IPR2019-00207
`Patent Owner’s Preliminary Response
`
`Filed on behalf of Almirall, LLC
`
`By:
`JAMES S. TRAINOR, Reg. No. 52,297
`JENNIFER R. BUSH, Reg. No. 50,784
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`Telephone: 212.430.2600
`Facsimile: 650.938.5200
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`
`
`Case IPR2019-00207
`Patent 9,517,219
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`Patent Owner’s Preliminary Response
`
`Filed on behalf of Almirall, LLC
`
`By:
`JAMES S. TRAINOR, Reg. No. 52,297
`JENNIFER R. BUSH, Reg. No. 50,784
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`Telephone: 212.430.2600
`Facsimile: 650.938.5200
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`
`
`Case IPR2019-00207
`Patent 9,517,219
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Preliminary Response
`
`
`TABLE OF CONTENTS
`
`Page
`
`2.
`
`3.
`
`PATENT OWNER’S EXHIBIT LIST .................................................................... vi
`I.
`INTRODUCTION .......................................................................................... 1
`II.
`BASES FOR DENYING INSTITUTION ...................................................... 3
`A.
`The General Plastic Factors Demonstrate that the Board
`Should Exercise Its Discretion Under 35 U.S.C. § 314(a) ................... 3
`1.
`Factor 1: whether the same petitioner previously filed a
`petition directed to the same claims of the same patent .............. 6
`Factor 2: 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 ........................................... 10
`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 .......................................................................... 11
`Factor 4: elapsed time ................................................................ 14
`Factor 5: 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
`Factor 6: the finite resources of the Board and the
`one-year final decision requirement ........................................... 17
`Factor 7: Additional Considerations ......................................... 18
`7.
`8. Weighing the Factors ................................................................. 18
`
`4.
`5.
`
`6.
`
`
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`i
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`PGR2019-00207
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`TABLE OF CONTENTS
`(Continued)
`
`B.
`
`Page
`The Board Should Deny Institution Under § 325(d) .......................... 18
`1.
`Factor (a): The similarities and material differences
`between the asserted art and the prior art involved
`during examination .................................................................... 20
`Factor (b): The cumulative nature of the asserted art
`and the prior art evaluated during examination ......................... 23
`Factor (c): The extent to which the asserted art was
`evaluated during examination, including whether
`the prior art was the basis for rejection ...................................... 25
`Factor (d): The extent of the overlap between the
`arguments made during examination and the manner
`in which Petitioner relies on the prior art or Patent
`Owner distinguishes the prior art ............................................... 31
`Factor (e): Whether Petitioner has pointed out
`sufficiently how the Examiner erred in its evaluation
`of the asserted prior art ............................................................... 33
`Factor (f): The extent to which additional evidence
`and facts presented in the Petition warrant
`reconsideration of prior art or arguments................................... 35
`C. Weighing the Factors.......................................................................... 39
`III. CONCLUSION ............................................................................................. 41
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`
`
`
`
`
`ii
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Abiomed, Inc. v. Maquet Cardiovascular, LLC,
`IPR2017-02134, Paper 7 (PTAB April 16, 2018) .......................................passim
`Abiomed, Inc. v. Maquet Cardiovascular, LLC,
`IPR2017-02150, Paper 11 (PTAB March 12, 2018) ............................................ 5
`Apple Inc. v. Immersion Corp.,
`IPR2017-01371, Paper 7 (PTAB Nov. 21, 2017) ............................................. 5, 8
`Arris Grp, Inc. v. Cirrex Sys. LLC,
`IPR2015-00530, Paper 12 (PTAB Jul. 27, 2015) ............................................... 17
`Becton, Dickenson and Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ........................................passim
`Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.,
`IPR2017-01301, Paper 7 (PTAB Oct. 13, 2017) ................................................ 17
`General Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`Case IPR2016–01357, Paper 19 (PTAB Sept. 6, 2017) ..............................passim
`Harmonic Inc. v. Avid Tech, Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) .......................................................................... 19
`Hologic, Inc. v. bioMérieux, Inc.,
`IPR2018-00566, Paper 9 (PTAB Aug. 24, 2018) ........................................passim
`In re Harris,
