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 IPR2020-01318
`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 .................... 4
`The Fintiv Factors Compel Denial of Institution Based on
`
`Concurrent ITC Proceedings. ................................................................ 5
`Factor 1 (stay of proceedings) ..................................................... 7
`
`Factor 2 (proximity of trial date to projected deadline for
`
`final written decision) ................................................................. 8
`Factor 3 (investment in the ITC proceeding) ............................10
`
`Factor 4 (overlap of issues) .......................................................11
`
`Factor 5 (same parties) ..............................................................13
`
`Factor 6 (other circumstances) ..................................................13
`
`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. ...........................................................14
`The Asserted Art is not Materially Different from Art
`
`Evaluated by the Examiner During Prosecution (Becton
`Dickinson Factors (a) and (b)) ..................................................16
`The Examiner Evaluated and Rejected Arguments that
`Essentially Overlap with Those Presented by Petitioner
`(Becton Dickinson Factor (d)) ...................................................21
`The Examiner Extensively Evaluated Art and Arguments
`Essentially Similar to Those Asserted by Petitioner, and
`Developed a Thorough Record (Becton Dickinson Factor
`(c)). ............................................................................................24
`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)). ..................................................26
`
`
`
`
`
`
`
`i
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`

`

`
`
`
`
`
`
` Person of Ordinary Skill and Claim Construction .........................................27
`IV. Petitioner has failed to carry its burden of proving that there is a
`likelihood that any challenged claim is unpatentable ....................................27
`Reuter is not prior art...........................................................................27
`
`The Petition Does Not Demonstrate That Reuter Was
`
`Publicly Available Before The Claimed Priority Date .............27
`Even If Reuter Were Published Before The Claimed
`Priority Date, The Subject Matter Of The ʼ631 Patent
`Claims Was Invented Prior to Reuter’s Publication Date ........32
`Petitioner has failed to demonstrate that any of the claims are
`unpatentable over the combination of Lam in view of Reuter
`(Ground 1) ...........................................................................................36
`Petitioner Ignores Deficiencies of Lam ....................................36
`
`Petitioner Ignores Disclosures of Reuter ..................................37
`
`Petitioner Fails to Show Why a POSA Would Have Been
`
`Motivated to Combine Lam and Reuter to Make the
`Claimed Invention .....................................................................39
`Petitioner Fails To Demonstrate that a POSA Would Have Had
`A Reasonable Expectation of Success in Combining Lam and
`Reuter ..................................................................................................44
`The Petition Fails to Address Secondary Considerations
`Supporting the Non-obviousness of the Claimed Inventions. ............46
`Claims 1–26 of the ’631 Patent Would Not Have Been Obvious
`over the Combination of Lam and Reuter. ..........................................49
` CONCLUSION ..............................................................................................50
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Advanced Bionics, LLC. V. Med-El Elektromedizinishce Gerate
`GMBH,
`No. IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) ......................... 5, 16, 24, 27
`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) ........................................ 8, 14
`Apple Inc. v. Maxell, Ltd.,
`IPR2020-00203, Paper 12 (PTAB July 6, 2020) .................................................. 9
`Arctic Cat Inc. v. GEP Power Prod., Inc.,
`919 F.3d 1320 (Fed. Cir. 2019) .......................................................................... 34
`ATI Techs. ULC v. Iancu,
`920 F.3d 1362 (Fed. Cir. 2019) .......................................................................... 33
`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) ......................................... 8, 14
`Crocs, Inc. v. Int’l Trade Comm’n,
`598 F.3d 1294 (Fed. Cir. 2010) .......................................................................... 46
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 4
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) .......................................................................... 48
`Fitbit, Inc. v. Koninklijke Philips N.V.,
`IPR2020-00772, Paper 14 (P.T.A.B. Oct. 19, 2020) ...................................passim
`
`iii
`
`

