Paper No. __
`Filed: May 18, 2016
`
`
`
`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.
`__________________
`
`IPR2015-01097 (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
`__________________
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE
`
`
`
`
`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.
`
`
`Filed: May 18, 2016
`
`
`
`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.
`__________________
`
`IPR2015-01097 (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
`__________________
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE
`
`
`
`
`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.
`
`
`
`
`I.
`
`II.
`
`III.
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`
`The Board Should Deny Petitioners’ Motion to Exclude Because
`Exhibit 2323 and Mr. Jarosz’s Testimony Were Within the Scope of
`Petitioners’ Cross-Examination ....................................................................... 1
`
`Petitioners Have Failed to Meet Their Burden of Showing that Exhibit
`2323 or Mr. Jarosz’s Testimony Should Be Excluded Under
`Applicable Legal Authority ............................................................................. 5
`
`IV. Conclusion ....................................................................................................... 9
`
`
`
`
`
`ii
`
`
`
`I.
`
`
`Introduction
`
`
`
`Patent Owner respectfully opposes Petitioners’ motion to exclude Exhibit
`
`2323 and testimony from Mr. John Jarosz relating to Exhibit 2323. (Paper No. 43
`
`in IPR2015-1099; Paper No. 45 in IPR2015-1097; and Paper No. 44 in IPR2015-
`
`1105 and 1100.) Petitioners’ arguments for exclusion lack merit, and Exhibit 2323
`
`and Mr. Jarosz’s testimony should not be excluded. The party moving to exclude
`
`evidence bears the burden of establishing that it is entitled to the relief requested—
`
`namely, that the material sought to be excluded is inadmissible under the Federal
`
`Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a). Petitioners themselves
`
`placed at issue the very materials involving Mr. Jarosz that they now are seeking to
`
`exclude, and thus Petitioners have wholly failed to establish entitlement to
`
`exclusion under any Federal Rule of Evidence. Accordingly, the Board should
`
`deny Petitioners’ Motion to Exclude.
`
`II. The Board Should Deny Petitioners’ Motion to Exclude Because Exhibit
`2323 and Mr. Jarosz’s Testimony Were Within the Scope of Petitioners’
`Cross-Examination
`
`As Petitioners concede, during the March 16, 2016, cross-examination of Mr.
`
`Jarosz, Petitioners asked several questions about Mr. Jarosz’s expert reports in the
`
`parallel district court litigation, including his reply expert report, Exhibit 2323.
`
`(EX1089 at 69:7-75:20; 78:8-81:7; 83:3-14.) Petitioners inquired into many issues
`
`during their cross examination, including attempting to characterize Mr. Jarosz’s
`
`
`
`1
`
`
`
`opinions and asking him about his opinions on commercial success as a whole, the
`
`marketplace success of Prolensa®, the nexus between the market success and the
`
`patents at issue, and whether the marketplace success of Prolensa® was tied to any
`
`particular patent. (Id. at 70:15-71:12; 71:18-72:6; 72:16-9.) Further, as Petitioners
`
`readily admit, they also probed whether there were any differences between the
`
`opinions offered in Exhibit 2323 and Mr. Jarosz’s opinions in the declarations
`
`submitted in the instant IPRs and whether Mr. Jarosz applied different analytical
`
`frameworks for them. (Id. at 73:11-75:20; 78:8-81:7; 83:3-14.) By directly
`
`exploring these issues and the substance of Mr. Jarosz’s expert reports from the
`
`parallel district court proceeding, Petitioners opened the door for Patent Owner to
`
`explore Mr. Jarosz’s expert reports from the district court proceedings, and
`
`specifically Exhibit 2323, on redirect examination.
`
`
`
`To the extent that Petitioners argue that door was not opened specifically as
`
`to Mr. Jarosz’s opinions in Exhibit 2323, there can be no question that the portions
`
`of Exhibit 2323 discussed on redirect examination are directly related to the issues
`
`explored initially by Petitioners during cross-examination. For example, during
`
`cross-examination Petitioners extensively questioned Mr. Jarosz on his reliance on
`
`IMS data to support his commercial success opinions. (E.g., EX1089 at 91:8-92:4;
`
`93:10-105:1; 108:8-111:7; 129:5-131:7). On redirect, Mr. Jarosz testified about
`
`Exhibit 2323, explaining why the IMS data he used to support his commercial
`
`
`
`2
`
`
`
`success opinions are reliable. (Id. at 183:14-185:22.) Exhibit 2323 and Mr.
