IN THE 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., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`__________________
`
`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)1
`__________________
`
`BEFORE FRANCISCO C. PRATS, ERICA A. FRANKLIN, and GRACE
`KARAFFA OBERMANN, Administrative Patent Judges
`
`CONSOLIDATED REPLY BRIEF IN SUPPORT OF MOTION FOR
`JOINDER AND PROPOSED SCHEDULING ORDER
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`
`heading.
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`
`TABLE OF CONTENTS
`STATEMENT OF THE PRECISE RELIEF REQUESTED......................... 1
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ...................... 1
`
`I.
`
`II.
`
`A.
`
`B.
`
`C.
`
`Joinder will not cause undue prejudice or cause undue delay............. 1
`
`InnoPharma does not raise material new substantive issues that
`preclude joinder ................................................................................. 4
`
`InnoPharma has offered to coordinate with Metrics to promote
`efficiency, avoid duplicate efforts, and preventing
`inconsistencies................................................................................... 8
`
`III. CONCLUSION ......................................................................................... 10
`
`CERTIFICATION OF SERVICE........................................................................ 11
`
`i
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`TABLE OF AUTHORITIES
`
`CASES
`ABB Inc. v. ROY-G-BIV Corp., IPR2013-00282 ................................................................5
`
`Page(s)
`
`Apotex, Inc. v. Novartis AG, IPR2015-00518......................................................................7
`
`Ariosa Diagnostics v. Isis Innovation Ltd., IPR2013-00250 ...........................................5
`
`Dell, Inc. v. Network-1 Security Solutions, Inc., IPR2013-00385 ...................... 5-6, 8, 9
`
`Enzymotech Ltd. v. Neptune Techs., IPR2014-00556....................................................5, 9
`
`Medtronic, Inc. v. Norred, IPR2014-00823 ..................................................................... 4-5
`
`Motorola Mobility LLC v. SoftView LLC, IPR2013- 00256 ........................................ 8-9
`
`NetApp, Inc. v. Personal Web Techs., LLC, IPR2013-00319 ..........................................3
`
`Samsung Electronics Co., Ltd. v. Black Hills Media LLC, IPR2014-00740................9
`
`SAP Am. Inc. v. Clouding IP, LLC, IPR2014-00306 .........................................................9
`
`Sony Corp. of Am. v. Network-1 Security Solutions, Inc., IPR2013-00386 .................3
`
`Standard Innovation Corp. v. Lelo, Inc., IPR2014-00907................................................3
`
`STATUTES
`
`35 U.S.C. § 314 ...........................................................................................................................5
`
`35 U.S.C. § 315 ...................................................................................................................3, 4, 5
`
`35 U.S.C. § 316 ...........................................................................................................................4
`
`REGULATIONS
`
`37 C.F.R. § 42.22 ........................................................................................................................4
`
`37 C.F.R. § 42.100(c).................................................................................................................4
`
`37 C.F.R. § 42.122(b) ................................................................................................................4
`
`ii
`
`

`
`I.
`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`InnoPharma Licensing Inc., InnoPharma Licensing LLC, InnoPharma Inc.,
`
`InnoPharma LLC, Mylan Pharmaceuticals Inc., and Mylan Inc. (collectively
`
`“InnoPharma”) hereby respectfully requests that
`
`the Board grant
`
`joinder of
`
`IPR2015-00902 and 00903 (“InnoPharma IPRs”) with IPR2014-01043 and 01041
`
`(“Metrics IPRs”), respectively.2 InnoPharma does not raise new substantive issues
`
`and is willing to coordinate with Metrics, Inc. (“Metrics”).
`
`InnoPharma is also
`
`willing to accommodate a schedule that will not cause undue delay or undue
`
`prejudice and submits that the proposed schedule is reasonable. See Papers 11; 9.3
`
`II.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED
`A.
`Joinder will not cause undue prejudice or cause undue delay
`Senju Pharmaceutical Co., Ltd., Bausch & Lomb, Inc., and Bausch & Lomb
`
`Pharma Holdings Corp. (collectively “Senju” or “Patent Owner”) and Metrics both
`
`argue that they will be unduly prejudiced under the Proposed Scheduling Order.
