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 IPR2020-01317
`Patent 9,220,631
`
`__________
`
`
`NOVARTIS PHARMA AG, NOVARTIS TECHNOLOGY LLC, AND
`NOVARTIS PHARMACEUTICALS CORPORATION’S
`PATENT OWNER SUR-REPLY
`
`
`
`
`
`
`
`
`__________
`
`
`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 SUR-REPLY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`The Fintiv Factors Compel Denial of Institution. ........................................... 2
`Factor 1: There Is No Prospect of a Stay in the ITC Proceeding
`or in Regeneron’s District Court Litigation. ......................................... 2
`Factor 2: The ITC Will Issue a Final Written Decision on
`Validity Before the Projected Date for the Board’s Final
`Written Decision. ................................................................................... 3
`Factor 3: The Parties and the ITC (ALJ and Staff Attorney)
`Have Already Invested Significant Resources in the ITC
`Proceeding. ............................................................................................ 5
`Factor 4: There Is Substantial Overlap of Issues Between the
`Petition and the ITC Proceeding. .......................................................... 7
`Factors 5, 6, and Conclusion: The Parties Are Identical, and the
`Factors as a Whole Overwhelmingly Favor Denying Institution. ........ 8
`Institution Should Also Be Denied Under 35 U.S.C. § 325(d). .................... 10
`Becton Dickinson Factors (a)–(c) Support Denying Institution. ........ 11
`Becton Dickinson Factors (d)–(f) Support Denying Institution. ........ 14
`
`
`
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`
`
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`
`
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`
`
`
`
`i
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`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (P.T.A.B. May 13, 2020) ................. 1, 2, 3, 4, 5, 9, 10
`Fitbit, Inc. v. Koninklijke Philips N.V.,
`IPR2020-00772, Paper 14 (P.T.A.B. Oct. 19, 2020) ................................ 2, 4, 6, 9
`Garmin Int’l, Inc. v. Koninklijke Philips N.V.,
`IPR2020-00754, Paper 11 (P.T.A.B. Oct. 27, 2020) .................................... 2, 6, 9
`Google LLC et al. v. Agis Software Development, LLC,
`IPR2020-00873, Paper 16 (P.T.A.B. Nov. 25, 2020) ........................................... 7
`Google LLC v. EcoFactor, Inc.,
`IPR2020-0968, Paper 10 (P.T.A.B. Nov. 18, 2020) ................................... 2, 9, 10
`Google LLC v. Personalized Media Comm’cns, LLC,
`IPR2020-00719, Paper 16 (P.T.A.B. Aug. 31, 2020) ....................................... 5, 7
`Philip Morris Prods., S.A. v. RAI Strategic Holdings, Inc.,
`(IPR2020-00919) (P.T.A.B.) ................................................................................ 9
`Philip Morris Prods., S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-00919, Paper 9 (P.T.A.B. Nov. 16, 2020) ....................................... 4, 10
`Philip Morris Prods., S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-00921, Paper 9 (P.T.A.B. Nov. 16, 2020) ............................................. 4
`SK Innovation Co. v. LG Chem, Ltd.,
`IPR2020-00991, Paper 14 (P.T.A.B. Nov. 30, 2020) ....................................... 2, 9
`VMware v. Intellectual Ventures I LLC,
`IPR2020-00470, Paper 13 (P.T.A.B. Aug. 13, 2018) ........................................... 8
`Statutes
`35 U.S.C. §§ 102-103 ................................................................................................ 5
`
`ii
`
`
`
`35 U.S.C. § 314 .......................................................................................................... 1
`35 U.S.C. § 314 .......................................................................................................... 1
`35 U.S.C. § 325(d) ............................................................................................... 1, 10
`35 U.S.C. § 325(d) ............................................................................................... 1, 10
`
`
`
`iii
`
`iii
`
`
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`
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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, 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.
`
`
`
`vii
`
`
`
`Exhibit
`
`Description
`
`Ex. 2045 Regeneron’s Initial Invalidity Contentions in ITC Inv. No. 337-TA-
`1207, 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 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.
`Ex. 2047 Order No. 8: Procedural Schedule in ITC Inv. No. 337-TA-1207
`
`Ex. 2049
`
`Ex. 2048 Order No. 20: Modifying the Procedural Schedule in ITC Inv. No.
