`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case No. IPR2018-01676
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
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`
`
`
`
`
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`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION .......................................................................................... 1
`
`THE BOARD SHOULD EXERCISE ITS DISCRETION UNDER 35
`U.S.C. §§ 314(A) AND 324(A) TO DENY INSTITUTION .......................... 4
`
`A.
`
`B.
`
`C.
`
`Procedural Background ......................................................................... 5
`
`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
`
`Petitioner relies on the same prior art in the Petition as in
`the District Court case ............................................................... 11
`
`Trial in the District Court case 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 ................................................................................... 13
`
`1.
`
`General Plastic 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
`
`i
`
`
`
`2.
`
`3.
`
`elapsed between the filings of multiple petitions directed
`to the same claims of the same patent ....................................... 14
`
`General Plastic 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 ......................................................... 16
`
`General Plastic 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 ........................................................................................ 18
`
`IV. CLAIM CONSTRUCTION .......................................................................... 23
`
`A.
`
`B.
`
`“main housing” .................................................................................... 23
`
`“tubular clutch” and “clicker” ............................................................. 26
`
`V.
`
`TO DEMONSTRATE A
`FAILED
`PETITIONER HAS
`REASONABLE LIKELIHOOD OF SUCCESS ON GROUNDS 1
`AND 2 ............................................................................................................ 27
`
`A. Ground 1 Should Be Denied Because Steenfeldt-Jensen Does
`Not Render Obvious the Challenged Claims ...................................... 27
`
`1.
`
`2.
`
`Overview of U.S. Patent No. 6,235,004 (“Steenfeldt-
`Jensen”) (Ex. 1014) ................................................................... 27
`
`Steenfeldt-Jensen Does Not Teach or Render Obvious a
`“drive sleeve comprising an internal threading … adapted
`to engage an external thread of said piston rod” ....................... 32
`
`a)
`
`Steenfeldt-Jensen’s Disclosure on Switching the
`Piston Rod Guide and Nut Element Is Made for a
`Different Embodiment That Is Not the Basis for the
`Ground ............................................................................ 34
`
`ii
`
`
`
`b)
`
`c)
`
`A POSA Would Not Have Been Motivated to Make
`Petitioner’s Proposed Modification to the Fifth
`Embodiment Because the Fifth Embodiment Does
`Not Suffer the Same Drawbacks as the First
`Embodiment .................................................................... 36
`
`The Petitioner’s Modification to Switch the Piston
`Rod Guide and Nut Element
`to
`the Fifth
`Embodiment Results in an Inferior Pen Injector ............ 42
`
`B.
`
`Ground 2 Should Be Denied Because Møller, Alone or in
`Combination with Steenfeldt-Jensen, Does Not Render Obvious
`the Challenged Claims ........................................................................ 45
`
`1.
`
`2.
`
`Overview of U.S. Patent Application Publication No.
`2002/0052578 (“Møller”) ......................................................... 46
`
`The Combination of Møller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious “a drive sleeve extending
`along a portion of said piston rod” ............................................ 48
`
`a)
`
`b)
`
`A POSA Would Not Have Considered Connection
`Bars 12 and Nut 13 Functionally and Structurally
`Equivalent to Connection Element 112 and Nut 113
` ........................................................................................ 51
`
`A POSA Would Not Have Expected Connection
`Bars 12 with Nut 13 Could Be Formed as a Tubular
`Structure That Encompasses Piston Rod 4 Without
`Affecting the Device’s Operation ................................... 55
`
`3.
`
`A POSA Would Not Have Been Motivated to Combine
`the Teachings of Møller and Steenfeldt-Jensen as
`Petitioner Contends ................................................................... 56
`
`a) Møller Teaches Away From Steenfeldt-Jensen’s
`Externally-Grooved Dose Scale Drum ........................... 57
`
`b)
`
`A POSA Would Not Have Been Motivated to Make
`the Relied-Upon Combination Due to a Purported
`Benefit Alleged by Petitioner ......................................... 58
`iii
`
`
`
`4.
