UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case No. IPR2018-01675
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`

`

`
`
`I. 
`
`II. 
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION .......................................................................................... 1 
`
`THE BOARD SHOULD EXERCISE ITS DISCRETION TO DENY
`INSTITUTION PURSUANT TO §§ 314(A) AND 324(A) ............................ 4 
`
`A. 
`
`B. 
`
`C. 
`
`Procedural Background ......................................................................... 6 
`
`The Board Has Discretion to Deny Institution Under 35 U.S.C.
`§§ 314(a) and 324(a) ............................................................................. 8 
`
`NHK Spring Co. v. Intri-Plex Technologies, Inc., IPR2018-
`00752 ..................................................................................................... 9 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`The parties are engaged in District Court litigation on the
`same patent ................................................................................ 10 
`
`The Petitioner relies on the same prior art in the Petition
`as in the District Court case ...................................................... 11 
`
`The District Court trial will conclude before the IPR ............... 12 
`
`Instituting the IPR permits the Petitioner a tactical
`advantage .................................................................................. 12 
`
`D.  General Plastic Industrial Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357 ................................................................................... 14 
`
`1. 
`
`General Plastics Factors 1, 2, 4, and 5: whether the same
`petitioner previously filed a petition directed to the same
`claims of the same patent; whether at the time of filing of
`the first petition the petitioner knew of the prior art
`asserted in the second petition or should have known of it;
`the length of time that elapsed between the time the
`petitioner learned of the prior art asserted in the second
`petition and the filing of the second petition; whether the
`petitioner provides adequate explanation for the time
`elapsed between the filings of multiple petitions directed
`to the same claims of the same patent ....................................... 15 
`i
`
`

`

`2. 
`
`3. 
`
`General Plastics Factor 3: whether at the time of filing of
`the second petition the petitioner already received the
`patent owner’s preliminary response to the first petition or
`received the Board’s decision on whether to institute
`review in the first petition ......................................................... 17 
`
`General Plastics Factors 6 and 7: the finite resources of
`the Board; and the requirement under 35 U.S.C. §
`316(a)(11) to issue a final determination not later than 1
`year after the date on which the Director notices institution
`of review ................................................................................... 17 
`
`III.  THE 044 PATENT ........................................................................................ 19 
`
`IV.  CLAIM CONSTRUCTION .......................................................................... 24 
`
`A. 
`
`B. 
`
`“helical groove” (claim 11) ................................................................. 24 
`
`“tubular clutch” (claim 11) and “clicker” (claim 14) .......................... 28 
`
`V. 
`
`THE PRIOR ART .......................................................................................... 29 
`
`A. 
`
`Burroughs ............................................................................................ 29 
`
`VI.  REASONS WHY THE PETITION SHOULD BE DENIED ....................... 36 
`
`A.  Ground 1 Should Be Denied Because Burroughs Does Not
`Disclose Or Render Obvious A Helical Groove Provided Along
`An Outer Surface Of Said Dose Dial Sleeve ...................................... 36 
`
`1. 
`
`2. 
`
`3. 
`
`Burroughs Does Not Disclose A Helical Groove Provided
`Along An Outer Surface Of Said Dose Dial Sleeve ................. 36 
`
`Burroughs In View Of The Knowledge Of A POSA Does
`Not Render Obvious A Helical Groove Provided Along
`An Outer Surface Of Said Dose Dial Sleeve ............................ 36 
`
`Petitioner Does Not Establish A Motivation To Modify
`Burroughs’ Threads To Include A Groove ............................... 39 
`
`ii
`
`