`337-TA-1207
`Excerpt of Transcript of Markman Hearing in ITC Inv. No. 337-TA-
`1207
`Ex. 2050 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
`Examiner search for U.S. patent publications naming Jeurgen Sigg as
`an inventor in Prosecution File History of U.S. Patent No. 9,220,631
`PCT Patent Publication No. WO 2007/084765 to Deschatelets et al.
`(“Deschatelets”)
`PCT Patent Publication No. WO 97/44068 to Tack et al. (“Tack”)
`
`Ex. 2051
`
`Ex. 2052
`
`Ex. 2053
`
`Ex. 2054
`
`Ex. 2055
`
`Ex. 2056
`
`English Translation of PCT Patent Publication No. WO 97/44068 to
`Tack et al. (“Tack”)
`5/14/2014 List of references cited in Prosecution File History of U.S.
`Patent No. 9,220,631
`3/15/2015 Information Disclosure Statement in Prosecution File
`History of U.S. Patent No. 9,220,631
`Ex. 2057 Regeneron Pharms., Inc. v. Novartis Pharma AG et al., No. 20-cv-
`5502 (S.D.N.Y.), ECF No. 1
`
`
`
`viii
`
`
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`The Board should exercise its discretion to deny institution. Under 35
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`
`U.S.C. § 314 and Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (P.T.A.B.
`
`May 13, 2020), the Board has repeatedly denied institution when presented with
`
`the same fact-pattern at issue here—i.e., when there is a pending ITC investigation
`
`involving the same parties and the same patent claims, which will produce a final
`
`determination before the Board’s final written decision. Because Regeneron
`
`cannot plausibly argue that institution is appropriate under these decisions, it is left
`
`to suggest they were wrong. Reply 10-11. But Regeneron provides no sound basis
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`for the Board to revisit prior decisions, especially because the grounds for denying
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`institution here are so clear. Although Regeneron insists (Reply 1) that it has
`
`“strived to streamline the proceedings”—having moved to terminate its second IPR
`
`after putting Novartis through the burden of responding—it neglects to mention
`
`that it launched its own district court action attacking the ’631 patent. And, as
`
`discussed further below, the narrow stipulation that Regeneron touts (Reply 1, 12)
`
`would not meaningfully reduce the overlap between its petition and its ITC
`
`invalidity contentions. As it has repeatedly done, the Board should hold that such
`
`an narrow stipulation does not overcome the factors that favor denying institution.
`
`The Board should also exercise its discretion to deny institution pursuant to
`
`35 U.S.C. § 325(d) because the petition relies on art and arguments that are
`
`cumulative of art and arguments before the Examiner.
`
`1
`
`
`
`
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`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`
`The Fintiv Factors Compel Denial of Institution.
`
`Factor 1: There Is No Prospect of a Stay in the ITC Proceeding or
`in Regeneron’s District Court Litigation.
`Regeneron concedes that proceedings in the ITC involving the same patent
`
`claims have not been stayed, and even represents that requesting a stay would be
`
`“futile.” Reply 9. That concession shows that Factor 1 favors denial of institution.
`
`Resisting that conclusion, Regeneron attacks Board precedent, arguing that
`
`ITC proceedings should not be given the same weight as parallel district court
`
`proceedings. The Board has rejected that exact argument multiple times. See, e.g.,
`
`Google LLC v. EcoFactor, Inc., IPR2020-0968, Paper 10 at 10–11 (P.T.A.B. Nov.
`
`18, 2020); Garmin Int’l, Inc. v. Koninklijke Philips N.V., IPR2020-00754, Paper 11
`
`at 10–11 (P.T.A.B. Oct. 27, 2020); Fitbit, Inc. v. Koninklijke Philips N.V.,
`
`IPR2020-00772, Paper 14 at 15–16 (P.T.A.B. Oct. 19, 2020); Fintiv at 8–9. And
`
`the Board has repeatedly denied institution in the posture presented here, where a
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`district court infringement action is stayed but an ITC investigation is pending.
`
`E.g., SK Innovation Co. v. LG Chem, Ltd., IPR2020-00991, Paper 14 at 11, 19
`
`(P.T.A.B. Nov. 30, 2020); Garmin at 9–10, 18–19; EcoFactor at 10–11, 18.
`
`Regeneron contends that the Board’s prior decisions are wrong, asserting
`
`that it erred by “discount[ing] the non-preclusive effect of ITC invalidity findings.”
