Filed: April 13, 2016
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`————————————————
`
`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
`
`Petitioners,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.
`
`Patent Owner.
`
`————————————————
`
`Case No. IPR2015-00643 (8,232,250 B2)
`Case No. IPR2015-00644 (8,399,413 B2)
` Case No. IPR2015-00830 (8,969,302 B2)1,2
`
`————————————————
`
`PETITIONERS’ MOTION TO EXCLUDE
`
`
`1 Case Nos. IPR2015-01976, IPR2015-01980 and IPR2015-01981 have been
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`joined with these proceedings.
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`2 A word-for-word identical Motion is being filed in each proceeding.
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`

`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS
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`I.
`
`FACTUAL BACKGROUND .......................................................................... 1
`
`FACTUAL BACKGROUND ........................................................................ ..1
`
`ALL EXHIBITS AND TESTIMONY REFERRING TO IMS DATA
`
`II. ALL EXHIBITS AND TESTIMONY REFERRING TO IMS DATA
`SHOULD BE EXCLUDED. ........................................................................... 2
`
`SHOULD BE EXCLUDED. ......................................................................... ..2
`
`A.
`
`A.
`
`B.
`B.
`
`EXHIBITS 2108-2114 AND 2120-2122 SHOULD BE EXCLUDED .............. 2
`
`EXHIBITS 2108-2114 AND 2120-2122 SHOULD BE EXCLUDED ............ ..2
`
`PARAGRAPHS 13-14, 16-17, 19, 26-32, 39 AND 41-45 OF DR.
`PARAGRAPHS 13-14, 16-17, 19, 26-32, 39 AND 41-45 OF DR.
`GRABOWSKI’S DECLARATION (EX. 2133) SHOULD BE EXCLUDED ........ 4
`GRABOwsKI’s DECLARATION (EX. 2133) SHOULD BE EXCLUDED ...... ..4
`
`III.
`
`THE INCOMPLETE PHYSICIAN SURVEY EXHIBITS AND
`
`III. THE INCOMPLETE PHYSICIAN SURVEY EXHIBITS AND
`CORRESPONDING TESTIMONY SHOULD BE EXCLUDED ................. 6
`
`CORRESPONDING TESTIMONY SHOULD BE EXCLUDED ............... ..6
`
`A.
`
`A.
`
`B.
`
`B.
`
`EXHIBITS 2115-2119 SHOULD BE EXCLUDED ........................................ 6
`
`EXHIBITS 2115-2119 SHOULD BE EXCLUDED ...................................... ..6
`
`PARAGRAPHS 38 AND 40-44 OF DR. GRABOWsKI’s DECLARATION
`
`PARAGRAPHS 38 AND 40-44 OF DR. GRABOWSKI’S DECLARATION
`(EX. 2133) SHOULD BE EXCLUDED ........................................................ 8
`(EX. 2133) SHOULD BE EXCLUDED ...................................................... .. 8
`
`IV.
`
`TESTIMONY BASED ON EVIDENCE NOT OF RECORD IN THIS
`
`IV. TESTIMONY BASED ON EVIDENCE NOT OF RECORD IN THIS
`PROCEEDING SHOULD BE EXCLUDED .................................................. 9
`
`PROCEEDING SHOULD BE EXCLUDED ................................................ ..9
`
`V.
`
`CONCLUSION .............................................................................................. 11
`
`CONCLUSION ............................................................................................ ..1 1
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`
`
`
`
`i
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`
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`

