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 IPR2016-00089 (Patent 8,754,131)
`
`__________________
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`__________________
`
`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 IPR2016-00089 (Patent 8,754,131)
`
`__________________
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`
`I.
`
`PRELIMINARY STATEMENT OF RELIEF REQUESTED
`
`The petition filed by the InnoPharma petitioners (“InnoPharma”) continues
`
`to attack the patentability of U.S. Patent No. 8,754,131 by retreading ground
`
`already covered by the Lupin petitioners (“Lupin”) in the IPR2015-01097
`
`proceeding. InnoPharma waited until the last possible moment, after the institution
`
`of the Lupin IPR, to file its redundant petition. As explained herein, the
`
`InnoPharma petition relies on the same references and the same or substantially the
`
`same arguments as the Lupin petition. Congress created the IPR system to provide
`
`faster and less costly alternatives to civil litigation to challenge patents, not to
`
`multiply disputes or to promote harassment of patent owners. In these
`
`circumstances, often the later filing petitioner requests joinder with the earlier
`
`proceeding. As explained in Senju’s Opposition to InnoPharma’s motion for
`
`joinder, although InnoPharma filed a petition that is substantially the same as the
`
`Lupin petition and ostensibly wishes to join the Lupin IPR, but it has not only
`
`intentionally delayed in filing its piecemeal IPRs, but also unduly procrastinated to
`
`potentially resolve the joinder issue. To permit InnoPharma to benefit from its
`
`inaction, by instituting the redundant InnoPharma petition, represents a misuse of
`
`the IPR system and would be unfair to Senju and burdensome to the Board. Senju
`
`thus requests that the Board exercise its § 325(d) power and discretion under 37
`
`C.F.R. § 42.208(b) to deny the InnoPharma petition.
`
`
`
`1
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`II. BACKGROUND
`In November 2014, Senju sued InnoPharma for infringement of the ’131
`
`patent; InnoPharma filed its Answer on January 23, 2015. (Ex. 2002; Ex. 2003.)
`
`The ’131 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 ¶¶ 17-20.)
`
`A.
`
`InnoPharma waited until the last possible moment to file its
`redundant petition.
`
`After responding to Senju’s complaint, InnoPharma sat by and watched
`
`while its competitor Lupin initiated an IPR challenging the ’131 patent. On April
`
`23, 2015, Lupin initiated IPR2015-01097 challenging the ’131 patent (“the Lupin
`
`IPR”). IPR2015-01097, Paper 1. The Board instituted the Lupin IPR on October
`
`27, 2015, on a single ground of unpatentability, namely obviousness over Sallmann
`
`and Ogawa. IPR2015-01097, Paper 9 at 22.
`
`InnoPharma waited until after the Lupin IPR was instituted, nearly a full
`
`year, to initiate its own IPR challenging the ’131 patent (“the InnoPharma IPR”)
`
`and request joinder with the Lupin IPR. InnoPharma Licensing, Inc. v. Senju
`
`Pharm. Co., Ltd., IPR2016-00089, Paper 3.
`
`
`
`2
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`
`B. As InnoPharma readily admits, the InnoPharma petition relies on
`the same references and substantially the same arguments as the
`Lupin IPR.
`
`Despite having access to the Board’s Institution Decision in the Lupin IPR,
`
`InnoPharma did not pattern its first ground after the sole ground instituted by the
`
`Board in the Lupin IPR to facilitate joinder, but rather it attempted a second bite at
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`the apple and reformulated the arguments presented by Lupin in the Lupin IPR into
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`three “new” grounds. Nonetheless, as explained herein, the two petitions are the
`
`same or substantially the same.
`
`1.
`
`The InnoPharma and Lupin petitions rely on the same prior
`art.
`First and foremost, InnoPharma’s arguments rely on the same prior art
`
`references as the Lupin IPR. InnoPharma admits this in its motion for joinder.
`
`IPR2016-00089, Paper 3 at 5 n.1. InnoPharma’s three grounds, all based on §103
`
`arguments, involve combinations of Ogawa (Ex. 1004), Sallmann (Ex. 1009), Fu
`
`(Ex. 1011), and Yasueda (Ex. 1012). IPR2016-00089, Paper 2 at 11. The first
`
`three references, Ogawa, Sallmann, and Fu, collectively formed the basis of both
`
`of Lupin’s grounds of invalidity in the Lupin IPR. IPR2015-01097, Paper 1 at 11.
