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)
`
`__________________
`
`
`
`PATENT OWNER’S OPPOSITION TO MOTION FOR JOINDER
`
`
`
`
`__________________
`
`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)
`
`__________________
`
`
`
`PATENT OWNER’S OPPOSITION TO MOTION FOR JOINDER
`
`
`
`
`
`IPR2016-00091 (Patent 8,927,606)
`
`
`I.
`
`PRELIMINARY STATEMENT OF RELIEF REQUESTED
`
`Patent Owner Senju opposes the motion for joinder submitted on November
`
`2, 2015, by the InnoPharma petitioners (“InnoPharma”) concurrently with its
`
`corresponding IPR petition on USP 8,927,606. InnoPharma Licensing, Inc. v.
`
`Senju Pharm. Co., Ltd., IPR2015-00091 at Paper 3. The ’606 patent represents one
`
`of five patents-in-suit between Senju and InnoPharma, as well as Lupin in parallel
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`District Court proceedings, of which the Board is well aware. The ’606 patent was
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`issued before InnoPharma was sued in District Court by Senju et al. and long
`
`before InnoPharma filed two other IPRs on two other patents-in-suit. See
`
`IPR2015-00902; IPR2015-00903. Allowing InnoPharma to join Lupin’s instituted
`
`IPR2015-01100 on the ’606 patent (“the Lupin IPR”) would unduly prejudice
`
`Senju with piecemeal filings of IPRs designed by InnoPharma to harass Senju.
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`This is particularly true given that InnoPharma has deliberately delayed and
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`staggered its filing of this and two other IPRs, IPR2015-00089 and IPR2015-00090,
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`and has also dragged its feet in pursuing a potential resolution on the joinder issue
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`to the point where it no longer makes sense to join them. In fairness, InnoPharma’s
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`petition should independently go forward or not based the Board’s consideration of
`
`that petition in light of Senju’s Preliminary Response. Indeed, joining InnoPharma
`
`not would not only prejudice Senju, but also it condone InnoPharma’s intentional
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`gaming of the system solely to harass Senju.
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`1
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`IPR2016-00091 (Patent 8,927,606)
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`InnoPharma will argue that it just recently submitted, after almost three
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`months of delay and at the eleventh hour, an email to the Board agreeing to “accept
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`a back-seat, ‘understudy’ role in the joined proceedings.” (Ex. 2007.) But
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`InnoPharma has not actually implemented what it says it agrees to do. Moreover,
`
`the lack of specificity in InnoPharma’s “back-seat role” email just creates more
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`questions than it answers, including additional pages for briefing, procedures for
`
`conducting depositions, or contingencies in the event of settlement by Lupin. For
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`example, InnoPharma says that it will cease to take a back-seat role should Lupin
`
`drop out of the proceedings. What InnoPharma does not address is, if that
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`contingency were to occur, whether InnoPharma would go forward with Lupin’s
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`position and Lupin’s expert or instead seek to resurrect its own positions and its
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`expert who opined on those positions. Shortly before InnoPharma sent its belated
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`“back-seat role” email to the Board, Senju specifically asked InnoPharma to
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`provide its basis for reaching a potential resolution on joinder. InnoPharma ignored
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`Senju’s request and sent its “back-seat role” email to the Board instead.
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`At this late stage of this phase of the proceeding, InnoPharma’s
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`gamesmanship just further prejudices Senju from focusing on the tasks at hand,
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`including preparing for depositions of Lupin’s expert and filing a Patent Owner’s
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`Response in IPR2015-01100, as well as preparing for the upcoming trial in the
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`District Court proceeding. Senju therefore respectfully requests that InnoPharma’s
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`2
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`IPR2016-00091 (Patent 8,927,606)
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`motion for joinder be denied and that this proceeding independently move to the
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`Board’s combined consideration of InnoPharma’s petition and Senju’s Preliminary
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`Response on the question of institution.
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`II. BACKGROUND
`In May 2015, Senju sued InnoPharma for infringement of the ’606 patent;
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`InnoPharma filed its Answer on August 17, 2015. (Ex. 2002; Ex. 2003.) The
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`district court case involving the ’606 patent was consolidated with the then-
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`ongoing litigation between Senju and InnoPharma involving the ’813 and ’131
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`patents, among others. (Ex. 2005.) The ’606 patent claims, among other things,
`
`formulations of bromfenac for ophthalmic administration, sold under the name
`
`Prolensa®, specifically for treatment of pain and inflammation in patients
`
`undergoing cataract surgery. (Ex. 2002 at ¶¶ 23-25.) The ’606 patent is related to
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`four other patents also directed to formulation of bromfenac—all five of which are
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`involved in IPR proceedings. In March 2015, InnoPharma filed two IPRs against
`
`Senju’s U.S. Patent No. 8,129,431 (IPR2015-00903) and Senju’s U.S. Patent No.
