Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 13
`Entered: January 25, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`_______________
`
`Case IPR2015-01871
`Patent 8,129,431
`_______________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Inter Partes Review and
`Granting Petitioner’s Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F.R. § 42.122(b)
`
`
`
`
`

`

`IPR2015-01871
`Patent 8,129,431
`
`
`Petitioner (“Lupin”) filed a petition (Paper 2, “Pet.”) requesting an inter
`partes review of claims 1–22 of U.S. Patent No. 8,129,431 (Ex. 1001, “the ’431
`patent”). Patent Owner (“Senju”) waived filing a preliminary response. Paper 11.
`With the petition, Lupin filed a motion (Paper 3, “Mot.”) requesting joinder of the
`instant proceeding with IPR2015-00903 (“IPR 903”). Lupin’s petition asserts the
`same grounds, directed to the same patent claims, as those set for trial in IPR 903,
`which was initiated by a different entity (“InnoPharma”). IPR 903, Paper 15,
`(“903 Dec.”). Senju opposes Lupin’s motion for joinder. Paper 7, (“Opp.”).
`During a telephone conference with the Board held November 17, 2015,
`Senju, Lupin, and InnoPharma clarified their respective positions relating to the
`petition and motion. Paper 10, (“Order”). In the event of joinder, Lupin agreed to
`proceed based solely on the arguments and evidence presented by InnoPharma in
`IPR 903. Id. at 4. Lupin also consented to being added to the case caption of
`IPR 903 as a petitioner, “without any active participation or involvement that is
`separate from InnoPharma, unless authorized by the Board upon a request
`pertaining to an issue unique to Lupin alone.” Id. InnoPharma agreed to permit
`Lupin to rely on the declaration of InnoPharma’s witness. Id. at 3. Senju
`continued to oppose Lupin’s request for joinder. Id. at 4.
`
`Institution of Inter Partes Review
`We first address whether Lupin’s petition warrants review; only then do we
`address whether joinder is appropriate. See 35 U.S.C. § 315 (c) (joinder provision,
`relating to inter partes reviews, requires, as an initial matter, a determination that
`the petition accompanying the joinder motion warrants institution of review). We
`have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review
`may be authorized only if “the information presented in the petition . . . and any
`[preliminary] response . . . shows that there is a reasonable likelihood that the
`
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`IPR2015-01871
`Patent 8,129,431
`
`petitioner would prevail with respect to at least 1 of the claims challenged in the
`petition.” 35 U.S.C. § 314(a).
`For reasons that follow, we are persuaded that Lupin’s petition warrants
`institution of an inter partes review, for the same reasons stated in our decision
`instituting review in IPR 903. Lupin’s petition challenges the same patent claims,
`on the same grounds, as those set for trial in IPR 903. Pet. 20; 903 Dec. 19. The
`argument and evidence presented in Lupin’s petition, and the argument and
`evidence presented in InnoPharma’s petition, are essentially identical in substance.
`See generally Pet.; IPR 903, Paper 2 (“903 Pet.”). For example, although Lupin’s
`petition is supported by the declaration of a different witness, Lupin’s witness in
`the instant proceeding provides essentially identical testimony as that supplied by
`InnoPharma’s witness in IPR 903. Compare Ex. 1054 (Declaration of Dr. M.
`Jayne Lawrence) with IPR 903, Ex. 1003 (Declaration of Dr. Paul A. Laskar).
`In IPR 903, we have already determined that the argument and evidence
`presented in InnoPharma’s petition warrants institution of an inter partes review.
`903 Dec. 19. Given that Lupin presents substantively identical arguments and
`evidence as that raised by InnoPharma in IPR 903, we determine that Lupin’s
`petition demonstrates a reasonable likelihood of prevailing with respect to at least
`one claim of the ’431 patent. In particular, for the reasons stated in our decision
`instituting review in IPR 903, Lupin is reasonably likely to show that (1) claims 1–
`5, 7–14, and 18–19 are unpatentable as obvious over Ogawa and Sallman; and (2)
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`IPR2015-01871
`Patent 8,129,431
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`claims 6, 15–17, and 20–22 are unpatentable as obvious over Ogawa,1 Sallmann,2
`and Fu.3 Id. at 4–19.
