throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________________
`
` LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`
`Patent Owner
`_____________________________
`
`IPR2015-01871
`Patent 8,129,431
`____________________________________________
`
`OPPOSITION TO MOTION FOR JOINDER
`
`
`
`
`
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`PRELIMINARY STATEMENT OF RELIEF REQUESTED ........................ 1
`
`BACKGROUND ............................................................................................. 4
`
`III. THE BOARD SHOULD DENY JOINDER ................................................... 5
`
`A.
`
`B.
`
`Lupin bears the burden of establishing that joinder is
`appropriate. ............................................................................................ 5
`
`Joinder is not appropriate here, because it would affect
`the Board’s ability to timely complete its review and would
`unduly prejudice both InnoPharma and Senju. ..................................... 7
`
`1.
`
`Joinder without extension will affect the Board’s ability
`to timely complete the review. .................................................... 7
`
`a)
`
`b)
`
`Substance .......................................................................... 7
`
`Procedure .......................................................................... 9
`
`2.
`
`Granting joinder would unduly prejudice both
`InnoPharma and Senju, whereas Lupin would not be
`unduly prejudiced if joinder was denied. .................................. 13
`
`IV. CONCLUSION ..............................................................................................15
`
`
`
`

`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Patent Trial and Appeal Board Proceedings
`Enzymotech Ltd. v. Neptune Techs.,
`IPR2014-00556, Paper 19 (July 9, 2014) ........................................................... 12
`
`Fifth Third Bank v. Leon Stambler,
`IPR2014-00244, Paper 4 ..................................................................................... 15
`
`InnoPharma Licensing, Inc. v. Senju Pharm. Co., Ltd.,
`IPR2015-00903, Paper 2 ............................................................................... 1, 2, 7
`
`Lupin Ltd. v. Senju Pharm. Co., Ltd.,
`IPR2015-01097, Paper 1; IPR2015-01099, Paper 1;
`IPR2015-01105. Paper 1; IPR2015-01100, Paper 1 ............................................. 3
`
`
`
`
`Metrics, Inc. v. Senju Pharm. Co., Ltd.,
`IPR2014-01041, Paper 1 ....................................................................................... 1
`
`NetApp, Inc. v. PersonalWeb Techs., LLC,
`IPR2013-00319, Paper 18 (July 22, 2013) ....................................................... 6, 9
`
`Samsung Electronics Co., Ltd. & LG Electronics, Inc. v. Black Hills,
`LLC,
`IPR2014-00737, -00717, -00735, -00709, -00711, -00723, and
`-00740 joined by IPR2015-00334 to -00340 (Jan. 28, 2015) ....................... 10, 12
`
`Samsung Electronics Co. v. Arendi S.A.R.L.,
`IPR2014-01144, Paper 11 ................................................................................... 11
`
`SAP Am. Inc. v. Clouding IP, LLC,
`IPR2014-00306, Paper 13 (May 19, 2014) ......................................................... 12
`
`Sony Corp. of Am. v. Network-1 Sec. Solutions, Inc.,
`IPR2013-00386, Paper 16 (July 29, 2013) ............................................... 6, 10, 13
`
`Teva Pharmaceuticals USA, Inc. v. VIIV Healthcare Co.,
`IPR2015-00550, Paper 11 ................................................................................... 11
`
`i
`
`

`
`Unified Patents, Inc. v. Personalized Media Communications, LLC,
`IPR2015-00521, Paper 14 ............................................................................... 9, 10
`
`Federal Statutes
`
`Hatch–Waxman Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984) ............................... 4
`
`21 U.S.C. § 355(j)(2)(B)(ii)(I) ................................................................................... 5
`
`35 U.S.C. § 315(c) ..................................................................................................... 5
`
`35 U.S.C. § 316(a)(11) ........................................................................................... 1, 4
`
`Regulations
`
`37 C.F.R. § 42.20(c) ................................................................................................... 6
`
`37 C.F.R. § 42.122 ................................................................................................. 5, 6
`
`
`
`ii
`
`
`
`

