UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`____________________
`
`IPR2015-01097 (US Patent No. 8,751,131)
`IPR2015-01099 (US Patent No. 8,669,290)
`IPR2015-01100 (US Patent No. 8,927,606)
`IPR2015-01105 (US Patent No. 8,871,813)1
`____________________
`
`
`
`PETITIONERS’ MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`heading. IPR2016-00089 has been joined with IPR2015-01097; IPR2016-00091
`
`has been joined with IPR2015-01100; and IPR2016-00090 has been joined with
`
`IPR2015-01105. Each of these joined proceedings includes Petitioners
`
`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., Mylan
`
`Pharmaceuticals Inc., and Mylan Inc. (collectively, “InnoPharma”) in addition to
`
`the parties identified above.
`
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`____________________
`
`IPR2015-01097 (US Patent No. 8,751,131)
`IPR2015-01099 (US Patent No. 8,669,290)
`IPR2015-01100 (US Patent No. 8,927,606)
`IPR2015-01105 (US Patent No. 8,871,813)1
`____________________
`
`
`
`PETITIONERS’ MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`heading. IPR2016-00089 has been joined with IPR2015-01097; IPR2016-00091
`
`has been joined with IPR2015-01100; and IPR2016-00090 has been joined with
`
`IPR2015-01105. Each of these joined proceedings includes Petitioners
`
`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., Mylan
`
`Pharmaceuticals Inc., and Mylan Inc. (collectively, “InnoPharma”) in addition to
`
`the parties identified above.
`
`
`
`Contents
`Introduction .................................................................................................... 1
`
`Petitioners Timely Objected ......................................................................... 1
`
`I.
`
`II.
`
`III. Exhibit 2323 and Related Testimony During the Redirect of Mr.
`Jarosz Should Be Excluded ........................................................................... 2
`
`IV. Conclusion ...................................................................................................... 6
`
`
`
`
`
`I.
`
`Introduction
`
`Pursuant to 37 C.F.R. § 42.64(c) and the Scheduling Order (Paper 10) as
`
`modified (Paper 14), Lupin Ltd., Lupin Pharmaceuticals, Inc., InnoPharma
`
`Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., InnoPharma LLC,
`
`Mylan Pharmaceuticals Inc., and Mylan Inc., (collectively, “Petitioners”)
`
`respectfully move to exclude Exhibit 2323 submitted by Senju Pharmaceutical Co.,
`
`Ltd., Bausch & Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp.
`
`(collectively “Patent Owner”) as well as all testimony relating to Exhibit 2323
`
`elicited from Mr. John Jarosz, Patent Owner’s expert, during redirect following the
`
`cross-examination on March 16, 2016. See EX1089 at 178:9-203:6. Patent
`
`Owner’s Exhibit 2323 was introduced for the first time during the redirect of Mr.
`
`Jarosz in an effort to backdoor evidence into the record. See EX1089 at 178:9-
`
`203:6. Notwithstanding the disregard of the Board’s rules, Patent Owner’s Exhibit
`
`2323 and all related testimony must be excluded.
`
`
`
`II.
`
`Petitioners Timely Objected
`
`Timely objections were made to Exhibit 2323 and the testimony related to
`
`Exhibit 2323 during the redirect of Mr. Jarosz as outside the scope of cross,
`
`improper redirect, calling for narrative, foundation, and as not of record in the
`
`proceeding. See EX1089 at 179:4-5, 18-21; 180:6; 183:11-12; 184:12-14; 185:10-
`
`
`
`1
`
`
`
`12; 186:8-10; 187:5-7, 17-19; 188:10-12; 189:6-13; 190:1-17; 191:22-192:2;
`
`192:12-14; 193:8-10, 16-18; 194:2-4; 195:8-10; 195:16-196:3; 197:4-6, 14-16;
`
`198:7-9, 19; 201:7-9; 202:3-5.
`
`
`
`III. Exhibit 2323 and Related Testimony During the Redirect of Mr. Jarosz
`Should Be Excluded
`
`During the March 16, 2016 deposition of Mr. Jarosz, the Patent Owner
`
`improperly elicited redirect testimony from Mr. Jarosz responding to opinions
`
`proffered by the economics expert in the co-pending district court litigation, Mr.
`
`Ivan Hofmann. Mr. Hofmann was not part of the IPR proceeding at the time of the
`
`deposition. Exhibit 2323, entered into the record during redirect, is the district
`
`court Reply Report of John C. Jarosz on Objective Indicia of Non-obviousness,
`
`which, as stated at paragraph 2 of Exhibit 2323, was written in order to reply to a
`
`report by Mr. Ivan Hofmann. EX2323 at ¶2. Patent Owner focused exclusively on
`
`paragraphs of Exhibit 2323 that mentioned Mr. Hofmann’s opinions and included
`
`the rebuttal thereto. Thus, Patent Owner’s introduction of Exhibit 2323 was a
`
`blatant attempt to introduce rebuttal evidence to Mr. Hofmann.
`
`To the extent that Patent Owner wanted to preemptively rebut possible
`
`arguments that might be made by Mr. Hofmann, not yet a witness in this
`
`proceeding, the time to do so would have been in Mr. Jarosz’s expert declaration
`
`submitted with the Patent Owner Response. See 37 CFR 42.53(a) (requiring
`
`
`
`2
`
`
`
`uncompelled direct testimony be submitted in the form of an affidavit). As Mr.
`
`Jarosz admitted on recross, he had a copy of Mr. Hofmann’s report in the district
`
`court litigation prior to filing his declaration in these IPRs. See EX 1089, 203:13-
`
`16. And his declaration in these IPRs was filed after Exhibit 2323 was signed by
`
`Mr. Jarosz. Further, Mr. Jarosz admitted in recross that he chose to respond to
`
`some of Mr. Hofmann’s points in his declaration, but not all of them. See EX1089
`
`at 204:3-12.