`
`Moreover, Lupin also relied on Yasueda as part of the state-of-the-art discussion to
`
`support its contention that polysorbate 80 could be substituted for tyloxapol in
`
`ophthalmic formulations. IPR2015-01097, Paper 1 at 10. Importantly, this is the
`
`
`
`3
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`very same reason that InnoPharma relies on Yasueda in its Ground 3. See
`
`IPR2016-00089, Paper 2 at 48-50.
`
`2.
`
`InnoPharma offers no new claim construction, relies on the
`same art for its state-of-the-art, and relies on the same
`arguments contesting objective indicia of non-obviousness.
`
`Further mimicking Lupin, InnoPharma did not offer any new claim
`
`constructions, relying completely on the Board’s decision in the Lupin IPR
`
`Institution Decision that no express construction was necessary for any term.
`
`IPR2016-00090, Paper 2 at 7. As to its state-of-the-art discussion, InnoPharma
`
`relies on nearly all the same references as Lupin, but with different exhibit
`
`numbers:
`
`InnoPharma’s Exhibits
`IPR2016-00089
`Ex. 1005 (Desai et al., USP 5,603,929)
`Ex. 1017 (Kapin, WO 2002/13804)
`Ex. 1002 (Hara paper)
`Ex. 1010 (Guttman paper)
`Ex. 1030 (Prince paper)
`Ex. 1006 (Desai et al., USP 5,558,876)
`Ex. 1022 (Bergamini paper)
`Ex. 1035 (Wong, WO 94/15597)
`
`Lupin’s Exhibits
`IPR2016-01097
`Ex. 1012
`Ex. 1036
`Ex. 1006
`Ex. 1042
`Ex. 1057
`Ex. 1013
`Ex. 1039
`Ex. 1027
`
`
`As to objective indicia of non-obviousness, InnoPharma offers the same
`
`arguments as Lupin in contesting Senju’s ability to establish unexpected results
`
`
`
`4
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`regarding tyloxapol’s stabilizing effects; long-felt, but unmet, need; copying; and
`
`commercial success. Compare IPR2016-00089, Paper 2 at 55-60 with IPR2015-
`
`01097, Paper 1 at 54-59. InnoPharma brings nothing new to the table on any of
`
`these issues.
`
`3.
`
`InnoPharma’s grounds of unpatentability are the same or
`substantially the same as those presented by Lupin.
`
`In connection with the Lupin IPR, the Board has already considered all of
`
`the references and arguments presented by InnoPharma in its petition. After
`
`relying on the same main references and nearly identical state-of-the-art references,
`
`proposing no new claim construction, and making similar arguments regarding the
`
`alleged lack of objective indicia of non-obviousness, InnoPharma sets forth
`
`substantially the same arguments, albeit spread over three grounds of
`
`unpatentability, rather than only two, as Lupin did in its petition. As a result, the
`
`Board should use its discretion to end this serial challenge to the ’131 patent as
`
`redundant.
`
`a. InnoPharma’s Ground 1 is the same as Lupin’s
`Instituted Ground 2.
`
`In its Ground 1, InnoPharma argues that claims 1-30 of the ’131 are
`
`unpatentable under 35 U.S.C.§ 103(a) over Ogawa and Sallmann. InnoPharma’s
`
`Ground 1 is identical to Lupin’s Ground 2, which the Board instituted. The order
`
`of the references makes no difference. See IPR2014-01041, Paper 19 at 19 (citing
`
`
`
`5
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`In re Bush, 296 F.2d 491, 496 (CCPA 1961) for the proposition that “‘[T]o term
`
`one reference primary and the other secondary’ is a distinction ‘of little
`
`consequence, and []basing arguments on’ such distinctions is an attempt ‘to make a
`
`mountain out of a mole-hill.’”).
`
`In its petition, Lupin argues that Sallmann discloses ophthalmic solutions for
`
`treating inflammatory conditions of the eye with the NSAID diclofenac in a
`
`solution with tyloxapol as the solubilizer and BAC as the preservative. IPR2015-
`
`01097, Paper 1 at 35-36. Lupin further argues that Ogawa describes formulations
`
`for ophthalmic solutions containing bromfenac and polysorbate 80. Id. at 36.