`
`I.
`
`PRELIMINARY STATEMENT OF RELIEF REQUESTED
`
`Patent Owner Senju opposes the motion for joinder submitted by the Lupin
`
`Petitioners (“Lupin”), which presents new claim construction positions and new
`
`evidence, including a new declaration, that would require burdensome additional
`
`discovery and expert testimony, unduly prejudicing Senju and unduly burdening
`
`the Board. In the alternative, should the Board grant joinder, the Board should
`
`exercise its discretion under 35 U.S.C. § 316(a)(11) and extend the schedule in the
`
`joined proceedings to account for the additional complexity in these proceedings.
`
`In December 2013, Lupin sent a Notice Letter informing Senju that Lupin
`
`had filed an Abbreviated New Drug Application (“ANDA”) with a Paragraph IV
`
`Certification challenging Senju’s U.S. Patent No. 8,129,431 (“the ’431 patent”).
`
`The ’431 patent covers the highly successful drug Prolensa for treatment of pain
`
`and inflammation in patients undergoing cataract surgery. (EX2001.) Senju sued
`
`Lupin for infringement of the ’431 patent on January 31, 2014, and the waiver of
`
`service of summons was filed on February 21, 2014. (EX2002; EX2003.)
`
`Lupin then sat by and watched while other companies initiated IPRs
`
`challenging the ’431 patent. Metrics, Inc. (“Metrics”) initiated IPR2014-01041
`
`challenging the ’431 patent (“the Metrics IPR”) on June 26, 2014. Metrics, Inc. v.
`
`Senju Pharm. Co., Ltd., IPR2014-01041, Paper 1. A group of InnoPharma
`
`petitioners (“InnoPharma”) then initiated IPR2015-00903 challenging the ’431
`
`
`
`

`
`
`patent (“the InnoPharma ’431 IPR”) on March 19, 2015. InnoPharma Licensing,
`
`IPR2015-01871
`Patent 8,129,431
`
`Inc. v. Senju Pharm. Co., Ltd., IPR2015-00903, Paper 2. In fact, InnoPharma
`
`moved to join the Metrics IPRs, while Lupin sat and watched. Only when Metrics
`
`agreed to a consent judgment and injunction acknowledging the validity of the
`
`’431 patent, and the Metrics IPR settled, did Lupin belatedly speak up, engaging in
`
`highly improper ex parte communication with a PTAB paralegal. (EX2004.) Lupin
`
`asked various questions about the Metrics IPR and the InnoPharma ’431 IPR,
`
`including whether joinder with the InnoPharma ’431 IPR was still possible.1 Id.
`
`Almost two years (1 year and 9 months) after Lupin sent its Paragraph IV
`
`Notice Letter—and likely three years after Lupin knew it would challenge the ’431
`
`
`
` 1
`
` The manner in which Lupin’s counsel engaged in this improper ex parte
`
`communication confused the PTAB paralegal, further exacerbating the impropriety
`
`of Lupin’s actions. Lupin’s counsel left a voicemail asking generally whether
`
`another petitioner could file an IPR with a joinder motion challenging the ’431
`
`patent. Lupin’s counsel did not inform the PTAB paralegal, however, that Lupin
`
`itself intended to file its own IPR and joinder motion challenging the ’431 patent.
`
`This confused the PTAB paralegal, who was led to believe that counsel for
`
`InnoPharma, not Lupin, placed this call. (EX2004.)
`
`2
`
`

`
`
`patent’s validity,2 Lupin finally initiated these proceedings on the last business day
`
`IPR2015-01871
`Patent 8,129,431
`
`before the deadline for requesting joinder with the InnoPharma ’431 IPR. Lupin
`
`did so, however, with a new declarant and different claim construction positions
`
`than those in the InnoPharma ’431 IPR. And Lupin did so several months after
`
`having submitted four separate IPRs challenging other Senju patents covering the
`
`same drug product. Lupin Ltd. v. Senju Pharm. Co., Ltd., IPR2015-01097, Paper 1;
`
`IPR2015-01099, Paper 1; IPR2015-01105. Paper 1; IPR2015-01100, Paper 1.
`
`Short of extending the schedule appropriately, joinder would not efficiently
`
`resolve patent validity, will unduly prejudice Senju and InnoPharma, and will
`
`unduly burden the Board. Unlike 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. And
`
`Lupin does not agree to extend the schedule of the InnoPharma ’431 IPR, which is
`
`scheduled for oral hearing on April 19, 2016, right on the heels of trial in a parallel
`
`
` 2
`
` It takes at least a year in most cases to prepare an ANDA and at least a few
`
`months for the FDA to initially review the ANDA before giving the applicant
`
`permission to send its Paragraph IV Notice Letter. Lupin sent its Paragraph IV
`
`Notice Letter in December 2013.
`
`3
`
`