`409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) ............................................ 33
`In re Peterson,
`315 F.3d 1325, 65 USPQ2d 1379 (Fed. Cir. 2003) ............................................ 32
`In re Wertheim,
`541 F.2d 257,191 USPQ 90 (CCPA 1976) ......................................................... 32
`
`iii
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`TABLE OF AUTHORITIES
`(Continued)
`
`Page(s)
`
`
`In re Woodruff,
`919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) ............................................ 32
`NetApp Inc. v. Realtime Data LLC,
`IPR2017-01195, Paper 9 (PTAB Oct. 12, 2017) .................................................. 8
`Samsung Elecs. Co., Ltd. v. Elm 3DS Innovations, LLC,
`IPR2017-01305, Paper 11 (PTAB Oct. 17, 2017) .............................................. 13
`Samsung Elecs. Co., Ltd. v. Rembrandt Wireless Techs., LP,
`IPR2015-00555, Paper 20 (PTAB June 19, 2015) ............................................. 18
`Toyota Motor Corp. v. Cellport Sys., Inc.,
`IPR2015-01423, Paper 7 (PTAB Oct. 28, 2015) .................................................. 9
`Unilever v. Procter & Gamble Co.,
`IPR2014-00506, Paper 25 (Dec. 10, 2014)........................................................... 9
`
`
`STATUTES
`35 U.S.C. § 103 ........................................................................................................ 21
`35 U.S.C. §314(a) .............................................................................................passim
`35 U.S.C. § 316(a)(11) ............................................................................................... 4
`35 U.S.C. § 325(d) ............................................................................................passim
`
`OTHER AUTHORITIES
`37 C.F.R. § 1.132 ............................................................................................... 35, 38
`37 C.F.R. § 42.107(a) ................................................................................................. 1
`
`iv
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`Patent Owner’s Preliminary Response
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`TABLE OF AUTHORITIES
`(Continued)
`
`Page(s)
`
`37 C.F.R. § 42.108(a) ................................................................................................. 5
`MPEP §716.02 ................................................................................................... 37, 38
`MPEP §2144.05 ....................................................................................................... 33
`
`v
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`PGR2019-00207
`Patent Owner’s Preliminary Response
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`
`PATENT OWNER’S EXHIBIT LIST
`
`Description
`International Patent Application Publication No. WO 2009/108147
`(“Garrett 2”)
`International Patent Application Publication No. WO 2010/105052
`(“Hani”)
`Redline Comparison of Petitions in IPR2018-00608 and
`IPR2019-00207
`Redline Comparison of Michniak-Kohn Declarations in
`IPR2018-00608 and IPR2019-00207
`Redline Comparison of Gilmore Declarations in IPR2018-00608
`and IPR2019-00207
`
`Exhibit No.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`
`
`
`
`vi
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`PGR2019-00207
`Patent Owner’s Preliminary Response
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`Pursuant to 37 C.F.R. § 42.107(a), Patent Owner Almirall LLC (“Almirall”)
`
`submits the following Preliminary Response to the Petition for Inter Partes Review
`
`of U.S. Patent No. 9,517,219 (“the ’219 Patent”) submitted by Petitioners Amneal
`
`Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC (collectively,
`
`“Amneal”). The Board should deny the Petition and decline to institute trial.
`
`I.
`
`INTRODUCTION
`Patent Owner respectfully requests that the Board employ its discretion
`
`under section 314(a) and/or 325(d) to deny institution.
`
`The Board should exercise its discretion under 35 U.S.C. §314(a) to refuse
`
`to institute this “later-filed petition,” which presents the precise potential for abuse
`
`warned against in General Plastic Industries Co. v. Canon Kabushiki Kaisha, Case
`
`IPR2016–01357, Paper 19 (PTAB Sept. 6, 2017), which arises when information
`
`from a prior Board proceeding is available for a subsequent proceeding. The
`
`factors set forth in General Plastic weigh heavily in support of denial. The
`
`Petitioner challenges a division of the patent previously challenged by Petitioner
`
`and instituted by the Board in IPR2018-00608 (“’926 IPR”). According to the
`
`Petitioner itself, the divisional patent at issue in this proceeding, the ’219 patent,
`
`covers a method of treatment for using the composition claimed in its parent, U.S.
`
`Patent No. 9,161,926. Petitioner transparently attempts to use lessons learned in
`
`1
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`PGR2019-00207
`Patent Owner’s Preliminary Response
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`the ongoing proceeding in the ’926 IPR, for which the oral hearing date is now less
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`than four months away, to its tactical benefit in this proceeding.