`
`TABLE OF AUTHORITIES
`
`CASES
`United States v. Appolon,
`695 F.3d 44 (1st Cir. 2012) ................................................................................. 4
`
`United States v. Fahnbulleh,
`752 F.3d 470 (D.C. Cir. 2014) ............................................................................ 4
`
`United States v. Mitchell,
`No. 14-3039, __ F.3d __, 2016 WL 874750 (D.C. Cir. Mar. 8, 2016) .............. 3
`
`Westlake Servs., LLC v. Credit Acceptance Corp.,
`No. CBM2014-00176, 2015 WL 576798 (P.T.A.B. Feb. 9, 2015) .................... 5
`
`RULES AND REGULATIONS
`
`37 C.F.R. § 42.6 ....................................................................................................... 2
`
`37 C.F.R. § 42.61 ..................................................................................................... 1
`
`37 C.F.R. § 42.62 ................................................................................................. 1, 2
`
`37 C.F.R. § 42.64 ..................................................................................................... 1
`
`37 C.F.R. § 42.65 ..................................................................................................... 5
`
`Fed. R. Evid. 106 ..................................................................................................... 7
`
`Fed. R. Evid. 702 ............................................................................... 2, 4, 5, 8, 9, 10
`
`Fed. R. Evid. 703 ................................................................................... 2, 5, 8, 9, 11
`
`Fed. R. Evid. 1006 ........................................................................................... 2, 3, 4
`
`ii
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`
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`
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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
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`exclude the following:
`
`(1) Paragraphs 13-23, 26-32, 37-45 and 50-56 of the Grabowski
`
`Declaration (Ex. 2133); and
`
`(2) Exhibits 2108-2122.
`
`I.
`
`FACTUAL BACKGROUND
`
`The patents at issue claim a glatiramer acetate (“GA”) dosing regimen in
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`which three 40 mg subcutaneous injection are administered each week. Petitioners
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`have conclusively shown that the claimed dosing regimen is obvious over prior art
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`disclosing, inter alia, the safety of 20 mg and 40 mg GA subcutaneous dosing
`
`regimens administered every-other-day. In response, the Patent Owner argues that
`
`its alleged invention is a commercial success, relying on the declaration of Dr.
`
`Henry Grabowski (Ex. 21333) (“the Grabowski Declaration”), which relies on
`
`Exhibits 2108-2122. The Grabowski Declaration and the evidence identified in
`
`alleged support thereof suffer from a major unalterable defect: most of the
`
`evidence is not of record. While the Grabowski Declaration identified over fifty
`
`references, only a few of those references are of record in this proceeding.
`
`3 The Grabowski Declaration is filed with the same exhibit number in IPR2015-
`
`00643, IPR-2015-00644, and IPR2015-00830. The Grabowski Declaration filed in
`
`each proceeding is substantively identical.
`
`1
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`

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`
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`Because Patent Owner failed to file with the Board most of the evidence it relies on
`
`in the Grabowski Declaration, most of the Declaration is entirely unsupported,
`
`rendering it unreliable and inadmissible under Fed. R. Evid. 702 and 703.
`
`Accordingly, and for the reasons explained more fully below, Petitioners
`
`move to exclude Exhibits 2108-2122 and paragraphs 13-23, 26-32, 37-45 and 50-
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`56 of the Grabowski Declaration (Exhibit 2133).
`
`II. ALL EXHIBITS AND TESTIMONY REFERRING TO IMS DATA
`SHOULD BE EXCLUDED.
`
`Exhibits 2108-2114 and 2120-2122 are summary demonstrative exhibits
`
`prepared specifically for the Grabowski Declaration. These exhibits summarize
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`data compiled from a third party vendor, IMS, into tables and graphs to illustrate
`
`purported sales and prescription trends for Copaxone and a subset of other MS
`
`treatments. The underlying IMS data, however, was not produced to Petitioners
`
`and is not of record in this case. Indeed, Patent Owner moved to supplement the
`
`record (IPR2015-00643, Paper 42), but that motion was denied as to the IMS data
`
`(IPR2015-00643, Paper 48).
`
`A. EXHIBITS 2108-2114 AND 2120-2122 SHOULD BE EXCLUDED
`Federal Rule of Evidence 1006 requires that the underlying evidence used to
`
`create a summary exhibit must be made available and produced to the other party.
`
`Fed. R. Evid. 1006; see 37 C.F.R. 42.62(a) (“[T]he Federal Rules of Evidence shall
`
`apply to a proceeding.”); 37 C.F.R. § 42.6(c) (“Each exhibit must be filed with the
`
`2
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`

`
`
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`first document in which it is cited except as the Board may otherwise order.”).
`
`Exhibits 2108-2114 and 2120-2122 should be excluded under this rule. Each of
`
`Exhibits 2108-2114 and 2120-2122 identifies “IMS” as its source. See Ex. 2108-
`
`2114 and 2120-2122 at lower left. Yet Patent Owner never filed or served the IMS
`
`data underlying these summary graphs and tables.
`
`After Petitioners alerted Patent Owner to its failure to file or serve the IMS
`
`data, Patent Owner sought to file supplemental evidence, including the IMS data.
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`IPR2015-00643, Paper 42; Ex. 2139 (identifying as proposed Exhibit 2149 the
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`IMS data to be filed as supplemental evidence). Patent Owner’s motion was
`
`denied as it related to the IMS data. IPR2015-00643, Paper 48. The IMS data
`
`used to create Exhibits 2108-2114 and 2120-2122 are thus not of record in this
`
`proceeding. Consequently, these summary demonstrative exhibits are improper
`
`summaries under Fed. R. Evid. 1006 and should be excluded.4
`
`Moreover, a summary prepared under Fed. R. Evid. 1006 must be accurate.
`
`See United States v. Mitchell, No. 14-3039, __ F.3d __, 2016 WL 874750, at *8
`
`(D.C. Cir. Mar. 8, 2016) (“To be admissible, the summary must be ‘accurate and
`
`4 Petitioners timely objected to these exhibits. IPR2015-00643, Paper 28 (Nov. 30,
`
`2015); IPR2015-00644, Paper 29 (Nov. 30, 2015); IPR2015-00830, Paper 23 (Dec.
`
`3, 2015). Specifically, Petitioners objected to these exhibits as improper
`
`summaries under FRE 1006 (objection T).
`
`3
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`