`
`2 Courtesy copies are being served on counsel of record for Metrics. The Board
`
`has directed InnoPharma to file its consolidated reply in all four proceedings, but
`
`InnoPharma has been advised by PTAB support staff during a phone call on June
`
`8, 2015 that it should file this paper in IPR2015-00902 and IPR2015-00903.
`
`3 Unless otherwise specified, citations to the paper numbers and page numbers
`
`refer to filings and orders in IPR2015-00902 and IPR2015-00903, respectively.
`
`1
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`Neither party, however, explains how their interests or rights are prejudiced. Senju
`
`and Metrics instead are arguing for schedules that will be convenient or
`
`advantageous to their interests, which does not constitute undue prejudice. The
`
`proposed schedule extends the proceeding by a mere two months and falls between
`
`those proposed by Senju and Metrics.
`
`Senju asserts that both Senju and Metrics will be unduly prejudiced, because
`
`InnoPharma allegedly raises new arguments and substantive issues. Papers 14 at
`
`11; 12 at 11 (collectively “Senju Oppositions”). Metrics does not seem to share
`
`Senju’s concern, raising no such objection to the substance of InnoPharma’s
`
`petition. The Grounds of invalidity asserted by InnoPharma are the same as those
`
`instituted in the Metrics IPRs. See Petition in IPR2015-00902, Paper 2 at 18;
`
`Decision to Institute in IPR2014-01043, Paper 19 at 16; Petition in IPR2015-
`
`00903, Paper 2 at 19; Decision to Insitute in IPR2014-01043, Paper 19 at 20.
`
`Metrics’ Oppositions alleges that Metrics will be unduly prejudiced because
`
`InnoPharma’s modest extension will delay approval of its ANDA. Metrics
`
`Oppositions at 2-3; at 2-3. Any such prejudice is speculative. Metrics does not
`
`present evidence that an extension will directly impact its ANDA schedule, nor
`
`that approval without issue is guaranteed. Further, Metrics’ speculative financial
`
`loss due to a two-month delay does not rise to the level of undue prejudice.
`
`2
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`Putting Metrics aside, Senju’s assertions of new arguments and grounds of
`
`invalidity are exaggerations. Further, the cases Senju relies on to allege prejudice
`
`are inapposite.
`
`For example, NetApp involved a motion for joinder where
`
`discovery process and trial schedule was being coordinated and synchronized with
`
`five related IPRs, and the petition challenged an additional claim that recited
`
`different terms and raised new construction and invalidity issues. NetApp, Inc. v.
`
`Personal Web Techs., LLC, IPR2013-00319, Paper 18 at 2, 5, 7-9. Likewise, the
`
`petitioners in Sony challenged a new claim, asserted three new grounds, asserted a
`
`new ground as to the new claim, and asserted five new prior art references. Sony
`
`Corp. of Am. v. Network-1 Security Solutions, Inc., IPR2013-00386, Paper 16 at 7.
`
`Further, Senju incorrectly argues that joinder would unduly prejudice it
`
`because it would provide InnoPharma a “second bite at
`
`the apple.”
`
`Senju
`
`Oppositions at 11; at 11.
`
`If joinder is denied, as Senju wishes, Metrics and
`
`InnoPharma individually have the opportunity to invalidate the patents because
`
`InnoPharma is not time-barred. Joinder removes the need for Senju to defend its
`
`patent twice, and for the Board to decide the issue twice.4
`
`4 Standard Innovation is distinguishable because it involved the same petitioner
`
`filing a second IPR after the one-year time bar had passed, to address a prior denial
`
`of institution. Standard Innovation Corp. v. Lelo, Inc., IPR2014-00907, Paper 10
`
`at 1-3.
`
`3
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`Moreover, InnoPharma diligently and timely filed its petition and motion for
`
`joinder within the time set by statute. See 37 C.F.R. §§ 42.22 and 42.122(b).
`
`InnoPharma also seeks an extension that is within the amount prescribed by statute.
`
`See 37 C.F.R. § 42.100(c); 35 U.S.C. § 316(a)(11).