`
`Grant of the Motion for Joinder
`Lupin and InnoPharma “relied upon testimony from separate experts” in
`their respective petitions. Mot. 6. However, “in order to further simplify the
`proceeding, Lupin will rely on the same expert as InnoPharma” in any consolidated
`proceeding, “should InnoPharma permit it.” Id. at 7. In that regard, during the
`telephone conference held on November 17, 2015, these facts became apparent:
`InnoPharma and Lupin have reached an agreement, regarding their respective roles
`and the content of the evidence, should the Board join this proceeding with IPR
`903. In particular, InnoPharma agrees to permit Lupin to rely on the declaration of
`InnoPharma’s witness, Dr. Laskar, filed in support of InnoPharma’s petition in
`IPR 903. Lupin agrees to accept a back-seat role as an “understudy” in any joined
`proceeding, without any right to separate briefing or discovery in IPR 903.
`Order 3–4.
`To the extent that Lupin’s petition in this proceeding differs from the
`petition that InnoPharma filed in IPR 903, Lupin agrees to withdraw all additional
`arguments, as well as its supporting declaration of Dr. Lawrence, and proceed in
`IPR 903 based on the arguments and evidence provided by InnoPharma in
`IPR 903. Lupin agrees to assume a primary role in IPR 903 only if InnoPharma
`
`
`1 Ogawa et al., U.S. Patent No. 4,910,225, issued Mar. 20, 1990 (Ex. 1004)
`(“Ogawa”).
`2 Sallmann et al., U.S. Patent No. 6,107,343, issued Aug. 22, 2000 (Ex. 1009)
`(“Sallmann”).
`3 Fu, Austl. Patent Application No. AU-B-22042/88, published Mar. 16, 1989
`(Ex. 1011) (“Fu”).
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`IPR2015-01871
`Patent 8,129,431
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`ceases to participate in IPR 903. In other words, Lupin requests permission to be
`added to the case caption as a petitioner in IPR 903, without any active
`participation or involvement that is separate from InnoPharma, unless authorized
`by the Board upon a request pertaining to an issue unique to Lupin alone. Id. at 4.
`The Board several times requested counsel for Senju to address what burden,
`if any, Senju would bear, should joinder be granted on the above terms agreed to
`between InnoPharma and Lupin. Counsel for Senju advocated that consolidation
`of ten reviews (including IPR 903, any review instituted in the instant proceeding,
`and eight other reviews identified during the telephone conference) would foster
`consistency and efficiency, while opposing consolidation of this proceeding and
`IPR 903; averred that extending the statutory due date of a final decision in
`IPR 903, so that the ten reviews can be decided simultaneously, would permit the
`parties to focus on a trial presently set for April, 2016, in co-pending district court
`litigation that involves issues similar to those presented here; and argued that the
`ability of Lupin to request Board pre-authorization to provide separate argument or
`evidence in IPR 903, on issues unique to Lupin alone, is vague and presents
`uncertainties that may burden Senju. Id. None of those arguments, presented
`during the telephone conference, persuades us that any prejudice to Senju
`outweighs the interests of economy and speed that will be facilitated by granting
`Lupin’s request for joinder.
`Senju argued also, during the conference and in its written opposition, that
`Lupin “sat by and watched while other companies initiated IPRs challenging
`the ’431 patent.” Opp. 1. Our authorizing statute, however, sets forth the
`conditions under which a delay in filing a petition for an inter partes review will
`preclude a petitioner from seeking relief in our forum—and Senju does not
`establish sufficiently that those conditions are present in this case. See 35 U.S.C.
`
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`IPR2015-01871
`Patent 8,129,431
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`§ 315(b) (an IPR may not be filed if the petition requesting the proceeding is filed
`more than one year after the date on which the petitioner, real party in interest, or
`privy of the petition is served with a complaint alleging infringement of the
`patent). Under the circumstances, Senju fails to demonstrate an undue delay that
`justifies our denial of Lupin’s petition or motion.