`

`B. 
`
`Ground 1 Should Be Denied Because Burroughs Does Not
`Disclose Or Render Obvious That The Helical Groove Of The
`Dose Dial Sleeve Has A Different Lead Than The Internal
`Threading Of The Drive Sleeve .......................................................... 41 
`
`1. 
`
`2. 
`
`3. 
`
`Burroughs Does Not Disclose Or Render Obvious A
`Helical Groove Of The Dose Dial Sleeve ................................. 41 
`
`Burroughs Does Not Disclose That The First Lead And
`Second Lead Are Different ....................................................... 42 
`
`Burroughs Does Not Render Obvious That The First Lead
`And Second Lead Are Different ............................................... 42 
`
`C. 
`
`The Petition Fails To Put Patent Owner On Notice Of How The
`Claims Are To Be Construed In The Grounds As Required By
`37 C.F.R. § 42.104(b) .......................................................................... 45 
`
`VII.  CONCLUSION .............................................................................................. 48 
`
`
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases 
`Compass Bank, Commerce Bankshares, Inc. v. Intellectual Ventures II, LLC,
`IPR2014-00786, Paper 46 (P.T.A.B. Sept. 23, 2015) .......................................... 38
`Corning Inc. v. DSM IP Assets,
`IPR2013-00050, Paper 77 (P.T.A.B. May 1, 2014) ............................................. 38
`Cutsforth, Inc. v. MotivePower, Inc.,
`636 F. App’x 575 (Fed. Cir. 2016) ...................................................................... 40
`Gen. Electric Co. v. Vestas Wind Systems A/S,
`IPR2018-00928, Paper 9 (P.T.A.B. Nov. 5, 2018) .............................................. 46
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017) ................................. 5, 14, 16
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) ............................................................................ 40
`Microsoft Corp. v. Koninklijke Philips N.V.,
`IPR2018-00277, Paper 10 (P.T.A.B. June 8, 2018) ............................................... 5
`NetApp, Inc. v. Realtime Data LLC,
`PR2017-01195, Paper 9 (P.T.A.B. Oct. 12, 2017) ....................................... 14, 17
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (P.T.A.B. Sept. 12, 2018) .................................... passim
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) ..................................................................... 40, 44
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) ............................................................................ 29
`Statutes and Rules 
`21 C.F.R. § 314.50, et seq. .....................................................................................6, 7
`21 C.F.R. § 314.52 ..................................................................................................... 6
`
`iv
`
`

`

`21 U.S.C. § 355(b)(2) and (3) .................................................................................... 6
`21 U.S.C. § 355(b)(3)(b)(ii) ....................................................................................... 7
`21 U.S.C. § 355(c)(3)(C) ........................................................................................... 8
`35 U.S.C. § 314(a) ........................................................................................... passim
`35 U.S.C. § 315(b) .............................................................................................. 7, 16
`35 U.S.C. § 316(a)(11) ............................................................................................. 17
`35 U.S.C. §§ 314(a) and 324(a) ....................................................................... passim
`35 U.S.C. §§ 316(b) and 326(b) ................................................................................. 9
`37 C.F.R. § 42.104, et seq. ............................................................................... passim
`37 C.F.R. § 42.65(a) ................................................................................................. 38
`
`v
`
`

