Paper No. __
`Filed: May 23, 2016
`
`
`
`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 (Patent 8,754,131)
`IPR2015-01099 (Patent 8,669,290)
`IPR2015-01100 (Patent 8,927,606)
`IPR2015-01105 (Patent 8,871,813)
`
`
`PETITIONERS’ REPLY TO
`PATENT OWNER’S OPPOSITION TO PETITIONERS’
`MOTION TO EXCLUDE1
`
`
`
`1 A word-for-word identical paper has been 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 23, 2016
`
`
`
`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 (Patent 8,754,131)
`IPR2015-01099 (Patent 8,669,290)
`IPR2015-01100 (Patent 8,927,606)
`IPR2015-01105 (Patent 8,871,813)
`
`
`PETITIONERS’ REPLY TO
`PATENT OWNER’S OPPOSITION TO PETITIONERS’
`MOTION TO EXCLUDE1
`
`
`
`1 A word-for-word identical paper has been 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.
`
`
`
`Patent Owner’s Opposition fails as it mischaracterizes Mr. Jarosz’s redirect
`
`testimony as “within the scope” of Petitioners’ cross-examination. Opposition at 1.
`
`Not only is this incorrect, it is a straw-man argument. The real issue is that the
`
`Jarosz redirect testimony set forth opinions that were outside the scope of the
`
`Jarosz Declaration, and were disclosed for the first time in this proceeding after
`
`Petitioners concluded their cross-examination. Patent Owner had the burden to
`
`fully present those opinions in the first instance rather than concealing them until
`
`redirect. Therefore, those new opinions (and Exhibit 2323) should be excluded.
`
`I. Mr. Jarosz’s Redirect Testimony Was Improper Gamesmanship as It
`Was Outside the Scope of the Jarosz Declaration
`
`Patent Owner attempts to revise the history of the proceedings here to
`
`conceal its deliberate deprivation of Petitioners’ cross-examination of Mr. Jarosz.
`
`In reality, Mr. Jarosz’s February 23, 2016 Declaration gave no analysis of lifecycle
`
`management of the bromfenac franchise or the effects of such lifecycle
`
`management on the commercial success of Prolensa®. See EX2130. The Jarosz
`
`Declaration also provided no analysis (or very limited analysis) on a number of
`
`other issues related to commercial success. It was thus surprising—and
`
`prejudicial—when Mr. Jarosz’s redirect examination was on matters not within the
`
`scope of Mr. Jarosz’s Declaration and exhibits not entered in the current
`
`proceedings. See, e.g., EX1089, 198:12-203:6.
`
`Even worse, Mr. Jarosz’s redirect testimony was in rebuttal to an expert
`
`1
`
`
`
`report that was not yet even part of this proceeding; Mr. Hofmann did not submit
`
`his Declaration in this proceeding until over one month later. See EX1122. Patent
`
`Owner effectively granted itself a sur-reply on commercial success without the
`
`Board’s permission by shoehorning new Jarosz opinions into the record as “pre-
`
`rebuttal” to the Hofmann Declaration. And Patent Owner did it by surprise. With
`
`little more than a few moments to prepare probing questions about the Jarosz
`
`opinions newly disclosed in these proceedings, Petitioners were deprived a
`
`meaningful opportunity to re-cross Mr. Jarosz. Patent Owner’s argument that
`
`Petitioners have been aware of Mr. Jarosz’s opinions and Exhibit 2323, Opposition
`
`at 6-7, is a red herring. Petitioners’ cross-examination was confined to the
`
`opinions actually expressed in the Jarosz Declaration in this proceeding. See 37
`
`C.F.R. § 42.53(d)(5)(ii). Petitioners need not be prepared to cross-examine Mr.
`
`Jarosz on all declarations submitted in any proceeding. This is the entire reason for
`
`requiring Patent Owner to fully present its positions in the Patent Owner Response.
`
`See Medtronic, Inc. v. Nuvasive, Inc., IPR2014-00087, Paper 44, at 21.
`
`Patent Owner’s redirect “questions” highlight Patent Owner’s strategy to
`
`shovel new opinions into the record that are outside the scope of the Jarosz
`
`Declaration entered in this proceeding: “Would you please summarize the bases
`
`for your disagreement with Mr. Hoffman’s [sic] conclusions?” and “What opinion
`
`do you set forth in paragraph 17 of Senju Exhibit 2323?” EX1089, 180:3-5,
`
`2
`
`
`
`183:14-15. Patent Owner also appears oblivious to its own conduct during the
`
`deposition, claiming in its Opposition that it did not “read Exhibit 2323 or instruct
`
`Mr. Jarosz to read Exhibit 2323 into the record.” Opposition at 8. Patent Owner
`
`did just that. At one point, when Mr. Jarosz asked Patent Owner whether he
`
`should “read” various “bullet points” of the text of Exhibit 2323, Patent Owner
`
`responded, “Yes. Please.”2 EX1089, 198:5-18; see also, e.g., id. at 183:14-18 (“Q.
`
`What opinion do you set forth in paragraph 17 of Senju Exhibit 2323? A. If you
`
`don’t mind I’ll just read instead of paraphrasing. Q. Please do.”).