`
`Relying on a “swapping” theory, Lupin concludes that: “[i]t would have been
`
`obvious to a [person of ordinary skill in the art (POSA)] to substitute bromfenac
`
`for diclofenac in [Sallmann], at least in view of the disclosure of [Ogawa]” and
`
`“the POSA would have been motivated to substitute tyloxapol [disclosed in
`
`Sallmann] for polysorbate 80 [disclosed in Ogawa].” Id. at 37-38. Likewise,
`
`InnoPharma makes the same “swapping” argument. The core of InnoPharma’s
`
`argument is that “it would have been obvious to substitute tyloxapol from
`
`Sallmann’s Example 2 for polysorbate 80 in Ogawa’s Example 6,” IPR2016-
`
`00089, Paper 2 at 18, and “to try to prepare a bromfenac ophthalmic formulation
`
`containing tyloxapol,” id. at 21. Even InnoPharma admits its Ground 1 is
`
`
`
`6
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`“essentially the same” as the instituted ground in the Lupin IPR. IPR2016-00089,
`
`Paper 3 at 5. The Board need not review this ground as it is redundant.
`
`b. InnoPharma’s Ground 3 is substantially the same as
`Lupin’s Instituted Ground 2.
`
`InnoPharma’s Ground 3 also covers substantially the same arguments as
`
`Lupin’s Ground 2. Both grounds center on Ogawa, Sallmann, and Yasueda. Lupin
`
`discussed Yasueda in its state-of-the-art section, alleging that Yaseuda discloses
`
`“tyloxapol was better than polysorbate 80 at solubilizing” in an ophthalmic
`
`solution. IPR2015-01097, Paper 1 at 10. InnoPharma merely promotes Yasueda
`
`from the state-of-the-art to a secondary reference, arguing that Yasueda “further
`
`substantiate[s]” replacing polysorbate 80 with tyloxapol. IPR2016-00090, Paper 2
`
`at 48-49, 51. InnoPharma uses Yasueda in the same way that Lupin did. In its
`
`analysis of the Lupin’s Ground 2, involving Ogawa and Sallmann, on which the
`
`Board later instituted IPR proceedings, the Board specifically discussed the
`
`disclosure of Yasueda. IPR2015-01097, Paper 9 at 10. As result, InnoPharma’s
`
`Ground 3 does not warrant fresh review by the Board.
`
`c. InnoPharma’s Ground 2 is substantially the same as
`Lupin’s Non-Instituted Ground 1.
`
`In its second ground, InnoPharma relies on Ogawa, Sallmann, and Fu, which
`
`is substantially the same as Lupin’s Ground 1, which relies on Ogawa and Fu. The
`
`Board considered Lupin’s Ground 1, but declined to institute on it. Like Lupin,
`
`
`
`7
`
`
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`IPR2016-00089 (Patent 8,754,131)
`
`InnoPharma relies on Fu and its purported disclosure of greater stability for
`
`ethoxylated octylphenols, of which it alleges tyloxapol is one, as further motivation
`
`for a proposed modification of Ogawa and Sallmann that involved replacing
`
`polysorbate 80 with tyloxapol. Compare IPR2016-00089, Paper 2 at 43 with
`
`IPR2015-01097, Paper 1 at 17-18. In this case, InnoPharma’s addition of
`
`Sallmann does not change that InnoPharma’s Ground 2 is substantially the same as
`
`a ground already considered by the Board.
`
`In sum, in the Lupin IPR, the Board had before it Ogawa, Sallmann, Fu, and
`
`Yasueda, as well as the common state-of-the-art references listed above, as part of
`
`its evaluation of Lupin’s grounds of unpatentability. IPR2015-01097, Paper 9. As
`
`a result, the Board has already considered all of the references and arguments
`
`presented by InnoPharma in its petition and should use its discretion to end this
`
`serial challenge to the ’131 patent.
`
`III. THE PETITION SHOULD BE DENIED BECAUSE IT REPRESENTS
`A MISUSE OF THE IPR PROCESS
`
`This petition, one part of a delayed and constant attack on Senju’s patents by
`
`various petitioners, constitutes litigation gamesmanship rather than usage of IPR
`
`for its intended purpose—speedier and more efficient resolution of legitimate
`
`defenses. The Board should use its statutory authority to deny petitions like these
`
`to prevent misuse.
`
`
`
`8
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`
`A. The Board has the discretionary power to deny this petition.