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`8,669,290 (IPR2015-00902). Lupin later filed for review of the ’431 patent
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`(IPR2015-01871, which is now joined with the -00902 proceeding) and the ’290
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`patent (IPR2015-01099).
`
`
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`3
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`IPR2016-00091 (Patent 8,927,606)
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`A.
`
`InnoPharma’s IPR challenges of Senju’s related patents are a
`piecemeal approach designed to harass Senju.
`
`After filing its first two petitions, InnoPharma sat by and watched while its
`
`competitor Lupin initiated an IPR challenging the ’606 patent (“the Lupin IPR”) on
`
`two grounds. IPR2015-01100, Paper 1 (filed April 23, 2015). Lupin also filed
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`challenges against two other members of this patent family, U.S. Patent No.
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`8,754,131 (subject of the Lupin’s IPR2015-01097) and U.S. Patent No. 8,871,813
`
`(subject of Lupin’s IPR2015-01105). The Board instituted the Lupin IPR on
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`October 27, 2015, on a single ground of unpatentability. IPR2015-01100, Paper 9
`
`at 17.
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`But InnoPharma waited in the wings nearly a full year, until after the Lupin
`
`IPR was instituted, to initiate its own IPR challenging the 606 patent (“the
`
`InnoPharma IPR”) and request joinder with the Lupin IPR.1 IPR2016-00091,
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`Paper 3. Despite having access to the Board’s Institution Decision in the Lupin
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`IPR, InnoPharma did not file a “copycat” petition, as petitioners often do in
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`connection with a request for joinder with an instituted petition. Instead,
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`InnoPharma relied on three grounds that were worded differently than Lupin’s two
`
`grounds, but in fact relied on the same prior art. InnoPharma also complicated
`
`matters by relying on a different expert, Dr. Paul Laskar.
`
`
`1 InnoPharma also filed IPRs challenging the ’131 patent and the ’813 patent.
`4
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`
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`IPR2016-00091 (Patent 8,927,606)
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`
`B.
`
`InnoPharma made overtures toward working on a plan to join the
`Lupin IPR, but did not follow the Board’s advice from December
`11.
`
`Shortly after InnoPharma filed its motion for joinder, the parties discussed a
`
`consolidated schedule including potential schedule extensions to accommodate the
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`newly-filed, second round of InnoPharma IPRs. But, in the December 9, 2015,
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`email from the Board and in the Board’s December 11 Conference Call with the
`
`parties, the Board indicated that it was not inclined to change the June 2016
`
`hearing date for the Lupin IPR and expected that, if this proceeding and the Lupin
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`IPR were joined, then the parties would contend with an “abbreviated discovery
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`schedule.” (Ex. 2001 at 16:17-17:3; see also Ex. 2004.)
`
`In view of the Board’s disinclination to move the June hearing in the Lupin
`
`IPR, the December 11 Conference Call included extensive discussion of how
`
`InnoPharma might streamline its petition to join the InnoPharma IPR to the Lupin
`
`IPR with as little disruption as possible. At the time, it was almost two months
`
`until Senju’s Patent Owner Response was due in the Lupin IPR. See IPR2015-
`
`01100, Paper 12. On the December 11 call, the Board and counsel for InnoPharma
`
`discussed whether InnoPharma would be willing to drop the additional grounds in
`
`InnoPharma’s petition (a proposal that counsel for InnoPharma had yet to discuss
`
`with his client at the time) and the feasibility of InnoPharma’s continued reliance
`
`on Dr. Laskar in a potentially joined proceeding. (Ex. 2001 at 12-13, 16, 19-21.)
`
`
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`5
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`IPR2016-00091 (Patent 8,927,606)
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`While no agreement was reached, the Board suggested that to join the proceedings,
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`InnoPharma would need to modify its Petition to clarify the ground(s) at issue and
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`to change its supporting expert declaration accordingly. (Id. at 19:5-22.)
