`571-272-7822 Date: February 25, 2016
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC, MYLAN
`PHARMACEUTICALS INC., and MYLAN INC.
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2016-00091
`Patent 8,927,606 B1
`____________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
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`IPR2016-00091
`Patent 8,927,606 B1
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`I.
`INTRODUCTION
`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma
`Inc., InnoPharma LLC, Mylan Pharmaceuticals Inc., and Mylan Inc.
`(collectively, “Petitioner” or “InnoPharma”) timely filed a Petition
`requesting an inter partes review of claims 1–30 of U.S. Patent No.
`8,927,606 B1 (Ex. 1001, “the ’606 patent”). Paper 2 (“Pet.”). Petitioner
`also timely filed a Motion for Joinder to join this proceeding with Lupin Ltd.
`et al. v. Senju Pharmaceutical Co., Ltd., Case IPR2015-01100 (the “Lupin
`IPR”) which was instituted on October 27, 2015. Paper 3 (“Mot.”).
`Senju Pharmaceutical Co., Ltd. (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 11 (“Prelim. Resp.”). By Order we
`modified the Patent Owner’s time for filing an Opposition to the Motion for
`Joinder to coincide with the due date for the Preliminary Response. Paper
`10. With that authorization, Patent Owner filed an Opposition to Petitioner’s
`Motion for Joinder on the same date that it filed the Preliminary Response.
`Paper 12 (“Opp.”).
`For the reasons set forth below, we (1) institute an inter partes review
`based on the same grounds as instituted in the Lupin IPR, and (2) grant
`InnoPharma’s Motion for Joinder, subject to the conditions detailed herein.
`II.
`INSTITUTION OF INTER PARTES REVIEW
`In the Lupin IPR, we instituted trial on the following ground: Claims
`1–30 of the ’606 patent under 35 U.S.C. § 103(a) as obvious over Sallmann
`(U.S. Patent No. 5,891,913, issued Apr. 6, 1999) (“the ’913 patent”) and
`Ogawa (U.S. Patent No. 4,910,225, issued Mar. 20, 1990) (Ex. 1004). Lupin
`IPR, Paper 9, 18.
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`2
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`IPR2016-00091
`Patent 8,927,606 B1
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`InnoPharma’s Petition is substantially identical to the petition in the
`Lupin IPR, with respect to the ground challenging claims 1–30 as obvious
`over Sallmann1 and Ogawa. InnoPharma’s Petition includes additional
`grounds not authorized in the inter partes review instituted the Lupin IPR.
`By email correspondence to the Board, dated February 4, 2016, InnoPharma
`stated that “in the interests of facilitating joinder, InnoPharma will agree to
`proceed in [] IPR2015-01100 based only upon the arguments and evidence
`advanced by Lupin in its earlier-filed actions and accept[s] a back-seat,
`‘understudy’ role in [the] joined proceedings.” Ex. 3001. In other words,
`InnoPharma confirmed that it seeks institution only as to the single ground
`of unpatentability that corresponds to the ground authorized by the Board in
`the Lupin IPR.
`Further, InnoPharma’s Petition is supported by the declaration of a
`different witness than in the Lupin IPR. Both declarants, however, provide
`essentially the same testimony regarding the ground challenging claims 1–30
`as obvious over Sallmann and Ogawa. Compare Ex. 1003 (Declaration of
`Dr. Paul A. Laskar) with the Lupin IPR, Ex. 1005 (Declaration of Dr. M.
`Jayne Lawrence).
`In the Preliminary Response, Patent Owner acknowledges that
`InnoPharma’s Petition “relies on the same references and the same or
`substantially the same arguments as the Lupin petition.” Prelim. Resp. 1.
`Rather than addressing those arguments, Patent Owner requests that we
`
`
`1 The Sallmann reference applied in InnoPharma’s Petition is U.S. Patent
`No. 6,107,343, which issued Aug. 22, 2000 (Ex. 1009) from a divisional
`application of the parent application that issued as the ’913 patent. Due to
`that relationship, the Sallmann references have identical disclosures.
`3
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`IPR2016-00091
`Patent 8,927,606 B1
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`exercise our discretion to deny InnoPharma’s Petition pursuant to 35 U.S.C.