`

`
`
`Exhibit #
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`EXHIBIT LIST
`
`Description
`Press Release, “Mylan Enhances Partnership with Biocon through
`Strategic Collaboration for Insulin Products”, Feb. 13, 2013 (PR
`Newswire), available at http://newsroom.mylan.com/press-
`releases?item=122834
`Press Release, “Mylan Commences Phase III Clinical Trials for its
`Generic Version of Advair Diskus® and Insulin Analog to Lantus®”,
`Sept. 16, 2014 (PR Newswire), available at
`http://newsroom.mylan.com/press-releases?item=123251
`Press Release, “Mylan and Biocon Present Clinical Data on Insulin
`Glargine at the American Diabetes Association’s 77th Scientific
`Sessions”, June 10, 2017 (PR Newswire), available at
`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-
`Present-Clinical-Data-on-Insulin-Glargine-at-the-American-
`Diabetes-Associations-77th-Scientific-Sessions
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH v. Eli Lilly and Company, C.A.
`No. 1-14-cv-00113-RGA (D. Del), Dkt. No. 1
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop Industrie
`v. Merck Sharp & Dohme Corp., C.A. No. 1-16-cv-00812-RGA (D.
`Del), Dkt. No. 1
`Stipulation and Proposed Order, Sanofi-Aventis U.S. LLC v. Mylan,
`N.V., Civil Action No. 17-9105-SRC-SLW (D.N.J. Feb 5, 2018),
`Dkt. No. 45
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC et al.
`v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.
`Oct. 24, 2017), Dkt. No. 1
`Excerpts from Defendants’ Invalidity Contentions, dated Jan. 25,
`2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No.
`2:17-cv-09105-SRC-CLW (D.N.J.)
`Excerpts from Mylan GMBH’s Amended Invalidity Contentions,
`dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V.
`et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Excerpts from Mylan GMBH’s Exhibit C to Amended Invalidity
`Contentions, dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v.
`Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`vi
`
`

`

`2011
`
`2012
`2013
`
`2014
`
`2015
`
`Aug. 13, 2018 Service of Sanofi’s Responses to Mylan’s Amended
`Contentions, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al.,
`Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`MP4 file of Sanofi’s Patented Pen animation
`Excerpts from McGraw Hill Dictionary of Scientific and Technical
`Terms (Sixth edition, McGraw-Hill 2003), p. 972 and 1873
`Excerpts from Merriam-Webster’s Collegiate Dictionary (10th
`edition, Merriam-Webster, Inc. 2001), p. 538
`
`The New Oxford American Dictionary (Oxford University Press
`2001), p. 789-90
`
`
`
`
`
`
`
`
`vii
`
`

`

`
`
`I.
`
`INTRODUCTION
`The Board should decline to institute a trial on the Petition. The Petition
`
`asserts an invalidity ground that will already be decided in a co-pending District
`
`Court case before any final written decision is due here, fails to demonstrate a
`
`reasonable likelihood of success that at least one of the challenged claims is
`
`unpatentable, and fails to comply with the requirements of 37 C.F.R. § 42.104(b).
`
`First, the facts and circumstances under which this Petition was filed justify
`
`the Board exercising its discretion to deny institution under 35 U.S.C. §§ 314(a) and
`
`324(a). Petitioner raises the same invalidity grounds here as it did nearly a year
`
`ago—and continues to assert—in a co-pending district court case that is on schedule
`
`for trial before the end of this year. Sanofi-Aventis U.S. LLC v. Mylan N.V. et al.,
`
`Case No. 2:17-cv-09105-SRC-CLW (D.N.J.) (“District Court case”). The 044 Patent
`
`has been listed in the FDA’s Orange Book as covering Patent Owner’s insulin
`
`glargine prefilled pen drug product since 2014 and Petitioner identified the 044
`
`Patent in its Paragraph IV notice served well over a year prior to filing this Petition.
`
`Moreover, Patent Owner previously asserted the 044 Patent in related lawsuits
`
`against Eli Lilly and Merck. Petitioner thus has long had notice of the 044 Patent,
`
`but waited until near the eve of the one-year statutory period to file the instant
`
`Petition. Because of Petitioner’s own delay, the invalidity grounds at issue here will
`
`
`
`