`

`In re Fritch,
`972 F.2d 1260 (Fed. Cir. 1992) .......................................................................... 36
`Guardian Alliance Techs., Inc. v. Tyler Miller,
`IPR2020-00031, Paper 27 (PTAB Jul. 27, 2020) ............................................... 29
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) ............................................................................ 4
`Hulu, LLC v. Sound View Innovations, LLC,
`IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) ....................................... 28, 32
`Impax Labs. Inc. v. Lannett Holdings Inc.,
`893 F.3d 1372 (Fed. Cir. 2018) .......................................................................... 48
`In-depth Geophysical, Inc. v. ConocoPhillips Co.,
`IPR2019-00849, Paper 17 (PTAB Mar. 30, 2020) ................................. 28, 29, 32
`Intel Corp. v. Alacritech, Inc.,
`IPR2017-01395, Paper 8 (PTAB Nov. 22, 2017) ......................................... 28, 30
`Intel Corp. v. VLSI Tech. LLC,
`IPR2020-00106, Paper 17 (PTAB May 5, 2020) ................................................. 9
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 40
`Laboratory Corp. of America v. Quest Diagnostics LLC,
`IPR2019-01425, Paper 9 (PTAB Feb. 6, 2020) .................................................. 30
`Medtronic Inc. v. Barry,
`891 F.3d 1368 (Fed. Cir. 2018) .......................................................................... 28
`Mylan Pharm. Inc. v. Research Corp. Techs., Inc.,
`914 F.3d 1366 (Fed. Cir. 2019) .......................................................................... 49
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ............................................. 5, 9
`Novartis Pharma AG v. Regeneron Pharm. Inc.,
`1:20-cv-00690 (N.D.N.Y.) .................................................................................... 7
`
`iv
`
`

`

`Perfect Surgical Techs., Inc. v. Olympus Am., Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) .......................................................................... 35
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) .......................................................................... 42
`Samsung Elec. Co., Ltd. v. Bell Northern Research, LLC,
`IPR2020-00611, Paper 11 (PTAB Aug. 24, 2020) ............................................. 31
`Samsung Elecs. Co., Ltd. v. Bell Northern Research, LLC,
`IPR2020-00613, Paper 10 (PTAB Aug. 24, 2020) ....................................... 28, 32
`Samsung Electronics America, Inc. v. Prisua Eng. Corp.,
`IPR2017-01188, Paper 22 (PTAB Oct. 11, 2017) .............................................. 30
`Samsung Electronics America, Inc. v. Uniloc 2017 LLC,
`IPR2019-01218, Paper 7 (PTAB Jan. 7, 2020) .................................................... 9
`Solvay S.A. v. Honeywell Int'l, Inc.,
`622 F.3d 1367 (Fed. Cir. 2010) .......................................................................... 36
`Stryker Corp. v. KFX Medical, LLC,
`IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019)............................................. 46
`Supercell Oy v. Gree, Inc.,
`IPR2020-00310, Paper 13 (PTAB June 18, 2020) ............................................... 9
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .......................................................................... 40
`VIZIO, Inc. v. Polaris PowerLED Tech.,
`IPR2020-00043, Paper 30 (PTAB May 4, 2020) ................................................. 9
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) .......................................................................... 47
`Statutes
`28 U.S.C. § 1659 ........................................................................................................ 7
`35 U.S.C. § 102 .................................................................................................. 28, 34
`35 U.S.C. § 102(a) ................................................................................................... 32
`
`v
`
`

`

`35 U.S.C. § 313 .......................................................................................................... 1
`35 U.S.C. § 314(a) ................................................................................................. 2, 4
`35 U.S.C. § 316(b) ..................................................................................................... 6
`35 U.S.C. § 325(d) ............................................................................................passim
`Other Authorities
`37 C.F.R. § 42.24 ....................................................................................................... 1
`37 C.F.R. § 42.65 ..................................................................................................... 44
`37 C.F.R. § 42.107 ..................................................................................................... 1
`37 C.F.R. § 42.108(c) ............................................................................................... 14
`
`
`vi
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`

`

`
`
`Patent Owner’s Exhibit List
`
`Exhibit
`
`Description
`
`Ex. 2001 Declaration of Karl R. Leinsing, PE
`
`Ex. 2002 Order No. 8: Procedural Schedule, INV. No. 337-TA-1207
`
`Ex. 2003 Regeneron’s Initial Invalidity Contentions in 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 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 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
`
`vii
`
`

`

`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
`
`viii
`
`

`

`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
`
`ix
`
`

`

`Exhibit
`
`Description
`
`Ex. 2030
`
`Inventor declaration (Picci)
`
`Ex. 2031 Novartis PowerPoint presentation, entitled “Lucentis®
`Pharmaceutical Technical review. October 2011.”
`
`Ex. 2032 Novartis report entitled: "Risk assessment: Changes in starting
`material and manufacturing process between registration stability and
`process validation campaigns.”
`
`Ex. 2033
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Aug. 6, 2012)
`
`Ex. 2034
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Aug. 20, 2012)
`
`Ex. 2035
`
`Lucentis® PFS TRD SubTeam Draft Meeting Minutes (Sept. 3, 2012)
`
`Ex. 2036
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 1, 2012)
`
`Ex. 2037
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 15, 2012)
`
`Ex. 2038
`
`Lucentis® PFS TRD SubTeam Meeting Minutes (Nov. 12, 2012)
`
`Ex. 2039
`
`Lucentis® PFS TRD SubTeam Draft Meeting Minutes (Dec. 10,
`2012)
`
`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)
`
`
`x
`
`

