Filed: May 3, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`————————————————
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS
`LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC.,
`TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`
`Petitioners,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`
`Patent Owner.
`
`————————————————
`Case IPR2016-013321
`Patent 8,822,438 B2
`
`————————————————
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`UNDER 37 C.F.R. § 42.64(c)
`
`
`1 Case IPR2017-00853 has been joined with this proceeding.
`
`

`

`TABLE OF CONTENTS
`
`III. 
`
`
`FACTUAL BACKGROUND ......................................................................... 1 
`I. 
`II.  ALL TESTIMONY ORIGINATING FROM THE AMERIGEN IPR,
`AND JANSSEN’S RELIANCE ON IT, SHOULD BE EXCLUDED. ......... 2 
`JANSSEN’S ADDITIONAL PATENT OWNER RESPONSE (EX.
`2151), AND JANSSEN’S RELIANCE ON IT, SHOULD BE
`EXCLUDED. .................................................................................................. 5 
`IV.  EXHIBIT JSN 2134 AND CERTAIN PORTIONS OF THE
`DECLARATION AND DEPOSITION TESTIMONY BY DR.
`CHRISTOPHER VELLTURO, AND JANSSEN’S RELIANCE ON
`THEM, SHOULD BE EXCLUDED. ............................................................. 7 
`V.  DECLARATION TESTIMONY BY DR. JOHANN DE BONO, AND
`JANSSEN’S RELIANCE ON IT, SHOULD BE EXCLUDED. ................. 11 
`VI.  CONCLUSION ............................................................................................. 13 
`
`
`
`i
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`

`

`
`
`TABLE OF AUTHORITIES
`
`
`CASES
`BTG Int’l Ltd. v. Actavis Labs. FL, Inc.,
`Civil Action No. 2:15-cv-05909 (D.N.J.) ........................................................... 12
`
`Kirk v. Raymark Indus., Inc.,
`61 F.3d 147 (3d Cir. 1995) ................................................................................... 5
`
`PPC Broadband, Inc. v. Corning Optical Commc’ns RF, LLC,
`815 F.3d 734 (Fed. Cir. 2016) .............................................................................. 9
`
`SAS Inst., Inc. v. ComplementSoft, LLC,
`825 F.3d 1341 (Fed. Cir. 2016) ............................................................................ 9
`
`Standard Innovation Corp. v. Lelo, Inc.,
`IPR2014-00148, Paper No. 42 (Apr. 23, 2015) .................................................... 8
`
`TRW Auto. U.S. LLC v. Magna Elecs., Inc.,
`IPR2014-01347, Paper No. 25 (Jan. 6, 2016) ....................................................... 8
`
`United States v. Mitchell,
`816 F.3d 865 (D.C. Cir. 2016) ............................................................................ 11
`
`US Endodontics, LLC v. Gold Standard Instruments, LLC,
`PGR2015-00019, Paper 54 (Dec. 28, 2016) ............................................... 4, 7, 13
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.24(b) .................................................................................................. 7
`
`37 C.F.R. § 42.62(a) ................................................................................................... 8
`
`37 C.F.R. § 42.64(c) ................................................................................................... 2
`
`37 C.F.R. § 42.65 ..................................................................................................... 11
`
`Fed. R. Civ. P. 32(a)(1)(A) ........................................................................................ 5
`
`Fed. R. Evid. 106 ................................................................................................. 7, 10
`
`Fed. R. Evid. 403 ................................................................................................. 5, 10
`
`
`
`ii
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`

`

`
`
`TABLE OF AUTHORITIES
`continued
`
`Fed. R. Evid. 801(c) ......................................................................................... 3, 6, 12
`
`Fed. R. Evid. 802 ............................................................................................. 3, 6, 13
`
`Fed. R. Evid. 901(a) ................................................................................................... 7
`
`Fed. R. Evid. 1006 ......................................................................................... 7, 10, 11
`
`
`
`
`
`iii
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`

