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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`AMNEAL PHARMACEUTICALS LLC, and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and
`MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`
`Case IPR2019-002071
`Patent 9,517,219
`
`
`PATENT OWNER’S REQUEST FOR A REHEARING
`UNDER 37 C.F.R. § 42.71(d)
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`
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`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
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`
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`IPR2019-00207
`Patent Owner’s Request for Rehearing
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`TABLE OF CONTENTS
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`Page
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`I.
`REQUEST FOR REHEARING ...................................................................... 1
`LEGAL STANDARD ..................................................................................... 1
`II.
`INTRODUCTION ........................................................................................... 2
`III.
`IV. ARGUMENT ................................................................................................... 5
`A.
`The Board Overlooked and/or Misapprehended Evidence
`and Argument Showing That Petitioners Failed to Carry
`Their Burden .......................................................................................... 5
`Amneal’s Indefiniteness Argument in the District Court
`Confirms That the Prior Art Did Not Teach the Claimed
`Invention .............................................................................................. 10
`CONCLUSION .............................................................................................. 15
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`B.
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`V.
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`i
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`IPR2019-00207
`Patent Owner’s Request for Rehearing
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`
`TABLE OF AUTHORITIES
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`Page(s)
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`CASES
`Almirall, LLC v. Amneal Pharms. LLC,
`19-cv-658, D.I. 110 ............................................................................................... 7
`Apple Inc. v. Immersion Corp.,
`IPR2016-01372, Paper 7 (P.T.A.B. Jan. 11, 2017) .............................................. 7
`BlackBerry Corp. v. MobileMedia Ideas, LLC,
`IPR2013-00036, Paper 65 (P.T.A.B. Mar. 7, 2014) ............................................. 8
`CareFusion Corp. v. Baxter Int’l Inc.,
`IPR2016-01456, Paper 9 (P.T.A.B. Feb. 6, 2017) ................................................ 7
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 2
`Facebook, Inc. v. Sound View Innovations, LLC,
`IPR2017-00998, Paper 13 (P.T.A.B. Sept. 5, 2017) ......................................... 5, 7
`Fisher & Paykel Healthcare Ltd. v. ResMed Pty Ltd.,
`IPR2017-00061, Paper 37 (P.T.A.B. July 5, 2018) .............................................. 1
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) .................................................................................................. 8
`In re Steele,
`305 F.2d 859 (C.C.P.A. 1962) .............................................................................. 8
`Intendis GMBH v. Glenmark Pharm. Ltd.,
`117 F. Supp. 3d 549 (D. Del. July 15, 2015), aff’d sub nom.
`Intendis GMBH v. Glenmark Pharm. Inc., 822 F.3d 1355
`(Fed. Cir. 2016) ....................................................................................... 10, 11, 14
`IPLearn-Focus, LLC v. Microsoft Corp.,
`14-cv-00151, D.I. 67 (N.D. Cal. Dec. 12, 2014) .............................................. 5, 8
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`ii
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`IPR2019-00207
`Patent Owner’s Request for Rehearing
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`
`TABLE OF AUTHORITIES
`(Continued)
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`Page(s)
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`Microsoft Corp. v. IPLearn-Focus, LLC,
`IPR2015-00095, Paper 6 (P.T.A.B. Dec. 17, 2014) ............................................. 6
`Microsoft Corp. v. Uniloc 2017 LLC,
`IPR2019-01125, Paper 8 (P.T.A.B. Nov. 27, 2019) ............................................. 8
`Neptune Generics, LLC v. Eli Lilly & Co.,
`921 F.3d 1372 (Fed. Cir. 2019) ............................................................................ 2
`Orexo AB, et al., v. Actavis Elizabeth LLC,
`903 F.3d 1265 (Fed. Cir. 2018) .......................................................................... 11
`Orthopediatrics Corp. v. K2M, Inc.,
`IPR2018-01547, Paper 9 (P.T.A.B. Feb. 22, 2019) .............................................. 5
`Power Integrations, Inc. v. Lee,
`797 F.3d 1318 (Fed. Cir. 2015) ........................................................................ 3, 6
`Samsung Elecs. Am., Inc. v. Prisua Eng’g Corp.,
`948 F.3d 1342 (Fed. Cir. 2020) ........................................................................ 2, 9
`Sanofi-Aventis U.S. LLC v. Immunex Corp.,
`IPR2017-01129, Paper 19 (P.T.A.B. Oct. 4, 2017) .......................................... 6, 7
`SAS Inst. Inc. v. Iancu,
`138 S. Ct. 1348 (2018) ...................................................................................... 2, 8
`Toyota Motor Corp. v. Blitzsafe Texas, LLC,
`IPR2016-00422, Paper 12 (P.T.A.B. July 6, 2016) .............................................. 7