`
`
`district court action on the ’431 patent.3 Joinder without an extension of time
`
`IPR2015-01871
`Patent 8,129,431
`
`would seriously alter the procedure, substance and scope of these proceedings and
`
`would significantly prejudice Senju. Accordingly, and as discussed below, Senju
`
`requests that the Board deny joinder or, in the alternative, extend the schedule of
`
`both IPRs, as contemplated by 35 U.S.C. § 316(a)(11).
`
`II. BACKGROUND
`Senju’s ’431 patent discloses and claims novel aqueous liquid preparations
`
`of bromfenac, the active ingredient in the highly successful drug Prolensa, which
`
`revolutionized treatment of inflammation and pain in patients who undergo
`
`cataract surgery. On December 19, 2013, Lupin sent a Paragraph IV Notice Letter
`
`notifying Senju that Lupin had filed an ANDA to market exact generic copies of
`
`Prolensa and alleging (in 27 pages) that the ’431 patent was invalid as obvious.
`
`(EX2001 at 22.) As contemplated by the Hatch–Waxman Act, Pub. L. No. 98-417,
`
`98 Stat. 1585 (1984), Senju sued Lupin and other generic challengers for
`
`
` Both Lupin and InnoPharma are parties to the parallel district court proceedings
`
` 3
`
`involving the ’431 patent. The District Court Judge scheduled trial for April 4,
`
`2016, which is expected to last about a week. This places the trial’s conclusion a
`
`mere week or so before the final hearing date scheduled in the InnoPharma IPRs.
`
`(EX2005.)
`
`4
`
`

`
`
`infringement of the ’431 patent. (Paper No. 6.) Those proceedings cannot be stayed
`
`IPR2015-01871
`Patent 8,129,431
`
`and are set for trial on April 4, 2016. (EX2005.)
`
`Lupin knew for a long time, long before it sent its Paragraph IV Notice
`
`Letter on December 19, 2013, that it would be challenging the ’431 patent’s
`
`validity. Lupin’s Paragraph IV Notice Letter did not advance non-infringement
`
`positions regarding many of the claims of the ’431 patent, confirming Lupin’s
`
`intention to exactly copy Prolensa®. (EX2003.) Lupin instead devotes 27 pages of
`
`its Paragraph IV Notice Letter to challenging the validity of the ’431 patent, which
`
`Lupin clearly did not prepare overnight. In fact, to be in a position to send out this
`
`letter, Lupin had to file its ANDA months earlier to give the FDA time to initially
`
`review the ANDA for substantial completeness before authorizing Lupin to send
`
`its Notice Letter. 21 U.S.C. § 355(j)(2)(B)(ii)(I). Moreover, the preparation of
`
`Lupin’s ANDA would have been underway roughly a year before its ANDA filing
`
`date. Given that the ’431 patent issued in March 2012 and IPR proceedings became
`
`effective September 2012, Lupin delayed for about three years, until the last
`
`possible moment on September 4, 2015, to file its IPR against the ’431 patent.
`
`III. THE BOARD SHOULD DENY JOINDER
`A. Lupin bears the burden of establishing that joinder is
`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.
`
`5
`
`

`
`
`§ 42.122. A party must request joinder by motion within a month of institution, and
`
`IPR2015-01871
`Patent 8,129,431
`
`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).
`
`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, Lupin has not met this burden.
`
`6
`
`

`
`
`
`B.
`
`IPR2015-01871
`Patent 8,129,431
`
`Joinder is not appropriate here, because it would affect the
`Board’s ability to timely complete its review and would unduly
`prejudice both InnoPharma and Senju.
`1.
`
`Joinder without extension will affect the Board’s ability to
`timely complete the review.
`Substance
`a)
`The Lupin IPR presents significant new substantive issues. It seeks to
`
`broaden the InnoPharma ’431 IPR with new claim construction positions and new
`
`evidence, including a new declaration. In addition, it raises the potential for
`
`additional discovery beyond that which Senju is already seeking in the InnoPharma
`
`’431 IPR. Lupin has failed to carry its burden of adequately explaining the impact
`
`of these new substantive issues on the trial schedule. Indeed, these significant new
`
`issues will affect the Board’s ability to timely complete its review, thus warranting
`
`denial of joinder.
`
`Instead of addressing the significant new issues, Lupin argues that its
`
`petition is identical to the one in the InnoPharma ’431 IPR. It is not. Unlike
`
`InnoPharma, which construed the phrase “consisting essentially of” and argued
`
`“BAC is an optional component of the aqueous liquid preparation of claim 1,”
`
`IPR2015-00903, Paper 2 at 15–16, Lupin simply “reserve[d] their right to . . .
`
`propose express constructions . . . in later briefing,” IPR2015-01871, Paper 2 at
`
`17-18. This reservation alone establishes that joinder would unnecessarily
`
`complicate and delay the InnoPharma ’431 IPR.
`
`7
`
`