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`
`
`Pursuant to 37 C.F.R. §§ 42.61(a), 42.62, and 42.64(c), Petitioners move to
`
`exclude the following:
`
`(1) All testimony given in the proceedings styled Amerigen Pharms. Ltd.
`
`v. Janssen Oncology, Inc., IPR2016-00286 (“Amerigen IPR”), and
`
`Janssen’s citations to, and reliance on, it;
`
`(2)
`
`Janssen’s Patent Owner Response from the Amerigen proceeding,
`
`filed as an additional exhibit in this proceeding, and Janssen’s
`
`citations to, and reliance on, it;
`
`(3) Exhibit JSN 2134 and associated declaration and deposition testimony
`
`given by Dr. Christopher Vellturo, and Janssen’s citations to, and
`
`reliance on, them; and
`
`(4) All declaration testimony by Dr. Johann de Bono, and Janssen’s
`
`citations to, and reliance on, it.
`
`I.
`
`FACTUAL BACKGROUND
`
`This proceeding involves a challenge to U.S. Patent No. 8,822,438 (“’438
`
`patent”), which claims methods of treating prostate cancer using a therapeutically
`
`effective amount of abiraterone acetate and a therapeutically effective amount of
`
`prednisone. In the grounds instituted by the Board, Petitioners showed that the
`
`claimed method is obvious over prior art disclosing both abiraterone acetate and its
`
`known use to inhibit testosterone production by disrupting steroid synthesis, and
`
`1
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`

`

`
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`the use of prednisone in patients taking other drugs that inhibit testosterone
`
`production by disrupting steroid synthesis. Janssen opposed these arguments by
`
`relying on, among other information: expert testimony given in a separate
`
`proceeding regarding the same patent, which was not subject to cross-examination
`
`here; a Patent Owner Response filed in a separate proceeding; expert testimony not
`
`permitted by the Federal Rules of Evidence; and fact testimony unsupported by
`
`any evidence.
`
`On March 8, 2017, Janssen filed its Patent Owner Response in this
`
`proceeding, including the several exhibits objected to in this motion to exclude.
`
`See Paper 35; Paper 36 (Janssen Oncology Inc.’s Updated Exhibit List); Exs. 2006-
`
`2152. On March 15, 2017, Petitioners filed their objections to the Janssen exhibits.
`
`See generally Paper 37. For the reasons explained more fully below, Petitioners
`
`now move to exclude this evidence. Each objection was properly made in the
`
`record, and is renewed and relied upon here. 37 C.F.R. § 42.64(c); Paper 37.
`
`II. ALL TESTIMONY ORIGINATING FROM THE AMERIGEN IPR,
`AND JANSSEN’S RELIANCE ON IT, SHOULD BE EXCLUDED.
`
`Exhibits 2010, 2037, 2120, 2122, 2124, 2125, and 2127 embody testimony
`
`prepared specifically for the proceeding styled Amerigen Pharms. Ltd. v. Janssen
`
`Oncology, Inc., IPR2016-00286. In particular, Ex. 2010 is the 12/4/2015
`
`Declaration of Dr. Scott R. Serels, M.D. (used as an exhibit in the 2/16/2017
`
`deposition of Mylan’s expert, Dr. Marc Garnick); Ex. 2037 is the Transcript of the
`
`2
`
`

