IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`LIQUIDIA TECHNOLOGIES, Inc.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793
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`
`PATENT OWNER UNITED THERAPEUTIC CORPORATION’S
`PRELIMINARY RESPONSE
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`4826-0990-5385.2
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`U.S. Patent No. 10,716,793 B2
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LIQUIDIA TECHNOLOGIES, Inc.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`PATENT OWNER UNITED THERAPEUTIC CORPORATION’S
`PRELIMINARY RESPONSE
`
`
`
`
`
`4826-0990-5385.2
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`
`
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`I.
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`II.
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`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`A.
`Background ........................................................................................... 4
`B.
`The Challenged ’793 Patent .................................................................. 6
`THE BOARD SHOULD DENY INSTITUTION ........................................... 9
`A.
`The Board Should Exercise Discretionary Denial Under 35 U.S.C.
`§ 314(a) .................................................................................................. 9
`1.
`The District Court Litigation .................................................... 10
`2.
`Analysis of Fintiv Factors ......................................................... 12
` Whether the court granted a stay or evidence
`exists that one may be granted if a proceeding is
`instituted .................................................................................... 13
`Proximity of the court’s trial date to the
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`Board’s projected statutory deadline for final
`written decision ......................................................................... 14
`Investment in the parallel proceeding by the
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`court and the parties .................................................................. 17
`Overlap between issues raised in the petition
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`and the parallel proceeding ....................................................... 20
` Whether the petitioner and the defendant in
`the parallel proceeding are the same party ................................ 23
`Other circumstances that impact the Board’s
`
`exercise of discretion, including the merits .............................. 24
`UTC Respectfully Requests That the Board Exercise Discretionary
`Denial Under 35 U.S.C. § 325(d) ........................................................ 25
`Grounds 1-6 Should Be Denied Because Each Ground Relies On
`Publications That Liquidia Has Failed to Establish Are Prior Art ...... 26
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`C.
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`B.
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`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`1.
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`2.
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`Liquidia Has Failed to Establish That the Undated
`Optineb Manual Was Publicly Available at the Priority
`Date (Grounds 1-2) ................................................................... 28
`Liquidia Has Failed to Establish that Ghofrani and
`Voswinckel 2006 Are Prior Art “by others” under 102(a)
`(Grounds 3-6). ........................................................................... 32
`Ghofrani .......................................................................... 34
`Voswinckel 2006 ............................................................ 39
`D. Grounds 1-2, 4, and 6 Should Be Denied Because Liquidia Has
`Failed to Show That They Would Succeed on the Merits .................. 42
`1.
`The ’212 Patent Teaches Away From Per Breath Dosing
`And Exemplifies Inhalers That Are Incapable Of
`Providing The Claimed Dosing ................................................ 44
`Voswinckel JESC Teaches Continuous Nebulization Like
`The ’212 Patent And Teaches Away From The Claimed
`Dosing ....................................................................................... 50
`Voswinckel JAHA Cites A “Pulsed” Optineb Device,
`Which Is Not Described In Any Printed Publication ................ 53
`III. CONCLUSION .............................................................................................. 55
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`2.
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`3.