`
`The Combination of Møller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious “said dose dial sleeve
`comprising a helical groove configured to engage a
`threading provided by said main housing, said helical
`groove provided along an outer surface of said dose dial
`sleeve” ....................................................................................... 63
`
`VI. 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) ................................................. 67
`
`VII. CONCLUSION .............................................................................................. 70
`
`
`
`
`
`
`iv
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Gen. Electric Co. v. Vestas Wind Systems A/S,
`IPR2018-00928, Paper 9 (P.T.A.B. Nov. 5, 2018) .............................................. 68
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017) .................................... passim
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ....................................................................... 33, 45
`Microsoft Corp. v. Koninklijke Philips N.V., lIPR2018-00277,
`Paper 10 (P.T.A.B. June 8, 2018) .......................................................................... 5
`Millennium Pharms., Inc. v. Sandoz Inc.,
`862 F.3d 1356 (Fed. Cir. 2017) ............................................................................ 58
`Nestle USA, Inc. v. Steuben Foods, Inc.,
`686 F. App’x 917 (Fed. Cir. 2017) ............................................................... 24, 26
`NetApp, Inc. v. Realtime Data LLC,
`IPR2017-01195, Paper 9 (P.T.A.B. Oct. 12, 2017) ...................................... 14, 16
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (P.T.A.B. Sept. 12, 2018) .................................... passim
`Omega Eng’g, Inc. v. Raytek Corp.,
`334 F.3d 1314 (Fed. Cir. 2003) ............................................................................ 24
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ..................................................................... 10, 24
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ............................................................... 33, 45
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) ............................................................................ 27
`Statutes and Rules
`21 C.F.R. § 314.50, et seq. .....................................................................................6, 7
`v
`
`
`
`21 C.F.R. § 314.52 ..................................................................................................... 6
`21 U.S.C. § 355(b)(2) & 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) ................................................................................................... 11
`35 U.S.C. § 315(b) .............................................................................................. 7, 15
`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) ................................................................................. 8
`37 C.F.R. § 42.104(b) ...................................................................................... passim
`
`
`vi
`
`
`
`
`
`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.)
`vii
`
`
`
`
`
`
`
`
`2011
`
`2012
`
`2013
`
`2014
`2015
`
`2016
`
`2017
`2018
`
`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
`Excerpt from Defendants’ opening claim construction brief, dated
`October 12, 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.)
`Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp &
`Corp., Case No. 16-cv-812-RGA (D. Del.), Dkt. No. 192
`International Patent WO 99/3855
`Excerpt from Joint claim construction statement, Ex. A, dated
`October 8, 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.)
`Animation depicting Møller’s first embodiment
`Animation depicting Møller’s second embodiment
`
`viii
`
`
`
`
`
`I.
`
`INTRODUCTION
`The Board should decline to institute a trial on the Petition. The Petition
`
`asserts the same invalidity grounds that will be decided in a co-pending litigation in
`
`district court 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 Board should exercise its discretion to deny institution under 35
`
`U.S.C. §§ 314(a) and 324(a), because 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, and Patent Owner had previously asserted the 044
`
`Patent in related lawsuits against Eli Lilly and Merck. Petitioner has thus long had
`
`notice of the 044 Patent but waited until the eve of the one-year statutory deadline
`
`to file the instant Petition. Because of Petitioner’s own delay, the identical invalidity
`
`grounds raised in this Petition will tried in the co-pending District Court case before
`
`a final written decision on this Petition will be due.
`
`
`
`
`
`
`
`In these circumstances, 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 and be highly inefficient. 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 that waste the Board’s and the parties’
`
`resources. Thus, the Board should exercise its discretion to deny institution under §§
`
`314(a) and 324(a).
`
`Second, the Petition should be denied because it fails to demonstrate a
`
`reasonable likelihood of success that at least one claim is unpatentable. In Ground
`
`1, Petitioner concedes that Steenfeldt-Jensen fails to disclose a drive sleeve that
`
`engages with a piston rod via a threaded connection as required by the challenged
`
`claims. Petitioner and its expert argue obviousness but a person of ordinary skill in
`
`the art (“POSA”) would not have been motivated to make the Petition’s proposed
`
`modification. The proposed modification would result in an inferior (if not
`
`inoperable) device without any beneficial tradeoff.
`
`In Ground 2, Petitioner relies on the combination of Steenfeldt-Jensen and
`
`Møller. A POSA, however, would not have been motivated to combine Steenfeldt-
`
`Jensen’s scale drum with Møller’s injection pen, because Møller disparages and
`
`2
`
`
`
`
`
`rejects Steenfeldt-Jensen’s scale drum. Moreover, the Petition does not apply the
`
`correct construction for “main housing.” When properly construed, Møller fails to
`
`disclose or render obvious a “dose dial sleeve … configured to engage a threading
`
`provided by said main housing” as required by claim 11. Møller also fails to teach
`
`or render obvious a “drive sleeve” as required by claim 11 of the 044 Patent.