`

`
`
`8/22/2016 Deposition of Scott Serels, M.D.; Ex. 2120 is the 12/4/2015 Declaration
`
`of Dr. Scott R. Serels, M.D.; Ex. 2122 is the 1/16/2017 Declaration of Dr. Scott R.
`
`Serels, M.D.; Ex. 2124 is the Transcript of the 1/23/2017 Deposition of Mark J.
`
`Ratain, M.D.; Ex. 2125 is the Transcript of the 1/19/2017 Deposition of Richard
`
`Dorin, M.D.; and Ex. 2127 is the Transcript of the 1/21/2017 Deposition of Scott
`
`R. Serels, M.D. (collectively, the “Amerigen testimony”).
`
`On March 15, 2017, Petitioners objected to the Amerigen testimony on
`
`several grounds, including that it is hearsay and lacks authentication, and that
`
`Mylan was excluded from participating in the prior depositions of those witnesses.
`
`Janssen refused to produce the witnesses for deposition in this proceeding.
`
`Under the Federal Rules of Evidence, hearsay is “a statement that: (1) the
`
`declarant does not make while testifying at the current trial or hearing; and (2) a
`
`party offers in evidence to prove the truth of the matter asserted in the statement.”
`
`Fed. R. Evid. 801(c). The Amerigen testimony is hearsay: each exhibit embodies a
`
`statement, not made in the Mylan IPR, and offered by Janssen as proof of the
`
`matter asserted in the statement (as shown by Janssen’s reliance on the Amerigen
`
`testimony in these proceedings). Id. Hearsay is inadmissible unless an exception
`
`applies, Fed. R. Evid. 802, and here there is no exception allowing the Amerigen
`
`testimony into evidence. Therefore, under the Board’s precedent, each exhibit
`
`comprising the Amerigen testimony must be given no weight, and Janssen should
`
`3
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`

`

`
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`be precluded from relying on it. US Endodontics, LLC v. Gold Standard
`
`Instruments, LLC, PGR2015-00019, Paper 54 (Dec. 28, 2016) at 38-43.
`
`Further, the Board should strike any portions of Janssen’s Patent Owner
`
`Response that rely on the Amerigen testimony as substantive evidence, including
`
`material on at least the following pages: Janssen’s Patent Owner Response at 2, 7,
`
`12-15, 17-21, 23-24, 27, 29, 35, 38, 40, 42, 46, and 61.
`
`Notably, Mylan requested permission to attend the depositions of the expert
`
`witnesses in the Amerigen proceeding, but Janssen’s counsel excluded Mylan’s
`
`counsel not only from participating, but even attending these depositions. Ex.
`
`1148 (Email from Munoz to White, dated August 19, 2016). Nevertheless, on
`
`March 8, 2017, Janssen filed the Amerigen testimony in this proceeding as exhibits
`
`accompanying Janssen’s Patent Owner Response (Paper No. 35). On March 9,
`
`2017, after reviewing the nature of the Amerigen testimony submitted by Janssen,
`
`Mylan requested that Janssen produce each of the declarants/prior deponents for
`
`deposition in this proceeding to permit Mylan to test the testimony Janssen relied
`
`upon. See Ex. 1149 (Email from White to Patent Owner, dated March 9, 2017).
`
`The same day, Janssen refused Mylan’s request, asserting that the exhibits
`
`comprising the Amerigen testimony “were not prepared for purposes of the
`
`[Mylan] inter partes review, but rather constitute ‘preexisting documentary
`
`evidence that was filed previously in another proceeding,’” and for which cross-
`
`4
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`

`

`
`
`examination would not be provided as routine discovery. See Ex. 1149 (Email
`
`from Donovan to White, dated March 9, 2017). Janssen’s response admits that the
`
`Amerigen testimony is hearsay, but does not establish a hearsay rule exception.
`
`Given Janssen’s refusal to produce for deposition those witnesses who
`
`provided the Amerigen testimony, Petitioners were unable to test the substance of
`
`the testimony given by each declarant and deponent. It would therefore be unfairly
`
`prejudicial to Mylan to allow Janssen to rely on that testimony in this proceeding.
`
`See Fed. R. Evid. 403 (evidence may be excluded when its probative value is
`
`substantially outweighed by a danger of unfair prejudice); Kirk v. Raymark Indus.,
`
`Inc., 61 F.3d 147, 163-64 (3d Cir. 1995) (citing Fed. R. Evid. 801(d)(2)(C) and
`
`holding that an expert witness’s testimony in a first trial for one party was hearsay
`
`in a second trial involving a second party); see also Fed. R. Civ. P. 32(a)(1)(A) (a
`
`deposition may be used against a party only if, among other requirements, the party
`
`was present or represented at the taking of the deposition).
`
`Accordingly, the Board should exclude exhibits 2010, 2037, 2120, 2122,
`
`2124, 2125, and 2127 and material on at least pages 2, 7, 12-15, 17-21, 23-24, 27,
`
`29, 35, 38, 40, 42, 46, and 61 of Patent Owner’s Response.
`
`III. JANSSEN’S ADDITIONAL PATENT OWNER RESPONSE (EX.
`2151), AND JANSSEN’S RELIANCE ON IT, SHOULD BE
`EXCLUDED.
`Exhibit 2151 is Janssen’s Patent Owner Response filed in the Amerigen IPR
`
`5
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`