`
`It would be axiomatic that a
`
`petition, motion for joinder, and extension that complies with all the rules does not
`
`cause undue delay. Although InnoPharma was well within its rights to seek
`
`joinder, Senju faults InnoPharma for allegedly delaying the filing of these petitions
`
`(Senju Oppositions at 14; at 14), but then Senju proposes that the proceeding be
`
`extended by more time.
`
`Senju also argues that extending the schedule by five months will avoid the
`
`risk of inconsistent appellate decisions (Senju Oppositions at 14; at 14), but does
`
`not provide an explanation. The fact that separate proceedings may reach different
`
`results does not pertain to prejudice. Congress established these proceedings with
`
`specific rules to address such issues and InnoPharma’s actions accord to those
`
`rules. 35 U.S.C. § 315. Senju’s conflicting arguments based on speculation show
`
`that its request is one of convenience, not prejudice. Senju’s convenience in view
`
`of the district court schedule is irrelevant in whether to grant joinder.
`
`B.
`
`InnoPharma does not raise new substantive issues that preclude
`joinder
`
`“The joinder provision . . . does not require the scope of issues raised to be
`
`identical to issues in the existing inter partes review.” Medtronic, Inc. v. Norred,
`
`4
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`IPR2014-00823, Paper 12 at 8-9 (stating that § 315(c) permits the joinder of any
`
`issue related to a ground of unpatentability so long as § 314 is met); see also
`
`Enzymotech Ltd. v. Neptune Techs., IPR2014-00556, Paper 19 at (“There is no
`
`language in either § 311 or § 315(c) requiring us to limit Enzymotec’s Petition to
`
`identical issues in IPR2014-00003.”).
`
`Contrary to Senju’s contentions,
`
`InnoPharma does not present new
`
`substantive issues, arguments, claim constructions, or evidence. Senju Oppositions
`
`at 5; at 5. To illustrate that point, Metrics—which also opposes joinder—does not
`
`note any such substantive differences in its Oppositions. Presumably if differences
`
`existed, it would be to Metrics benefit to point that out to the Board. InnoPharma
`
`raises the same grounds based on the same prior art as instituted by the Board in
`
`the Metrics IPR. Moreover, the Board has allowed joinder where material changes
`
`did exist between the petitions. See, e.g., Ariosa Diagnostics v. Isis Innovation
`
`Ltd., IPR2013-00250, Paper 24 at 2-4 (allowing joinder of additional grounds
`
`against new dependent claims and new prior art); ABB Inc. v. ROY-G-BIV Corp.,
`
`IPR2013-00282, Paper 15 at 4 (allowing joinder where “joinder introduces only
`
`two pieces of new prior art (both of which are exhibits . . . ).”).5
`
`5 Any difference with Metrics’ petition is immaterial because InnoPharma’s
`
`petition is consistent with the Board’s Decision to Institute. See Dell, Inc. v.
`
`5
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`Senju also argues that InnoPharma makes different arguments about the
`
`references. Senju Oppositions at 7; at 7. The pages of the respective petitions
`
`Senju points to do not show such substantive differences. Senju’s argument that
`
`the use of different translators or the removal of exhibits will complicate the
`
`proceeding is also without merit. See Senju Oppositions at 7-8; at 7. Senju alleges
`
`that InnoPharma’s Exhibit 1002 and Metrics’ Exhibit 1002, both translations of a
`
`document authored by Yoshiyuki Hara entitled “Bromfenac sodium hydrate,” are
`
`by different translators. The two translations are the same. Further, Senju does not
`
`explain how the removal of an exhibit complicates the proceeding.
`
`Nor does InnoPharma take a claim construction position that is different
`
`from Metrics. For example, InnoPharma did not seek construction of certain terms
`
`because the Board had already determined that the claim terms did not require
`
`express construction. See Petition in IPR2015-00902 at 16; Petition in IPR2015-
`
`00903 at 15. Otherwise, InnoPharma and Metrics take the same positions. See,
`
`e.g., Petition in IPR 2015-00903 at 14-16; Petition in IPR2014-01041 at 15-16.