`
`In addition to introducing new claim construction positions, Lupin also
`
`IPR2015-01871
`Patent 8,129,431
`
`
`
`introduced new evidence, relying on a new declarant with a new declaration
`
`(EX1054) that is cited throughout Lupin’s petition. This new declarant, Dr.
`
`Lawrence, presents new evidence and opinions in her declaration. Not only does
`
`Dr. Lawrence base her declaration on the Board’s institution decision in the
`
`InnoPharma ’431 IPR, relying on the decision to avoid independently addressing
`
`claim construction (EX1054 at ¶ 3, FN1), but Dr. Lawrence also attempts to
`
`correct InnoPharma’s declarant, Dr. Laskar (EX1054 at FN25), regarding a claim
`
`term presently being construed in parallel district court proceedings. At a
`
`minimum, Senju and the Board would need to address these new positions
`
`introduced by Dr. Lawrence in any joint proceeding.
`
`Senju and the Board would also need to separately address the credibility
`
`and qualifications of this new declarant. While Lupin suggests it might be willing
`
`to withdraw Dr. Lawrence’s declaration in favor of Dr. Laskar’s declaration in
`
`certain circumstances, doing so would not free Senju or the Board from addressing
`
`Dr. Lawrence’s declaration. Having already referenced her declaration throughout
`
`its petition, there is no way for Lupin to unring the bell. Neither Senju nor the
`
`Board will be able to ignore her declaration. It would thus unnecessarily
`
`complicate and delay the InnoPharma ’431 IPR.
`
`8
`
`

`
`The Lupin IPR also raises the potential for additional discovery beyond that
`
`IPR2015-01871
`Patent 8,129,431
`
`
`
`which Senju is already seeking in the InnoPharma ’431 IPR. Specifically, if the
`
`Lupin IPR is instituted, Senju will seek additional discovery regarding, at a
`
`minimum, Lupin’s copying of Senju’s patented aqueous liquid preparations of
`
`bromfenac. The mere potential for this additional discovery weighs in favor of
`
`denying joinder. Unified Patents, Inc. v. Personalized Media Communications,
`
`LLC, IPR2015-00521, Paper 14 at 5.
`
`In short, the Lupin IPR’s new claim construction positions and new
`
`evidence, as well as the potential for additional discovery, will impact the Board’s
`
`ability to timely complete its review, and Lupin has not carried its burden to
`
`explain otherwise. This alone dictates denial of Lupin’s motion. See, e.g., NetApp,
`
`IPR2013-00319, Paper 18 at 5-6.
`
`b)
`Nor has Lupin addressed in its joinder motion significant procedural issues
`
`Procedure
`
`associated with its request, including how joinder with the InnoPharma ’431 IPR
`
`would impact IPR2015-00902, another InnoPharma IPR challenging U.S. Patent
`
`No. 8,669,290 (“the InnoPharma ’290 IPR”), which Lupin itself is separately
`
`challenging in IPR2015-01099. The schedules in these InnoPharma IPRs are
`
`synchronized, so any delay in the InnoPharma ’431 IPR would also delay the
`
`InnoPharma ’290 IPR. As the Board has previously recognized, such delay
`
`9
`
`

`
`
`warrants denying joinder. Unified, IPR2015-00521, Paper 14 at 6-7. But Lupin’s
`
`IPR2015-01871
`Patent 8,129,431
`
`proposed joinder presents more than just a scheduling problem. The parties to the
`
`InnoPharma IPRs have already agreed to limit depositions of all declarants to
`
`seven hours, EX2006, and such depositions will involve both InnoPharma
`
`IPR2015-00902 and IPR2015-00903. Lupin has provided no explanation how it
`
`would also participate in such depositions without prejudicing all involved.
`
`Lupin has also failed to account for the tremendous complexity that would
`
`be introduced into the InnoPharma ’431 IPR by its new declarant. Lupin could
`
`have retained the same declarant and filed only the same declaration as
`
`InnoPharma with Lupin’s petition, as is often done. Cf. Samsung Electronics Co.,
`
`Ltd. & LG Electronics, Inc. v. Black Hills, LLC, IPR2014-00737, -00717, -00735,
`
`-00709, -00711, -00723, and -00740 joined by IPR2015-00334 to -00340 (Jan. 28,
`
`2015). Instead, Lupin included an additional declarant, necessitating additional
`
`deposition time and increasing the amount of discovery that would be required if
`
`joinder were permitted. See, e.g., Sony, IPR2013-00386, Paper 16, at 7 (denied)
`
`(“Petitioners also include with their Petition a declaration from [a new expert
`
`declarant], which likely would increase the amount of discovery (e.g., depositions)
`
`that would be required if joinder is permitted.”) (citation omitted).
`
`Moreover, Senju expects to submit at least five substantive declarations with
`
`its Patent Owner’s Response. Lupin and InnoPharma likely will respond to these
`
`10
`
`

