Paper No. _
`Date Filed: May 19, 2017
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF
`PATENT OWNER’S MOTION TO EXCLUDE EXHIBITS 1089-1090
`
`
`
`Date Filed: May 19, 2017
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF
`PATENT OWNER’S MOTION TO EXCLUDE EXHIBITS 1089-1090
`
`
`
`
`Table of Contents
`
`Mylan Has Not Authenticated Exhibits 1089-1090 as IMS Data ................... 1
`
`I.
`
`A.
`
`Exhibits 1089-1090 Are Not Self-Authenticating ................................ 1
`
`B. Mr. McSorley’s Testimony Is Insufficient ............................................ 1
`
`C.
`
`Reliability of IMS Data Generally Is Irrelevant .................................... 3
`
`D.
`
`Exhibits 1089-1090 Are Undisputedly Inaccurate ................................ 4
`
`II.
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`Exhibits 1089-1090 Do Not Qualify as Hearsay Exceptions .......................... 5
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`III. Conclusion ....................................................................................................... 5
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`
`
`
`
`i
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`
`
`Cases
`
`Table of Authorities
`
`Alessandra v. Colvin,
`No. 12CV397A, 2013 WL 4046295
`(W.D.N.Y. Aug. 8, 2013) ................................................................................ 2
`
`Neste Oil Oyj v. REG Synthetic Fuels, LLC,
`IPR2013-00578, Paper 52 (P.T.A.B. Mar. 12, 2015) ...................................... 1
`
`Standard Innovation Corp. v. Lelo, Inc.,
`IPR2014-00148, Paper 42 (P.T.A.B. Apr. 23, 2015) ...................................... 5
`
`Rules
`
`Fed. R. Evid. 803 ....................................................................................................... 5
`
`Fed. R. Evid. 807 ....................................................................................................... 5
`
`Fed. R. Evid. 901 .............................................................................................. 2, 3, 4
`
`
`
`ii
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`
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`Patent Owner Aventis Pharma S.A. (“Aventis”) submits this Reply to
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude Exhibits 1089-1090
`
`(Paper 77, “Opp.”). Petitioner (“Mylan”) spends much of its brief asserting the
`
`reliability of IMS, but fails to prove whether Exhibits 1089-1090 are in fact from
`
`IMS. As explained in Paper 61 (“Mot.”) and below, they should be excluded.
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`I. Mylan Has Not Authenticated Exhibits 1089-1090 as IMS Data
`
`A. Exhibits 1089-1090 Are Not Self-Authenticating
`
`There can be no question that Exhibits 1089-1090 are not self-authenticating
`
`because they lack identifying information. (Mot. at 2-3). Mylan asserts that
`
`Aventis’s Neste Oil case is inapposite because allegedly there was an enhanced
`
`standard for testimony establishing prior invention. (Opp. at 1-2). But the portion
`
`of the case upon which Aventis relies is relevant because it shows that spreadsheets
`
`such as Exhibits 1089-1090 need testimony to establish their authenticity. Neste
`
`Oil Oyj v. REG Synthetic Fuels, LLC, IPR2013-00578, Paper 52 at 3-5 (P.T.A.B.
`
`Mar. 12, 2015). As explained below, such testimony is lacking here.
`
`B. Mr. McSorley’s Testimony Is Insufficient
`
`Mylan repeatedly attempts to establish the authenticity of Exhibits 1089-
`
`1090 by stating that Mr. McSorley received the documents from counsel. (Opp. at
`
`1-4). But Mr. McSorley’s evidentiary declaration does not say that the exhibits
`
`came from counsel at his request, and at his deposition he specifically said that he
`
`was not relying on communications with counsel. (Exh. 2261 at 86:15-87:5,
`
`
`
`1
`
`
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`95:22-97:1, 98:13-24). Nor did Mylan’s counsel submit a declaration establishing
`
`where Exhibits 1089-1090 came from. (See Exh. 2262). It is improper for Mylan
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`to now simply state that counsel provided the documents, still without explaining
`
`how they were retrieved.1 See Alessandra v. Colvin, No. 12CV397A, 2013 WL
`
`4046295, at *3 (W.D.N.Y. Aug. 8, 2013) (unsworn attorney assertion was not a
`
`substitute for sworn testimony on personal knowledge).
`
`Moreover, Mylan’s assertion that Mr. McSorley’s testimony establishes
`
`authenticity under Federal Rule of Evidence 901(b)(1), (3), (4), and (9) is
`
`incorrect. For Rule 901(b)(1), while Mr. McSorley testified that “Wilson Sonsini
`
`got it from IMS Health,” he has no foundation to provide this testimony, and only
`
`bases this testimony on his assumption that it is IMS data in the first place. (Opp.
`
`at 3-4). For Rule 901(b)(3), (4), Mr. McSorley has not compared Exhibits 1089-
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`1090 with an “authenticated specimen” that has been established to be IMS data or
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`testified that the appearance of Exhibits 1089-1090 is so distinct as to necessarily
`
`be IMS data. Even if Mr. McSorley believed the exhibits are similar to IMS data
`
`he has seen in the past, he did not know when Exhibits 1089-1090 were created,
`
`and was not sure how the documents were obtained, which means he would not
`
`
`1 Mylan’s assertion that Mr. McSorley was “not permitted” to see the exhibits is
`
`incorrect; Aventis’s counsel offered to provide any exhibit at any time if he wanted
`
`it to “assist” in providing testimony. (Opp. at 4; Exh. 2261 at 8:10-15).
`
`
`
`2
`
`
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`know if the data had been altered in any way. Exh. 2261 at 103:6-104:13. For
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`Rule 901(b)(9), Mr. McSorley has not testified about the process for creating IMS
`
`data that would distinctly identify Exhibits 1089-1090 as being true and correct
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`copies of unaltered IMS data.