`STATUTES AND RULES
`35 U.S.C. §§ 102 and 103 .......................................................................................... 2
`35 U.S.C. § 315(e) ..................................................................................................... 9
`OTHER AUTHORITIES
`37 C.F.R. § 42.5 ......................................................................................................... 1
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`iii
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`IPR2019-00207
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`TABLE OF AUTHORITIES
`(Continued)
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`Page(s)
`37 C.F.R. § 42.11 ....................................................................................................... 6
`37 C.F.R. § 42.51(b) .................................................................................................. 6
`37 C.F.R. § 42.71 ................................................................................................... 1, 2
`37 C.F.R. §42.104(b) ................................................................................................. 6
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`
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`iv
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`IPR2019-00207
`Patent Owner’s Request for Rehearing
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`I.
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`REQUEST FOR REHEARING
`Pursuant to 37 C.F.R. § 42.71(d), Patent Owner Almirall, LLC (“Patent
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`Owner” or “Almirall”) respectfully requests a rehearing of the Patent Trial and
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`Appeal Board’s (the “Board”) Final Written Decision dated May 29, 2020. See
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`Paper 58. Specifically, Almirall requests that the Board modify its Final Written
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`Decision to find that Petitioners2 have not met their burden to show that Claims 1-8
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`of U.S. Patent No. 9,517,219 (the “’219 Patent”) are unpatentable. In the alternative,
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`Patent Owner respectfully requests that the Board reconsider Patent Owner’s motion
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`to file supplemental information (Paper 57) and authorize supplemental briefing on
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`the issues raised below. See, e.g., Fisher & Paykel Healthcare Ltd. v. ResMed Pty
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`Ltd., IPR2017-00061, Paper 37 (P.T.A.B. July 5, 2018) (authorizing supplemental
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`briefing for a request for rehearing under 37 C.F.R. § 42.5).
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`II. LEGAL STANDARD
`The standard of review for a rehearing is abuse of discretion. See 37 C.F.R.
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`§ 42.71(c). The rehearing request must “specifically identify all matters the party
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`believes the Board misapprehended or overlooked, and the place where each
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`2 Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC,
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`(together with Amneal Pharmaceuticals LLC, “Amneal”) and Mylan
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`Pharmaceuticals Inc. (“Mylan,” collectively with Amneal, “Petitioners”).
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`1
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`matter was previously addressed in a motion, an opposition, or a reply.” See
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`37 C.F.R. § 42.71(c).
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`III.
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`INTRODUCTION
`Congress expressly limited inter partes review petitions to challenges raised
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`under 35 U.S.C. §§ 102 and 103. Neptune Generics, LLC v. Eli Lilly & Co.,
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`921 F.3d 1372, 1378 (Fed. Cir. 2019). The Board cannot institute inter partes
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`review or cancel patent claims for indefiniteness. See Samsung Elecs. Am., Inc. v.
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`Prisua Eng’g Corp., 948 F.3d 1342, 1350 (Fed. Cir. 2020) (“The statutory
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`provisions governing the inter partes review process do not permit the Board to
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`institute inter partes review of claims for indefiniteness.”) (internal quotes
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`omitted); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2141–42 (2016)
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`(“[N]or does our interpretation enable the agency to act outside its statutory limits
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`by, for example, canceling a patent claim for ‘indefiniteness’ under § 112.”). A
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`Petitioner that raises indefiniteness concerns for any claim risks having institution
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`denied on all claims because the Board must institute all or none of the claims.
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`SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018).