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`TABLE OF AUTHORITIES
`
`Page(s)
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`
`Cases
`Allergan, Inc. v. Apotex Inc., 754 F.3d 952 (Fed. Cir. 2014) ..................... 33, 38, 41
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016) ....................................... 9
`In re Katz, 687 F.2d 450 (CCPA 1982) ...................................................... 33, 34, 37
`In re Land, 368 F.2d 866 (CCPA 1996) ........................................................... 33, 38
`
`Lacks Industries, Inc. v. McKechnie Vehicle Components USA, Inc.,
`322 F.3d 1335 (Fed. Cir. 2003) ............................................................................ 32
`Minerva Surgical, Inc. v. Hologic, Inc., et al., No. 20-440, 2021 WL 77248
`(U.S. Jan. 8, 2021) ................................................................................................ 23
`SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348 (2018) .................................................. 9, 42
`Sewall v. Walters, 21 F.3d 411 (Fed. Cir. 1994)...................................................... 34
`Statutes
`21 U.S.C. § 355(j)(5)(B)(iii) .................................................................................... 15
`35 U.S.C. § 102(a) ................................................................................................... 32
`35 U.S.C. § 314 ............................................................................................... 4, 9, 42
`35 U.S.C. § 325(d) ............................................................................................ 25, 42
`Other Authorities
`Adaptics Ltd. v. Perfect Company,
`IPR2018-01596, Paper 20 (PTAB Mar. 6, 2019) ................................................. 31
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) ................................................. 25
`
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB May 13, 2020) ....................................... passim
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`Becton Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ................................................. 26
`Cellco Partnership v. Bridge and Post, Inc.,
`IPR2018-00054, Paper 40 (PTAB Apr. 15, 2019) ........................................ 33, 38
`
`CSL Behring LLC v. Bioverative Therapeutics Inc.,
`IPR2018-01313, Paper 10 (PTAB Jan. 9, 2019) .................................................. 34
`
`Google LLC v. IPA Technologies,
`IPR2019-00734, Paper 14 (PTAB Oct. 17, 2019) ......................................... 26, 33
`Hulu, LLC v. Sound View Innovations, LLC,
`IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) ........................................ 26, 28
`Liquidia Tech., Inc. v. United Therapeutics Corp.,
`IPR2020-00769, Paper 7 (PTAB Oct. 13, 2020) .................................................. 14
`Liquidia Tech., Inc. v. United Therapeutics Corp.,
`IPR2020-00770, Paper 7 (PTAB Oct. 13, 2020) .................................................. 14
`Microsoft Corp. v. Parallel Networks Licensing, LLC,
`IPR2015-00483, Paper 10 (PTAB Jul. 15, 2015) ................................................. 25
`NHK Spring Co., Ltd. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (PTAB Sep. 12, 2018) ................................................... 9
`Philip Morris Prods., S.A. v. Rai Strategic Holdings, Inc.,
`IPR2020-01097, Paper 9 (PTAB Jan. 19, 2021) .................................................. 19
`Snap, Inc. v. SRK Technology, LLC,
`IPR2020-00820, Paper 15 (PTAB Oct. 21, 2020) ................................................ 14
`
`Trans Ova Genetics, LC v. XY, LLC,
`IPR2018-00250, Paper 35 (PTAB Jun. 26, 2019) ......................................... 33, 38
`Rules
`37 C.F.R. § 42.107 ..................................................................................................... 1
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`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`EXHIBIT LIST
`
`Description
`Exhibit
`EX2001 Declaration of Dr. Aaron Waxman
`EX2002 Dr. Waxman’s curriculum vitae
`EX2003 Declaration of Dr. Werner Seeger
`EX2004 Declaration of Dr. Hossein A. Ghofrani
`EX2005 Declaration of Dr. Frank Reichenberger
`EX2006 Declaration of Dr. Friedrich Grimminger
`EX2007
`Tyvaso Orange Book listing
`EX2008 Hill, N., 2005, Therapeutic Options for the Treatment of Pulmonary
`Hypertension, Medscape Pulmonary Medicine 9(2).
`Substantive Submission filed in 12/591,200 (Mar. 9, 2015)
`EX2009
`EX2010 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-1 (public
`docket).
`EX2011 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-11 (public
`docket).
`EX2012 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-16 (public
`docket).
`EX2013 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), unnumbered docket
`entry dated 7/30/2020
`EX2014 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-20 (public
`docket)(excerpted).
`EX2015 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-29 (public
`docket).
`EX2016 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-45 (public
`docket).
`EX2017 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-21 (public
`docket).
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`U.S. Patent No. 10,716,793 B2
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`Description
`Exhibit
`EX2018 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-41 (public
`docket).
`EX2019 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-49 (public
`docket).
`EX2020 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-68 (public
`docket).
`EX2021 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-71 (public
`docket).
`EX2022 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-40 (public
`docket).
