Paper 10
`Trials@uspto.gov
`571-272-7822
`
` Entered: November 13. 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`KAKEN PHARMACEUTICAL CO., LTD. and VALEANT
`PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`Case IPR2017-01429
`Patent 7,214,506 B2
`
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
`571-272-7822
`
` Entered: November 13. 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`KAKEN PHARMACEUTICAL CO., LTD. and VALEANT
`PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`Case IPR2017-01429
`Patent 7,214,506 B2
`
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`IPR2017-01429
`Patent 7,214,506 B2
`
`
`
`
`
`I. INTRODUCTION
`Argentum Pharmaceuticals LLC (“Patent Owner”) filed a Petition
`requesting an inter partes review of claims 1 and 2 of U.S. Patent No.
`7,214,506 B2 (Ex. 1001, “the ’506 patent”). Paper 2 (“Pet.”). Patent Owner
`Kaken Pharmaceutical Co., Ltd. and Valeant Pharmaceuticals International,
`Inc. (collectively, “Patent Owner”) waived filing a Preliminary Response.
`Paper 9 (“Waiver”).
`We have authority to determine whether to institute an inter partes
`review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). To institute an inter
`partes review, we must determine that the information presented in the
`Petition shows “a reasonable likelihood that the petitioner would prevail
`with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C.
`§ 314(a). For the reasons set forth below, we conclude that Petitioner has
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of each of the challenged claims of the ’506 patent.
`Therefore, we institute an inter partes review for claims 1 and 2 of the ’506
`patent on the grounds identified in the Order section of this Decision.
`
`A. Related Proceedings
`Petitioner identifies Acrux DDS Pty Ltd. v. Kaken Pharmaceutical
`
`Co., Ltd., IPR2017-00190 (PTAB) (“Acrux IPR”) involving the ’506 patent
`to which Petitioner seeks joinder. Pet. 1. Petitioner further states that the
`grounds asserted in this Petition “are consistent with those presented in the
`Acrux IPR and on which the Board instituted IPR of the challenged claims.”
`Id. at 3.
`
`
`
`2
`
`
`
`IPR2017-01429
`Patent 7,214,506 B2
`
`
`
`
`
`In IPR2017-00190, we instituted an inter partes review of claims 1
`
`and 2 based on the following grounds.
`
`Claims Challenged
`Basis
`References
`1 and 2
`§ 103(a)
`JP ’6391 and Ogura2
`1 and 2
`§ 103(a)
`’367 Patent3 and Ogura
`1 and 2
`§ 103(a)
`Hay4 and Ogura
`1 and 2
`§ 103(a)
`JP ’639 and Kaken Abstracts5
`1 and 2
`§ 103(a)
`’367 Patent and Kaken Abstracts
`Hay and Kaken Abstracts
`§ 103(a)
`1 and 2
`Petitioner filed a Motion for Joinder, seeking to join the instant
`proceeding with the Acrux IPR. Paper 3 (“Mot.”). In a separate decision,
`we grant Petitioner’s Motion for Joinder, joining the instant proceeding with
`IPR2017-00190, and terminating the instant proceeding.
`
`
`1 Yoichi Ohta and Yukari Tsutsumi, Japanese Pat. App. Pub. No. 10-226639,
`pub. Aug. 25, 1998 (Ex. 1011, “JP ’639”).
`2 Hironobu Ogura et al., Synthesis and Antifungal Activities of (2R,3R)-2-
`Aryl-1-azolyl-3-(substituted amino)-2-butanol Derivatives as Topical
`Antifungal Agents, 47 CHEM. PHARM. BULL. 1417–25 (1999) (Ex. 1012,
`“Ogura”).
`3 Teresa J. DeVincentis et al., U.S. Patent No. 5,391,367, issued Feb. 21,
`1995 (Ex. 1013, “’367 patent”).
`4R.J. Hay, R.M. Mackie, and Y.M. Clayton, “Tioconazole nail solution—an
`open study of its efficacy in onychomycosis,” 10 CLIN. AND EXPERIMENTAL
`DERMATOLOGY 111–15 (1985) (Ex. 1014, “Hay”).
`5 H. Ogura et al., “KP-103, a Novel Topical Antifungal Triazole: Structure-
`Activity Relationships of Azolylamine Derivatives,” ABSTRACTS OF THE 36TH
`ICAAC F78 (1996); Y. Tatsumi et al., “In Vitro Activity of KP-103, a Novel
`Topical Antifungal Triazole,” ABSTRACTS OF THE 36TH ICAAC F79 (1996);
`Y. Tatsumi et al., “Therapeutic Efficacy of KP-103, a Novel Topical
`Antifungal Triazole, on Experimental Superficial Mycosis,” ABSTRACTS OF
`THE 36TH ICAAC F80 (Ex. 1015, collectively, “Kaken Abstracts”).
`3
`
`
`
`
`
`IPR2017-01429
`Patent 7,214,506 B2
`
`
`
`
`
`Petitioner also identifies as a related matter U.S. Patent Application
`No. 15/405,171, a reissue application for the ’506 patent. Id.