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`Specifically, the Board noted clarity of the record was paramount. (Id. at 22:13-
`
`19.) In closing, the Board encouraged the parties to meet and confer and return to
`
`the Board with a concrete proposal, and extended Senju’s deadline for filing its
`
`Opposition to Joinder as a result. (Id. at 30:1-9.)
`
`C.
`
`For nearly three months, InnoPharma dragged its feet before
`finally informing the Board at the eleventh hour that InnoPharma
`“will agree” to a back-seat role, but without sufficient details.
`
`It was some time until Senju heard from InnoPharma again. Several weeks
`
`passed, and on December 29, 2015, Senju actually inquired about whether
`
`InnoPharma had made a decision about dropping the additional grounds, in view of
`
`the approaching February 1 Patent Owner’s Response deadline in the Lupin IPR.
`
`(Ex. 2006 at 5.) More than two weeks later on January 13, InnoPharma finally
`
`responded that it was now “prepared to drop” additional Grounds 2 and 3, but still
`
`wished to rely on Dr. Laskar. (Ex. 2006 at 4-5.) In view of the deadline for the
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`Patent Owner’s Response (which by then had been extended to February 8, 2015,
`
`due to the late availability of Lupin’s expert for cross examination), Senju
`
`responded that same day that too much time had passed for InnoPharma to file its
`
`substitute petition and realign the Laskar declaration, for the Board to institute and
`
`
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`6
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`IPR2016-00091 (Patent 8,927,606)
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`join the proceedings, and for Senju to depose Dr. Laskar and respond to Dr.
`
`Laskar’s arguments in its Patent Owner response, then due in less than one month.
`
`(Ex. 2006 at 4.) As a result, Senju stated that it would only be possible to join the
`
`Lupin and InnoPharma IPRs if InnoPharma would agree to no longer rely on Dr.
`
`Laskar and take a secondary role to Lupin in the joined proceedings. (Ex. 2006 at
`
`4.) The parties continued to discuss this matter by phone on January 21 and by
`
`email on January 25 and 26, with Senju maintaining its position that time was short.
`
`(Ex. 2006 at 1-3.) On January 26, Senju reiterated its position that unless the issue
`
`was fully resolved by February 9 (the due date of this paper), Senju would oppose
`
`joinder. (Id.) On February 1, InnoPharma appeared to have made no progress
`
`toward a concrete plan and again requested clarification of Senju’s position “before
`
`our discussions with our client.” (Id. at 1-2.) In response, Senju requested
`
`clarification about InnoPharma’s specific proposal to the Board on joinder, noting
`
`that the burden for establishing the appropriateness of joinder rested with
`
`InnoPharma, not Senju. (Id. at 1.) Rather than respond to Senju, InnoPharma
`
`ignored Senju’s request and, on February 4, sent its “back-seat role” email to the
`
`Board. (Ex. 2007.) In that email, InnoPharma stated that it “will agree” to “accept
`
`a back-seat, ‘understudy’ role in the joined proceedings.” (Ex. 2007 at 1-2.) But
`
`InnoPharma’s email contained few other details about how and when this “back-
`
`seat” plan could come to fruition. (Id.)
`
`
`
`7
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`IPR2016-00091 (Patent 8,927,606)
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`Meanwhile, the Lupin IPR has proceeded at full steam. Senju is preparing to
`
`cross examine Lupin’s expert in one week. February 25 is the deadline for Senju
`
`to file its Patent Owner Response in the Lupin IPR and then Lupin will have the
`
`option to depose Senju’s declarants. Moreover, expert discovery continues in the
`
`related District Court proceedings, which are scheduled for trial in less than two
`
`months on April 4, 2016.
`
`III. THE BOARD SHOULD DENY JOINDER
`Petitioner bears the burden of establishing that joinder is
`A.
`appropriate.
`
`The America Invents Act permits the Board in its discretion to join multiple
`
`IPR proceedings only in certain circumstances. 35 U.S.C. § 315(c); 37 C.F.R.
`
`§ 42.122. A party must request joinder by motion within a month of institution,
`
`and the movant bears the burden of establishing that joinder is appropriate. See id.;
`
`37 C.F.R. § 42.20(c). A Motion for Joinder must:
`
`(1) set forth the reasons why joinder is appropriate;
`
`(2) identify any new grounds of unpatentability asserted in the petition;
`
`(3) explain what impact (if any) joinder would have on the trial schedule for
`
`the existing review; and
`
`(4) address specifically how briefing and discovery may be simplified.