`

`
`
`be tried in the co-pending District Court case before a final written decision on this
`
`Petition will be due.
`
`Instituting an IPR trial would not serve as a “quick and cost effective
`
`alternative[] to litigation,” but would rather subject Petitioner to defending the same
`
`arguments in different forums. H.R. Rep. No. 112–98, pt. 1, at 48 (2011); see also
`
`NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8 at 19-20
`
`(P.T.A.B. Sept. 12, 2018) (“NHK Spring”). The Board should not permit repeated
`
`and duplicative attacks on the same patent claims using the same invalidity grounds
`
`at the expense of the Board’s and the parties’ resources. Thus, the Board should
`
`exercise its discretion to deny institution under §§ 314(a) and 324(a).
`
`Second, Petitioner’s single obviousness ground based on one prior art
`
`reference should be denied institution because the proposed obviousness ground fails
`
`to disclose multiple limitations of the challenged claims. Petitioner admits that its
`
`prior art reference, U.S. Patent No. 6,221,046 (“Burroughs”), does not disclose either
`
`the required “helical groove” on an outer surface of a dose dial sleeve in a pen-type
`
`injector or that this helical groove has a different lead than the internal threading
`
`found in a drive sleeve of such an injector. Petition at 39, 40.
`
`Despite acknowledging these shortcomings in Burroughs, Petitioner proposes
`
`a modification of the reference that similarly does not include a helical groove on
`
`the dose dial sleeve, which Petitioner arrives at by applying a fundamentally flawed
`
`2
`
`

`

`
`
`interpretation of the term “helical” that is unsupported by the intrinsic evidence or
`
`the knowledge of a person of ordinary skill in the art (“POSA”). Moreover,
`
`Petitioner fails to offer any motivation to modify the Burroughs disclosure to include
`
`either a helical groove or an internal threading that has a different lead from the
`
`helical groove.
`
`Finally, 37 C.F.R. § 42.104(b) requires that a petition identify “[h]ow the
`
`challenged claim is to be construed” and “[h]ow the construed claim is unpatentable”
`
`so as to put a patent owner sufficiently on notice of the alleged grounds. 37 C.F.R.
`
`§ 42.104(b)(3)-(4). See also Section VI.C, infra (discussing the purpose of the rule
`
`from its rulemaking history). The Petition runs afoul of these requirements in two
`
`ways. First, the Petition fails to clearly identify what constructions it relies upon.
`
`The Petition proffers the “plain and ordinary meaning” generally for all claim terms
`
`yet does not articulate a plain and ordinary meaning for those terms. Leading to
`
`further confusion, Petitioner identifies the claim constructions proposed by Patent
`
`Owner in the co-pending District Court litigation, but does not state whether these
`
`are the plain and ordinary meanings applied in the Petition. 1 Second, where the
`
`
`1 In the District Court case, Petitioner articulates constructions for various claim
`
`terms, but Petitioner does not identify whether it is applying those constructions as
`
`the plain and ordinary meaning in this Petition.
`
`3
`
`

`

`
`
`Petition does clearly proffer claim constructions (for what it incorrectly contends are
`
`means-plus-function limitations), the Petition does not use these constructions
`
`consistently in its grounds and thus does not explain how the claims, as construed,
`
`are unpatentable. For example, the Petition construes “clicker” as a means-plus-
`
`function term and identifies “component 50” in Figures 6-8 as the corresponding
`
`structure. In contrast, when discussing the prior art, the Petition identifies “the
`
`helically extending arms of clicker 50” and “splines on the housing” as the
`
`corresponding clicker structure. See, e.g., Petition at 44. This internal inconsistency
`
`fails to put Patent Owner on notice for “[h]ow the challenged claim is to be
`
`construed” and “[h]ow the construed claim is unpatentable ….” 37 C.F.R. §
`
`42.104(b)(3)-(4).
`
`For these reasons, as detailed further below, Patent Owner respectfully
`
`requests that the Board deny institution of inter partes review.
`
`II. THE BOARD SHOULD EXERCISE ITS DISCRETION TO DENY
`INSTITUTION PURSUANT TO §§ 314(A) AND 324(A)
`The Board should exercise its discretion and deny the Petition under 35 U.S.C.
`
`§§ 314(a) and 324(a). It would waste the Board’s finite resources and is
`
`fundamentally unfair and inefficient to require Patent Owner to expend resources on
`
`an IPR trial where the final written decision will issue only after the conclusion and
`
`resolution of the identical validity challenge in the related District Court case.
`
`4
`
`