`Senju also avers in the written opposition that, “[u]nlike many parties that
`have sought to prevent the undue procedural and substantive prejudice associated
`with joinder by agreeing to schedule extensions and procedural safeguards, Lupin
`does not agree to subordinate itself, even though that is in line with common Board
`practice.” Opp. 3. Lupin’s subsequent representations to the Board, during the
`telephone conference of November 17, 2015, obviate those objections.
`Specifically, Lupin expressly agrees to “subordinate itself,” id., to “a back-seat role
`as an ‘understudy’ in any consolidated proceeding, without any right to separate
`briefing or discovery in IPR 903.” Order 3–4. Lupin’s representations during the
`telephone conference effectively overcome Senju’s objections to joinder.
`For example, Senju alleges that joinder will negatively affect the Board’s
`ability to timely complete review, given that Lupin’s petition “presents significant
`new substantive issues.” Opp. 7. Senju’s concern that Lupin presents “new claim
`construction positions and new evidence, including a new declaration,” id., is
`substantially removed by Lupin’s subsequent agreement to forgo its own
`arguments and evidence and allow IPR2015-00903 to proceed based on
`InnoPharma’s arguments and evidence alone. Order 3–4.
`We have considered also the other arguments presented by Senju, but none
`persuades us that joinder is inappropriate in this case, given the concessions made
`by Lupin during the telephone conference of November 17, 2015. Opp. 7–15;
`Order 3–4. The interests of efficiency and speed in the resolution of this
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`IPR2015-01871
`Patent 8,129,431
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`proceeding outweigh the considerations raised by Senju in opposition to Lupin’s
`request for joinder. Under the circumstances, we conclude that Lupin has
`demonstrated persuasively that it is entitled to the requested relief. 37 C.F.R.
`§ 42.20(c).
`
`It is
`ORDERED that Lupin’s challenge to claims 1–22 is instituted;
`FURTHER ORDERED that Lupin’s motion for joinder is granted;
`FURTHER ORDERED that this proceeding is joined with IPR2015-00903;
`FURTHER ORDEED that the grounds on which IPR2015-00903 was
`instituted are unchanged, and no other grounds are instituted;
`FURTHER ORDERED that the Scheduling Order in place for IPR2015-
`00903 shall govern the proceeding;
`FURTHER ORDERED that, throughout IPR2015-00903, any paper, except
`for a motion that does not involve the other party, shall be filed by InnoPharma, as
`a single, consolidated filing on behalf of InnoPharma and Lupin, and InnoPharma
`will identify each such filing as a consolidated filing;
`FURTHER ORDERED that IPR2015-00903 will proceed without any active
`participation or involvement by Lupin that is separate from InnoPharma, unless
`authorized by the Board upon a request pertaining to an issue unique to Lupin
`alone;
`FURTHER ORDERED that except as otherwise agreed by counsel,
`InnoPharma will conduct cross-examination and other discovery on behalf of
`InnoPharma and Lupin, and that Senju is not required to provide separate
`discovery responses or additional deposition time as a result of the consolidation;
`
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`IPR2015-01871
`Patent 8,129,431
`
`
`FURTHER ORDERED that IPR2015-01871 is terminated under 37 C.F.R.
`§ 42.72, and all further filings are to be made in IPR2015-00903;
`FURTHER ORDERED that a copy of this Decision will be entered into the
`record of IPR2015-01871 and IPR2015-00903; and
`FURTHER ORDERED that the case caption in IPR2015-00903 shall be
`changed to reflect joinder with this proceeding in accordance with the attached
`example.
`
`
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`IPR2015-01871
`Patent 8,129,431
`
`For Petitioner:
`
`Deborah Yellin
`Jonathan Lindsay
`CROWELL & MORING LLP
`dyellin@crowell.com
`JLindsay@crowell.com
`
`
`For Patent Owner:
`
`Bryan Diner
`Justin Hasford
`Joshua Goldberg
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`bryan.diner@finnegan.com
`justin.hasford@finnegan.com
`joshua.goldberg@finnegan.com
`
`
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`IPR2015-01871
`Patent 8,129,431
`
`
`
`
`
`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., MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`________________
`
`Case IPR2015-009034
`Patent 8,129,431 B2
`_______________
`
`
`
`
`
`4 IPR2015-01871 has been joined with this proceeding.
`
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`