`
`See Sony Corp. of Am. v. Network-1 Sec. Solutions, Inc., IPR2013-00386, Paper 16
`
`at 4 (July 29, 2013).
`
`
`
`8
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`IPR2016-00091 (Patent 8,927,606)
`
`
`The Board determines each joinder request individually, in light of the
`
`equities, the facts, and the procedural and substantive issues, including, for
`
`example, new claim construction positions. A petitioner seeking joinder has the
`
`burden to “explain adequately the impact of those new substantive issues on the
`
`patent owner, other petitioners, and the trial schedule of [the earlier IPR].” NetApp,
`
`Inc. v. PersonalWeb Techs., LLC, IPR2013-00319, Paper 18 at 6 (July 22, 2013).
`
`As discussed below, InnoPharma has not met this burden.
`
`B.
`
`Joinder is not appropriate here, because InnoPharma has not set
`forth a concrete plan for joining the Lupin IPR, and doing so at
`this late date would unduly prejudice both Lupin and Senju.
`
`At the outset, InnoPharma has not made this process easy by filing a
`
`“copycat” petition, as is often done by those wishing to join an instituted IPR.
`
`Instead, InnoPharma has created additional work for Senju, Lupin, and the Board
`
`by filing a redundant petition and in failing in a timely fashion to devise any
`
`detailed plan to align the InnoPharma petition to join it into the on-going Lupin
`
`IPR.
`
`Moreover, to complicate matters, InnoPharma indicated some potential
`
`willingness to align its petition with the Lupin IPR to facilitate joinder, but actually
`
`wasted valuable time—more than three months from early November to present—
`
`in finally making its request to the Board. (Ex. 2007.) And when that request was
`
`made, it was in a brief email submitted only days before Senju’s papers were due
`
`
`
`9
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`
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`IPR2016-00091 (Patent 8,927,606)
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`and raised yet more questions. InnoPharma has still not set forth a concrete plan
`
`for joining the Lupin IPR or the details for implementing such a plan, such as
`
`additional pages for briefing, procedures for conducting cross examinations, or
`
`contingencies in the event of settlement by Lupin. For instance, the parties to the
`
`Lupin IPRs have already agreed to limit cross examinations of all declarants to
`
`seven hours, and such cross examinations will involve IPR2015-01097, -01099,
`
`and -01105. InnoPharma has provided no specific plan how it would also
`
`participate in such cross examinations without prejudicing all involved.
`
`It is InnoPharma’s burden—not Senju’s or any other party’s—to show in a
`
`timely manner than joinder is appropriate. As noted above, the Board has
`
`indicated that it is not inclined to move the June hearing date and so time to resolve
`
`all of these issues is short. (Ex. 2001 at 16-17; see also Ex. 2004). Discovery and
`
`briefing are well underway in the Lupin IPR. As a result, InnoPharma’s February
`
`4 email was too little, too late, and InnoPharma should not be rewarded for its
`
`delay with joinder in the Lupin IPR—instead InnoPharma’s petition should be
`
`considered separately on its own merit for institution.
`
`IV. CONCLUSION
`
`As discussed above, 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. It would
`
`
`
`10
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`IPR2016-00091 (Patent 8,927,606)
`
`also effectively condone InnoPharma’s piecemeal filing approach and reward it for
`
`sitting on its hands until the last possible moment to file its redundant IPR petition.
`
`Accordingly, Senju requests denial of IPR joinder with the Lupin ’606 IPR and
`
`that InnoPharma’s petition should go forward or not based the Board’s
`
`consideration of that petition in light of Senju’s Preliminary Response.
`
`Respectfully submitted,
`
`
`
`
`
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Justin J. Hasford, Back-up Counsel
`Reg. No. 62,180
`Joshua L. Goldberg, Back-up Counsel
`Reg. No. 59,369
`Finnegan, Henderson, Farabow,
`Garrett
` & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
`
`Date: February 9, 2016
`
`
`
`
`
`
`
`
`
`11
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`IPR2016-00091 (Patent 8,927,606)
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing PATENT
`
`OWNER’S OPPOSITION TO MOTION FOR JOINDER was served on
`
`February 9, 2016, via email directed to counsel of record for the Petitioner at the
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`following:
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Lance Soderstrom
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`james.abe@alston.com
`
`
`
`Date: February 9, 2016
`
`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
`
`
`
`
`12
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