`
`Petitioner has re-asserted in this proceeding the same prior art from the prior
`
`petition in the ’926 IPR – art known to it for at least nine months prior to filing this
`
`Petition. Petitioner tailored its exhibits and arguments responsive to the objections
`
`and responses filed by the Patent Owner, and the Board’s reactions thereto in the
`
`institution decision, in the ’926 IPR. By all reasonable appearances, Petitioner
`
`leverages this information for its strategic advantage; Petitioner provided no
`
`explanation for why it delayed nearly nine months between the filing the petition in
`
`the prior ’926 IPR and the present Petition. The Petition reflects a calculated
`
`attempt to reframe previously-known prior art references and previously-made
`
`arguments as a roadmap in fashioning Grounds allegedly supporting institution
`
`here. The Petition should be denied accordingly, under 35 U.S.C. §314(a).
`
`Alternatively, the Board should exercise its discretion under 35 U.S.C.
`
`§ 325(d) to deny institution of this proceeding, because it is based on the same or
`
`cumulative art and arguments already considered by the Examiner during
`
`prosecution. Petitioner does not identify any art or arguments that differ
`
`substantially from those raised during examination that compel the Board now to
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`reach a different conclusion. Petitioner’s arguments regarding how to combine and
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`2
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`modify the references asserted of record virtually mirror the Examiner’s rejections
`
`during prosecution, which were overcome by evidence of unexpected results.
`
`Petitioner now alleges examiner error and asks the Board to reconsider
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`substantially the same prior art and arguments already considered during
`
`prosecution. Petitioner fails, moreover, to provide any persuasive evidence that the
`
`Examiner erred in relying on the unexpected result evidence. Thus, institution
`
`should be denied under § 325(d).
`
`II. BASES FOR DENYING INSTITUTION
`A. The General Plastic Factors Demonstrate that the Board Should
`Exercise Its Discretion Under 35 U.S.C. § 314(a)
`Section 35 U.S.C. § 314(a) grants the Director discretion to deny institution
`
`of a later-filed petition. See also General Plastic Indus. Co. v. Canon Kabushiki
`
`Kaisha, IPR2016–01357, Paper 19, p. 15 (PTAB Sept. 6, 2017) (precedential).
`
`General Plastic sets forth seven non-exhaustive factors that inform the
`
`analysis:
`
`1. whether the same petitioner previously filed a petition directed to the
`
`same claims of the same patent;
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`2. 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;
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`3
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`PGR2019-00207
`Patent Owner’s Preliminary Response
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`3. whether at the time of filing of the second petition the petitioner
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`already received the patent owner’s preliminary response to the first
`
`petition or received the Board’s decision on whether to institute
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`review in the first petition;
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`4.
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`the length of time that elapsed between the time the petitioner learned
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`of the prior art asserted in the second petition and the filing of the
`
`second petition;
`
`5. whether the petitioner provides adequate explanation for the time
`
`elapsed between the filings of multiple petitions directed to the same
`
`6.
`
`7.
`
`claims of the same patent;
`
`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
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`notices institution of review.
`
`See id. at 16.
`
`The Board has found, in applying this analysis, that “[n]o one factor is
`
`dispositive” and “not all the factors need to weigh against institution for us to
`
`exercise our discretion under § 314(a).”
`
` See Abiomed, Inc. v. Maquet
`
`Cardiovascular, LLC, IPR2017-02134, Paper 7, p. 7 (April 16, 2018) (“Abiomed 2”
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`4
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`herein); see also Abiomed, Inc. v. Maquet Cardiovascular, LLC, IPR2017-02150,
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`Paper 11, p. 7 (Mar. 12, 2018).
`
`As further explained in the Decision Denying Institution in Abiomed 2:
`
`In exercising discretion under 35 U.S.C. § 314(a) and
`37 C.F.R. § 42.108(a), we are mindful of the goals of the
`[America Invents Act (“AIA”)]—namely, to improve
`patent quality and make the patent system more efficient by
`the use of post-grant review procedures.” General Plastic,
`slip op. at 16 (citing H.R. Rep. No. 112-98, pt. 1, at 40
`(2011)). Additionally, although “an objective of the AIA is
`to provide an effective and efficient alternative to district
`court litigation, . . . [there is a] potential for abuse of the
`review process by repeated attacks on patents.” Id. at 16–
`17. “A central issue addressed by the General Plastic
`factors is balancing the equities between a petitioner and a
`patent owner when information is available from prior
`Board proceedings for a subsequent proceeding.