`

`
`
`The efficient resolution of patent challenges is foundational to the IPR system
`
`and the AIA generally. To this end, it is “an objective of the AIA . . . to provide an
`
`effective and efficient alternative to district court litigation.” Gen. Plastic Indus. Co.
`
`v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 16–17 (P.T.A.B. Sept. 6,
`
`2017) (precedential) (“Gen. Plastic”); see also Microsoft Corp. v. Koninklijke
`
`Philips N.V., IPR2018-00277, Paper 10 at 7 (P.T.A.B. June 8, 2018) (explaining that
`
`“AIA proceedings ‘are not to be used as tools for harassment….Doing so would
`
`frustrate the purpose of the section as providing quick and cost effective alternatives
`
`to litigation’” quoting H.R. Rep. No. 112-98, pt. 1, at 48 (2011)). This purpose is
`
`frustrated when, as here, a party delays filing a petition until such time that the IPR,
`
`if instituted, would result in a final written decision only after the same validity
`
`issues have been resolved by a district court. See NHK Spring, IPR2018-00752,
`
`Paper 8.
`
`The Board has also recognized “the potential for abuse of the review process
`
`by repeated attacks on patents” in deciding to exercise its discretion under §§ 314(a)
`
`and 324(a). See Gen. Plastic, IPR2016-01357, Paper 19 at 16-17. Here, Petitioner
`
`has filed multiple petitions on the 044 Patent not as “an effective and efficient
`
`alternative to district court litigation,” id., but instead in an inefficient and
`
`intentionally staggered attempt to take the same shot at the same patent in different
`
`forums.
`
`5
`
`

`

`
`
`
`
`A.
`Procedural Background
`Petitioner and
`its
`identified real-party-in-interest Biocon entered a
`
`collaboration to develop and commercialize a follow-on version of insulin glargine
`
`in 2013 (Ex. 2001), commenced clinical trials by 2014 (Ex. 2002), and announced
`
`the results of those trials by June 10, 2017 (Ex. 2003). By this time in 2017, Patent
`
`Owner had already asserted the 044 Patent against two other competitors seeking
`
`approval of follow-on glargine products. See Ex. 2004 at 6-7, Ex. 2005 at 1.
`
`Relatedly, the publication of the FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (the “Orange Book”) has listed the 044 Patent
`
`since 2014 as covering Patent Owner’s Lantus® SoloSTAR® product (i.e., Sanofi’s
`
`insulin glargine formulation and the injector pen device for the administering the
`
`formulation). Thus, Petitioner was long on notice of the 044 Patent, and that the
`
`Patent Owner was actively enforcing it against competitors.
`
`
`
`On April 27, 2017, Petitioner submitted its application to market its follow-
`
`on insulin glargine product to the FDA. Thereafter, as required by the rules
`
`governing follow-on drug applications—21 U.S.C. § 355(b)(2) and (3), and 21
`
`C.F.R. §§ 314.50(i) and 314.52—Petitioner sent Patent Owner a letter dated
`
`September 15, 2017 that noticed the submission of Petitioner’s FDA application and
`
`contained so-called “Paragraph IV” certification alleging that Petitioner’s proposed
`
`glargine product would not infringe the claims of the 044 Patent, which Petitioner
`
`6
`
`