`
`B. Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds of unpatentability, which are
`identical to the grounds on which we instituted trial in IPR2017-00190:
`
`References
`JP ’639 and Ogura
`’367 Patent and Ogura
`Hay and Ogura
`JP ’639 and Kaken Abstracts
`’367 Patent and Kaken Abstracts
`Hay and Kaken Abstracts
`
`Basis
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`
`Claims Challenged
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`
`II. ANALYSIS
`
`A. Claim Construction
`Although neither Petitioner in this Petition nor the petition in
`IPR2017-00190 expressly construes any claim term, both rely on the express
`definition of a claim term, “nail,” in the ’506 patent. Compare Pet. 6-7, with
`’190 Pet. 6-7. We construed this claim term in IPR2017-00190. See ’190
`Dec. 8. For the purposes of the instant decision, we incorporate our previous
`analysis, see ’190 Dec. 6–9, and apply that claim construction here.
`
`B. Obviousness over the Ogura with
` JP ’639, the ’367 patent, or Hay
`In its Petition, Petitioner asserts the same three grounds of
`unpatentability based on Ogura with either JP ’639, the ’367 patent, or Hay,
`as that on which a trial was instituted in IPR2017-00190. See Pet. 4; ’190
`Dec. 11–18, 25. Petitioner’s arguments are substantively identical to the
`
`
`
`4
`
`
`
`IPR2017-01429
`Patent 7,214,506 B2
`
`
`
`
`
`arguments made by Petitioner in IPR2017-00190, including identical claim
`charts for each ground. Compare Pet. 23–42, with ’190 Pet. 21–40.
`Petitioner also proffers the same Declaration of Kenneth A. Walters, Ph.D.,
`that Petitioner submitted in support of the ’190 Petition, compare Ex. 1105,
`with IPR2017-00190, Ex. 1005, in addition to a Declaration of Maurizio Del
`Poeta, M.D, see Ex. 1047. Dr. Del Poeta testifies that he agrees “in all
`material respects with the analysis and opinions set forth by Acrux’s expert,
`Dr. Walter, in the declaration that was submitted in the Acrux IPR and
`share[s] the same opinions . . . .” Ex. 1047 ¶ 17.
`We incorporate our previous analysis regarding the three asserted
`grounds of unpatentability based on Ogura with either JP ’639, the ’367
`patent, or Hay (’190 Dec. 11–18), and determine that Petitioner has
`demonstrated a reasonable likelihood of prevailing on those three grounds of
`unpatentability.
`
`
`C. Obviousness over Kaken Abstracts with
`JP ’639, the ’367 patent, or Hay
`Petitioner also asserts the same three grounds of unpatentability based
`on the Kaken Abstracts with either JP ’639, the ’367 patent, or Hay, as that
`on which a trial was instituted in IPR2017-00190. See Pet. 4; ’190 Dec. 18–
`25. Petitioner’s arguments are substantively identical to the arguments made
`by Petitioner in IPR2017-00190, including identical claim charts for each
`ground. Compare Pet. 42–57, with ’190 Pet. 40–62. Petitioner again relies
`on the same Declaration of Dr. Walters relied upon in the ’190 Petition,
`compare Ex. 1105, with IPR2017-00190, Ex. 1005, as well as the
`
`
`
`5
`
`
`
`IPR2017-01429
`Patent 7,214,506 B2
`
`
`
`
`
`Declaration of Dr. Del Poeta, who agrees in all material respects with the
`analysis and opinions of Dr. Walters. Ex. 1047 ¶ 17.
`We incorporate our previous analysis regarding the three asserted
`grounds of unpatentability based on the Kaken Abstracts with either JP ’639,
`the ’367 patent, or Hay (’190 Dec. 18–24), and determine that Petitioner has
`demonstrated a reasonable likelihood of prevailing on those three grounds of
`unpatentability.
`
`III. CONCLUSION
`For the foregoing reasons, we determine that the information
`presented in the Petition shows that there is a reasonable likelihood that
`Petitioner would prevail in challenging claims 1 and 2 of the ’506 patent as
`unpatentable under 35 U.S.C. § 103(a). At this stage in the proceeding, we
`have not made a final determination with respect to claim construction or
`that patentability of the challenged claims.
`
`
`
`IV. ORDER
`For the foregoing reasons, it is:
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`review is hereby instituted on the following grounds;
`
`
`
`6
`
`
`
`IPR2017-01429
`Patent 7,214,506 B2
`
`
`
`
`
`References
`JP ’639 and Ogura
`’367 Patent and Ogura
`Hay and Ogura
`JP ’639 and Kaken Abstracts
`’367 Patent and Kaken Abstracts
`Hay and Kaken Abstracts
`
`Basis
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`
`Claims Challenged
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`
`FURTHER ORDERED that no other ground of unpatentability
`asserted in the Petition is authorized for this inter partes review; and
`
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; the trial
`will commence on the entry date of this decision.
`
`
`
`
`
`
`
`
`7
`
`
`
`
`
`IPR2017-01429
`Patent 7,214,506 B2
`
`
`
`
`
`For PETITIONER:
`
`Teresa Rea
`Shannon Lentz
`CROWELL & MORING LLP
`trea@crowell.com
`slentz@crowell.com
`
`Tyler Liu
`Argentum Pharmaceuticals, LLC
`tliu@agpharm.com
`
`
`
`PATENT OWNER:
`
`John Livingstone
`Naoki Yoshida
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, L.L.P.
`John.livingstone@finnegan.com
`Naoki.yoshida@finnegan.com
`
`Toan Vo
`VALEANT PHARMACEUTICALS NORTH AMERICA LLC
`Taon.vo@bausch.com
`
`
`
`
`
`
`8
`
`
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