`
`Nor does Dr. Laskar’s declarations, which opine on the same grounds and
`
`prior art as Dr. Kompella’s, raise new issues. The Board has allowed joinder in
`
`similar situations where a petitioner seeking joinder relied on a different expert that
`
`Network-1 Security Solutions, Inc., IPR2013-00385, Paper 17 at 4 (comparing the
`
`grounds raised with the grounds instituted).
`
`6
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`provided similar testimony compared to the expert relied on by the other petitioner.
`
`See Apotex, Inc. v. Novartis AG, IPR2015-00518, Paper 8 at 3. That Dr. Laskar
`
`independently formed his opinions (as he must) and considered the Board’s
`
`Decision to Institute in the Metrics IPRs does not alter the fact that Dr. Laskar does
`
`not raise new issues. See Senju Oppositions at 6; at 6. More specifically, both
`
`experts specifically discuss Example 6 of U.S. Patent No. 4,910,225 (“Ogawa”)
`
`and Example 2 of U.S. Patent No. 6,107,343 (“Sallmann”). See, e.g., Laskar Decl.
`
`in IPR2015-00902, ¶¶ 52-70; Kompella Decl. in IPR2014-01043, ¶¶ 52-70; Laskar
`
`Decl. in IPR2015-00903, ¶¶ 49-64; Kompella Decl. in IPR2014-01041, ¶¶ 49-64.
`
`The similarities continue throughout the respective declarations.
`
`Senju also argues that Dr. Laskar provides “new and different opinions
`
`discussing the chemical structures of suprofen and flurbiprofen,” and presents “a
`
`new discussion of tyloxapol based on [Yasueda].” Senju Oppositions at 7; at 7.
`
`Senju, however, only points to Dr. Laskar’s elaboration of issues already raised by
`
`Dr. Kompella, such as showing the structures of compounds already identified by
`
`Dr. Kompella.
`
`For example, Dr. Kompella’s declaration already discusses
`
`suprofen and flurobiprofen, which inherently have the structure Dr. Laskar points
`
`out. See Kompella Decl. in IPR2014-01043, ¶ 28; Laskar Decl. in IPR2015-00902,
`
`¶ 28; Kompella Decl. in IPR2014-01041, ¶ 26; Laskar Decl. in IPR2015-00903, ¶
`
`26.
`
`Further, Dr. Kompella opined that Bromfenac “shares certain structural
`
`7
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`characteristics with the other NSAIDs diclofenac, ketorolac and flurbiprofen.” See
`
`Kompella Decl. in IPR2014-01043, ¶ 29; Kompella Decl. in IPR2014-01041, ¶ 27.
`
`Dr. Laskar also held that same opinion. See Laskar Decl. in IPR2015-00902, ¶ 29;
`
`Laskar Decl. in IPR2015-00903, ¶ 27. Dr. Laskar opines on the same grounds of
`
`invalidity and prior art as Dr. Kompella, thus no new issues are raised and Dr.
`
`Laskar’s declaration would not complicate the proceedings.
`
`C.
`
`InnoPharma has offered to coordinate with Metrics to promote
`efficiency, avoid duplicate efforts, and preventing inconsistencies
`Senju’s assertion that InnoPharma has “offered no meaningful concessions”
`
`is not true. Senju Oppositions at 10; at 10.
`
`InnoPharma has offered several
`
`concessions in accordance with precedent. InnoPharma has offered to consolidate
`
`filings with Metrics, to work with Metrics to manage the questioning at depositions
`
`to avoid redundancy, and to work with Metrics to manage the presentations at the
`
`hearing. Motions for Joinder, Paper 3 at 5-6; Paper 0 at 5-6.
`
`InnoPharma’s
`
`proposed concessions are comparable to those adopted in Dell, Inc. v. Network-1
`
`Security Solutions, Inc., IPR2013-00385 and Motorola Mobility LLC v. SoftView
`
`LLC, IPR2013- 00256.6
`
`6 Metrics has not indicated that it is unwilling to coordinate with InnoPharma and
`
`does not object to InnoPharma’s proposed concessions.
`
`8
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`Additionally, joinder does not require one of the petitioners to essentially
`
`stay silent.