`

`
`
`(Paper 33 in IPR2016-00286, “Patent Owner’s Amerigen Response”). On March
`
`8, 2017, Janssen filed Patent Owner’s Amerigen Response in this proceeding as an
`
`exhibit accompanying Janssen’s Patent Owner Response (Paper No. 35). On
`
`March 15, 2017, Petitioners objected to the use of Patent Owner’s Amerigen
`
`Response in this proceeding, including that Patent Owner’s Amerigen Response is
`
`hearsay and lacks authentication, that Mylan was unable to test any of the positions
`
`asserted, and that the filing of Patent Owner’s Amerigen Response violates the
`
`page limits of 37 C.F.R. § 42.24(b). Paper No. 37 at 14.
`
`Under the Federal Rules of Evidence, Patent Owner’s Amerigen Response is
`
`hearsay: it embodies a statement, not made in the Mylan IPR, and that is offered by
`
`Janssen as proof of the matter asserted in the statement (as shown by Janssen’s
`
`reliance on Patent Owner’s Amerigen Response in these proceedings). Fed. R.
`
`Evid. 801(c). Hearsay is inadmissible unless an exception applies, Fed. R. Evid.
`
`802, and here there is no exception allowing Patent Owner’s Amerigen Response
`
`into evidence. In addition, Patent Owner’s Amerigen Response comprises 13,989
`
`words of substantive argument, pushing Janssen’s total submission far beyond the
`
`14,000 words allowed under 37 C.F.R. § 42.24(b) (Janssen’s Patent Owner
`
`Response in this proceeding, Paper 35, was 13,632 words, yielding a total of
`
`27,621 words).
`
`Accordingly, the Board should exclude Patent Owner’s Amerigen Response,
`
`6
`
`

`

`
`
`Ex. 2151, or give it no weight, because it is hearsay, and Janssen should be barred
`
`from relying on it. US Endodontics, PGR2015-00019, Paper 54 at 38-43. Exhibit
`
`2151 should also be stricken because it violates the word count limits of 37 C.F.R.
`
`§ 42.24(b). The Board should also strike material on page 2 of Patent Owner’s
`
`Response (Paper 35), which relies on Patent Owner’s Amerigen Response as
`
`substantive evidence.
`
`IV. EXHIBIT JSN 2134 AND CERTAIN PORTIONS OF THE
`DECLARATION AND DEPOSITION TESTIMONY BY DR.
`CHRISTOPHER VELLTURO, AND JANSSEN’S RELIANCE ON
`THEM, SHOULD BE EXCLUDED.
`
`Exhibit 2134 is a summary of Zytiga market share data relied upon by
`
`Janssen’s economics expert, Dr. Vellturo, in preparing his declaration and giving
`
`his testimony. Because Exhibit 2134 has not been authenticated, is hearsay, is
`
`incomplete under Federal Rule of Evidence 106, and is an improper summary
`
`under Federal Rule of Evidence 1006, it should be excluded, along with related
`
`portions of Dr. Vellturo’s declaration (e.g., Ex. 2044 ¶¶ 48-52, Appendix C, C-1,
`
`D) and deposition testimony (Ex. 1136), and Janssen’s Patent Owner Response
`
`(Paper No. 35 at 58-62). Mylan properly objected to Exhibit 2134. Paper No. 37
`
`at 13.
`
`“To satisfy the requirement of authenticating or identifying an item of
`
`evidence, the proponent must produce evidence sufficient to support a finding that
`
`the item is what the proponent claims it is.” Fed. R. Evid. 901(a); see 37 C.F.R.
`
`7
`
`