`EX2023 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-47 (public
`docket).
`EX2024 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-75 (public
`docket).
`EX2025 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-80 (public
`docket).
`EX2026 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-81 (public
`docket).
`EX2027 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-92 (public
`docket).
`EX2028 United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-74 (public
`docket).
`EX2029 Hess et al., 2007, A guide to aerosol delivery devices for respiratory
`therapists. American Association for Respiratory Care
`EX2030 Dennis JH, 2002, Standardization issues: in vitro assessment of
`nebulizer performance. Respir. Care. 47(12):1455-1458
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`Description
`Exhibit
`EX2031 Hess et al., 1996, Medication nebulizer performance. Effects of
`diluent volume, nebulizer flow, and nebulizer brand. Chest,
`110(2):498-505
`Rubin BK et al., 2008 Treatment Delivery Systems (in Clinical
`Asthma), https://www.sciencedirect.com/topics/medicine-and-
`dentistry/nebulizer
`EX2033 Gardenhire, D.S. et al., 2017, A Guide to Aerosol Delivery Devices
`for Respiratory Therapists (4th Ed.) American Association for
`Respiratory Care.
`Tyvaso® Label 2021
`Bourge et al., Cardiovascular Therapeutics, 31:38-44 (2013)
`
`EX2032
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`EX2034
`EX2035
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`Pursuant to 37 C.F.R. § 42.107, Patent Owner United Therapeutics
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`Corporation (“UTC” or “Patent Owner”) submits this Preliminary Response to the
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`above-captioned Petition for Inter Partes review of U.S. Patent No. 10,716,793
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`(“Petition” or “Pet.”).1
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`I.
`
`INTRODUCTION
`Petitioner Liquidia Technologies Inc. (“Liquidia” or “Petitioner”) waited six
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`months to bring this Petition while actively litigating the validity of the ’793 patent
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`before the United States District Court for the District of Delaware. During that six-
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`month period, Liquidia prepared and served its preliminary invalidity contentions
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`relying on several identical art combinations and arguments as those found here.
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`Liquidia had the opportunity to raise any ’793 patent claim construction issues it
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`wished for the court to consider. It strategically elected to remain silent. Liquidia has
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`served and responded to discovery on the ’793 patent in the underlying case. A claim
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`construction hearing is imminent, and depositions are about to begin.
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`The only events Liquidia can point to in an effort to take attention away from
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`the advanced nature of the case and Liquidia’s own delay in bringing this IPR is a
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`UTC motion the court denied, and the fact that UTC provided a list of asserted claims
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`1
`All emphases added, unless otherwise noted.
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`to Liquidia three months before Liquidia filed the instant Petition. First, the court
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`denied UTC’s motion to enforce assignee/inventor estoppel because of the highly
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`factual nature of the inquiry, suggesting that the court will want a full record, such
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`as a complete trial record, before ultimately deciding the issue. And second, the
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`receipt of UTC’s statement of asserted claims had no effect on Liquidia’s timing or
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`strategy. Liquidia did not use the receipt of the list of asserted claims to inform or
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`alter its challenge. Liquidia seeks review of three unasserted claims of the ’793
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`patent, thereby sweeping in each claim of the ’793 patent—asserted or not.
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`Because the Delaware Litigation is all but certain to have concluded prior to
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`the projected Board final written decision date here, this Petition is the epitome of a
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`petition warranting application of the Board’s discretionary power to deny
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`institution.