`Abiomed 2, IPR2017-02134, Paper 7, pp. 7-8 (emphasis added) (quoting Apple Inc.
`
`v. Immersion Corp., Case IPR2017-01371, Paper 7 at 10–11 (Nov. 21, 2017).
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`5
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`Patent Owner’s Preliminary Response
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`1.
`
`Factor 1: whether the same petitioner previously filed a
`petition directed to the same claims of the same patent
`The ’219 patent is a division of U.S. Patent No. 9,161,926 (“’926 patent”),
`
`which is the subject of Amneal Pharmaceuticals LLC et al. v. Almirall, LLC,
`
`IPR2018-00608 (“’926 IPR” herein).
`
`The ’219 Petition challenges claims 1-8, which recite methods of treating a
`
`dermatological condition using a particular topical pharmaceutical composition.
`
`Ex. 1001; see Pet. 16. According to Petitioner, “[t]he specific compositions recited
`
`in these claims are identical to those recited in the ‘926 patent, which is the subject
`
`of a related IPR… IPR2018-00608.” Pet. 17 (emphasis in original). Accepting
`
`Petitioner’s admission thus compels that the challenged claims differ only from the
`
`’219 claims in reciting methods of treating a dermatological condition using the
`
`particular topical pharmaceutical composition of the ’926 patent, as shown below.
`
`The difference between the claims are shown in bold font.
`
`’219 Patent – Claims 1 and 6
`
`’926 Patent – Claims 1 and 5
`
`1. A method for treating a
`dermatological condition selected from
`the group consisting of acne vulgaris
`and rosacea comprising administering
`to a subject having the dermatological
`condition selected from the group
`consisting of acne vulgaris and rosacea
`a topical pharmaceutical composition
`
`1. A topical pharmaceutical
`composition comprising:
`
`
`
`
`
`
`
`6
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`PGR2019-00207
`Patent Owner’s Preliminary Response
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`’219 Patent – Claims 1 and 6
`
`’926 Patent – Claims 1 and 5
`
`comprising:
`about 7.5% w/w dapsone;
`about 30% w/w to about 40% w/w
`diethylene glycol monoethyl ether;
`about 2% w/w to about 6% w/w of a
`polymeric viscosity builder comprising
`acrylamide/sodium acryloyldimethyl
`taurate copolymer;
`and water;
`wherein the topical pharmaceutical
`composition does not comprise
`adapalene.
`
`6. A method for treating a
`dermatological condition selected from
`the group consisting of acne vulgaris
`and rosacea comprising administering
`to a subject having the dermatological
`condition selected from the group
`consisting of acne vulgaris and rosacea
`a topical pharmaceutical composition
`comprising:
`about 7.5% w/w dapsone;
`about 30% w/w diethylene glycol
`monoethyl ether;
`about 4% w/w of a polymeric viscosity
`builder comprising acrylamide/sodium
`acryloyldimethyl taurate copolymer;
`
`about 7.5% w/w dapsone;
`about 30% w/w to about 40% w/w
`diethylene glycol monoethyl ether;
`about 2% w/w to about 6% w/w of a
`polymeric viscosity builder
`consisting of acrylamide/sodium
`acryloyldimethyl taurate copolymer;
`and water;
`wherein the composition does not
`comprise adapalene.
`
`5. A topical pharmaceutical
`composition comprising:
`
`
`
`
`about 7.5% w/w dapsone;
`about 30% w/w diethylene glycol
`monoethyl ether;
`about 4% w/w of a polymeric
`viscosity builder consisting of
`acrylamide/sodium acryloyldimethyl
`taurate copolymer;
`
`7
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`Patent Owner’s Preliminary Response
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`’219 Patent – Claims 1 and 6
`
`’926 Patent – Claims 1 and 5
`
`
`and water;
`wherein the topical pharmaceutical
`composition does not comprise
`adapalene.
`
`and water;
`wherein the composition does not
`comprise adapalene.
`
`The Board has found that challenging non-identical claims does not
`
`automatically weigh in favor of institution. See, e.g., Abiomed 2, IPR2017-02134,
`
`Paper 7, pp. 9-10. For example, the Board has denied institution because “the
`
`Second Petition overwhelmingly challenges claims covering essentially the same
`
`scope as the claims challenged in the First Petition.” Apple Inc. v. Immersion
`
`Corp., IPR2017-01371, Paper 7, pp. 12-13 (Nov. 21, 2017) (emphasis added).