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`2
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`IPR2019-00207
`Patent Owner’s Request for Rehearing
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`On November 6, 2018, Amneal filed a petition for inter partes review
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`challenging the patentability of Claims 1-8 of the ’219 Patent. See Paper 3.3
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`Amneal did not assert any claims were indefinite. See id. at 19-20. On March 8,
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`2019, Amneal filed its Reply to Patent Owner’s Preliminary Response. See Paper
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`10. Amneal’s Reply again failed to raise concerns that any claim terms were
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`potentially indefinite. Amneal’s Reply, however, justified the delay in filing its
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`Petition because the district court’s pending claim construction of “polymeric
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`viscosity builder,” would be “relevant to this Petition.” See id. at 5 (citing Power
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`Integrations, Inc. v. Lee, 797 F.3d 1318, 1327 (Fed. Cir. 2015) (explaining that the
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`Board should consider parallel district court claim constructions)). On November
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`1, 2019, Amneal submitted its Reply to Patent Owner’s Response to Institution.
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`See Paper 28. For the third time, Amneal failed to disclose their apparent belief
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`that some claim terms were allegedly indefinite.4 On February 7, 2020, this Board
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`held an oral hearing for the patentability of the ’219 Patent. See Paper 55.
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`3 Mylan was joined on November 27, 2019 after Amneal had submitted its
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`briefing. See Paper 35.
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`4 P.T.A.B. Consolidated Trial Practice Guide, November 2019, 47 (“Preferably,
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`the prior claim construction determination should be submitted with the petition,
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`preliminary response, or response, along with explanations.”) (“Trial Guide”).
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`3
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`Only seventeen days after this Board’s oral hearing, in a parallel district
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`court litigation, Amneal advanced arguments that claim phrases “about 2% w/w to
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`about 6% w/w of a polymeric viscosity builder [PVB] comprising
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`acrylamide/sodium acryloyldimethyl taurate copolymer [A/SA]” and “wherein the
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`polymeric viscosity builder is present at a concentration of about 4% w/w” of the
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`’219 Patent were indefinite.5 See Almirall, LLC v. Amneal Pharms. LLC, 19-cv-
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`658, D.I. 46, 53 (D. Del. Feb. 24, 2020) (“Ex. 2071”). Even more, Amneal cited
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`Papers and Exhibits from this IPR as proof of indefiniteness. See Ex. 2071 at 6-7
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`of 13.
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`Patent Owner attempted to apprise this Board of Amneal’s conflicting
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`representations to this Board and the district court. See Paper 57. The Board
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`denied Patent Owner’s request. See id. at 3.6 In the district court, claim
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`5 Amneal argues that the indefiniteness of these claim phrases renders every claim
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`invalid.
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`6 In denying Patent Owner’s motion, this Board stated, “Patent Owner has not
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`previously sought any claim constructions in this proceeding.” To be clear,
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`Amneal proposed these claim phrases for construction. Almirall does not believe
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`the claim phrases require construction. This is not a case where the Petitioner is
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`merely adopting the Patent Owner’s proposed construction arguendo.
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`4
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`construction has been fully briefed, expert depositions completed, and oral
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`argument scheduled for July 30, 2020. See Almirall, 19-cv-658, D.I. 107.