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`Furthermore, even if the Board chooses not to exercise its discretion to deny
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`the institution, Liquidia has failed to establish that the references it seeks to rely upon
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`are prior art. Grounds 1 and 2, for example, explicitly rely upon Exhibit 1037, an
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`undated Optineb manual, as the lone piece of information establishing the
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`nebulization rate of the Optineb ultrasound nebulizer disclosed in Voswinckel JESC
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`and, thus, the dosage of treprostinil delivered to the patients disclosed in Voswinckel
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`JESC. And that nebulization rate is the critical piece of the Petition’s speculative
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`(and incorrect) calculation in order to meet one of the claim limitations to support
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`Grounds 1 and 2. Surprisingly, neither the Petition nor either of the expert
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`declarations submitted by Liquidia provide any evidence that the undated Optineb
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`manual is prior art. Indeed, Liquidia fails to even address the threshold question of
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`whether the undated Optineb manual was available before the critical date.2 Nor does
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`Liquidia offer any evidence that even if the manual were available as of the critical
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`date that the Optineb device described in the manual is the same device as the
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`unspecified Optineb device referenced in the cited abstracts. Liquidia’s double-
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`deficiency disarms Grounds 1 and 2.
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`Similarly, the remaining grounds all expressly rely upon either Ghofrani or
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`Voswinckel 2006. However, the Petition and the underlying declarations do nothing
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`to establish that either of those references are “by others.” While under no obligation
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`to do so, UTC has provided declarations establishing that the relied upon art is not
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`“by others,” and therefore is not prior art.
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`Contrary to Liquidia’s suggestion, these threshold failures of proof are not
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`capable of being fixed later. These are fundamental failures of proof upon which
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`Liquidia’s grounds must be evaluated before institution. Liquidia had every
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`2 Liquidia submitted a third expert declaration that provides an “expert opinion
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`regarding the public availability of a number of publications,” but is silent on
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`EX1037. EX1036.
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`opportunity—six months’ worth of delay—to develop its proof as to the art it chose
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`to rely upon. Liquidia elected strategically to remain silent about the public
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`availability of the undated Optineb manual—the cornerstone of its arguments under
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`Grounds 1 and 2— and elected to rely upon art in Grounds 3 through 6 that it knew
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`were not “by others.” Liquidia employed until recently one of the named inventors
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`of the ’793 patent, and yet chose not to include any factual offering to demonstrate
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`that Ghofrani or Voswinckel 2006 were “by others.”
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`While Liquidia’s challenges to the ’793 patent are riddled with substantive
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`errors and suffer from shortcomings of proof which UTC will establish, if needed,
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`UTC respectfully submits in this paper that Liquidia fundamentally fails to provide
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`proof of qualifying art sufficient to establish for any of the challenged claims, a
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`reasonable likelihood of success on any asserted ground of invalidity. Because of
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`this clear threshold failure, UTC submits the Petition should be denied and no inter
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`partes review should be instituted under 35 U.S.C. § 314.
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`A. Background
`The ’793 patent relates to the treatment of pulmonary hypertension and is
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`listed in the Orange Book for the product Tyvaso® (treprostinil) Inhalation Solution,
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`a drug-device combination for delivery of treprostinil by inhalation. EX1001, 18:2-
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`3; EX2007. At the time of the invention, as today, pulmonary hypertension was a
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`poorly understood, often fatal, disease with limited treatment options. The first
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`approved treatment for pulmonary hypertension—and sole approved treatment for
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`over five years—was epoprostenol.
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`Epoprostenol is administered by continuous intravenous infusion, and the
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`need for a permanent transcutaneous intravenous catheter posed risks of infection,
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`occlusion, and sepsis. EX2008. Further, the half-life of this drug is just a few
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`minutes, which means that even a short interruption in infusion could increase the
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`risk of hemodynamic collapse and even death because of delivery complications. Id.
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`Moreover, epoprostenol requires daily mixing and refrigeration, thus requiring the
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`patient to carry a cold pack to avoid degradation at room temperature and an infusion
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`pump to administer the drug. Id.
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`Later-approved intravenous and subcutaneous administration of treprostinil
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`had some benefits over epoprostenol. For example, it is stable at room temperature
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`and has a half-life of several hours rather than several minutes. This freed patients
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`of the burden of having to carry ice packs to ensure the safety and efficacy of the
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`drug. Id. There were still limitations to intravenous and subcutaneous delivery of
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`treprostinil, such as intolerable site pain in some instances. EX1018, 1.