`

`
`
`alleged to be amongst a list of patents that are not “not valid, unenforceable, and/or
`
`will not be infringed.”
`
` See 21 U.S.C. § 355(b)(3)(b)(ii); 21 C.F.R. §
`
`314.50(i)(1)(i)(A)(4).
`
`
`
`On October 24, 2017 Patent Owner filed a patent infringement case against
`
`Petitioner asserting the 044 Patent, among others. As part of that patent infringement
`
`case, Petitioner served its invalidity contentions on Patent Owner on January 25,
`
`2018 (amended April 25) that included the exact same prior art grounds of invalidity
`
`now advanced in the Petition—i.e., obviousness of claims 11, 14, 15, 18, and 19 of
`
`the 044 Patent over Burroughs.2 See Section II.C.2, infra.
`
`
`
`On August 12, 2018 (approximately a month before filing the Petition),
`
`Petitioner received and reviewed Patent Owner’s detailed validity contentions
`
`responding to those grounds. Despite long having notice of the 044 Patent and its
`
`assertion against Petitioner, it was not until September 10, 2018—the eve of the one-
`
`year statutory bar under 35 U.S.C. § 315(b)—that Petitioner filed this Petition, along
`
`with eight others, asserting substantially the same invalidity grounds it alleged in the
`
`
`2 Petitioner’s invalidity contentions in the District Court case expressly state that
`
`with respect to alleged obviousness of the 044 Patent, Petitioner is “more likely to
`
`rely on … Burroughs, alone or in combination with” other specified references. Ex.
`
`2009 at 268-269 (emphasis added).
`
`7
`
`

`

`
`
`District Court case. See IPR2018-01670, IPR2018-01676, IPR2018-01678,
`
`IPR2018-01679, IPR2018-01680, IPR2018-01682, IPR2018-01696, IPR2019-
`
`00122.
`
`In the meantime, the parties have been actively litigating the District Court
`
`case. A Markman hearing is likely to occur in early February 2019, and the parties
`
`have jointly requested a trial for October 2019 in order to achieve resolution of the
`
`issues before the end of the FDA’s 30-month stay of regulatory approval of
`
`Petitioner’s FDA application (March 18, 2020).3 See Ex. 2006, ¶ 8 (“The parties
`
`hereby agree to jointly request the Court to schedule trial in the Action in October
`
`2019”). Accordingly, resolution of the District Court case should occur well before
`
`the April 2020 due date for a final written decision in this IPR if a trial were to be
`
`instituted.
`
`B.
`
`The Board Has Discretion to Deny Institution Under 35 U.S.C. §§
`314(a) and 324(a)
`The Board has discretion under §§ 314(a) and 324(a) to deny institution. See
`
`August 2018 Update to the Office Patent Trial Practice Guide at 8 (Aug. 13, 2018)
`
`
`3 As part of the Hatch-Waxman process, Patent Owner’s District Court case against
`
`Petitioner triggered a 30-month period during which the FDA will not approve
`
`Petitioner’s follow-on application without resolution of the District Court case. See
`
`21 U.S.C. § 355(c)(3)(C).
`
`8
`
`

`

`
`
`(“August 2018 Trial Practice Guide Update”). This “discretion is informed by 35
`
`U.S.C. §§ 316(b) and 326(b), which require the Director to ‘consider the effect of
`
`any such regulation [under this section] on the economy, the integrity of the patent
`
`system, the efficient administration of the Office, and the ability of the Office to
`
`timely complete proceedings instituted under this chapter.’” Id. at 9. In discussing
`
`this discretion, the August 2018 Trial Practice Guide Update recognizes that the
`
`“AIA was ‘designed to establish a more efficient and streamlined patent system that
`
`will improve patent quality and limit unnecessary and counterproductive litigation
`
`costs.’” Id. (citing H.R. Rep. No. 112-98, pt. 1, at 40 (2001), 2011 U.S.C.C.A.N. 67,
`
`69). Indeed, the Board has exercised its discretion to deny institution under
`
`§§ 314(a) and 324(a) on facts substantially similar to those before this Board. See
`
`NHK Spring, IPR2018-00752, Paper 8.
`
`C. NHK Spring Co. v. Intri-Plex Technologies, Inc., IPR2018-00752
`In NHK Spring, like the instant case, (1) the parties were engaged in advanced
`
`district court litigation on the same patent, (2) the petitioner was relying on the same
`
`prior art in the petition as in the litigation, and (3) the district court trial would
`
`conclude before the IPR. See NHK Spring, IPR2018-00752, Paper 8. The Board
`
`denied institution, reasoning that “instituting a trial under the facts and
`
`circumstances here would be an inefficient use of Board resources,” and “would not
`
`9
`
`