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`IV. ARGUMENT
`A. The Board Overlooked and/or Misapprehended Evidence and
`Argument Showing That Petitioners Failed to Carry Their Burden
`Almirall respectfully submits that the Board overlooked and/or
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`misapprehended Amneal’s contradictory indefiniteness claim constructions in
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`parallel district court litigation. Amneal should have disclosed its contradictory
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`claim constructions to this Board. See Facebook, Inc. v. Sound View Innovations,
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`LLC, IPR2017-00998, Paper 13 at 17-18 (P.T.A.B. Sept. 5, 2017) (denying
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`institution partly because “[P]etitioner’s failure to inform us of its differing claim
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`construction arguments before the district court raises the specter of lack of
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`candor.”); Orthopediatrics Corp. v. K2M, Inc., IPR2018-01547, Paper 9 at 10-11
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`(P.T.A.B. Feb. 22, 2019) (finding that “where Petitioner advocated for a different
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`claim construction in the related district court litigation, we determine that
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`construction of the claim terms in dispute is necessary for the resolution of issues
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`before us. Lacking such claim construction, the Petition fails to comply with 37
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`C.F.R. § 42.104(b)(3).”); IPLearn-Focus, LLC v. Microsoft Corp., 14-cv-00151,
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`D.I. 67 at 22:1-16 (N.D. Cal. Dec. 12, 2014) (“I’m going to order you to submit a
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`statement to the PTAB that you have maintained to this Court that these claims are
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`5
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`IPR2019-00207
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`indefinite.”); Sanofi-Aventis U.S. LLC v. Immunex Corp., IPR2017-01129, Paper
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`19 at 12 (P.T.A.B. Oct. 4, 2017) (“We are troubled by Petitioner’s failure to inform
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`us of its contention before the district court that the claims should be
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`construed….”); Microsoft Corp. v. IPLearn-Focus, LLC, IPR2015-00095, Paper 6
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`(P.T.A.B. Dec. 17, 2014) (ordering Petitioner to file any claim construction ruling
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`from district court with 10 days); see also Trial Guide, 47–49 (“Submission of a
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`prior claim construction determination is mandatory under 37 C.F.R. § 42.51(b), if
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`it is ‘relevant information that is inconsistent with a position advanced by the party
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`during the proceeding.’”); 37 C.F.R. § 42.51(b)(1)(iii) (“Unless previously served,
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`a party must serve relevant information that is inconsistent with a position
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`advanced by the party during the proceeding concurrent with the filing of the
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`documents or things that contains the inconsistency.”); 37 C.F.R. §§ 42.11,
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`42.104(b)(3). The intrinsic record did not change between Amneal’s Petition and
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`its proposed claim construction in the district court. Amneal was fully capable of
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`informing this Board of its indefiniteness argument at the time of filing its Petition
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`and remained fully capable throughout this entire proceeding. And, as Amneal has
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`already admitted, Amneal knew its claim construction in the district court was
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`relevant to this proceeding. See Paper 10 at 5 (citing Power Integrations, 797 F.3d
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`at 1327).
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`6
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`IPR2019-00207
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`Amneal’s failure to advance its indefiniteness position in this proceeding
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`was self-serving. Amneal admits that it knew that the Board cannot institute on
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`indefinite claims. See Almirall, LLC v. Amneal Pharms. LLC, 19-cv-658, D.I. 110
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`at 65 of 79 (D. Del. Jun. 8, 2020) (“Thus, even if the PTAB recognized the
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`indefiniteness of these claims, it would not be authorized to rule on this issue.”)
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`(“Ex. 2072”); see also Apple Inc. v. Immersion Corp., IPR2016-01372, Paper 7 at
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`20 (P.T.A.B. Jan. 11, 2017) (the PTAB denying institution as to a subset of claims
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`because “we are unable to determine the scope and meaning of claims 12-18.”);
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`CareFusion Corp. v. Baxter Int’l Inc., IPR2016-01456, Paper 9 at 10 (P.T.A.B.
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`Feb. 6, 2017); Sanofi, IPR2017-01129, Paper 19 at 14; Facebook, IPR2017-00998,
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`Paper 13 at 17-18; Toyota Motor Corp. v. Blitzsafe Texas, LLC, IPR2016-00422,
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`Paper 12 at 28 (P.T.A.B. July 6, 2016). By withholding its indefiniteness
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`argument, Amneal avoided an unfavorable institution decision. But, this type of
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`self-serving behavior has not escaped the ridicule of district courts:
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`[Judge Donato]: [Microsoft’s counsel is] missing the point, and
`this is all lawyerly tap dancing. The point is this. You’re coming to
`my [district] court and you’re saying the proposition that I should rely
`on is that these patents are indefinite. You’re going to PTAB, and not
`only are you not mentioning that, you’re affirmatively not telling them
`that you told me that these patents are indefinite, apparently out of
`fear of this case law.
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`7
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`So I don’t want to hear about who is doing what. I want you to
`address the more basic proposition, which is the foundation of judicial
`estoppel, that you cannot whipsaw courts. You cannot tell in the same
`case, two different courts, two different stories.
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`IPLearn-Focus, 14-cv-00151, D.I. 67 at 18:23-19:9 (ordering [Microsoft/Petitioner]
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`to disclose claim construction arguments in district court to PTAB).