`
`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, 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 case, but does not state whether these are the
`
`plain and ordinary meanings applied in the Petition.1 Second, where the Petition
`
`
`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
`
`
`
`
`
`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 a “flexible arm 52”
`
`and “splines 42,” or “saw teeth” 55 and 66 as the corresponding clicker structure.
`
`See, e.g., Petition at 43. 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 UNDER 35
`U.S.C. §§ 314(A) AND 324(A) TO DENY INSTITUTION
`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.
`
`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
`4
`
`
`
`
`
`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); see also Microsoft Corp. v. Koninklijke Philips N.V.,
`
`lIPR2018-00277, 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.
`
`A.
`
`Procedural Background
`
`5
`
`
`
`
`
`
`
`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 the time of the June 2017
`
`press release, 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 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) & 3; 21 C.F.R. §§
`
`314.50(i) & 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 alleged to be
`
`6
`
`
`
`
`
`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 that included the exact same prior art advanced in the Petition and amended
`
`those contentions on April 25, 2018 to include the exact same prior art grounds now
`
`advanced in the Petition—i.e., obviousness of claims 11, 14, 15, 18, and 19 of the
`
`044 Patent over Steenfeldt-Jensen and also over Møller in combination with
`
`Steenfeldt-Jensen. 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
`
`District Court case. See IPR2018-01670, IPR2018-01675, IPR2018-01678,
`
`IPR2018-01679, IPR2018-01680, IPR2018-01682, IPR2018-01696, IPR2019-
`
`00122.
`
`7
`
`
`
`
`
`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).2 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)
`
`(“August 2018 Trial Practice Guide Update”). This “discretion is informed by 35
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`U.S.C. §§ 316(b) and 326(b), which require the Director to ‘consider the effect of
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`any such regulation [under this section] on the economy, the integrity of the patent
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`2 As part of the Hatch-Waxman process, Patent Owner’s District Court case against
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`Petitioner triggered a 30-month period during which the FDA will not approve
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`Petitioner’s follow-on application without resolution of the District Court case. See
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`21 U.S.C. § 355(c)(3)(C).
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`8
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`system, the efficient administration of the Office, and the ability of the Office to
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`timely complete proceedings instituted under this chapter.’” Id. at 9. In discussing
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`this discretion, the August 2018 Trial Practice Guide Update recognizes that the
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`“AIA was ‘designed to establish a more efficient and streamlined patent system that
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`will improve patent quality and limit unnecessary and counterproductive litigation
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`costs.’” Id. (citing H.R. Rep. No. 112-98, pt. 1, at 40 (2001), 2011 U.S.C.C.A.N. 67,
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`69). Indeed, the Board has exercised its discretion to deny institution under §§
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`314(a) and 324(a) on facts substantially similar to those before this Board. See NHK
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`Spring, IPR2018-00752, Paper 8.
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`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
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`district court litigation on the same patent, (2) the petitioner was relying on the same
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`prior art in the petition as in the litigation, and (3) the district court trial would
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`conclude before the IPR. See NHK Spring, IPR2018-00752, Paper 8. The Board
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`denied institution, reasoning that “instituting a trial under the facts and
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`circumstances here would be an inefficient use of Board resources,” and “would not
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`be consistent with ‘an objective of the AIA . . . to provide an effective and efficient
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`alternative to district court litigation.’” Id. at 20.
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`9
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`Given the near identical circumstances3 with NHK Spring, the Board should
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`use its discretion to reach the same outcome here: it would be an inefficient use of
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`Board resources to institute this IPR.
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`1.
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`The parties are engaged in district court litigation on the
`same patent
`In NHK Spring, the challenged patent was being asserted by the patent owner
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`against the petitioner in a co-pending District Court case. NHK Spring, IPR2018-
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`00752, Paper 8 at 19. Here, too, the 044 Patent is asserted by Patent Owner against
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`Petitioner in Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-
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`09105-SRC-CLW, filed October 24, 2017. See Ex. 2007.