`
`Similarly, in NetApp Inc. v. Realtime Data LLC, IPR2017-01195, Paper 9, p. 12
`
`(Oct. 12, 2017), institution was denied even though the Petition challenged a new
`
`claim because the challenges to the new claim were “based on…references that
`
`were cited in the[] earlier-filed proceedings.” In the present Petition, as in NetApp,
`
`Petitioners rely on the same references previously cited in the ’926 IPR. In
`
`addition, Petitioner relied on expert declarations in the Petition nearly identical to
`
`those filed in the ’926 IPR. See Exhibits 2004 (Redline Comparison of Michniak-
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`8
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`Kohn Declarations in IPR2018-00608 and IPR2019-00207), 2005 (Redline
`
`Comparison of Gilmore Declarations in IPR2018-00608 and IPR2019-00207).
`
`In Abiomed 2, the Board addressed the issue of non-identical claims
`
`head-on, and found that claims like those at issue here, “which contain limitations
`
`in common with the claims [previously] challenged,” led to this factor being “at
`
`best neutral if not slightly weighing against institution.” Abiomed 2, IPR2017-
`
`02134, Paper 7, p. 10, FN 2 (emphasis added) (finding no one factor dispositive);
`
`see also pp. 9-10.
`
`Petitioner should not be allowed to force Patent Owner to defend serial
`
`attacks, spaced in time based on a roadmap developed from this Board’s earlier
`
`decision. See Conopco, Inc. dba Unilever v. Procter & Gamble Co., IPR2014-
`
`00506, Paper 25, pp. 4-5 (Dec. 10, 2014); Toyota Motor Corp. v. Cellport Sys.,
`
`Inc., IPR2015-01423, Paper 7, p. 25 (Oct. 28, 2015). The accused overlap
`
`conceded by Petitioner between the claims challenged here and the claims in the
`
`’926 IPR petition outweighs the fact that the instant Petition challenges
`
`non-identical claims.
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`9
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`2.
`
`Factor 2: 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
`Every reference asserted by Petitioner in the present petition was also
`
`asserted in the ’926 IPR, as shown below. Indeed, Petitioner cannot assert that it
`
`did not know of the prior art presented in the Petition, as all the references and
`
`grounds are recycled from the prior ’926 IPR petition.
`
`As shown below, the grounds, basis, and art asserted in the present petition
`
`are identical to those in the ’926 IPR, except for the differences in the number of
`
`claims between the cases.
`
`’219 Patent
`
`
`
`
`
`
`
`’926 Patent
`
`
`
`
`
`Ground 1
`
`Claims
`1-8
`
`103: Garrett
`in view of
`Nadau-
`Fourcade
`
` Ground 1
`
`Claims
`1-6
`
`Ground 2
`
`Claims
`1-8
`
`103: Garrett
`in view of
`Bonacucina
`
` Ground 2
`
`Claims
`1-6
`
`103:
`Garrett in
`view of
`Nadau-
`Fourcade
`
`103:
`Garrett in
`view of
`Bonacucina
`
`
`
`Curiously, Petitioners have not addressed this issue. The evidence is
`
`conclusive that Petitioner knew of these references, at minimum, nine months prior
`
`to filing this petition, i.e., at least as early as the filing date of the prior ’926 IPR
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`10
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`petition, which was February 12, 2018. Thus, Factor 2 weighs heavily in favor of
`
`denying institution.
`
`3.
`
`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
`At the time of the filing this petition, Petitioner had received in the ’926 IPR:
`
`(1) Patent Owner’s Preliminary Response to the prior petition, filed June 6, 2018,
`
`(2) the Board’s Institution Decision, filed August 29, 2018, and (3) Patent Owner’s
`
`Objections to Evidence, filed September 13, 2018. See ’926 IPR, IPR2018-00608,
`
`Papers 9 (Prelim, Resp.), 10 (Institution Decision), and 12 (Objections to
`
`Evidence).
`
`Petitioner thus had the benefit of evaluating and considering Patent Owner’s
`
`responsive arguments in both Patent Owner’s Preliminary Response and Objections
`
`to Evidence, and the Board’s guidance in the Institution Decision in the ’926 IPR
`
`for several months before filing this petition. Indeed, nearly five months elapsed
`
`between Patent Owner’s Preliminary Response in the ’926 IPR and the filing of the
`
`Petition in this case, and more than two months elapsed between the Board’s
`
`Institution Decision in the prior case and the filing of the Petition in this case.