`

`Exhibit
`
`Description
`
`Ex. 2044 U.S. Patent Application Publication No. 2014/0012227 to Sigg, et al.
`
`Ex. 2045 Regeneron’s Initial Invalidity Contentions Exhibit A3: Invalidity
`Claim Chart of Lam, alone or in 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 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.
`
`Ex. 2047 Modified Default Protective Order
`
`Ex. 2048 Redline Comparison of the Default Protective Order and the proposed
`Modified Default Protective Order
`
`xi
`
`

`

`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 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. Moreover, the
`
`ITC Investigation will be tried approximately nine months, and decided
`
`approximately six months, before any potential final written decision (“FWD”)
`
`here. In addition, the parties, the ITC Administrative Law Judge (“ALJ”), and the
`
`staff attorneys at the Office of Unfair Import Investigation have already expended
`
`significant resources on the case, and by the time an institution decision is due
`
`here, 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) (precedential). Accordingly, the Board should decline
`
`IPR2020-01318
`
`Page 1 of 51
`
`

`

`
`
`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.
`
`Regeneron has engaged in in additional efforts to pile-on and have the Board
`
`engage in needlessly duplicative proceedings. Not only has Regeneron filed two
`
`separate Petitions with the Board making essentially the same arguments (see
`
`IPR2020-01317), both Petitions rely on substantially the same art and arguments
`
`that were before the examiner during prosecution. In this Petition, Regeneron
`
`relies on Lam for its teaching of terminal sterilization and Reuter for its teaching of
`
`baked-on siliconization. But the Petition is fundamentally flawed in that Petitioner
`
`has failed to provide any reliable evidence that Reuter is publicly accessible or
`
`even prior art—and since Reuter is the common reference in all of the challenges,
`
`the Petition fails, as a matter of law. Notwithstanding Reuter’s deficiencies, the
`
`obviousness challenges fail because the specification itself explicitly acknowledges
`
`that terminal sterilization was taught in the prior art, and the Badkar reference,
`
`which was of record during prosecution, disclosed baked-on siliconization. For
`
`these reasons, the Board 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 in
`
`demonstrating the unpatentability of any claim. Petitioner has failed to
`
`IPR2020-01318
`
`
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`Page 2 of 51
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`

`
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`demonstrate that a person of ordinary skill in the art (“POSA”) would have been
`
`motivated to combine Lam and Reuter. As discussed above, Reuter is not prior art
`
`to the ’631 patent, and, even if it were, neither Lam nor Reuter discloses the low
`
`amounts of silicone oil required by all of the claims. Moreover, if a POSA were to
`
`have combined Lam and Reuter in the manner suggested by Petitioner, there would
`
`have been no reason to expect the combination to be successful because neither
`
`reference discloses a working syringe having the claimed, low amounts of silicone
`
`oil.
`
`There is also real-world evidence that makes it plain that Petitioner’s attempt
`
`to portray the claimed inventions as an obvious combination of prior art elements
`
`is based on nothing more than hindsight. In its Petition, 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 no pharmaceutical
`
`company was able to put a PFS on the market before the priority date of the ’631
`
`patent. In fact, Genentech had tried for years to develop a PFS, but ultimately
`
`abandoned the project after its efforts failed. Genentech was only able to get its
`
`VEGF-antagonist drug 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.
`
`IPR2020-01318
`
`
`
`Page 3 of 51
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`

`
`
`In sum, based on the Petition’s failure to demonstrate either motivation to
`
`combine Lam and Reuter or a reasonable expectation of success even if a POSA
`
`were to do so, combined with its failure to address secondary considerations of
`
`non-obviousness, 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
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`ITC Investigation; a decision is set to issue in the ITC Investigation six months
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`before any final written decision here; the parties, ALJ and OUII staff have already
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`expended, and continue to expend, significant resources in the ITC Investigation;
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`and the arguments in the Petition are weak. See generally Fintiv I.
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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, and
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`Petitioner fails to establish any error by the Examiner. Becton, Dickinson and Co.
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`v. B. Braun Melsungen AG, No. IPR2017-01586, Paper 8 at 17–19 (PTAB Dec. 15,
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`2017) (precedential); Advanced Bionics, LLC. V. Med-El Elektromedizinishce
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`Gerate GMBH, No. IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020)
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`(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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`(P.T.A.B. 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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`1 Novartis Pharma AG v. Regeneron Pharm. Inc., 1:20-cv-00690 (N.D.N.Y.).
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`ITC investigation, the stay will be lifted once the ITC investigation concludes. See
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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) (“Fintiv II”)
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`(institution denied where trial scheduled to begin two months before deadline for
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`final written decision); 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 w