`
`
`declarations with additional declarations of their own from additional separate
`
`IPR2015-01871
`Patent 8,129,431
`
`declarants. Because Lupin and InnoPharma are already using different declarants,
`
`it is reasonable to expect that they will similarly use different declarants moving
`
`forward, potentially leading to as many as fourteen depositions. The procedural
`
`complexity of an already substantively complex case will ratchet up considerably if
`
`joinder occurs within the confines of the current schedule, unduly prejudicing
`
`Senju and InnoPharma, and taxing the Board’s resources.
`
`Despite this procedural complexity, Lupin has offered no meaningful
`
`concessions to make joinder work within the current schedules of the InnoPharma
`
`’431 and ’290 IPRs. Instead, it has simply pointed to certain cases in which
`
`petitioners have agreed to work together on certain tasks. This is not enough. Lupin
`
`is silent as to whether it has actually made any such agreements with InnoPharma,
`
`and the Board has previously recognized the failure to do so as fatal to joinder
`
`motions. Teva Pharmaceuticals USA, Inc. v. VIIV Healthcare Co.,
`
`IPR2015-00550, Paper 11 at 6; see also Samsung Electronics Co. v. Arendi
`
`S.A.R.L., IPR2014-01144, Paper 11 at 6 (noting the silence of petitioner as to
`
`whether the earlier petitioner had agreed to work together and denying joinder
`
`motion). Moreover, Lupin has not offered to:
`
`1) Refrain from filing substantive responses in most cases;
`
`11
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`

`
`IPR2015-01871
`Patent 8,129,431
`
`
`
`2) Refrain from requesting or reserving any additional deposition
`time;
`3) Refrain from requesting or reserving any additional oral hearing
`time; or
`4) Assume a second-chair role as long as the first party remains in the
`proceeding.
`These limitations have previously been agreed upon and imposed where joinder
`
`motions have been granted. See, e.g., Samsung, IPR2014-00740, Paper 17,
`
`IPR2015-00340, Paper 9 (and six other related petitions) (all limitations noted
`
`above); Enzymotech Ltd. v. Neptune Techs., IPR2014-00556, Paper 19 (July 9,
`
`2014) (agreeing to procedural concessions, such as “consolidated” responses); SAP
`
`Am. Inc. v. Clouding IP, LLC, IPR2014-00306, Paper 13 (May 19, 2014) (same,
`
`agreeing not to rely on new declarant and to adopt first petitioner’s declarant).
`
`Here, by contrast, Lupin has taken new claim construction positions,
`
`retained a new declarant, and relied on new evidence. Yet Lupin has not explained
`
`how briefing and discovery may be simplified to avoid impacting the Board’s
`
`ability to timely complete its review. This dictates denial of Lupin’s motion.
`
`Moreover, as discussed above, as part of Lupin’s overall pattern of delay,
`
`Lupin’s counsel improperly engaged in ex parte communication with a PTAB
`
`paralegal, asking about, inter alia, whether joinder with the InnoPharma ’431 IPR
`
`was still possible. (EX2004.) Lupin’s only purported excuse for this improper
`
`12
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`