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`By the priority date of the ’793 patent, clinicians had begun to explore
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`inhalation therapy for the treatment of pulmonary hypertension. See, e.g., EX1007.
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`At that time, the only FDA-approved prostacyclin-type drug that could be given in
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`an inhalable form was iloprost, marketed as Ventavis®. At the priority date, the
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`results of an Aerosolized Iloprost Randomized (AIR) Study documenting the effects
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`of inhaled iloprost had been public about three and a half years, and Ventavis® had
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`been on the market for about one and a half years. EX2009 at 21. Nonetheless,
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`clinicians generally preferred intravenous administration of a prostacyclin analog
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`over inhaled delivery of iloprost. Id.
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`Further, adoption of Ventavis® posed a number of issues. For instance,
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`Ventavis® has a half-life between 20-25 min. Id. at 21, 23-24. As a result, Ventavis®
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`needs to be used 6-9 times a day, as frequently as every 2 hours, which was
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`considered challenging for patients to implement. Id. Moreover, the fact that
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`Ventavis® has a short half-life results periods of under-medicated while asleep
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`unless they wake at regular intervals to dose themselves. Id.
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`B.
`The Challenged ’793 Patent
`The ’793 patent relates to a break-through therapy permitting treatment of
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`pulmonary hypertension using inhaled treprostinil—a treatment addressing a variety
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`of limitations burdening Ventavis® treatment. Specifically, the ’793 patent relates to
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`a method of treating pulmonary hypertension by administering by inhalation a
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`therapeutically effective single event does that comprises from 15 micrograms to 90
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`micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in
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`1 to 3 breaths. The ’793 patent was granted on application claiming priority to a
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`provisional application, 60/800,016, filed on May 15, 2006. Liquidia does not
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`contest this priority date.
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`The ’793 patent has 8 claims—1 independent claim and 7 dependent claims.
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`Independent claim 1 requires “a method treating pulmonary hypertension
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`comprising administering by inhalation to a human suffering from pulmonary
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`hypertension a therapeutically effective single event dose of a formulation
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`comprising treprostinil or a pharmaceutically acceptable salt thereof with an
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`inhalation device, wherein the therapeutically effective single event dose comprises
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`15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable
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`salt there of delivered in 1 to 3 breaths.” Dependent claims 2 through 5 require
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`specific types of inhalation devices, namely a soft mist inhaler (claim 2), a pulsed
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`ultrasonic nebulizer (claim 3), a dry powder inhaler (claim 4) or a pressurized
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`metered dose inhaler (claim 5). Dependent claim 6 requires the formulation to be a
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`dry powder, and dependent claim 7 requires the powder to comprise particles less
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`than 5 micrometers in diameter. Dependent claim 8 requires the formulation to
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`contain no metacresol.
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`The specification of the ’793 patent teaches that administration of treprostinil
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`using the claimed method resulted in a significant reduction in pulmonary vascular
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`resistance (PVR) and pulmonary artery pressure (PAP) (’793 patent at FIG. 10;
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`16:32-42) and a significant increase in cardiac output (Id. at 16:40-42). The results
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`of the clinical studies described in the ’793 patent taught that, surprisingly, the time
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`of inhalation could be reduced significantly by increasing the concentration of
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`treprostinil aerosol using a novel pulsed ultrasonic nebulizer. Id. at 16:61-63; see
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`also id. at 17:44-46 (“Study iii) successfully demonstrated that the inhalation time
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`could be reduced to literally one single breath of 2000 μg/mL treprostinil solution,
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`thereby applying a dose of 15 μg.”) This single-breath drug administration induced
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`pulmonary vasodilation for longer than 3 hours with minimal side effects. Id. at
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`18:1-6. Surprisingly, high concentrations of treprostinil were well tolerated. Id.