`

`
`
`be consistent with ‘an objective of the AIA . . . to provide an effective and efficient
`
`alternative to district court litigation.’” Id. at 20.
`
`
`
`Given the near identical circumstances4 with NHK Spring, the Board should
`
`use its discretion to reach the same outcome here: it would be an inefficient use of
`
`Board resources to institute this IPR.
`
`1.
`
`The parties are engaged in District Court litigation on the
`same patent
`In NHK Spring, the challenged patent was asserted by the patent owner against
`
`the petitioner in a co-pending District Court case. NHK Spring, IPR2018-00752,
`
`Paper 8 at 19. Here, too, the 044 Patent is asserted by Patent Owner against Petitioner
`
`in Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-
`
`CLW, filed October 24, 2017. See Ex. 2007.
`
`
`4 Because the NHK Spring patent was expired, both the Board and District Court
`
`applied the Phillips standard for claim construction. Here, however, the 044 Patent
`
`is not expired and thus the Board will apply the BRI standard and the District Court
`
`will apply the Phillips standard for claim construction. This is a distinction without
`
`a difference, however, because Petitioner does not contend that the grounds rely on
`
`any constructions that would be different under the two standards. Indeed, the
`
`Petition cites Phillips to support its constructions. Petition at 14.
`
`10
`
`

`

`
`
`2.
`
`The Petitioner relies on the same prior art in the Petition as
`in the District Court case
`In support of its decision to deny institution under § 314(a), the Board in NHK
`
`Spring noted that “Petitioner relies on the same prior art … and arguments in its
`
`district court invalidity contentions as asserted in the Petition.” NHK Spring, Paper
`
`8 at 19. Here, Petitioner asserts that claims 11, 14, 15, 18, and 19 are obvious over
`
`Burroughs. Petition at 3. In the co-pending District Court case, Petitioner served
`
`invalidity contentions alleging that Burroughs alone renders these claims obvious.
`
`See Ex. 2008 at 202; Ex. 2009 at 268-269 (“… Mylan GmbH hereby identifies
`
`exemplary combinations that it may be more likely to rely on: … Burroughs, alone
`
`or in combination with Judson, Steenfeldt-Jensen, Atterbury, ....”) (emphasis added);
`
`Ex. 2010 at 11-12, 21, 35-38, 63-65, 81, 96-97, 116-117, 136-137, 156, 166, 176,
`
`190, 199-200. Thus, the same situation exists here as in NHK – the same prior art
`
`combinations used in the IPR are used in the litigation between the parties.5 See
`
`NHK Spring, Paper 8 at19-20.
`
`
`5 Moreover, Petitioner has filed eight other petitions that assert substantially the
`
`same arguments being litigated in the District Court case. See IPR2018-01670,
`
`IPR2018-01676, IPR2018-01678, IPR2018-01679, IPR2018-01680, IPR2018-
`
`01682, IPR2018-01696, IPR2019-00122.
`
`11
`
`