`
`
`action is that its communication was allegedly not “ex parte” because Lupin was
`
`IPR2015-01871
`Patent 8,129,431
`
`not a party to the InnoPharma ’431 IPR at the time. That excuse is disingenuous at
`
`best. Lupin has four related IPRs on file. Lupin knew it delayed filing the fifth one
`
`on the ’431 patent. Given its posture with respect to these related IPRs, Lupin
`
`cannot credibly argue that it had no interest in the Metrics IPR and hide behind the
`
`veil of not being a party. Lupin’s ex parte communication had definite substantive
`
`strategy and purpose. Lupin’s behavior in this regard and its harassment of Senju
`
`by filing multiple piecemeal IPRs challenging Senju’s Prolensa patent rights in
`
`belated fashion should not be countenanced and warrants denial of Lupin’s motion.
`
`For these additional reasons, the Board should deny Lupin’s joinder motion.
`
`See, e.g., Sony, IPR2013-00386, Paper 16, at 7.
`
`2. Granting joinder would unduly prejudice both InnoPharma
`and Senju, whereas Lupin would not be unduly prejudiced
`if joinder was denied.
`
`Granting joinder would severely prejudice InnoPharma and Senju. The
`
`InnoPharma ’431 and ’290 IPRs are both substantively complex. InnoPharma and
`
`Senju nevertheless have agreed to limit depositions of all declarants to seven hours.
`
`(EX2006.) Such depositions will involve both InnoPharma IPRs, and it is unclear
`
`how Lupin could participate in the depositions without jeopardizing the parties’
`
`existing agreement, thereby prejudicing both of them. Moreover, by presenting
`
`new claim construction positions and new evidence, including a new declarant,
`
`13
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`

`
`
`Lupin’s IPR would further complicate the proceedings. For example, because
`
`IPR2015-01871
`Patent 8,129,431
`
`Lupin’s new declarant opines on some of the same issues as InnoPharma’s
`
`declarant, Senju would need to depose both declarants simultaneously to avoid
`
`having one unfairly account for what happened during the other’s deposition. This
`
`procedural complication, needed to thwart gamesmanship and prevent unfairness
`
`to Senju, would substantially increase both InnoPharma’s and Senju’s costs.
`
`In contrast, any prejudice to Lupin that could result from the denial of
`
`joinder is simply the consequence of Lupin’s own delay. As discussed above,
`
`Lupin very likely knew it would be challenging the ’431 patent’s validity about
`
`three years ago, yet Lupin delayed filing its IPR. Lupin could have filed its IPR
`
`petition within one year of the suit. Still, Lupin chose not to. Lupin also could have
`
`sought to join the Metrics ’431 IPR earlier this year. Again, Lupin chose not to.
`
`Instead, after the Metrics ’431 IPR settled, Lupin panicked and chose to
`
`engage in highly improper ex parte communication with a PTAB paralegal,
`
`telephoning her to ask various questions about the Metrics ’431 IPR and the
`
`InnoPharma ’431 IPR, including whether Lupin would be able to join the
`
`InnoPharma ’431 IPR. Only then did Lupin finally file its petition, almost two
`
`years (1 year and 9 months) after sending its Paragraph IV Notice Letter and likely
`
`three years after it knew it would be challenging the ’431 patent’s validity. Lupin
`
`has no excuse for its improper behavior and delay, which the Board should not
`
`14
`
`

`
`
`reward by granting joinder. Lupin made a choice, and now Lupin must face the
`
`IPR2015-01871
`Patent 8,129,431
`
`consequences. See Fifth Third Bank v. Leon Stambler, IPR2014-00244, Paper 4 at
`
`5. Rather than litigating the validity of the ’431 patent here, Lupin will need to do
`
`so in the district court, where trial is set for April 4, 2016.
`
`IV. CONCLUSION
`As discussed above, joinder here will affect the substance, procedure, and
`
`scheduling of the two InnoPharma IPRs. Joinder also would unduly complicate the
`
`case and the issues and, absent an extension of time, would unduly prejudice Senju
`
`and InnoPharma. It would also effectively condone and reward Lupin for sitting on
`
`its hands for three years and passing up on numerous opportunities before finally
`
`filing its motion at the last possible moment, and only after engaging in an
`
`improper ex parte communication with the PTAB paralegal. Accordingly, Senju
`
`requests denial of IPR joinder with the InnoPharma ’431 IPR, absent extending the
`
`schedule in both InnoPharma IPRs.
`
`Dated: October 5, 2015
`
`Respectfully,
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`
`
`
`15
`
`

`
`
`
`CERTIFICATE OF SERVICE
`
`IPR2015-01871
`Patent No. 8,129,431
`
`
`I certify that I served a copy of the foregoing OPPOSITION TO MOTION
`
`FOR JOINDER on Monday, October 05, 2015 via email directed to counsel of
`
`record for the Petitioners at:
`
`Deborah Yellin
`DYellin@crowell.com
`
`Jonathan Lindsay
`JLindsay@crowell.com
`
`
`Respectfully,
`
` /Bradley J. Moore/
`Bradley J. Moore
` Litigation Clerk
`
`
`
`
`
` Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP.
`
`Dated: October 5, 2015
`
`
`
`
`
`
`
`
`
`
`
`
`16

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