`
`Jarosz’s testimony are therefore plainly relevant and probative to the issue of
`
`whether the patents at issue are commercially successful, and fall within the scope
`
`of Petitioners’ cross-examination. See Phigenix, Inc. v. Immunogen, Inc.,
`
`IPR2014-00676, Paper 39, Final Written Decision (finding Mr. Jarosz’s
`
`commercial success opinions provide probative value and rejecting Petitioner’s
`
`motion to exclude his opinion). Accordingly, and contrary to Petitioners’
`
`arguments, Exhibit 2323 and Mr. Jarosz’s testimony do not warrant exclusion
`
`under Federal Rules of Evidence 401 or 611(b) and should be allowed under
`
`Federal Rules of Evidence 702 and 703.
`
`Undoubtedly, Petitioners somehow sought to gain an advantage by
`
`questioning Mr. Jarosz during his cross-examination about his expert reports from
`
`the parallel district court litigation, regardless of whether or not Petitioners chose
`
`to mark any reports as exhibits during his cross-examination. Petitioners cannot
`
`now complain that Patent Owner seeks to elicit testimony about Mr. Jarosz’s prior
`
`report (Exhibit 2323), when Petitioners first tried to use those reports as a sword
`
`
`
`3
`
`
`
`against Mr. Jarosz.2 Fundamental fairness demands that Patent Owner be allowed
`
`to explore Mr. Jarosz’s opinions in Exhibit 2323 on redirect given that Petitioners
`
`asked Mr. Jarosz about this very document on cross. Moreover, to the extent
`
`Exhibit 2323 is inadmissible, which it is not, Mr. Jarosz’s testimony is still
`
`admissible under Federal Rule of Evidence 703, which allows experts to rely on
`
`otherwise inadmissible evidence to form their opinions. Accordingly, for at least
`
`the reasons stated above, Exhibit 2323 and Mr. Jarosz’s testimony regarding
`
`Exhibit 2323 should be allowed and do not warrant exclusion.
`
`
`2 In a lengthy footnote and throughout their Motion, Petitioners recklessly engage
`
`in unwarranted attacks against Patent Owner for eliciting this testimony from Mr.
`
`Jarosz. For at least the reasons discussed herein, Petitioner’s attacks are meritless.
`
`If anything, Petitioners—not Patent Owner—engaged in improper conduct during
`
`Mr. Jarosz’s redirect examination by launching into a litany of frivolous and
`
`inappropriate objections, in contravention of the Board’s rules. (E.g., EX1089 at
`
`183:1-3, 183:11-12, 184:12-14, 185:10-12, 186:8-10, 187:5-7, 187:17-19, 188:10-
`
`12, 189:6-13, 190:1-10, 191:22-192:2, 192:12-14, 193:8-10, 193:16-18, 194:2-4,
`
`195:16-196:3, 197:4-6, 197:14-16, 198:7-9, 201:7-9, 202:3-5.)
`
`
`
`4
`
`
`
`III. Petitioners Have Failed to Meet Their Burden of Showing that Exhibit
`2323 or Mr. Jarosz’s Testimony Should Be Excluded Under Applicable
`Legal Authority
`
`Citing 37 C.F.R. 42.53(a), Petitioners assert that Mr. Jarosz should have
`
`anticipated Mr. Hofmann’s arguments and included rebuttal testimony in his
`
`declaration submitted with the Patent Owner Response. (Paper No. 43 at 2 in
`
`IPR2015-1099; Paper No. 45 at 2 in IPR2015-1097; and Paper No. 44 at 2 in
`
`IPR2015-1105 and 1100). At the same time, Petitioners perplexingly argue that
`
`Exhibit 2323 and Mr. Jarosz’s testimony should be excluded as irrelevant under
`
`Federal Rule of Evidence 401 because Mr. Hofmann was not an expert in these
`
`IPR proceedings at the time of Mr. Jarosz’s deposition. (Paper No. 43 at 4-5 in
`
`IPR2015-1099; Paper No. 45 at 4-5 in IPR2015-1097; and Paper No. 44 at 4-5 in
`
`IPR2015-1105 and 1100.) Petitioners cannot have it both ways. Indeed,
`
`Petitioners’
`
`inherently contradictory arguments simply expose Petitioners’
`
`desperate attempt to exclude highly relevant and probative testimony from Mr.