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`
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`nonprejudicial; and the witness who prepared the summary should introduce it.’”)
`
`(quoting United States v. Fahnbulleh, 752 F.3d 470, 479 (D.C. Cir. 2014)); United
`
`States v. Appolon, 695 F.3d 44, 61 (1st Cir. 2012) (“Federal Rule of Evidence 1006
`
`provides that a party may summarize the contents of voluminous writings,
`
`recordings, or photographs which cannot conveniently be examined in court, so
`
`long as the summary is accurate, the underlying documents are made available to
`
`the other parties, and both the summary and the source materials are admissible.”)
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`(citations omitted). Here, because the IMS data is not of record in this proceeding,
`
`neither the Petitioners nor the Board can test the accuracy of the summaries
`
`prepared by Dr. Grabowski. For this additional reason, Exhibits 2108-2114 and
`
`2120-2122 must be excluded.
`
`B.
`
`PARAGRAPHS 13-14, 16-17, 19, 26-32, 39 AND 41-45 OF DR.
`GRABOWSKI’S DECLARATION (EX. 2133) SHOULD BE
`EXCLUDED
`
`Paragraphs 13, 14, 16, 17, 19, 26-32, 39, and 41-45 of the Grabowski
`
`Declaration (Ex. 2133) should be excluded.5 These paragraphs, which rely on the
`
`5 Petitioners timely objected to this exhibit. IPR2015-00643, Paper 28 (Nov. 30,
`
`2015); IPR2015-00644, Paper 29 (Nov. 30, 2015); IPR2015-00830, Paper 23 (Dec.
`
`3, 2015). Specifically, Petitioners objected to the exhibit as expert testimony not
`
`based on sufficient facts or data under Fed. R. Evid. 702 (objection G) and as
`
`improperly relying on unreliable evidence under Fed. R. Evid. 703 (objection H).
`
`4
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`

`
`
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`summary analyses in Exhibits 2108-2114 and 2120-2122, recite purported sales
`
`and prescription trends allegedly based on IMS data not of record in this case.
`
`Because the expert testimony is based on evidence inadmissible in this proceeding,
`
`it should be excluded under Fed. R. Evid. 702, which requires that such testimony
`
`be based on sufficient facts or data. Even if admissible, Dr. Grabowski’s
`
`unsupported testimony should be given no weight because the underlying data on
`
`which his opinions are based are not of record. See 37 C.F.R. § 42.65(a) (“Expert
`
`testimony that does not disclose the underlying facts or data on which the opinion
`
`is based is entitled to little or no weight.”); see also Westlake Servs., LLC v. Credit
`
`Acceptance Corp., No. CBM2014-00176, 2015 WL 576798, at *14 (P.T.A.B. Feb.
`
`9, 2015) (“Eve[n] if we were to consider Dr. Kursh’s testimony, however, it is of
`
`little value, as it is conclusory and does not disclose the underlying facts or data on
`
`which it is based.”) (citing 37 C.F.R. § 42.65(a)). Accordingly, for these reasons,
`
`and for the same reasons Exhibits 2108-2114 and 2120-2122 should be excluded,
`
`paragraphs 13, 14, 16, 17, 19, 26-32, 39, and 41 of the Grabowski Declaration (Ex.
`
`2133) should also be excluded.
`
`Paragraphs 42-45 of the Grabowski Declaration (Ex. 2133) address the
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`marketplace impact of Glatopa, a 20 mg GA product commercially marketed by
`
`Sandoz. Here again, the sole basis for Dr. Grabowski’s testimony in these
`
`paragraphs is IMS data not of record in this proceeding. See Ex. 2133 at 15-16 n.
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`5
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`