`
`Lastly, Mr. Tate has not testified about Exhibits 1089-1090 at all because he
`
`was not permitted to file a sur-reply paper; thus neither he nor anyone else at
`
`Aventis has supported their authenticity. (Contra Opp. at 5-6). Mr. Tate may have
`
`received Exhibits 2170-2171 and 2179 from counsel, but the authenticity of those
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`exhibits was established by a Sanofi employee with personal knowledge, not
`
`counsel for Aventis. (Exh. 2231). There is no such equivalent testimony for Mr.
`
`McSorley’s purported IMS data, Exhibits 1089-1090.
`
`C. Reliability of IMS Data Generally Is Irrelevant
`
`The reliability of IMS data and its use by pharmaceutical companies is
`
`irrelevant to the authenticity of Exhibits 1089-1090 because no one has established
`
`that the exhibits are in fact unaltered IMS data. While Mylan points to various
`
`uses of IMS data in Sanofi’s SEC filings, these filings note that IMS data will not
`
`match sales figures published by the companies, and therefore sales numbers have
`
`to be adjusted. (Exhs. 2128 at 2/335; 2129 at 3/335; 2130 at 4/458; 2131 at 3/304;
`
`2132 at 3/413; 2133 at 2/233). Furthermore, Mylan does not point to any specific
`
`use of IMS data relating to Jevtana®, and the SEC filings do not use IMS sales or
`
`
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`3
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`
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`prescription data to analyze Jevtana® market share. (See, e.g., Exhs. 2128 at
`
`27/335-28/335, 89/335; 2129 at 34/335, 110/335; 2130 at 39/458, 145/458; 2131 at
`
`33/304-34/304, 107/304; 2132 at 38/413, 124/413; 2133 at 33/233, 118/233). This
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`is consistent with the testimony of Mr. Tate that IMS data is not appropriate to
`
`analyze the relevant market for Jevtana®. (Exh. 1042 at 44:18-45:11; 48:16-50:3).
`
`Similarly, Mylan’s attempt to shift the burden by suggesting that Aventis
`
`should have produced its own IMS data, to the extent it existed for Jevtana®, to
`
`challenge Exhibits 1089-1090 is improper. (Opp. at 10). The proponent of non-
`
`self-authenticating documents must produce evidence sufficient to support a
`
`finding that the documents are what the proponent claims them to be. Fed. R.
`
`Evid. 901(a). Mylan has not done so.
`
`D. Exhibits 1089-1090 Are Undisputedly Inaccurate
`
`Mylan does not dispute that the prescriptions reported for Jevtana® in the
`
`purported IMS data are inaccurate to an unknown degree. (Opp. at 11). Because it
`
`is not known why the prescriptions are wrong, by how much, or whether the
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`prescriptions for other drugs are also incorrect, the data in Exhibits 1089-1090 are
`
`not probative of anything. Even if the purported data was from IMS and was
`
`accurate, as Mr. Tate has explained, the relevant market must take into
`
`consideration the indication for Jevtana® in patients previously treated with
`
`docetaxel to avoid unfairly comparing its sales with drugs that are FDA-approved
`
`
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`4
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`
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`in a wider population of patients. (Exh. 1042 at 44:18-45:11; 47:11-48:12). IMS
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`data does not permit that comparison, nor does data analyzing post-chemotherapy
`
`patients. (Id. at 44:18-45:11; 48:16-50:3; Exh. 2261 at 104:14-105:17).
`
`II. Exhibits 1089-1090 Do Not Qualify as Hearsay Exceptions
`
`Exhibits 1089-1090 do not qualify for the hearsay exceptions in Federal
`
`Rule of Evidence 803(17) or 807. As noted in the Motion and above, Mylan has
`
`not established that the data in Exhibits 1089-1090 come directly from IMS, and it
`
`is undisputed that at least the prescription data is inaccurate. Accordingly, the data
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`is not trustworthy enough to be “generally relied on by the public or by persons in
`
`particular occupations” to qualify under Federal Rule of Evidence 803(17). See
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`Advisory Committee Notes (“The basis of trustworthiness is general reliance by
`
`the public or by a particular segment of it . . . .”). Nor do the exhibits have
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`equivalent circumstantial guarantees of trustworthiness required of the residual
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`hearsay exception. Fed. R. Evid. 807(a)(1); see also Standard Innovation Corp. v.
`
`Lelo, Inc., IPR2014-00148, Paper 42 at 15 (P.T.A.B. Apr. 23, 2015) (declining to
`
`apply the residual exception to “Petitioner’s conclusory assertion that Exhibit 1013
`
`has equivalent circumstantial guarantees of trustworthiness”).
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`III. Conclusion
`
`For the foregoing reasons and the reasons set forth in the Motion, Aventis
`
`respectfully requests that the Board exclude Exhibits 1089-1090.
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`Respectfully submitted,
`
` /Dominick A. Conde/
`
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Attorney for Patent Owner,
`Aventis Pharma S.A.
`
`6
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`May 19, 2017
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`CERTIFICATE OF SERVICE
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`
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`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNER’S REPLY IN SUPPORT OF PATENT OWNER’S MOTION
`
`TO EXCLUDE EXHIBITS 1089-1090 was served on May 19, 2017 by causing it
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`to be sent by email to counsel for Petitioner at the following email addresses:
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`sparmelee@wsgr.com
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`mrosato@wsgr.com
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`jmills@wsgr.com
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`mreed@wsgr.com
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`namjadi@wsgr.com
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`wdevine@wsgr.com
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`
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`May 19, 2017
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`Respectfully submitted,
`
`
`
` /Dominick A. Conde/
`
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
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`7
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