`

`
`
`§ 42.62(a) (“[T]he Federal Rules of Evidence shall apply to a proceeding.”). Dr.
`
`Vellturo stated in both his declaration and deposition that Janssen or Janssen’s
`
`lawyers provided him with Exhibit 2134. Ex. 2044 ¶ 48; Ex. 1136 at 78:8-14,
`
`81:15-83:3. Dr. Vellturo testified that counsel gave him the understanding that
`
`Exhibit 2134 was prepared at Janssen, but he did not know how, why, or by whom
`
`Exhibit 2134 was prepared. On its face, Exhibit 2134 contains no identifying or
`
`authenticating information indicating how, why, or by whom Exhibit 2134 was
`
`prepared, and Janssen did not submit any supplemental authenticating evidence.
`
`Because it lacks proof of authenticity, Exhibit 2134 should be excluded. See TRW
`
`Auto. U.S. LLC v. Magna Elecs., Inc., IPR2014-01347, Paper No. 25 (Jan. 6, 2016)
`
`at 5-12; Standard Innovation Corp. v. Lelo, Inc., IPR2014-00148, Paper No. 42
`
`(Apr. 23, 2015) at 10-13 (both excluding exhibits for lacking proof of authenticity).
`
`Similarly, Exhibit 2134 is inadmissible hearsay. Exhibit 2134 is, and
`
`consists of, out-of-court statements offered to prove the truth of the matter
`
`asserted. Dr. Vellturo speculated that Exhibit 2134 was created in the ordinary
`
`course of business, but Janssen has not offered any proof to that effect. Ex. 1136 at
`
`82:11-83:14.
`
`Exhibit 2134 also appears to be incomplete. The first heading in Exhibit
`
`2134 is labeled “C” and no headings “A” or “B” appear in the document. Ex. 2134
`
`at 1. Dr. Vellturo testified that he does not know where headings “A” and B” are,
`
`8
`
`

`

`
`
`he never asked Janssen if headings “A” and “B” exist, and he does not know
`
`whether a longer form of Exhibit 2134 exists. Ex. 1136 at 79:16-80:16, 81:7-14,
`
`83:4-14. Janssen has never produced to Petitioners a longer version of Exhibit
`
`2134 or evidence that no longer version exists. Therefore, neither Petitioners nor
`
`the Board can know what information, if any, appears under headings “A” and
`
`“B.” Petitioners also have no assurances that the document ends at the conclusion
`
`of Exhibit 2134, or, because Exhibit 2134 lacks page numbers, any confirmation
`
`that interior pages have not also been omitted.
`
`Federal Rule of Evidence 106 requires introduction of an entire document if
`
`part of the document is offered and fairness necessitates that the entire document
`
`be considered. In this case, however, the proper remedy for Janssen’s failure to
`
`offer a complete version of Exhibit 2134 is its exclusion. Inter partes review
`
`proceedings are abbreviated—particularly this accelerated IPR—and do not
`
`typically allow for discovery beyond expert declarations and depositions. SAS
`
`Inst., Inc. v. ComplementSoft, LLC, 825 F.3d 1341, 1357 (Fed. Cir. 2016) (noting
`
`“the extremely limited discovery available to petitioners”); PPC Broadband, Inc. v.
`
`Corning Optical Commc’ns RF, LLC, 815 F.3d 734, 741 (Fed. Cir. 2016) (“Both
`
`discovery and trial proceed at a rapid pace.”). Janssen should have either
`
`submitted sufficient evidence in the first instance or corrected Exhibit 2134 after
`
`Petitioners objected. See Paper No. 37 at 13. They did neither. Exhibit 2134
`
`9
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`