`
`Reply 10. But Regeneron identifies just three cases over 30 years in which a
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`patent owner moved forward after an ITC invalidity finding (Reply 10–11), thus
`
`2
`
`
`
`providing no basis to second-guess the Board’s observation that “as a practical
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`
`matter, it is difficult to maintain a district court proceeding on patent claims
`
`determined to be invalid at the ITC.” Fintiv at 9. Regeneron also contends (Reply
`
`10) that the ITC defers to the Board’s expertise, but that is irrelevant here because
`
`the ITC’s final determination will come months before a final written decision.1
`
`
`
`Factor 2: The ITC Will Issue a Final Written Decision on Validity
`Before the Projected Date for the Board’s Final Written Decision.
`Factor 2 strongly favors denial of institution because the ITC is scheduled to
`
`issue a decision on the validity of the ’631 patent months before the projected
`
`January 2022 date for the Board’s final written decision—with the ITC hearing set
`
`to begin on April 19, 2021, an ALJ decision due by July 29, 2021, and a final
`
`determination from the Commission due by November 29, 2021. Ex. 2047.
`
`Regeneron quibbles with Novartis’s presentation of the ITC schedule, which
`
`noted (POPR 1, 9) that the ALJ’s initial decision will be six months before the
`
`Board’s target date for a final written decision; according to Regeneron (Reply 13),
`
`
`1 Regeneron is also inaccurate when it states that the only “two other proceedings
`concerning the ‘631 patent are the ITC investigation and the stayed district court
`case.” Reply 9. Regeneron also filed an antitrust complaint in the Southern
`District of New York in which “the heart” of its claims are directed at issuance of
`the ’631 patent. Ex. 2057 ¶¶ 90, 176. The complaint relies on the same basic
`argument advanced in its Petition—i.e., that Novartis’s ’631 patent would not
`have issued had the examiner known about the Sigg reference. Id. ¶¶ 90, 121–30,
`176, 184–86. This additional litigation, which also calls for analyzing Sigg in the
`context of the ’631 patent’s enforceability, further supports denying institution.
`
`3
`
`
`
`only the date of the ITC’s final determination matters. Even if credited, that
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`
`argument would not help Regeneron, since that latter date is almost two months
`
`before the Board’s deadline. See Philip Morris Prods., S.A. v. RAI Strategic
`
`Holdings, Inc., IPR2020-00919, Paper 9 at 9 (P.T.A.B. Nov. 16, 2020) (Factor 2
`
`weighed against institution where the ITC’s final determination was due two
`
`months before the Board’s final written decision). Moreover, Regeneron’s attempt
`
`to discount the ALJ decision date is flawed. When the Board considers parallel
`
`district court litigation, it looks to the trial date—it does not project when a
`
`decision will issue, much less account for post-judgment motions or appeals. See
`
`Fintiv at 9. The decision date by the ALJ is at least as probative. Unsurprisingly
`
`then, the Board has considered both the ALJ’s determination date and the ITC’s
`
`final determination date. See Fitbit at 16, 23 (“We weigh heavily the fact that in
`
`the ITC proceeding, both the Initial Determination and the final commission
`
`determination will pre-date a final written decision” (emphasis added)).
`
`Finally, Regeneron urges the Board to disregard timing in the ITC because
`
`of its “expediency in filing its petition.” Reply 14. But the Board has rejected
`
`“diligen[ce]” arguments under Factor 2. See Philip Morris Prods., S.A. v. RAI
`
`Strategic Holdings, Inc., IPR2020-00921, Paper 9 at 16 (P.T.A.B. Nov. 16, 2020).
`
`4
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`
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`IPR2020-01317
`U.S. Patent No. 9,220,631
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`Factor 3: The Parties and the ITC (ALJ and Staff Attorney) Have
`Already Invested Significant Resources in the ITC Proceeding.
`The parties and the ITC have devoted significant resources to adjudicating
`
`
`
`the validity of the ’631 patent. Indeed, as of this filing, the parties have responded
`
`to 365 requests for production and 58 interrogatories; collected, reviewed, and
`
`produced more than 4,339,775 pages; served 4,390 pages of contentions; and taken
`
`13 depositions. The parties have also briefed claim construction and held a
`
`Markman hearing with expert testimony. Ex. 2047. Opening expert reports are
`
`due on January 22, 2021, and summary determination motions on February 18,
`
`2021. Ex. 2048. The Board has held that similar progress in a parallel case favors
`
`denying institution. Google LLC v. Personalized Media Comm’cns, LLC,
`
`IPR2020-00719, Paper 16 at 12 (P.T.A.B. Aug. 31, 2020) (denying institution
`
`where parties had completed claim construction and expert discovery).