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`11
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`This delay unfairly provided Petitioner the opportunity to use the prior
`
`proceeding “as a roadmap” in formulating its arguments in this Petition. See Gen.
`
`Plastic, Paper 19, p. 17 (“The absence of any restrictions on follow-on petitions
`
`would allow petitioners the opportunity to strategically stage their prior art and
`
`arguments in multiple petitions, using our decisions as a roadmap, until a ground is
`
`found that results in the grant of review.”).
`
`Petitioner in fact used Patent Owner’s previous arguments to tailor their
`
`current arguments in several ways. First, Petitioner represented in the Petition that
`
`the compositions recited in the challenged claims are “identical” to those at issue in
`
`the ’926 IPR, and noted that case had been instituted. Pet. 17.
`
`Second, Petitioner revised the exhibits it filed in the present Petition as
`
`compared to those filed in the Petition in the ’926 IPR, apparently in response to
`
`Patent Owner’s Objections in that case. See ’926 IPR, IPR2018-00608, Paper 12.
`
`In particular, Exhibits 1020, 1021, 1030, and 1033 were objected to by Patent
`
`Owner in the Objections to Evidence filed in the ’926 IPR as unauthenticated. In
`
`this Petition, and in apparent consequence, Petitioner maintained the exhibit
`
`numbering from the ’926 IPR, including leaving exhibits 1021, 1030, and 1033
`
`intentionally blank in the exhibit list, while adding a Declaration of Christopher
`
`Butler as Exhibit 1020 in an effort to correct the authentication problem Patent
`
`12
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`PGR2019-00207
`Patent Owner’s Preliminary Response
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`Owner had as the basis of its objection. In the Declaration, Petitioner seeks to
`
`authenticate the papers filed as Exhibits 1020, 1021, and 1030 in the ’926 IPR.
`
`Petitioner did not submit as an exhibit in this case the final exhibit objected to in
`
`the ’926 IPR, Exhibit 1033.
`
`In addition, Petitioner revised several arguments in the present Petition
`
`relative to those in the ’926 IPR’s petition, in apparent reliance on the prior
`
`proceeding. For example, in the ’926 IPR, Petitioner did not suggest that any
`
`claim term required construction, whereas in the present Petition, the claim
`
`construction section newly proposes construction of the term “acne vulgaris.”
`
`Compare Pet. 19-20 with ’926 IPR, IPR2018-000608, Paper 1, p. 20; Exhibit 2003.
`
`It thus cannot reasonably be denied that Petitioner capitalized on Patent
`
`Owner’s responsive arguments and the Board’s guidance in the ’926 IPR, nor that
`
`it has since used that information as a roadmap to refine its positions before filing
`
`this Petition. See Gen. Plastic, Paper 19, p. 17; Samsung Elecs. Co., Ltd. v. Elm
`
`3DS Innovations, LLC, IPR2017-01305, Paper 11, p. 21 (Oct. 17, 2017) (denying
`
`institution because “[n]ot only did the Petitioner have [Patent Owner’s Response
`
`and Patent Owner’s expert testimony in the other related proceedings], but
`
`Petitioner used such information in its Petition”).
`
`13
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`PGR2019-00207
`Patent Owner’s Preliminary Response
`
`
`In Abiomed 2, the Board found that “[t]his factor weighs heavily in our
`
`analysis because Petitioner tailored its arguments here in light of the positions
`
`previously set forth by Patent Owner in its preliminary responses in the related
`
`proceedings. . . . As noted above, many of the other petitions filed by Petitioner
`
`relied upon one or more of the same references asserted here and, thus, Patent
`
`Owner’s preliminary responses in those proceedings were available to Petitioner
`
`for use in framing the arguments set forth in the present proceeding. Accordingly,
`
`we find that this factor weighs heavily against institution.” Abiomed 2, IPR2017-
`
`02134, Paper 7, p. 11 (emphasis added).
`
`As the Petitioner in this case likewise relies upon similar references and used
`
`the prior filings as guidance, Factor 3 also weighs heavily in favor of denying
`
`institution in this proceeding.
`
`Factor 4: elapsed time
`4.