`
`Jarosz that directly rebuts the flawed opinions of Petitioners’ alleged commercial
`
`success expert Mr. Hofmann.3
`
`
`3 In fact, the opinions of Mr. Hofmann, not those of Mr. Jarosz, warrant exclusion
`
`in these proceedings, based on Mr. Hofmann’s highly improper behavior during his
`
`cross examination as well as his lack of expertise in areas about which he has
`
`
`
`5
`
`
`
`Under Petitioners’ faulty interpretation of 37 C.F.R. 42.53(a), experts would
`
`be required to anticipate and include all rebuttal testimony in their expert
`
`declarations. But the rule requires no such crystal ball. Further, Petitioners’
`
`interpretation of 37 C.F.R. 42.53(a) would also effectively exclude all redirect
`
`testimony because it would never be “uncompelled direct testimony” in the form of
`
`an affidavit. Such a position defies common sense and directly contradicts the
`
`Federal Rules of Evidence and the PTAB rules, which clearly contemplate redirect
`
`testimony. See, e.g., 37 C.F.R. 42.53(c). Contrary to Petitioners’ unfounded
`
`assertions, 37 C.F.R. 42.53(a) does not warrant exclusion of Exhibit 2323 and Mr.
`
`Jarosz’s testimony.
`
`Petitioners also disingenuously assert that Patent Owner “prevented” them
`
`from having a meaningful opportunity to cross-examine the evidence (Paper No.
`
`43 at 3 in IPR2015-1099; Paper No. 45 at 3 in IPR2015-1097; and Paper No. 44 at
`
`3 in IPR2015-1105 and 1100), but Patent Owner did no such thing. Petitioners—
`
`not Patent Owner—deprived themselves of an opportunity to cross-examine Mr.
`
`Jarosz by failing to re-cross Mr. Jarosz on the substance of his opinions when
`
`given the opportunity. (EX1089 at 203:13-205:9.) Moreover, Petitioners have
`
`been fully aware of Mr. Jarosz’s opinions contained in Exhibit 2323 since February
`
`attempted to opine. (Paper No. 45 in IPR2015-1099; Paper No. 46 in IPR2015-
`
`1097; and Paper No. 46 in IPR2015-1105 and 1100.)
`
`
`
`6
`
`
`
`12, 2016, and as discussed above, specifically asked questions about these opinions
`
`during cross-examination. Petitioners cite HTC Corp., IPR2014-01198, Paper 41,
`
`but this case does not support Petitioners’ unfounded arguments for exclusion and
`
`simply does not apply here. HTC Corp. involved a witness who refused to appear
`
`for cross-examination. Here, by contrast, Mr. Jarosz appeared for cross-
`
`examination, Petitioners were fully aware of Mr. Jarosz’s opinions, and Petitioners
`
`had a full and fair opportunity to question Mr. Jarosz on his opinions. Thus, HTC
`
`Corp. is entirely inapposite and also does not support Petitioners’ arguments for
`
`exclusion.