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`
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`46-50. Dr. Grabowski offers no support for his understanding of Glatopa’s
`
`marketplace impact other than the cited documents. Accordingly, for these
`
`reasons, and for the same reasons Exhibits 2108-2114 and 2120-2122 should be
`
`excluded, paragraphs 42-45 of the Grabowski Declaration (Ex. 2133) should also
`
`be excluded.
`
`III. THE
`INCOMPLETE PHYSICIAN SURVEY EXHIBITS AND
`CORRESPONDING TESTIMONY SHOULD BE EXCLUDED
`
`The Grabowski Declaration also relies on a survey commissioned by Patent
`
`Owner. See, e.g., Ex. 2133 at ¶ 38. Selected pages of this survey are extracted and
`
`included as demonstrative exhibits. See Ex. 2115-2119. The Grabowski
`
`Declaration identifies this survey only as a “Mid-Year Tracker.” The complete
`
`survey is, however, not of record in this proceeding. As with the IMS data, Patent
`
`Owner was not permitted to belatedly supplement the record to file the complete
`
`survey. IPR2015-00643, Paper 48.
`
`A. EXHIBITS 2115-2119 SHOULD BE EXCLUDED
`Exhibits 2115-2119 each represent a single page of a document titled “Mid-
`
`Year Tracker.”6 The Mid-Year Tracker is at least 134 pages long,7 but only pages
`
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`6 Petitioners timely objected to this exhibit. IPR2015-00643, Paper 28 (Nov. 30,
`
`2015); IPR2015-00644, Paper 29 (Nov. 30, 2015); IPR2015-00830, Paper 23 (Dec.
`
`6
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`

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`
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`11, 32, 76, 103 and 134 are reproduced in Exhibits 2115-2119. The remaining
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`pages of the document, totaling at least 129 pages, including cited pages 35, 36,
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`and 77,8 are not of record, preventing both the Board and Petitioners from
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`reviewing the entire document.
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`With the Mid-Year Tracker not of record, selective citation and reliance on
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`excerpts from that much larger document is unfair and prejudicial, and contrary to
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`Fed. R. Evid. 106. Under Fed. R. Evid. 106, “[i]f a party introduces all or part of a
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`writing or recorded statement, an adverse party may require the introduction, at
`
`that time, of any other part—or any other writing or recorded statement—that in
`
`fairness ought to be considered at the same time.” Clearly, at least the entire Mid-
`
`Year Tracker should have been made of record. Because Petitioners and the Board
`
`cannot review and evaluate the remainder of the Mid-Year Tracker, it must be
`
`excluded.
`
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`3, 2015). Specifically, Petitioners objected to the exhibit as incomplete under Fed.
`
`R. Evid. 106 (objection I).
`
`7 The Grabowski Declaration cites to page 134 of the Mid-Year Tracker in footnote
`
`32, and Exhibit 2115 appears to show the selected page as page 134.
`
`8 Pages 35, 36 and 77 of the Mid-Year Tracker document are cited in footnotes 36,
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`37 and 41-43.
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`7
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`

`
`
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`B.
`
`PARAGRAPHS 38 AND 40-44 OF DR. GRABOWSKI’S
`DECLARATION (EX. 2133) SHOULD BE EXCLUDED
`
`Paragraphs 38 and 40-44 of the Grabowski Declaration (Ex. 2133) should
`
`also be excluded.9 These paragraphs, relying on the incomplete Mid-Year Tracker
`
`survey excerpted in Exhibits 2115-2119, recite information about the purported
`
`marketplace perception of Copaxone and patient and physician perception of
`
`Copaxone. This testimony is based on an incomplete third-party survey. As such,
`
`the testimony is not based on sufficient facts or data. See Fed. R. Evid. 702(b).
`
`Moreover, an expert economist would not reasonably rely on such incomplete
`
`surveys in forming her opinions.10 See Fed. R. Evid. 703. Because these
`
`
`9 Petitioners timely objected to this exhibit. IPR2015-00643, Paper 28 (Nov. 30,
`
`2015); IPR2015-00644, Paper 29 (Nov. 30, 2015); IPR2015-00830, Paper 23 (Dec.
`
`3, 2015). Specifically, Petitioners objected to the exhibit as expert testimony not
`
`based on sufficient facts or data under Fed. R. Evid. 702 (objection G) and as
`
`improperly relying on unreliable evidence under Fed. R. Evid. 703 (objection H).
`
`10 As Petitioners’ expert Dr. Hay explained in his declaration, there is no
`
`information at all about how the surveys were conducted. IPR2015-00643, Ex.
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`1099 ¶ 75. There is no information on the survey methodology; it is unclear who
`
`the participating physicians were, where they are from, or how they were selected.
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`There is no information on whether any physicians declined to be surveyed, or
`
`8
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`

