the Examiner. Becton, Dickinson and
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`Co. v. B. Braun Melsungen AG, No. IPR2017-01586, Paper 8 at 17–19 (PTAB
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`Dec. 15, 2017) (precedential); Advanced Bionics, LLC. V. Med-El
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`Elektromedizinishce Gerate GMBH, No. IPR2019-01469, Paper 6 at 10 (PTAB
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`Feb. 13, 2020) (precedential).
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` The Fintiv Factors Compel Denial of Institution Based on
`Concurrent ITC Proceedings.
`Regeneron’s Petition asks the Board to review the patentability of the same
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`patent claims, based on the same prior art and arguments, that are at issue in a
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`parallel ITC investigation between the same parties, which is set to be tried
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`approximately nine months before a final written decision in this IPR. The Board
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`has found that institution of an IPR under these circumstances amounts to a
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`multiplication of proceedings, is an inefficient use of resources, and is contrary to
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`Congress’s intent in establishing IPR proceedings. NHK Spring Co. v. Intri-Plex
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`Techs., Inc., IPR2018-00752, Paper 8 at 20 (PTAB Sept. 12, 2018) (precedential);
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`see also Fitbit, Inc. v. Koninklijke Philips N.V., IPR2020-00772, Paper 14 at 13
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`(PTAB Oct. 19, 2020) (Decisions denying institution based on parallel litigation
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`“promote efficient use of resources and the integrity of the patent system by
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`avoiding potentially conflicting decisions.”).
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`The Board made clear in its precedential order in Fintiv I that the
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`efficiencies gained by denying institution based on parallel proceedings applies to
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`a situation like this one where there is an active, advanced ITC investigation and a
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`stayed district court litigation. As the Board explained, “as a practical matter, it is
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`difficult to maintain a district court proceeding on patent claims determined to be
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`invalid at the ITC.” Fintiv I, IPR2020-00019, Paper 11 at 8–9. The November
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`2019 Patent Trial and Appeal Board Consolidated Trial Practice Guide
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`(“Consolidated Trial Guide”) specifically identifies parallel ITC proceedings as an
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`example of a situation that favors denying a petition because of the “‘effect…on
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`the economy, the integrity of the patent system, the efficient administration of the
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`Office, and the ability of the Office to timely complete proceedings.’” Id. at 56
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`(quoting 35 U.S.C. § 316(b)). This same conclusion was reached earlier this week
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`in the Fitbit decision, where the Board denied institution in circumstances similar
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`to those here, specifically finding that Fintiv I applies to parallel ITC proceedings.
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`Fitbit, IPR2020-00772, Paper 14 at 23.
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`In Fintiv I, the Board set forth the following factors to be considered in
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`determining whether to deny institution based on parallel proceedings:
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`1. whether the court granted a stay or evidence exists that one may be
`granted if a proceeding is instituted;
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`2. proximity of the court’s trial date to the Board’s projected statutory
`deadline for a final written decision;
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`3. investment in the parallel proceeding by the court and the parties;
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`4. overlap between issues raised in the petition and in the parallel
`proceeding;
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`5. whether the petitioner and the defendant in the parallel proceeding
`are the same party; and
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`6. other circumstances that impact the Board’s exercise of discretion,
`including the merits.
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`Fintiv I, IPR2020-00019, Paper 11 at 5–6. As set forth in detail below, each of the
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`Fintiv factors, alone and when balanced together, favors denial of institution in this
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`case.
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`Factor 1 (stay of proceedings)
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`The fact that parallel litigation has not been stayed favors denial of
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`institution. Id. 7–8. As the Board explained in Fintiv I, institution of an IPR while
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`parallel litigation on the same patent is ongoing leads to inefficiencies and
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`duplication of efforts. Id. at 6–8. In this case, the ITC investigation has not been
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`stayed, and is proceeding apace. While Novartis’s Northern District of New York
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`(“NDNY”) action1 was stayed pursuant to 28 U.S.C. § 1659 in view of the parallel
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`ITC investigation, the stay will be lifted once the ITC investigation concludes. See
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`1 Novartis Pharma AG v. Regeneron Pharm. Inc., 1:20-cv-00690 (N.D.N.Y.).