`

`
`
`should therefore be excluded under Federal Rule of Evidence 106, or alternatively
`
`under Federal Rule of Evidence 403, as its incompleteness renders it substantially
`
`more unfairly prejudicial than probative.
`
`Exhibit 2134 is also an improper summary under Federal Rule of Evidence
`
`1006, which requires that evidence underlying a summary exhibit be made
`
`available to the other party. Here, Exhibit 2134 identifies “IMS DDD,”
`
`“Symphony Health Solutions (SHS),” and “SHS data based on ZYTIGA® Xponent
`
`sample to IMS DDD universe (sample of claims from SPP/Pharmacy to Payer)” as
`
`its sources of Zytiga and Xtandi data. Ex. 2134 at 2. Exhibit 2134 does not
`
`disclose its data sources for any of the other drugs (or its “All Other” category)
`
`listed in its tables and graphs. Ex. 1136 at 99:14-102:12. As Dr. Vellturo’s
`
`testimony makes clear, Exhibit 2134 compares data from different data sets, with
`
`different sources, some of which may have been adjusted. Ex. 1136 at 83:15-
`
`102:12.
`
`Janssen refused to file or serve the data underlying Exhibit 2134’s summary
`
`graphs and tables despite Petitioners’ request that Janssen do so. See Ex. 1150
`
`(Email from Donovan to Swanson, dated April 4, 2017).2 Because the data
`
`2 Janssen’s response that Dr. Hofmann relied on IMS data is misleading because, in
`
`contrast to Dr. Vellturo, Dr. Hofmann merely relied on a public document’s
`
`reported figures. The public document cites IMS as its source.
`
`10
`
`

`

`
`
`underlying Exhibit 2134 is not of record in this proceeding, Petitioner and the
`
`Board cannot ascertain the extent to which Exhibit 2134’s various data and
`
`comparisons are accurate or reliable. See United States v. Mitchell, 816 F.3d 865,
`
`876 (D.C. Cir. 2016) (“To be admissible, the summary must be accurate and
`
`nonprejudicial; and the witness who prepared the summary should introduce it.”)
`
`(internal quotations omitted); Ex. 1136 at 78:22-79:15, 80:17-81:6 (Dr. Vellturo
`
`never reviewed the underlying data). Exhibit 2134 is therefore an improper
`
`summary under Federal Rule of Evidence 1006 and should be excluded.
`
`At minimum, Dr. Vellturo’s opinions relying on Exhibit 2134 should be
`
`accorded no weight under 37 C.F.R. § 42.65 because Dr. Vellturo fails to disclose
`
`the underlying facts or data on which his opinion is based.
`
`V. DECLARATION TESTIMONY BY DR. JOHANN DE BONO, AND
`JANSSEN’S RELIANCE ON IT, SHOULD BE EXCLUDED.
`
`Exhibit 2118 (“de Bono Declaration”) is the Declaration of Johann S. de
`
`Bono, an inventor of the ’438 patent. On March 8, 2017, Janssen filed the de Bono
`
`Declaration in this proceeding as an exhibit accompanying Janssen’s Patent Owner
`
`Response (Paper No. 35). The de Bono Declaration is not supported by any
`
`documentary evidence, although numerous exhibits are cited throughout the
`
`Declaration. On March 9, 2017, Mylan requested that Janssen produce Dr. de
`
`Bono for deposition in this proceeding, so that Mylan could test the accuracy of
`
`Dr. de Bono’s unsupported testimony. See Ex. 1149 (Email from White to Patent
`
`11
`
`