`Congress created IPR to “provide faster [and] less costly alternatives to civil
`
`litigation to challenge patents”—not to multiply disputes or to promote litigation
`
`gamesmanship. (Ex. 2008 at 17.) Further, the bill was designed to “significantly
`
`reduce the ability to use post-grant procedures for abusive serial challenges to
`
`patents.” (Id.) Before the Judiciary Committee of the House of Representatives,
`
`Hon. Paul Michel (Ret.), former Chief Judge of the Court of Appeals for the
`
`Federal Circuit expressed frustration with the delay in then-current post-issuance
`
`PTO proceedings (e.g., ex parte reexamination and inter partes reexamination) and
`
`the need for measures to guard against serial attacks in any new system. “So strong
`
`safeguards are needed, a threshold, a clear burden of proof, estoppel effects, and a
`
`ban on serial attacks on the same patent are examples of those safeguards.” (Ex.
`
`2009 at 8-9.) When a bill was introduced to try and expand the timing of filing an
`
`IPR until after the Markman hearing, Committee Chairman Lamar Smith strongly
`
`opposed the amendment, stating: “The inter partes proceeding in H.R. 1249 has
`
`been carefully written to balance the need to encourage its use while at [the] same
`
`time preventing the serial harassment of patent holders.” (Ex. 2010 at 72.)
`
`With this in mind, Congress created a structure aimed at preventing serial
`
`filings. The AIA contains numerous provisions evidencing such intent—barring
`
`review by those who have already filed declaratory judgment actions, providing for
`
`
`
`9
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`stays of civil actions, creating estoppel for petitioners, providing for joinder of
`
`interested parties, and, critically, providing broad discretion to the Board to decline
`
`institution where “the same or substantially the same prior art or arguments
`
`previously were presented to the Office.” 35 U.S.C. § 325(d). Moreover, the
`
`statute makes institution discretionary. See 35 U.S.C. § 324(a). And recently, the
`
`PTO recognized Congress’s requirement that, in addition to the one-year time bar,
`
`the AIA required the USPTO to establish regulations “to protect [Patent Owners]
`
`from harassment,” including “any . . . improper use of the proceeding.” (Ex. 2011
`
`at 33.) Further, the “Director may take into account whether the same or
`
`substantially [the] same prior art or arguments previously were presented to the
`
`PTO and may reject the petition on that basis.” (Id.)
`
`The PTO must use its regulations to combat the litigation gamesmanship
`
`exhibited here where InnoPharma has intentionally delayed filings to craft a
`
`petition based on events in other IPRs, timed filings to attempt to cause scheduling
`
`difficulties by creating additional rounds of cross examinations, and used this
`
`forum to seek multiple bites at the apple for additional arguments after other
`
`petitioners have already presented substantially the same arguments. In addition to
`
`its § 325(d) powers, the Board has broad discretion to “deny some or all
`
`grounds . . . .” 37 C.F.R. § 42.208(b). The Board should exercise that discretion
`
`here.
`
`
`
`10
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`
`B.
`
`The Board has already considered the references and arguments in
`InnoPharma’s petition and should decline institution under
`§ 325(d).
`
`Without joinder, InnoPharma’s petition represents nothing more than a serial
`
`attack on the ’131 patent, because InnoPharma’s petition relies on the same prior
`
`art and the same or substantially the same arguments as those the Board already
`
`considered in the Lupin IPR. Even though InnoPharma filed its petition just prior
`
`to the one-year bar, this action alone should not insulate it and its redundant
`
`arguments from the Board’s discretion. The Board should decline to reconsider
`
`references and arguments that it already fully considered.
`
`IV. CONCLUSION
`
`For the reasons discussed above, the Board should use its § 325(d) powers
`
`and discretion under 37 C.F.R. § 42.208(b), to deny the InnoPharma petition on
`
`two independent grounds: (1) because the InnoPharma’s arguments have been
`
`presented to the Board before in IPR proceedings already instituted and (2)
`
`because the Board should not condone InnoPharma’s misuse of IPR as a vehicle
`
`for litigation gamesmanship and harassment.
`
`Respectfully submitted,
`
`Date: February 9, 2015
`
`
`
`
`
`
`
`
`
`11
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`
`
`
`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
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`
`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
`
`
`
`12
`
`
`
`
`
`
`
`IPR2016-00089 (Patent 8,754,131)
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing PATENT
`
`OWNER’S PRELIMINARY RESPONSE was served on February 9, 2016, via
`
`email directed to counsel of record for the Petitioner at the 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
`
`
`
`
`13
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