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`Since Amneal now argues that the scope of the ’219 Patent claims cannot be
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`ascertained, the Board cannot apply Amneal’s asserted prior art to the claims of the
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`’219 Patent.7 See Microsoft Corp. v. Uniloc 2017 LLC, IPR2019-01125, Paper 8 at
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`17 (P.T.A.B. Nov. 27, 2019) (denying institution because “[w]ithout ascertaining
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`the proper claim scope, we cannot conduct a necessary factual inquiry for
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`determining obviousness—ascertaining differences between the claimed subject
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`matter and the prior art.” (citing Graham v. John Deere Co., 383 U.S. 1, 17-18
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`(1966)) (internal quotations omitted)); BlackBerry Corp. v. MobileMedia Ideas,
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`LLC, IPR2013-00036, Paper 65 at 19-20 (P.T.A.B. Mar. 7, 2014) (citing In re
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`Steele, 305 F.2d 859, 862-63 (C.C.P.A. 1962)). If the Board cannot ascertain the
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`7 The Board is limited to Amneal’s arguments. See, e.g., SAS, 138 S. Ct. at
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`1356-57 (“[T]he statute tells us that the petitioner’s contentions, not the Director’s
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`discretion, define the scope of the litigation all the way from institution through to
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`conclusion.”).
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`8
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`IPR2019-00207
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`scope of a claim, the Board should deny institution or not reach a decision on the
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`merits of whether the Petitioner met its burden to prove unpatentability. See
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`Samsung, 948 F.3d at 1353 (“[T]he proper course for the Board to follow, if it
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`cannot ascertain the scope of a claim with reasonable certainty for purposes of
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`assessing patentability, is to decline to institute the IPR or, if the indefiniteness
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`issue affects only certain claims, to conclude that it could not reach a decision on
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`the merits with respect to whether petitioner had established the unpatentability of
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`those claims under sections 102 or 103.”). The Board should put Almirall in the
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`position it would be had Amneal disclosed its indefiniteness arguments. Therefore,
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`Almirall requests that the Board modify the Final Written Decision to hold that
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`Petitioners did not meet their burden to prove that Claims 1-8 of the ’219 Patent
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`are unpatentable.
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`Further, Almirall’s proposed resolution does not prejudice Petitioners.
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`Petitioners will not be estopped from asserting any ground of invalidity at the
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`district court. See Samsung, 948 F.3d at 1353, n.3 (“To be clear, in cases in which
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`the Board cannot reach a final decision as to the patentability of certain claims
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`because it cannot ascertain the scope of those claims with reasonable certainty, the
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`petitioner would not be estopped by 35 U.S.C. § 315(e) from challenging those
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`claims under sections 102 or 103 in other proceedings.”). And, as Amneal
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`acknowledges, the issue is ripe for a decision in the district court as the parties
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`9
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`have expended significant resources on briefing, expert testimony, and depositions.
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`See Ex. 2072 at 24 of 79 (“By the [July 30, 2020] Markman Hearing, the issue will
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`be fully briefed, addressed by the parties’ respective experts, and the parties will
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`have the opportunity to present expert testimony and cross-examine the experts at
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`the three-hour hearing. The issue is ripe for a decision.”).
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`B. Amneal’s Indefiniteness Argument in the District Court Confirms
`That the Prior Art Did Not Teach the Claimed Invention
`Amneal’s claim construction position directly contradicts Amneal’s Grounds
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`that the claimed PVB comprising A/SA could be combined with the claimed
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`invention with a reasonable expectation of success. Amneal cannot simultaneously
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`argue that the claimed concentrations are incalculable while also “interchangeable”
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`with a specific concentration range taught in the prior art. The Board agreed with
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`Amneal that Carbopol and Sepineo’s substitution was “routine and predictable”
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`because “such thickening agents were known for use in topical compositions with
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`water insoluble drugs.” See Paper 58 at 39-40. But, Amneal must prove that the
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`prior art suggested the selection and exact combination of the claimed formulation
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`in the ’219 Patent with a reasonable expectation of success. See, e.g., Intendis
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`GMBH v. Glenmark Pharm. Ltd., 117 F. Supp. 3d 549, 590 (D. Del. July 15, 2015),
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`aff’d sub nom. Intendis GMBH v. Glenmark Pharm. Inc., 822 F.3d 1355 (Fed. Cir.