`§ 325(d) and 37 C.F.R. § 42.208(b).2 Id. In support of that request, Patent
`Owner asserts that InnoPharma “has not only intentionally delayed in filing
`its piecemeal IPRs, but also unduly procrastinated to potentially resolve the
`joinder issue.” Id. According to Patent Owner, granting the Petition would
`be unfair. Id. Patent Owner, however, has not persuasively supported those
`assertions or shown that the Petition was untimely filed. See id. at 1–11.
`When a petition for inter partes review challenges the same patent
`raised in a proceeding already before us, our decision whether to institute a
`trial is guided by 35 U.S.C. §§ 315(d) and 325(d). Section 315(d) states:
`during the pendency of an inter partes review, if another
`proceeding or matter involving the patent is before the Office,
`the Director may determine the manner in which the inter partes
`review or other proceeding or matter may proceed, including
`providing for stay, transfer, consolidation, or termination of any
`such matter or proceeding.
`
`Section 325(d) has similar language and further explains:
`In determining whether to institute or order a proceeding under
`this chapter, chapter 30, or chapter 31,[3] the Director may take
`into account whether, and reject the petition or request because,
`
`
`2 We interpret Patent Owner’s argument as seeking application of 37 C.F.R.
`§ 42.108(b), which applies to inter partes reviews, rather than 37 C.F.R.
`§ 42.208(b), which applies to post-grant reviews.
`3 Chapter 31 of the Patent Act covers inter partes review proceedings. Thus,
`although § 325(d) appears in Chapter 32, which is directed to post-grant
`reviews, it is applicable to inter partes reviews.
`4
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`IPR2016-00091
`Patent 8,927,606 B1
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`the same or substantially the same prior art or arguments
`previously were presented to the Office.
`
`Having considered the Petition, InnoPharma’s modification of the
`grounds to be considered in the Petition, Ex. 3001, and Patent Owner’s
`Preliminary Response, we determine that, under the current circumstances, it
`is appropriate to exercise our discretion to institute an inter partes review of
`the challenged claims based upon the same ground authorized and for the
`same reasons discussed in our Institution Decision in the Lupin IPR. See
`Lupin IPR, Paper 9. We find that proceeding in this manner is equitable for
`the parties.
`
`III.
`JOINDER OF INTER PARTES REVIEWS
`An inter partes review may be joined with another inter partes
`review, subject to the provisions 35 U.S.C. § 315(c), which governs joinder
`of inter partes review proceedings:
`(c) JOINDER. — If the Director institutes an inter partes
`review, the Director, in his or her discretion, may join as a party
`to that inter partes review any person who properly files a
`petition under section 311 that the Director, after receiving a
`preliminary response under section 313 or the expiration of the
`time for filing such a response, determines warrants the
`institution of an inter partes review under section 314.
`
`As the moving party, Petitioner bears the burden of proving that it is
`entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder
`should: set forth the reasons joinder is appropriate; identify any new grounds
`of unpatentability asserted in the petition; and explain what impact (if any)
`joinder would have on the trial schedule for the existing review. See
`Kyocera Corp. v. Softview, LLC, Case IPR2013-00004, slip op. at 4 (PTAB
`
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`Apr. 24, 2013) (Paper 15); see also, “Frequently Asked Questions H5,”
`http://www.uspto.gov/ip/boards/bpai/prps.jsp.
`Petitioner timely filed its Joinder Motion within one month of the
`institution of the Lupin IPR, as required by 37 C.F.R. § 42.122(b).
`As discussed in the Institution Decision, supra, InnoPharma sent an
`e-mail correspondence to the Board on February 4, 2016, offering certain
`concessions “in the interest of facilitating joinder.” Ex. 3001. Specifically,
`InnoPharma stated the following:
`InnoPharma will agree to proceed in IPR2015-01097, IPR2015-
`01100, and IPR2015-01105 based only upon the arguments and
`evidence advanced by Lupin in its earlier-filed actions and accept
`a back-seat, “understudy” role in those joined proceedings,
`without any right to separate or additional briefing or discovery,
`unless authorized by the Board upon a request to address an issue
`that is unique to InnoPharma. Only if Lupin drops out of the
`proceedings for any reason, will InnoPharma cease
`its
`understudy role. The conditions are the same as to what Lupin
`agreed to in connection with its corresponding motion for joinder
`to join InnoPharma’s IPR (IPR2015-00903), which the Board
`granted. See, e.g., IPR2015-0187 (Paper 13). Moreover,
`InnoPharma has contacted Lupin, and Lupin has agreed to permit
`InnoPharma to rely upon its declarant (Dr. Lawrence) in the
`joined proceedings.