`

`
`
`3.
`The District Court trial will conclude before the IPR
`When the Board in NHK Spring issued its decision, the district court
`
`proceeding was “nearing its final stages” with trial a little over six months away. Id.
`
`at 1 (decision entered September 12, 2018), 20 (noting a March 25, 2019 trial date).
`
`The Board noted that the IPR trial “on the same asserted prior art will not conclude
`
`until September 2019,” approximately six months after the March 2019 trial date.
`
`Id. at 20.
`
`
`
`The circumstances here are no different. In the co-pending District Court case,
`
`Petitioner and Patent Owner have jointly requested a trial in October 2019. And even
`
`if a trial does not take place in October 2019, the District Court is keenly aware that
`
`the 30-month stay of regulatory approval of Petitioner’s FDA application expires on
`
`March 18, 2020, and has indicated that it will decide the issue of validity in advance
`
`of that date. A Final Written Decision in an IPR trial on the same prior art and
`
`arguments would not issue until April 2020, six months after the likely date of the
`
`District Court case trial. Thus, as the Board found in NHK Spring, instituting an IPR
`
`trial “ultimately would be inefficient.” NHK Spring, Paper 8 at 19-20.
`
`4.
`
`Instituting the IPR permits the Petitioner a tactical
`advantage
`In NHK Spring, the patent owner argued that the petitioner waiting to file the
`
`petition until shortly before the expiration of the one-year deadline is a factor
`
`favoring denial of institution. The Board disagreed, but stated that the “Patent
`12
`
`

`

`
`
`Owner does not apprise us of any tactical advantage, or opportunity for tactical
`
`advantage, that the Petitioner gained by waiting to file the Petition.” NHK Spring,
`
`Paper 8 at 19. In contrast, here Petitioner waited to file the Petition until after it had
`
`obtained Patent Owner’s detailed validity positions in response to Petitioner’s
`
`invalidity contentions (as explained in Section II.A. and II.C.2), and is attempting to
`
`get the proverbial two bites at the apple. Even if the 044 Patent is found valid and
`
`infringed at trial in the District Court case, Patent Owner will be unfairly required to
`
`defend the validity of the 044 Patent in an IPR proceeding before the Board on the
`
`same prior art and arguments.
`
`
`
`This gamesmanship is highly prejudicial to Patent Owner, and antithetical to
`
`the purpose of the statute, which is to provide a “quick and cost effective alternatives
`
`to litigation.” H.R. Rep. No. 112–98, pt. 1, at 48 (2011) (emphasis added). Petitioner
`
`was fully aware of the timing of the District Court case and elected to file its Petition
`
`at the eleventh hour, despite having asserted invalidity contentions in the District
`
`Court case based on the same prior art at least as early as January 25, 2018. See,
`
`e.g., Ex. 2008 at 202 (“As examples, Defendants further identify the following
`
`combinations as rendering the asserted claims obvious … Burroughs, alone or in
`
`combination with Judson, Steenfeldt-Jensen, Harris ’895, and/or Horstman”). In
`
`these circumstances, Patent Owner respectfully submits that the Board should
`
`exercise its discretion to deny the Petition.
`
`13
`
`

`

`
`
`D. General Plastic Industrial Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357
`NHK Spring cites extensively to General Plastic Industrial Co. v. Canon
`
`Kabushiki Kaisha, IPR2016-01357 (Paper 19) (P.T.A.B. Sept. 6, 2017) (precedential
`
`as to § II.B.4.i) (“Gen. Plastic”). In General Plastic, the Board developed a set of
`
`non-exclusive factors to determine whether a discretionary denial is appropriate.
`
`Gen. Plastic, Paper 19 at 9-10. These factors likewise amply support denial of the
`
`Petition, as explained below.
`
`
`
`While the General Plastic factors were articulated in the context of denying a
`
`follow-on petition filed by the same petitioner on the same patent, the Board has
`
`since recognized that the logic underlying these factors is applicable in other
`
`contexts. See NetApp, Inc. v. Realtime Data LLC, PR2017-01195, Paper 9 at 10
`
`(P.T.A.B. Oct. 12, 2017) (applying the General Plastic factors where different
`
`petitioners filed petitions on the same patent); see also August 2018 Trial Practice
`
`Guide Update at 10 (“The General Plastic factors are also not exclusive and are not
`
`intended to represent all situations where it may be appropriate to deny a petition.”).
`
`14
`
`

`

`
`
`1. General Plastics Factors 1, 2, 4, and 5: whether the same
`petitioner previously fil