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`2016) (“[D]efendants have not carried their burden to demonstrate a reasonable
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`10
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`expectation of success in making the combination. Contrary to defendants’
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`representation, Dr. Michniak-Kohn never testified as to the ‘routine nature of
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`optimizing a formulation,’ but instead provided pointed testimony regarding
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`swapping particular excipients in two specific combinations… that excipients and
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`the active ingredient react differently depending on the formulation… leads the
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`court to understand that swapping ingredients in complex chemical formulations is
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`anything but ‘routine.’); Orexo AB, et al., v. Actavis Elizabeth LLC, 903 F.3d 1265,
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`1273 (Fed. Cir. 2018) (“The question is not whether the various references
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`separately taught components of the [claimed] formulation, but whether the prior art
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`suggested the selection and combination achieved by [the claimed invention].”).
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`The Intendis case is almost identical to this case in that Glenmark’s expert, Dr.
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`Michniak-Kohn (also Petitioners’ expert here), never testified about routine
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`optimization but instead argued, albeit unsuccessfully, the interchangeability of
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`excipients. In affirming non-obviousness the Federal Circuit said, “[t]he district
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`court did a commendable job in rendering its detailed and thorough opinion.”
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`See Intendis, 822 F.3d at 1367.
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`Orexo and Intendis clearly hold that it is not enough for an excipient to be
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`known, the prior art must teach that the excipient can be combined with the
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`claimed formulation as-a-whole with a reasonable expectation of success. In this
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`case, Petitioners must prove that the prior art taught a PVB comprising A/SA at the
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`11
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`claimed concentration would be compatible with the claimed invention as-a-whole
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`(e.g., compatible with dapsone, diethylene glycol monoethyl ether [DGME], and
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`methyl paraben at the claimed concentrations). Petitioners’ own expert even
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`affirms that a person of ordinary skill’s (“POSA”) expectation of success depends
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`on the gelling agent and specific formulation. See Ex. 2063 at 172:19–173:8
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`(“Again, all of them are classified as gelling agents, but they may not all be
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`interchangeable for all kinds of reasons, depending on what formulation of
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`dapsone I am using.”). The PVB’s interaction with the claimed formulation as-a-
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`whole could significantly impact the viscosity, stability (chemical and physical),
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`patient tolerability, adverse events, permeation rate, excipient compatibility,
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`crystallization, particle size, etc. See Ex. 2057 ¶¶ 63, 67. As explained below,
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`Amneal’s claim construction positions undermine that prior art taught the PVB
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`comprising A/SA limitations with a reasonable expectation of success.
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`First, Petitioners fail to show that the prior art taught PVB comprising A/SA
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`at the claimed concentration (e.g., % w/w). Amneal tries to thread the needle by
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`claiming that the claim phrases are indefinite because a POSA couldn’t calculate
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`the concentration of polymeric viscosity builder (i.e. the components that actually
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`create viscosity) at the district court. See Ex. 2072 at 10-11 of 79; id. at 70-71 of
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`79. Then, in this proceeding, Amneal claims the prior art taught that the claimed
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`12
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`formulation as-a-whole would be compatible with Sepineo, one embodiment of the
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`claims, at the claimed concentrations. Amneal’s positions are contradictory.