`
`Regeneron tries to downplay this investment by arguing (Reply 12) that the
`
`ALJ and ITC have not yet analyzed “obviousness issues.” Regeneron omits that
`
`the parties have exchanged detailed invalidity contentions on §§ 102–103, which
`
`overlap with the grounds in this petition. Moreover, Regeneron overlooks that
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`Factor 3’s purpose is to assess whether a proceeding is sufficiently “advanced” that
`
`a “stay may be less likely, and instituting would lead to duplicative costs.” Fintiv
`
`at 10. Here, it is undisputed that there will be no stay, and the ALJ has already told
`
`5
`
`
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`the parties that “this case is going to go to trial.” Ex. 2049.009 at 269:17–19.
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`
`Finally, Regeneron suggests that investment in the ITC proceeding should be
`
`balanced against its own efforts in filing IPR petitions. But Regeneron’s assertion
`
`(Reply 11) that it “could realistically not have brought its IPR challenges faster”
`
`does not withstand scrutiny. The ’631 patent issued in 2015, and Regeneron
`
`reports that it was approached by Novartis about a potential licensing deal both
`
`pre- and post-issuance. Ex. 2057 ¶¶ 137, 146. Regeneron thus had ample notice
`
`of the ’631 patent, and the record shows it started to investigate an IPR challenge
`
`no later than July 2018.2 In any event, even in cases where the petitioner was
`
`diligent, the Board has found that investments by “[t]he parties and the ALJ and
`
`staff of the ITC” still weigh “somewhat against institution.” Fitbit at 17–18;
`
`accord Garmin at 14 (crediting petitioner’s diligence but finding that Factor 3
`
`weighed “somewhat against institution” given the investment in the ITC).
`
`
`2 The declaration of James L. Mullins, who conducted prior-art searches for
`
`Regeneron, reports that he obtained a letter from a library in Germany regarding
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`the availability of journal on July 25, 2018. Ex. 1033.043. Mr. Mullins also ran
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`internet data base searches in 2018 to identify the publicly accessible art. See
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`Regeneron Ex. 1033 at .040, .065, .069, .094, .099, and .102. And Regeneron has
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`submitted an Internet Archive affidavit, which is dated in October 2018. Ex. 1037.
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`6
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`IPR2020-01317
`U.S. Patent No. 9,220,631
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`Factor 4: There Is Substantial Overlap of Issues Between the
`Petition and the ITC Proceeding.
`Factor 4 weighs against institution because the petition asks the Board to
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`review the same patent claims, based on the same prior art, that are at issue in the
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`ITC investigation. In arguing otherwise, Regeneron relies on its stipulation that “it
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`will not pursue in the ITC the invalidity grounds set forth in either petition.” Reply
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`12. But the Board has recognized that a “narrow stipulation” like Regeneron’s—
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`i.e., a promise not to pursue “the identical grounds” for invalidity in a parallel
`
`proceeding—at most “weighs marginally against exercising discretion to deny
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`institution.” Personalized Media at 13–14, 17 (denying institution and explaining
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`that a “broader” stipulation was needed to prevent duplication); see also Google
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`LLC et al. v. Agis Software Development, LLC, IPR2020-00873, Paper 16 at 14
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`(P.T.A.B. Nov. 25, 2020) (finding that a stipulation to waive the specific grounds
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`asserted in the IPR did not alleviate concerns of duplication given the petitioner’s
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`ability to rely on the same prior art by slightly varying the combinations).
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`Regeneron’s narrow stipulation would not meaningfully limit the overlap
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`between an IPR and the ITC proceeding (and it does not apply to the district court
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`litigation). Regeneron’s theory is that a skilled artisan would have combined
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`references that teach a method for terminal sterilization of PFS with a method for
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`baked-on siliconization of PFS. Pet. 29. Regeneron has cited numerous,
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`7
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`
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`cumulative references that it asserts can be used for each half of that argument.