`
`Petitioners also inaccurately allege that Patent Owner’s use of Exhibit 2323
`
`was “improper,” and Petitioners blatantly mischaracterize the manner in which
`
`Patent Owner conducted the redirect examination of Mr. Jarosz. (Paper No. 43 at
`
`3-4 in IPR2015-1099; Paper No. 45 at 3-4 in IPR2015-1097; and Paper No. 44 at
`
`3-4 in IPR2015-1105 and 1100.) Contrary to Petitioners’ unsupported assertions,
`
`there was absolutely nothing improper about Patent Owner’s use of Exhibit 2323
`
`during the redirect examination of Mr. Jarosz. As an initial matter and as
`
`discussed above, Exhibit 2323 was well within the scope of Petitioners’ cross-
`
`examination. Therefore, Patent Owner’s use of Exhibit 2323 to further explore the
`
`opinions of Mr. Jarosz contained in Exhibit 2323 was in full compliance with the
`
`
`
`7
`
`
`
`Federal Rules of Evidence and the PTAB rules and entirely appropriate. 4
`
`Petitioners concede that during redirect examination Patent Owner asked Mr.
`
`Jarosz about certain opinions that were contained in Exhibit 2323. Moreover,
`
`Patent Owner did not read Exhibit 2323 or instruct Mr. Jarosz to read Exhibit 2323
`
`into the record. Rather, it appears that Petitioners are upset by the manner in which
`
`Mr. Jarosz chose to respond to Patent Owner’s questions. But unhappiness with
`
`Mr. Jarosz’s testimony is not a proper grounds for excluding relevant and highly
`
`probative evidence on commercial success.
`
`Patent Owner’s questions during redirect examination were also not leading
`
`as Petitioners suggest. (Paper No. 43 at 5 in IPR2015-1099; Paper No. 45 at 5 in
`
`IPR2015-1097; and Paper No. 44 at 5 in IPR2015-1105 and 1100.) Rather, the
`
`questions that Petitioners apparently find objectionable were plainly background
`
`questions necessary to develop Mr. Jarosz’s testimony. Such questions, even if
`
`“leading” as Petitioners suggest, are clearly allowed under the plain language of
`
`4 As discussed above, in a lengthy footnote and throughout their Motion,
`
`Petitioners continue their reckless and unwarranted attacks against Patent Owner,
`
`making reference to their motions to exclude in separate IPR2015-00902 and
`
`IPR2015-00903. As fully explained by Patent Owner in its Oppositions (Paper 66
`
`in IPR2015-00903 and Paper 70 in IPR2015-00902), Petitioners arguments are
`
`without merit.
`
`
`
`8
`
`
`
`Federal Rule of Evidence 611(c). Moreover, Petitioners have failed to cite any
`
`case or any authority where relevant and probative expert testimony was excluded
`
`under Federal Rule of Evidence 611(c). Because Petitioners have again failed to
`
`meet their burden, Exhibit 2323 and Mr. Jarosz’s testimony should not be excluded
`
`under the Federal Rules of Evidence.
`
`IV. Conclusion
`Notably, Petitioners have not once attacked the substance of Mr. Jarosz’s
`
`opinions offered in Exhibit 2323 or his redirect testimony. Instead, Petitioners
`
`desperately seek to exclude Mr. Jarosz’s highly probative testimony on baseless
`
`procedural grounds that are wrong as a matter of fact and law. This is not a proper
`
`basis for exclusion, and there is no reason why the Board should exclude Mr.
`
`Jarosz’s opinions that directly rebut the incorrect opinions of Mr. Hofmann.
`
`Accordingly, and for the reasons set forth above, Patent Owner respectfully
`
`requests that the Board deny Petitioners’ Motion to Exclude.
`
`Date: May 18, 2016
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: /Bryan C. Diner/
`
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Counsel for Patent Owner
`
`
`
`
`
`9
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`
`
`Owner’s Opposition to Petitioners’ Motion to Exclude was filed on May 18,
`
`2016, and served via email directed to counsel of record for the Petitioners at the
`
`following:
`
`
`
`
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Teresa Stanek Rea
`TRea@crowell.com
`
`Chiemi Suzuki
`CSuzuki@crowell.com
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Bryan.skelton@alston.com
`
`Lance Soderstrom
`Lance.soderstrom@alston.com
`
`Hitetada James Abe
`James.abe@alston.com
`
`Joseph M. Janusz
`Joe.janusz@alston.com
`
`Shannon Lentz
`slentz@crowell.com
`
`
`
`
`Dated: May 18, 2016
`
`
`
`
`
`
`
`
` /Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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