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`The commercial embodiment of the ’793 patent, Tyvaso® (inhaled
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`treprostinil) has shown distinct advantages over the other available treatments for
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`pulmonary hypertension. For example, Tyvaso® (inhaled treprostinil) does not need
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`to be administered as frequently as Ventavis®, leading to higher patient compliance
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`and less risk of rebound hypertension. Tyvaso® (inhaled treprostinil) has a much
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`longer half-life than Ventavis® when inhaled by human subjects suffering from
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`pulmonary hypertension. This allows Tyvaso® to be administered markedly less
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`frequently—about 4 times a day. Patients are more likely to comply with a regimen
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`that requires less frequent administrations. Furthermore, because Tyvaso® has a
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`longer half-life than Ventavis®, there is less risk when the patient is asleep or
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`otherwise unable to take the medication.
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`U.S. Patent No. 10,716,793 B2
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`Another study reported that “the transition from inhaled iloprost to inhaled
`
`treprostinil resulted in a time saving of approximately 1.4 h per day.” EX2021, 5.
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`Patients transferring from inhaled iloprost to inhaled treprostinil also had improved
`
`six-minute walk distances (a common metric to assess pulmonary hypertension),
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`improved patient satisfaction, and improved quality of life. Id. at 5-6
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`II. THE BOARD SHOULD DENY INSTITUTION
`A. The Board Should Exercise Discretionary Denial Under 35 U.S.C.
`§ 314(a)
`Section 314(a) “invests the Director with discretion on the question whether
`
`to institute review.” SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018); Cuozzo
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`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.”). The
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`Board, in determining whether to exercise discretion to deny institution under 35
`
`U.S.C. § 314(a), may consider an early trial date in related litigation as part of an
`
`assessment of all relevant circumstances of the case, including the merits, in an effort
`
`to balance considerations such as efficiency and fairness. Apple Inc. v. Fintiv, Inc.,
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`IPR2020-00019, Paper 11 at 5-6 (PTAB May 13, 2020) (precedential) (“Fintiv
`
`Order”); NHK Spring Co., Ltd. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8
`
`(PTAB Sep. 12, 2018) (denying institution relying, in part, on § 314(a) because the
`
`parallel district court proceeding was scheduled to finish before the Board reached a
`
`final decision) (precedential).
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`When considering an early trial date in related litigation, the Board evaluates
`
`the following factors, referred to as the “Fintiv factors”:
`
`1. whether the court granted a stay or evidence exists that one may be
`granted if a proceeding is instituted;
`2. proximity of the court’s trial date to the Board’s projected statutory
`deadline for a final written decision;
`3. investment in the parallel proceeding by the court and the parties;
`4. overlap between issues raised in the petition and in the parallel
`proceeding;
`5. whether the petitioner and the defendant in the parallel proceeding are
`the same party; and
`6. other circumstances that impact the Board’s exercise of discretion,
`including the merits.
`Fintiv Order at 5–6. In evaluating these factors, “the Board takes a holistic view of
`
`whether efficiency and integrity of the system are best served by denying or
`
`instituting review.” Id. at 6.
`
`1.
`The District Court Litigation
`On June 4, 2020, UTC (Patent Owner to the present inter partes review) filed
`
`a complaint against Petitioner Liquidia Technologies, in the U.S. District Court for
`
`the District of Delaware. United Therapeutics Corporation v. Liquidia
`
`Technologies, Inc., Case No. 1:20-cv-00755-RGA-JLH (D.Del.) (the “Delaware
`
`Litigation”). The Complaint relates to Liquidia’s submission of New Drug
`
`Application (“NDA”) 213005 under § 505(b)(2) of the Federal Food, Drug and
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`4826-0990-5385.2
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`Cosmetic Act, which seeks approval to manufacture and market its version of an
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`inhaled treprostinil product based on FDA’s approval of UTC’s Tyvaso®
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`(treprostinil) Inhalation Solution (0.6 mg/mL), currently approved by FDA for the
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`treatment of pulmonary arterial hypertension. See EX2010 at ¶ 2. In the Complaint,
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`UTC alleges that Liquidia is seeking to market its treprostinil product prior to the
`
`expiration of, and thus will be infringing upon, UTC’s Orange Book-listed Patents
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`for Tyvaso®.