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`IPR2020-01317
`U.S. Patent No. 9,220,631
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`See POPR 18–22. Indeed, Regeneron’s initial ITC invalidity contentions identify
`
`over three dozen references that it mixes and matches, many of which “cross-
`
`reference and discuss one another.” Ex. 2050.010. That is significant, because
`
`Regeneron’s stipulation would not preclude it from relying on different
`
`combinations of the asserted references. Compare VMware v. Intellectual Ventures
`
`I LLC, IPR2020-00470, Paper 13 at 15–16, 20 & n.15 (P.T.A.B. Aug. 13, 2018).
`
`In particular, Regeneron’s now-terminated IPR2020-01318 and the present
`
`IPR put forward two lead references that disclose terminal sterilization methods
`
`(Lam and Sigg) and two lead references that disclose siliconization methods
`
`(Boulange and Reuter). Regeneron’s Ranking of Petitions at 2. The differences
`
`between the references in each category are modest and irrelevant to most of the
`
`claims. Id. at 3–4. It would thus be trivially easy for Regeneron to press the same
`
`arguments to the Board and the ITC without violating its stipulation—it need only
`
`change how it combines the reference types, e.g., by changing its IPR pairing of
`
`Sigg/Boulange to Sigg/Reuter and Lam/Boulange in the ITC. The parties would
`
`thus be adjudicating the same basic invalidity issues in at least two different fora.
`
`
`
`Factors 5, 6, and Conclusion: The Parties Are Identical, and the
`Factors as a Whole Overwhelmingly Favor Denying Institution.
`Regeneron concedes that Factor 5 favors denying institution because “the
`
`8
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`
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`parties at the ITC and here are the same.” Reply 14. (Regeneron and Novartis are
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`IPR2020-01317
`U.S. Patent No. 9,220,631
`
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`also both parties in the SDNY action). As to Factor 6, Regeneron’s petition is
`
`unlikely to succeed for the reasons explained in the POPR. Moreover, even if
`
`Regeneron had put forward a more compelling merits case, it would not outweigh
`
`the factors that support denying institution. See Fitbit at 23 (denying institution
`
`even though the Board “credit[ed] the apparent strength of the prior art”); see also
`
`SK Innovation at 18–19 (similar); Garmin at 16, 18–19 (similar).
`
`The Fintiv factors as a whole also overwhelmingly favor denial of
`
`institution: there are two parallel actions (neither of which has been stayed); the
`
`actions overlap substantially with the IPR since they involve the same parties, the
`
`same patent claims, and the same basic arguments and prior art; and the ITC
`
`proceeding is already advanced and will produce written determinations by both
`
`the ALJ and the Commission before a final written decision by the Board.
`
`Regeneron tries (Reply 14–15) to distinguish a few (but not all) of the
`
`numerous recent Board decisions denying institution due to a parallel ITC action,
`
`but its arguments fall short. For example, Regeneron emphasizes its stipulation,
`
`but as discussed, the narrow stipulation it has offered will not meaningfully reduce
`
`duplication. Moreover, the stipulation—which is, at most, relevant to Factor 4—is
`
`not a plausible basis to distinguish either Google LLC v. EcoFactor, Inc. or Philip
`
`Morris (IPR2020-00919), because the Board in those cases denied institution
`
`9
`
`
`
`despite finding that Factor 4 favored institution. See EcoFactor at 15, 18 (denying
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`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`
`institution even though “the Petition [was] directed to some substantively different
`
`claims than those before the ITC”); Philip Morris at 11–13 (denying institution
`
`despite “lack of complete overlap in the prior art”).
`
`The Phillip Morris decision is particularly instructive and shows why the
`
`Fintiv factors favor denying institution. There, the petitioner filed “less than one
`
`month after Patent Owner filed its complaints in the ITC,” but the Board denied
`
`institution based on the balance of other factors, i.e., “the proximity of the
`
`anticipated ITC hearing date, combined with an anticipated final determination
`
`from the ITC prior to the Board’s final decision on validity of claims in dispute
`
`between the same parties.” Id. at 10, 12–13. Those factors are equally applicable
`
`here. If anything, the reasons for denying institution are stronger here, given the
`
`overlap of the prior art in the petition and the ITC, and the fact that Regeneron
`
`compounded the inefficiency of parallel actions by bringing the SDNY action.
`
`
`
`Institution Should Also Be Denied Under 35 U.S.C. § 325(d).