`As outlined in connection with Factor 2, Petitioner knew of the prior art
`
`asserted in this Petition at the time of filing the petition in the ’926 IPR—in
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`February 2018. While Petitioner inarguably knew of the references relied upon in
`
`the prior petition in the months leading up to its filing, it is clear that it was aware
`
`of all the prior art references asserted in the present Petition by at least February
`
`2018. It follows that Petitioner had knowledge of these prior art references for
`
`14
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`Patent Owner’s Preliminary Response
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`nearly nine months before deciding to file this Petition. In Abiomed 2, the Board
`
`found that an even shorter delay between petitions – six months – was sufficient to
`
`find this factor weighed against institution. Abiomed 2, IPR2017-02134, Paper 7,
`
`p. 11. Thus, Factor 4 weighs even more heavily in favor of denying institution
`
`under the facts present in this proceeding than in Abiomed 2.
`
`5.
`
`Factor 5: 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
`Likely aware of the potential repercussions for its delay, Petitioner instead
`
`strained to preempt the issue:
`
`Denial under 314(a) is not warranted. The instant petition
`is the first time the ’219 patent has been challenged in the
`Office since the patent issued. This petition is not a follow-
`on petition and the ’219 patent stands separate from the
`related ’926 patent so there has there been no tactical
`advantage, or opportunity for tactical advantage, by any
`alleged delay in challenging the ’219 patent. Nor is this
`IPR an inefficient use to resources. Any inefficiency or
`burden can be alleviated through consolidation.
`Pet. 63.
`
`Petitioner’s representations are flawed for several reasons. First, as noted
`
`above, Petitioner itself characterized the claims at issue as pertaining to “specific
`
`15
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`PGR2019-00207
`Patent Owner’s Preliminary Response
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`compositions … identical to those recited in the ‘926 patent….” Pet. 17 (emphasis
`
`in original).
`
`Second, Petitioner relies on the fact that the ’219 and ’926 are different
`
`patents to reach its conclusion that “there has been no tactical advantage, or
`
`opportunity for tactical advantage, by any alleged delay in challenging the ’219
`
`patent.” Pet. 63. However, there has been not only opportunity for tactical
`
`advantage due to Petitioner’s delay, but actual advantage gained through exposure
`
`to Patent Owner’s Preliminary Response and the Board’s Institution Decision in
`
`the ’926 IPR. Indeed, far from the ’219 patent “stand[ing] separate from the
`
`related ’926 patent,” as Petitioner asserts, an illustrative comparison between the
`
`two petitions leaves no question of the similarity between Petitioner’s arguments in
`
`the two cases. See Exhibit 2003.
`
`Third, Petitioner’s pretense that “[a]ny inefficiency or burden can be
`
`alleviated through consolidation” fails in application, due to the substantial delay
`
`between the filings. In the ’926 IPR, the Patent Owner’s Response was filed just
`
`three weeks after the filing of the Petition in this case. As a result, the disparate
`
`stages of the proceedings of the two cases do not readily lend themselves to
`
`consolidation; indeed, Petitioner’s substantial delay in filing this Petition is the
`
`very reason for the disparity in the progress between the two cases. In any event,
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`16
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`PGR2019-00207
`Patent Owner’s Preliminary Response
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`Petitioner cannot have it both ways: either the patents are “distinct,” or they are
`
`similar enough that they could have been consolidated.
`
`All of this notwithstanding, the fact is that Petitioner provided no
`
`explanation for why it delayed nearly nine months after filing the petition in the
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`’926 IPR before filing the Petition in this case. As such, Petitioner’s strategic
`
`decision to delay the filing of the Petition in this case weighs strongly in favor of
`
`denying the Petition as unjustifiably belated. See e.g., Arris Grp, Inc. v. Cirrex
`
`Sys. LLC, IPR2015-00530, Paper 12, p. 10 (Jul. 27, 2015) (“Petitioner could have
`
`informed the Board of its desire to challenge the additional claims along with the
`
`[original IPR] well before [the joinder deadline], yet it chose to file its Second
`
`Petition on the very last day permitted under the rules.”).
`
`6.
`
`Factor 6: the finite resources of the Board and the one-year
`final decision requirement
`“[M]ultiple, staggered petition filings” are, in general, “an inefficient use of
`
`the inter partes review process and the Board’s resources.” See General Plastic,
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`IPR2016–01357, Paper 19, p. 21. Such is the case under the present facts, when
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`multiple challenges by the same Petitioner of similar claims and r
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