`
`By circumventing the rules, Patent Owner has prevented Petitioners from
`
`having a meaningful opportunity to cross-examine the evidence. Thus, the
`
`evidence improperly offered through Exhibit 2323 and during the redirect
`
`examination should be given no weight. See HTC Corp., IPR2014-01198, Paper
`
`41, pp. 3-5.
`
`Moreover, Patent Owner’s use of Exhibit 2323 during the deposition was
`
`improper. Patent Owner’s counsel did not use Exhibit 2323 to ask Mr. Jarosz
`
`substantive questions. Rather, the majority of counsel’s questions on redirect
`
`consisted of directing Mr. Jarosz’s attention to a particular paragraph of his Reply
`
`Expert Report, and asking “what opinions do you set forth” in that particular
`
`paragraph number. These questions prompted Mr. Jarosz to directly read and/or
`
`summarize at least 20 paragraphs from the report. See EX1089 at 179:14-203:8.
`
`This shows that the intent of the Patent Owner was not to further develop the
`
`
`
`3
`
`
`
`record with proper evidence, but rather to do an end run around the rules by
`
`submitting uncompelled direct testimony in the form of deposition testimony in
`
`contravention of 37 C.F.R. 42.53(a), which requires all uncompelled direct
`
`evidence to be submitted in the form of an affidavit. Exhibit 2323 and the
`
`testimony relating to it should be excluded on these bases alone.2
`
`Further, Exhibit 2323 and the related testimony should be excluded pursuant
`
`to the Federal Rules of Evidence. Because Mr. Hofmann was not an expert in the
`
`
`2 Patent Owner has made a habit of introducing improper evidence. As this
`
`Panel knows, during the Deposition of Dr. Laskar in IPR2015-00902 and IPR2015-
`
`00903, Patent Owners introduced a transcript of the videotaped deposition of Dr.
`
`Clayton Heathcock, who was not a declarant in the proceeding, as well as a copy of
`
`the transcript of the deposition of Dr. Robert Cykiert taken on February 26, 2016,
`
`who also was not declarant in those proceeding. Patent Owners further introduced
`
`the Reply Expert Report of Dr. Davies, Patent Owner’s own expert prepared in
`
`connection with the district court litigation. Patent Owner’s attorney simply read
`
`portions of Exhibits 2266, 2267, and 2268 into the record without even bothering
`
`to ask whether Dr. Laskar had any knowledge of the testimony or opinions of those
`
`witnesses from the district court action. See Petitioner’s Motion to Exclude in
`
`IPR2015-00902, Paper 62, pp. 5-6; and IPR2015-00903, Paper 56, p. 5.
`
`
`
`
`
`4
`
`
`
`proceedings at the time of the deposition, Exhibit 2323 and related testimony
`
`should be excluded as not relevant under Federal Rule of Evidence 401.
`
`Exhibit 2323 and the related testimony elicited by Patent Owner’s counsel
`
`should be also excluded as outside the scope of cross-examination under Federal
`
`Rule of Evidence 611(b). Petitioners did not “open the door” as Patent Owner
`
`alleged during the deposition. Instead, Petitioners’ counsel merely confirmed that
`
`Mr. Jarosz had filed various reports covering the subject matter at issue in his
`
`declaration in various proceedings, and asked whether his opinions remained
`
`consistent throughout. See EX1089 at 69:7-21, 71:5-75:20. Furthermore,
`
`Petitioners’ counsel did not mark as an exhibit or even show Mr. Jarosz his other
`
`reports or Mr. Hofmann’s expert reports.
`
`The testimony elicited by Patent Owner’s counsel should further be
`
`excluded under Federal Rule of Evidence 611(c) as improperly being obtained
`
`through leading questions. Patent Owner’s counsel did not ask Mr. Jarosz any
`
`proper questions during the redirect, but instead instructed him to essentially read
`
`several paragraphs of Exhibit 2323 into the record. This improper questioning
`
`continued for more than 25 pages of deposition transcript.
`
`
`
`5
`
`
`
`IV. Conclusion
`
`For the foregoing reasons, Petitioners respectfully requests that the Board
`
`grant the instant Motion to Exclude and exclude Exhibit 2323 and the testimony
`
`elicited from the introduction of this exhibit, i.e. Exhibit 1089 at 178:9-203:6.
`
`Respectfully submitted,
`
`
`
`/Deborah Yellin/
`
`Deborah Yellin, Lead Counsel
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone: (202) 624-2947
`Fax: (202) 628-8844
`
`Counsel for Petitioners
`
`
`
`
`
`
`
`Date: May 12, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6
`
`
`
`
`CERTIFICATION OF SERVICE
`
`
`
`The undersigned hereby certifies that the foregoing document entitled
`
`PETITIONERS’ MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c) was
`
`served electronically via email on May 12, 2016 to Patent Owner’s counsel of
`
`record and counsel of record for Petitioners InnoPharma at the following:
`
`
`
`
`
`
`May 12, 2016
`
`Patent Owner
`Bryan.Diner@finnegan.com
`Justin.Hasford@finnegan.com
`Joshua.Goldberg@finnegan.com
`
`Petitioners InnoPharma
`jitty.malik@alston.com;
`bryan.skelton@alston.com;
`lance.soderstrom@alston.com;
`james.abe@alston.com; and
`Joe.janusz@alston.com
`
`Respectfully submitted,
`
`
`
`/Shannon M. Lentz/
`Shannon M. Lentz
`Reg. No. 65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
`
`
`
`7
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