`
`II. Mr. Jarosz’s Redirect Testimony Was Outside the Scope of Petitioners’
`Cross-Examination
`
`Patent Owner’s attempts to characterize Mr. Jarosz’s redirect testimony as
`
`“within the scope of Petitioners’ cross-examination,” Opposition at 1-4, also fails
`
`even basic scrutiny. For example, the term “lifecycle management” appears
`
`nowhere in Mr. Jarosz’s Declaration and was not the subject of cross-examination
`
`by Petitioners. EX2130; EX1089, 7:7-172:19. Yet on redirect, Patent Owner and
`
`Mr. Jarosz discussed “lifecycle management” nearly ten times. EX1089, 180:21-
`
`
`
`2 Patent Owner’s allegations of “improper conduct” by Petitioners is no more than
`
`projection. Opposition at 4 n.2. Petitioners’ objections were well-founded and the
`
`volume necessary; Patent Owner refused to allow a standing objection to the
`
`improper questioning during redirect. See EX1089, 179:18-180:1.
`
`3
`
`
`
`181:9, 192:22-193:19, 194:7-195:7, 197:12-198:4, 198:5-17, 202:1-203:6.
`
`Therefore Patent Owner’s argument that Petitioners opened the door to this
`
`improper testimony, Opposition at 1-4, is demonstrably false.
`
`The “hook” that Patent Owner uses to argue Mr. Jarosz’s improper
`
`testimony was within the scope consists entirely of Petitioners’ broad questions
`
`about Mr. Jarosz’s various declarations in general. See Opposition at 1-2.
`
`Petitioners did not explore the specific details of those declarations during cross-
`
`examination or enter those declarations as exhibits. See, e.g., EX1089, 71:5-17.
`
`These high-level questions did not open the door for Patent Owner to explore Mr.
`
`Jarosz’s specific opinions in those declarations nor enter Mr. Jarosz’s declarations
`
`in other proceedings as exhibits here. Patent Owner’s argument otherwise fails to
`
`understand the basic legal construct of “scope.”
`
`Patent Owner relies primarily on the “relevance” of Mr. Jarosz’s testimony
`
`as proving that it is within the scope of cross-examination. Opposition at 3-4, 8-9.
`
`This is mistaken; relevance is not the issue here, scope and procedure are. Taking
`
`Patent Owner’s position to its logical conclusion would mean that a patent owner
`
`could submit an expert report containing only one sentence, for example,
`
`“commercial success supports the nonobviousness of the patents-at-issue,” and be
`
`within its rights to provide specific analysis of that broad topic during redirect
`
`examination. While that is an absurd conclusion, it follows Patent Owner’s
`
`4
`
`
`
`reasoning as any detailed testimony after the fact would of course be “relevant” as
`
`it would in some way relate to “commercial success.” That still fails to change the
`
`fact that the testimony is new. This example may be strange, but it is essentially
`
`what Patent Owner did here, and what Patent Owner argues for in its Opposition.
`
`III. Mr. Jarosz Should Have Included His Redirect Testimony and Exhibit
`2323 in His February Declaration, If at All
`
`Patent Owner and Mr. Jarosz had every opportunity to include the new
`
`redirect opinions in the Jarosz Declaration. If anything, because of the timing of
`
`the various related proceedings, Patent Owner had an advantage to anticipate
`
`arguments that were likely coming from Mr. Hofmann. See Motion to Exclude at
`
`2-3. As Mr. Jarosz testified, the new redirect opinions and Exhibit 2323 were
`
`available to Mr. Jarosz as he prepared his Declaration in these proceedings, as was
`
`the Hofmann declaration in the related proceedings allegedly “rebutted” during
`
`redirect here. EX1089, 203:13-16. Because Mr. Jarosz confirmed his opinions
`
`were consistent across his reports in the related proceedings, EX1089, 71:5-17,
`
`there was no legitimate reason to hold these opinions secret until redirect.
`
`IV. Conclusion
`
`Petitioners’ Motion to Exclude should be granted in its entirety.
`
`5
`
`
`
`
`
`
`May 23, 2016
`
`
`
`
`
`Respectfully submitted,
`
`
`
` /Deborah Yellin/
`Deborah H. Yellin
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
`
`6
`
`
`
`CERTIFICATION OF SERVICE
`
`
`
`The undersigned hereby certifies that the foregoing document entitled
`
`PETITIONERS’ REPLY TO PATENT OWNER’S OPPOSITION TO
`
`PETITIONERS’ MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c) was
`
`served electronically via email on May 23, 2016 to Patent Owner’s counsel of
`
`record and counsel of record for Petitioners InnoPharma at the following:
`
`Patent Owner
`Bryan.Diner@finnegan.com
`
`Justin.Hasford@finnegan.com
`
`Joshua.Goldberg@finnegan.com
`
`Petitioners InnoPharma
`
`Jitty.malik@alston.com
`
`bryan.skelton@alston.com
`
`James.abe@alston.com
`
`Lance.soderstrom@alston.com
`
`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
`
`
`May 23, 2016
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