`Regeneron’s reply to Novartis’s argument that the Board should deny review
`
`under § 325(d) asserts that the POPR “is laden with mischaracterizations,” and it
`
`charges Novartis with trying “to hide” material. Reply 2–3, 7–8. The record does
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`not support those dramatic accusations, but rather confirms that the petition relies
`
`on art and arguments that are cumulative of the record before the Examiner.
`
`10
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`
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`IPR2020-01317
`U.S. Patent No. 9,220,631
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` Becton Dickinson Factors (a)–(c) Support Denying Institution.
`Regeneron begins with the premise that “the primary references in the
`
`Petition (Sigg and Boulange, Ex. 1007 and 1008) were not considered by the
`
`Examiner.” Reply 2. That is incorrect. The file wrapper shows that the Examiner
`
`carried out a search for U.S. patent publications naming Jeurgen Sigg as an
`
`inventor, which would have identified the U.S. counterpart of Sigg. Ex 2051. In
`
`any event, as Novartis has explained (POPR at 17–22), Sigg and Boulange were
`
`cumulative of prior art before the Examiner, which disclosed the same terminal
`
`sterilization and siliconization techniques, respectively, taught in those references.
`
`Regeneron’s attempts to counter Novartis’s arguments fall short.
`
`1.
`
`Regeneron asserts (Reply 3) that “[t]here was not a single prior art
`
`reference before the Examiner disclosing terminal sterilization, much less terminal
`
`sterilization of a pre-filled syringe.” That is inaccurate. Deschatelets (WO
`
`2007/084765) discloses a syringe for intravitreal injection of a VEGF antagonist,
`
`which “may be preloaded with a composition comprising a therapeutic agent,” and
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`“sterilization can be performed after manufacture”—i.e., it can be terminally
`
`sterilized. Ex. 2052 ¶¶ 14, 17, 254, 255. Similarly, the English-language abstract
`
`of Tack (WO 97/44068) discloses a method of producing a “pre-filled sterile
`
`syringe” in which the syringe is filled with a fluid, sealed, packaged, “and the
`
`package container is then sterilized once again.” Ex. 2053.001. Deschatelets and
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`11
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`
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`Tack were disclosed on IDSs initialed by the Examiner. Ex. 2055, Ex. 2056.
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`IPR2020-01317
`U.S. Patent No. 9,220,631
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`The specification of the ’631 patent also discloses that terminal-sterilization
`
`techniques were known as of the priority date, including the method disclosed in
`
`Sigg using hydrogen peroxide. POPR 18. Regeneron contends (Reply 4–5) that
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`the cited passage from the specification “refutes Novartis’s argument,” because it
`
`shows only that gaseous terminal sterilization processes (EtO) or H2O2) were
`
`known without confirming they could be used on a PFS. But in quoting this
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`passage, Regeneron leaves out the introductory words “As noted above.” Ex. 1001
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`9:49. That preface is important, because “above,” the specification explains that
`
`sterilization “can be achieved by terminal sterilization in which the assembled
`
`product, typically already in its associated packaging, is sterilized using heat or a
`
`sterilizing gas.” Ex. 1001 1:12–21. Reading these passages together discloses that
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`terminal sterilization of a PFS using these gases was known.3
`
`
`3 Contrary to Regeneron’s assertion (Reply 5) Novartis did not take a contrary
`
`position in its ITC Markman brief. The passage from the ITC brief did not purport
`
`to interpret the specific specification statement at issue here. Ex. 1069.011.
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`Novartis’s consistent position—both in its POPR and before the ITC—is that the
`
`prior art taught terminal sterilization of a PFS, but did not disclose the terminally
`
`sterilized syringe recited in the claims or otherwise provide sufficient guidance on
`
`12
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`
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`Novartis also disclosed references describing siliconization, and the
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`IPR2020-01317
`U.S. Patent No. 9,220,631
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`2.
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`Examiner extensively evaluated the siliconization art (e.g., Hioki and Badkar)
`
`before allowing the claims. POPR 19–22. Regeneron insists that Boulange is not
`
`cumulative, but its arguments are inconsistent with the prosecution record.
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`First, Regeneron objects (Reply 6) to reliance on Hioki, because it disclosed
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`a “plastic (resin) barrel” and “did not contain any specific disclosures of slide
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`forces.” But the Examiner read Hioki to teach the same information that
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`Regeneron would glean from Boulange—i.e., to apply silicone oil to the inner
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`surface of a pre-filled glass syringe barrel and
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