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`3 Because the NHK Spring patent was expired, both the Board and District Court
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`applied the Phillips standard for claim construction. Here, however, the 044 Patent
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`is not expired and thus the Board will apply the BRI standard and the District Court
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`will apply the Phillips standard for claim construction. This is a distinction without
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`a difference, however, because Petitioner does not contend that the grounds rely on
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`any constructions that would be different under the two standards. Indeed, the
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`Petition cites Phillips to support its constructions. Petition at 14.
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`10
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`2.
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`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
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`Spring noted that “Petitioner relies on the same prior art … and arguments in its
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`district court invalidity contentions as asserted in the Petition.” NHK Spring, Paper
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`8 at 19. Here, Petitioner asserts that claims 11, 14, 15, 18, and 19 are obvious over
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`Steenfeldt-Jensen and also over the combination of Møller and Steenfeldt-Jensen.
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`Petition at 3. In the co-pending District Court case, Petitioner served invalidity
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`contentions alleging that Steenfeldt-Jensen alone renders these claims obvious, as
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`does the combination of Møller and Steenfeldt-Jensen. See Ex. 2008 at 202; Ex. 2009
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`at 268-269, Ex. 2010 at 10-12, 21, 27, 34-35, 39, 62-63, 65-67, 80-81, 95-97, 111-
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`113, 115-116, 132-136, 154-156, 164-166, 176-177, 188-190, 194-195, 198-199,
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`221-223, 226 (an invalidity chart applying Steenfeldt-Jensen’s and Møller’s
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`disclosures against claims 11, 14, 15, 18, and 19). Thus, the same situation exists
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`here as in NHK – the same prior art combinations used in the IPR are used in the
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`litigation between the parties.4 See NHK Spring, Paper 8 at19-20.
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`4 Moreover, Petitioner has filed eight other petitions that assert substantially the
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`same arguments being litigated in the District Court case. See IPR2018-01670,
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`IPR2018-01696, IPR2018-01675, IPR2018-01678, IPR2018-01680, IPR2018-
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`01679, IPR2018-01682, IPR2019-00122.
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`11
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`3.
`Trial in the District Court case will conclude before the IPR
`When the Board in NHK Spring issued its decision, the district court
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`proceeding was “nearing its final stages” with trial a little over six months away. Id.
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`at 1 (decision entered September 12, 2018), 20 (noting a March 25, 2019 trial date).
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`The Board noted that the IPR trial “on the same asserted prior art will not conclude
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`until September 2019,” approximately six months after the March 2019 trial date.
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`Id. at 20.
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`The circumstances here are no different. In the co-pending District Court case,
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`Petitioner and Patent Owner have jointly requested a trial in October 2019. And even
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`if a trial does not take place in October 2019, the District Court is keenly aware that
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`the 30-month stay of regulatory approval of Petitioner’s FDA application expires on
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`March 18, 2020, and has indicated that it will decide the issue of validity in advance
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`of that date. A Final Written Decision in an IPR trial on the same prior art and
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`arguments would not issue until April 2020, six months after the likely date of the
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`District Court case trial. Thus, as the Board found in NHK Spring, instituting an IPR
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`trial “ultimately would be inefficient.” NHK Spring, Paper 8 at 19-20.
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`4.
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`Instituting the IPR permits the Petitioner a tactical
`advantage
`In NHK Spring, the patent owner argued that the petitioner waiting to file the
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`petition until shortly before the expiration of the one-year deadline is a factor
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`favoring denial of institution. The Board disagreed, but stated that “the Patent
`12
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`Owner does not apprise us of any tactical advantage, or opportunity for tactical
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`advantage, that the Petitioner gained by waiting to file the Petition.” NHK Spring,
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`Paper 8 at 19. In contrast, here Petitioner waited to file the Petition until after it had
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`obtained Patent Owner’s detailed validity positions in response to Petitioner’s
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`invalidity contentions (as explained in Section II.A. and II.C.2), and is attempting to
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`get the proverbial two bites at the apple. Even if the 044 Patent is found valid and
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`infringed at trial in the District Court case, Patent Owner will be unfairly required to
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`defend the validity of the 044 Patent in an IPR proceeding before the Board on the
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`same prior art and arguments.
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`This gamesmanship is highly prejudicial to Patent Owner, and antithetical to
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`the purpose of the statute, which is to provide a “quick and cost effective alternatives
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`to litigation”.