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`After an extension of time, Liquidia filed its Answer and Counterclaims on
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`July 16, 2020. EX2011. Shortly thereafter, on July 22, 2020, UTC filed its First
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`Amended Complaint, which added the then-newly issued ’793 patent to the
`
`litigation. EX2012; see also EX1011, ¶¶ 69-83.
`
`A Rule 16(b) scheduling conference was held by telephone before the court
`
`on July 30, 2020. EX2013. The next day, on July 31, 2020, the court entered a
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`scheduling order including the following dates:
`
`Event
`Joint Claim Construction Brief
`Markman Hearing
`Fact Discovery Deadline
`Dispositive Motions Deadline
`Pretrial Conference
`3 day Bench Trial
`See EX2014.
`
`Date
`4/30/2021
`5/24/2021
`9/17/2021
`11/2/2021
`3/4/2022
`3/28/2022
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`4826-0990-5385.2
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`U.S. Patent No. 10,716,793 B2
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`On August 26, 2020, UTC filed a motion to dismiss certain of Liquidia’s
`
`invalidity counterclaims and defenses, based on a theory of assignor estoppel,
`
`specifically related to the ’793 patent. EX2015; EX 1013. In its motion, UTC
`
`provided evidence that Liquidia had hired in an executive capacity one of the’793
`
`patent’s named inventors, Robert Roscigno. UTC’s motion was fully briefed and
`
`denied by the court on November 3, 2020 due to the factually intense nature of the
`
`motion. EX2016; EX1014.
`
`Discovery has been active and ongoing in the Delaware Litigation. Both
`
`parties served (and responded to) discovery requests on each other, with the first
`
`discovery requests being served in August 2020. See e.g. EX2017-EX2019. The
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`parties have continued to serve and respond to discovery in the time since, including
`
`as recently as April 2021. See EX2020-EX2021. Additionally, UTC served its
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`Preliminary Infringement Contentions in October 2020, and Liquidia has served its
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`Preliminary Invalidity Contentions (in November 2020). EX2022-2023.
`
`At this time, the Delaware Litigation is in the claim construction phase, with
`
`the briefing completed and the hearing currently scheduled for May 24, 2021.
`
`EX2024-EX2025.
`
`2.
`Analysis of Fintiv Factors
`In the Fintiv Order, the Board set forth six factors, which “relate to whether
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`efficiency, fairness, and the merits support the exercise of authority to deny
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`U.S. Patent No. 10,716,793 B2
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`institution in view of an earlier trial date in the parallel proceeding . . . [I]n evaluating
`
`the factors, the Board takes a holistic view of whether efficiency and integrity of the
`
`system are best served by denying or instituting review.” Id. at 6. All of these factors
`
`favor UTC’s request that the Board exercise its authority to grant a discretionary
`
`denial and are discussed in turn below.
`
` Whether the court granted a stay or evidence exists
`that one may be granted if a proceeding is instituted
`As the Board explained with regards to the first Fintiv factor, “[i]f a court has
`
`denied a defendant’s motion for a stay pending resolution on a PTAB proceeding,
`
`and has not indicated to the parties that it will consider a renewed motion or
`
`reconsider a motion to stay, if a PTAB trial is instituted, this fact has sometimes
`
`weighed in favor of exercising authority to deny institution.” Fintiv Order at 8.
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`Neither party to the Delaware Litigation has moved for a stay, and there is not
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`currently any evidence that the court would grant such a stay if the present IPR were
`
`to be instituted. To the contrary, and as noted above, discovery is actively ongoing
`
`and a claim construction hearing scheduled to occur in two weeks’ time, on June 4,
`
`2021.
`
`Moreover, UTC notes that, in October 2020, the Board decided to institute
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`review on one other patent at issue in the Delaware Litigation and declined to
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`institute review on the other. Liquidia Tech., Inc. v. United Therapeutics Corp.,
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`13
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`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
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`IPR2020-00770, Paper 7 (PTAB Oct. 13, 2020
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