`
`Indeed, the Board in Dell rejected the petitioner’s request to restrict
`
`Dell’s involvement, because it would unduly prejudice Dell. Dell, IPR2013-
`
`00385, Paper 17 at 8-9, 12. Senju seeks even more restrictive conditions on
`
`InnoPharma. See also Motorola, IPR2013-00256, Paper 10 at 9-10. The cases
`
`Senju relies on do not list the restrictive conditions Senju requests nor mandate
`
`certain concessions. See Senju Oppositions at 10; at 10. For example, in SAP and
`
`Enzymotech, the petitioners were allowed to file “an additional paper, concurrent
`
`with each consolidated filing, not to exceed seven pages” to address points of
`
`disagreement and provided for the petitioners to coordinate for deposition and seek
`
`board approval for additional time. SAP Am. Inc. v. Clouding IP, LLC, IPR2014-
`
`00306, Paper 13 at 5-6; Enzymotech Ltd. v. Neptune Techs., IPR2014-00556, Paper
`
`19 at 7-8. Samsung merely shows that petitioner LG agreed to consolidate its
`
`filings and discovery with petitioner Samsung and that disputes between the
`
`petitioners will be directed to the Board. Samsung Electronics Co., Ltd. v. Black
`
`Hills Media LLC, IPR2014-00740, Paper 17 at 3.
`
`Senju also alleges that InnoPharma is seeking “to separately depose any
`
`Senju declarant.” Senju Oppositions at 9; at 9. As the record shows, InnoPharma
`
`merely stated that it was “not opposed to consolidating and working together,” but
`
`that it was not ready to accede to Senju’s request that InnoPharma be completely
`
`9
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`silenced during deposition. EX2001, 11:22-12:6. The total number of depositions
`
`would not increase to the level Senju speculates. See Senju Oppositions at 9; at 9.
`
`III. CONCLUSION
`For
`the foregoing reasons,
`
`InnoPharma respectfully requests that
`
`the
`
`InnoPharma IPRs be granted and that the proceedings be joined with the Metrics
`
`IPRs. Such a joinder will ensure a just, speedy and inexpensive resolution in both
`
`proceedings. Further, InnoPharma respectively requests that the Board exercise its
`
`discretion and adopt the Proposed Scheduling Order or a similar timeline.
`
`RESPECTFULLY SUBMITTED,
`
`ALSTON & BIRD LLP
`
`Date: June 9, 2015
`
`/s/Jitendra Malik
`
`Jitendra Malik (Reg. No. 55823)
`4721Emperor Boulevard, Suite 400
`Durham, North Carolina 27703
`Telephone: 919-862-2200
`Fax: 919-862-2260
`Jitty.Malik@alston.com
`
`Lead Counsel for Petitioners
`InnoPharma Licensing Inc., InnoPharma
`Licensing LLC, InnoPharma Inc.,
`InnoPharma LLC, Mylan
`Pharmaceuticals Inc., and Mylan Inc.x
`
`10
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`CERTIFICATION OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on the 9th day
`
`of June 2015, a complete copy of the foregoing “PROPOSED SCHEDULING
`
`ORDER” was served via email on counsel of record for the Patent Owner:
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`M. Andrew Holtman
`andy.holtman@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`joshua.goldberg@finnegan.com
`
`Courtesy copies of the foregoing were also served via email on counsel
`
`of record for the Petitioner in Metrics, Inc. v. Senju Pharmaceutical Co., Ltd.,
`
`IPR2014-01041 and IPR2014-01043 as follows:
`
`Patrick D. McPherson
`PDMcPherson@duanemorris.com
`
`Vincent L. Capuano
`VCapuano@duanemorris.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`
`11
`
`

`
`IPR2015-00902 (Patent 8,669,290)
`IPR2015-00903 (Patent 8,129,431)
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`bryan.skelton@alston.com
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Attorneys for Petitioners
`InnoPharma Licensing, Inc.,
`InnoPharma Licensing LLC,
`InnoPharma Inc., InnoPharma
`LLC, Mylan Pharmaceuticals
`Inc., and Mylan Inc.
`
`12