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`Neither Bonacucina or Nadau-Fourcade disclose the exact composition of
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`Sepineo, and according to Amneal’s proposed claim construction, if a POSA
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`doesn’t know the exact composition, a POSA can’t calculate the concentration of
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`the PVB. See Ex. 2072 at 31 of 79 (“But this renders the claim unworkable and
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`incomprehensible because the PVB component is not limited to Sepineo P 600 and
`
`is not something that has an art-recognized composition.”); id. at 34 of 79 (“In fact,
`
`the water and any additional unrecited ingredients can contribute up to 50% or
`
`more of the overall composition making it impossible to determine with reasonable
`
`certainty which of those ingredients and how much to attribute to the ‘[PVB]
`
`comprising [A/SA].’”). And, according to Amneal, even if the PVB composition
`
`was known, a POSA still wouldn’t be able to determine if it falls within the
`
`claimed concentration. See id. at 35 of 79 (“But even if a POSA knew the
`
`ingredients of Sepineo P 600, the POSA would still not be able to determine if the
`
`‘[PVB] comprising [A/SA]’ falls within the claimed concentration range of about
`
`2-6% w/w (or about 4% w/w)….”). For example, under Amneal’s claim
`
`construction, a POSA would not know if the “0.01% to 5%” Sepineo P 600®
`
`taught by Nadau-Fourcade was a 99% w/w or 0.1% w/w PVB. See Paper 58 at 15-
`
`17. If the prior art does not teach a PVB at its claimed concentration then the prior
`
`13
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`
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`IPR2019-00207
`Patent Owner’s Request for Rehearing
`
`art cannot teach whether a PVB could be combined with the claimed invention
`
`with a reasonable expectation of success. See Intendis, 117 F. Supp. 3d at 591
`
`(“The court was not presented with testimony or other evidence regarding the
`
`expectation of success in swapping ingredients in the specific combination(s)-at-
`
`issue and, therefore, cannot conclude that defendants have carried their burden in
`
`this regard.”) (emphasis added). Amneal cannot square its conflicting
`
`representations here and in the district court.
`
`Second, Amneal’s proposed claim construction undercuts the Board’s finding
`
`that Carbopol and Sepineo are interchangeable. The Board found that “Nadau-
`
`Fourcade teaches or suggests that Sepineo and Carbopol are interchangeable
`
`alternatives for such uses because they are included in a most preferred set of such
`
`agents, are indicated as used in the same preferred concentration range (0.01–5%),
`
`and are shown in examples to be used in very similar concentrations for similar
`
`formulations.” See Paper 58 at 38 (emphases added). But again, under Amneal’s
`
`proposed claim construction, a POSA would not know if the “0.01% to 5%”
`
`Sepineo P 600® taught by Nadau-Fourcade was a 99% w/w or 0.1% w/w PVB and
`
`likewise for Garrett’s teaching on Carbopol’s concentration. Hypothetically, under
`
`Amneal’s claim construction, Garrett’s “about 0.2% to about 4%” Carbopol could
`
`be 99% w/w PVB whereas Nadau-Fourcade’s “0.01% to 5%” Sepineo could be
`
`0.1% w/w PVB – drastically different PVB concentrations. A POSA looking at the
`
`14
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`IPR2019-00207
`Patent Owner’s Request for Rehearing
`
`asserted prior art under this construction would not be able to conclude that
`
`Carbopol and Sepineo are 1 to 1 PVB substitutions. Amneal’s proposed claim
`
`construction disintegrates the asserted prior art’s alleged teachings on the
`
`interchangeability of Carbopol and Sepineo.
`
`V. CONCLUSION
`For the reasons above, Patent Owner respectfully requests that the Board
`
`modify its Final Written Decision to hold that Petitioners did not meet their burden
`
`to prove Claims 1-8 of the ’219 Patent are unpatentable. Or, in the alternative,
`
`Patent Owner requests supplemental briefing on the issues raised above.
`
`
`
`Dated: June 29, 2020
`
`
`
`
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`15
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`
`
`IPR2019-00207
`Patent Owner’s Request for Rehearing
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on June 29, 2020, the
`
`foregoing PATENT OWNER’S REQUEST FOR REHEARING PURSUANT
`
`TO 37 C.F.R. § 42.71(d) was served by electronic mail on the following counsel
`
`of record for Petitioners:
`
`Dennies Varughese
`Adam C. LaRock
`Tyler C. Liu
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW, Suite 600
`Washington, DC 20005
`dvarughe-PTAB@skgf.com
`alarock-PTAB@skgf.com
`tliu-PTAB@skgf.com
`
`
`Jitendra Malik
`Alissa M. Pacchioli
`Heike S. Radeke
`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`heike.radeke@kattenlaw.com
`Lance Soderstrom
`Katten Muchin Rosenman LLP
`575 Madison Avenue
`New York, NY 10022-2585
`lance.soderstrom@kattenlaw.com
`
`Dated: June 29, 2020
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`16
`
`
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