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`
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`paragraphs are based wholly on incomplete and inadmissible exhibits, they should
`
`be excluded.
`
`IV. TESTIMONY BASED ON EVIDENCE NOT OF RECORD IN THIS
`PROCEEDING SHOULD BE EXCLUDED
`
`A number of paragraphs in the Grabowski Declaration are factually
`
`unsupported conclusions based on citations to references not of record in these
`
`proceeding.11 Other than the cited—but not filed—documents, no basis is stated in
`
`the Grabowski Declaration for Dr. Grabowski’s knowledge of the underlying facts.
`
`Because this testimony is based on evidence not of record in this proceeding, the
`
`testimony is not based on sufficient facts or data and should be excluded. See Fed.
`
`R. Evid. 702(b).
`
`
`whether the physicians were in the United States or elsewhere (the availability of
`
`MS drugs and treatment guidelines vary from country to country). Id.
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`Accordingly, these surveys do not meet a minimum threshold of scientific validity.
`
`Id.
`
`11 Petitioners timely objected to this exhibit. IPR2015-00643, Paper 28 (Nov. 30,
`
`2015); IPR2015-00644, Paper 29 (Nov. 30, 2015); IPR2015-00830, Paper 23 (Dec.
`
`3, 2015). Specifically, Petitioners objected to the exhibit as expert testimony not
`
`based on sufficient facts or data under Fed. R. Evid. 702 (objection G) and as
`
`improperly relying on unreliable evidence under Fed. R. Evid. 703 (objection H).
`
`9
`
`

`
`
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`Specifically, paragraphs 20-23 offer background discussion on MS
`
`therapies. The documents cited in the nine footnotes supporting the statements in
`
`paragraphs 20-23 are not of record. Dr. Grabowski offers no support for his
`
`understanding of the MS therapies other than the cited documents.
`
`Paragraphs 15 and 37 address the Patent Owner’s promotional materials for
`
`its Copaxone 40 mg product. Again, the documents cited in support of Dr.
`
`Grabowski’s assertions are not of record. Dr. Grabowski offers no basis for his
`
`understanding of Patent Owner’s promotion of Copaxone other than the cited
`
`documents.
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`Paragraphs 19 and 50-56 address the marketing and promotion of Copaxone.
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`Here too, the documents cited in support of Dr. Grabowski’s assertions are not of
`
`record. Dr. Grabowski offers no basis for his understanding of Patent Owner’s
`
`promotion of Copaxone other than the cited documents.
`
`Dr. Grabowski’s direct testimony in these paragraphs is grounded wholly on
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`hearsay statements and evidence not of record in this proceeding and therefore
`
`unavailable to Petitioners or the Board. Under Fed. R. Evid. 702 and 703, these
`
`paragraphs should be excluded as they are based on insufficient facts and data, and
`
`admission of such undisclosed evidence is prejudicial.
`
`10
`
`

`
`V. CONCLUSION
`For the reasons set forth above, Petitioners ask that paragraphs 13-23, 26-32,
`
`37-45 and 50-56 of the Grabowski Declaration (Ex. 2133); and Exhibits 2108-2122
`
`
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`be excluded.
`
`
`Dated: April 13, 2016
`
`
`
`
`
`/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
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`11
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`

`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Petitioners’ Motion to
`
`Exclude was served electronically via email as follows:
`
`Patent Owners:
`
`Elizabeth Holland
`Goodwin Procter LLP
`eholland@goodwinprocter.com
`
`William James
`Goodwin Procter LLP
`wjames@goodwinprocter.com
`
`Eleanor Yost
`Goodwin Procter LLP
`eyost@goodwinprocter.com
`
`Petitioner Amneal Pharmaceuticals LLC:
`
`
`Nicholas Mitrokostas
`Goodwin Procter LLP
`nmitrokostas@goodwinprocter.com
`
`Daryl Wiesen
`Goodwin Procter LLP
`dwiesen@goodwinprocter.com
`
`John Bennett
`Goodwin Procter LLP
`jbennett@goodwinprocter.com
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`1
`
`Vincent L. Capuano
`Duane Morris LLC
`VCapuano@duanemorris.com
`
`Christopher S. Kroon
`Duane Morris LLC
`CSKroon@duanemorris.com
`
`
`Dated: April 13, 2016