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`Exs. 2042, 2043. This is the precise situation addressed in both Fintiv and Fitbit.
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`Fintiv I, IPR2020-00019, Paper 11 at 8-9; Fitbit, IPR2020-00772, Paper 14 at 14–
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`16.
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`Thus, because the parallel ITC case has not been stayed, and the concurrent
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`district court action in the NDNY will resume once the ITC case is decided, Factor
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`1 favors denial of institution.
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`Factor 2 (proximity of trial date to projected deadline for
`final written decision)
`The parallel ITC hearing is set to begin on April 19, 2021, and the ITC is set
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`to issue a decision on the validity of the ’631 patent by July 29, 2021. Ex. 2002.
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`This is well before the January 2022 projected date for a final written decision
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`should institution be granted here. And there is no indication that this hearing or
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`the schedule for the ITC investigation will be delayed or otherwise impacted
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`because of issues related to COVID-19.
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`The Board regularly denies institution where the trial of parallel proceedings
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`will take place even closer in time to the PTAB’s projected statutory deadline for
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`its final written decision than the nine-month gap here. See, e.g., Apple Inc. v.
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`Fintiv Inc., IPR2020-00019, Paper 15 at 17 (PTAB, May 13, 2020) (institution
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`denied where trial scheduled to begin two months before deadline for final written
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`decision) (“Fintiv II”); Cisco Sys., Inc. v. Ramot at Tel Aviv University Ltd.,
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`IPR2020-00122, Paper 15 at 8 (PTAB May 15, 2020) (institution denied where
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`trial scheduled to begin six months before deadline for final written decision);
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`NHK Spring Co. v. Intri-Plex Tech., Inc., IPR2018-00752, Paper 8 at 20 (PTAB
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`Sept. 12, 2018) (institution denied where trial scheduled to begin six months
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`before deadline for final written decision); Supercell Oy v. Gree, Inc., IPR2020-
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`00310, Paper 13, at 10–12 (PTAB June 18, 2020) (institution denied where trial
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`scheduled to begin six months before deadline for final written decision); Samsung
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`Electronics America, Inc. v. Uniloc 2017 LLC, IPR2019-01218, Paper 7 at 10
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`(PTAB Jan. 7, 2020) (institution denied where trial scheduled to begin six months
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`before deadline for final written decision); Intel Corp. v. VLSI Tech. LLC,
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`IPR2020-00106, Paper 17 at 7 (PTAB May 5, 2020) (institution denied where trial
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`scheduled to begin seven months before deadline for final written decision);
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`VIZIO, Inc. v. Polaris PowerLED Tech., IPR2020-00043, Paper 30 at 8 (PTAB
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`May 4, 2020) (institution denied where trial scheduled to begin seven months
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`before deadline for final written decision); Apple Inc. v. Maxell, Ltd., IPR2020-
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`00203, Paper 12, at 10 (PTAB July 6, 2020) (institution denied where trial
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`scheduled to begin eight months before deadline for final written decision).
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`Here, since a final written decision would be due approximately nine months
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`after the ITC holds its hearing on the merits, and approximately six months after
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`the ITC issues its decision, Factor 2 strongly favors denial of institution.
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`Factor 3 (investment in the ITC proceeding)
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`By the time an institution decision is due on January 22, 2021, the ITC and
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`the parties will have already invested significant resources in the investigation.
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`Fact discovery is set to close on December 18, 2020. As of the date of this
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`Preliminary Response, the parties have already served responses to 365 requests
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`for production and 43 interrogatories; collected, reviewed, and produced more than
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`59,606 documents; served 3,710 pages of initial invalidity and infringement
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`contentions; served subpoenas on seven third parties; and have received 2,121
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`pages of production from those third parties. By the time the institution decision is
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`due, the parties will likely have produced thousands more documents and will
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`likely have taken more than a dozen fact depositions