`

`
`
`Owner, dated March 9, 2017). The same day, Janssen refused Mylan’s request,
`
`asserting that the de Bono Declaration “[was] not prepared for purposes of the
`
`[Mylan] inter partes review, but rather constitute[s] ‘preexisting documentary
`
`evidence that was filed previously in another proceeding,’”3 and for which cross-
`
`examination would not be provided as routine discovery. See Ex. 1149 (Email
`
`from Donovan to White, dated March 9, 2017). Janssen’s response admits that the
`
`Amerigen testimony is hearsay, but does not establish a hearsay rule exception.
`
`On March 15, 2017, Mylan objected to the use of the de Bono Declaration in
`
`this proceeding, including that the de Bono Declaration is hearsay and lacks
`
`authentication, the Declaration fails to provide the underlying facts or data on
`
`which the opinion is based, and that Janssen refused to produce Dr. de Bono for
`
`deposition. Paper No. 37 at 12.
`
`Under the Federal Rules of Evidence, the de Bono Declaration is hearsay: it
`
`is a statement, not made in the Mylan IPR, offered by Janssen as proof of the
`
`matters asserted in the Declaration (as shown by Janssen’s reliance on the de Bono
`
`Declaration as substantive evidence). Fed. R. Evid. 801(c). Hearsay is
`
`3 The de Bono Declaration and supporting exhibits were originally filed under seal
`
`in the parallel District Court proceedings on March 8, 2016. BTG Int’l Ltd. v.
`
`Actavis Labs. FL, Inc., Civil Action No. 2:15-cv-05909 (D.N.J.), ECF Nos. 176-4
`
`(sealed declaration) and 178 (motion to seal).
`
`12
`
`

`

`
`
`inadmissible unless an exception applies, Fed. R. Evid. 802, and here there is no
`
`exception allowing the de Bono Declaration into evidence.
`
`Accordingly, the Board should exclude the de Bono Declaration, Ex. 2118,
`
`or give it no weight, because it is hearsay. US Endodontics, PGR2015-00019,
`
`Paper 54 at 38-43. Further, the Board should strike material on page 52 of
`
`Janssen’s Patent Owner Response, and paragraph 202 of the Declaration of
`
`Matthew B. Rettig, M.D. (JSN 2038), each of which relies on the de Bono
`
`Declaration as substantive evidence.
`
`VI. CONCLUSION
`For the reasons set forth above, Petitioners ask that the Board exclude: 1) the
`
`exhibits embodying the declaration and deposition testimony of Drs. Serels,
`
`Ratain, and Dorin from the Amerigen IPR, and portions of Janssen’s submissions
`
`in this proceeding that rely upon those exhibits; 2) the Patent Owner Response
`
`filed in the Amerigen proceeding, and portions of Janssen’s submissions in this
`
`proceeding that rely upon that exhibit; 3) Exhibit 2134 and related portions of the
`
`declaration and deposition testimony of Dr. Christopher Vellturo, and portions of
`
`Janssen’s submissions in this proceeding that rely upon the exhibit and testimony;
`
`and 4) the declaration testimony of Dr. Johann de Bono, and portions of Janssen’s
`
`submissions in this proceeding that rely upon it.
`
`13
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`

`

`
`Dated: May 3, 2017
`
`
`
`
`
`
`
`/s/ Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`
`Counsel for Petitioner Mylan
`Pharmaceuticals Inc.
`
`14
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing Petitioners’ Motion to
`
`Exclude Evidence was served electronically via email as follows:
`
`Petitioners:
`
`Samuel S. Park
`Jovial Wong
`Ryan B. Hauer
`Winston & Strawn LLP
`spark@winston.com
`jwong@winston.com
`rhauer@winston.com
`
`Patent Owners:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`Akin Gump Strauss Hauer & Feld LLP
`JANS-ZYTIGA@akingump.com
`
`Todd L. Krause
`David T. Pritikin
`Bindu Donovan
`Paul J. Zegger
`Sidley Austin LLP
`ZytigaIPRTeam@sidley.com
`
`
`
`
`
`/s/ Brandon M. White
`Brandon M. White
`
`Counsel for Petitioner Mylan
`Pharmaceuticals Inc.
`
`
`Dated: May 3, 2017
`
`
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`1
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`