`
`Ex. 3001.
`In its Opposition, Patent Owner asserts that joinder would “unduly
`prejudice Senju with piecemeal filings of IPRs designed by InnoPharma to
`harass Senju.” Opp. 1. In particular, Patent Owner asserts that “joinder here
`will affect the procedure and scheduling of the Lupin IPR. Joinder also
`would unduly complicate the case and the issues and, given the June hearing
`date, would unduly prejudice Senju and Lupin.” Id. at 10.
`
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`We disagree with Patent Owner. As InnoPharma has agreed to
`“accept a back-seat, ‘understudy’ role” in a joined proceeding, joinder would
`essentially only add InnoPharma as a petitioner in the Lupin IPR.
`InnoPharma has acknowledged that its role in a joined proceeding would not
`“entitle it to any right” to separate or additional briefing or discovery, as
`long as Lupin remains a party to the proceeding. In the event that Lupin
`settles with Patent Owner, or otherwise does not continue as the petitioner in
`the Lupin IPR, InnoPharma may take on an active role as the petitioner.
`Whether or not Lupin remains the petitioner in the Lupin IPR, InnoPharma
`has agreed to proceed only upon the ground authorized in the Lupin IPR and
`to rely only upon Lupin’s declarant, Dr. Lawrence. Moreover, joinder
`would not affect the schedule in the Lupin IPR. Thus, we do not find that
`Patent Owner has established persuasively that joinder would unduly
`complicate any aspect of the case or unduly prejudice the parties.
`Having considered the motion for joinder, InnoPharma’s email
`correspondence, and the opposition to the motion for joinder, we determine
`that InnoPharma has established persuasively that joinder is appropriate and
`will have little to no impact on the timing, cost, or presentation of the trial on
`the instituted ground. Thus, in consideration of the foregoing, and in the
`manner set forth in the following Order, the Motion for Joinder is granted.
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that trial is instituted in IPR2016-00091 on the following
`ground:
`Claims 1–30 of the ’606 patent under 35 U.S.C. § 103(a) as obvious
`over Sallmann and Ogawa;
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`7
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`IPR2016-00091
`Patent 8,927,606 B1
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`FURTHER ORDERED that InnoPharma’s Motion for Joinder with
`IPR2015-01100 is granted;
`FURTHER ORDERED that IPR2016-00091 is terminated and joined
`with IPR2015-01100, pursuant to 37 C.F.R. §§ 42.72, 42.122, and based on
`the conditions stated in the Motion for Joinder, as modified by the Exhibit
`3001, and further clarified in this Decision;
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2015-01100 shall govern the joined proceeding;
`FURTHER ORDERED that all future filings in the joined proceeding
`are to be made only in IPR2015-01100;
`FURTHER ORDERED that the case caption in IPR2015-01100 for all
`further submissions shall be changed to add InnoPharma as a named
`Petitioner after the Lupin Petitioner, and to indicate by footnote the joinder
`of IPR2016-00091 to that proceeding, as indicated in the attached sample
`case caption; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2015-01100.
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`8
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`IPR2016-00091
`Patent 8,927,606 B1
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`FOR PETITIONER INNOPHARMA:
`
`Jitendra Malik
`Hidetada James Abe
`Lance Soderstrom
`ALSTON & BIRD LLP
`jitty.malik@alston.com
`james.abe@alston.com
`lance.soderstrom@alston.com
`
`
`FOR PETITIONER LUPIN (IPR2015-01100):
`
`Deborah H. Yellin
`Jonathan Lindsay
`CROWELL & MORING LLP
`DYellin@Crowell.com
`JLindsay@Crowell.com
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`PATENT OWNER SENJU:
`
`Bryan C. Diner
`Justin J. Hasford
`Joshua L. Goldberg
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`Bryan.Diner@finnegan.com
`Justin.Hasford@finnegan.com
`Joshua.Goldberg@finnegan.com
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`9
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`Sample Case Caption
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-011001
`Patent 8,927,606 B1
`____________
`
`
`
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`1 Case IPR2016-00091 has been joined with this proceeding.
`
`