UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`PHARMACOSMOS A/S,
`Petitioner,
`
`v.
`
`LUITPOLD PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`
`
`_______________
`
`IPR2015-01490; Patent 7,754,702 B2
`____________________________________________________________
`
`
`PATENT OWNER
`REPLY TO OPPOSITION TO MOTION TO EXCLUDE
`
`
`
`4845-6875-6023.2
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`PHARMACOSMOS A/S,
`Petitioner,
`
`v.
`
`LUITPOLD PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`
`
`_______________
`
`IPR2015-01490; Patent 7,754,702 B2
`____________________________________________________________
`
`
`PATENT OWNER
`REPLY TO OPPOSITION TO MOTION TO EXCLUDE
`
`
`
`4845-6875-6023.2
`
`
`
`IPR2015-01490
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`Reply to Opposition to Motion to Exclude
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`TABLE OF CONTENTS
`
`
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`Exs. 1055, 1056, 1057, 1059, 1060, 1061 Are Not Relevant .......................... 1
`
`III. Exs. 1055, 1056, 1057, 1059, 1060, 1061, 1063 Are Inadmissible
`Hearsay ............................................................................................................ 2
`
`IV. Exs. 1059, 1060, 1061, and 1063 Are Not Properly Authenticated ................ 3
`
`V.
`
`Ex. 1054 Is Mischaracterized .......................................................................... 5
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`VI. CONCLUSION ................................................................................................ 5
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`
`
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`4845-6875-6023.2
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`i
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`IPR2015-01490
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`Reply to Opposition to Motion to Exclude
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`TABLE OF AUTHORITIES
`
`CASES
`
`EMC Corp. v. PersonalwebTechs., LLC, IPR2013-0084, Paper 64 (PTAB May 15,
`2014) ..................................................................................................................... 4
`
`Joy Techs, Inc. v. Manbeck, 751 F.Supp 225 (D.D.C. 1990), aff’d 959 F.2d 226
`(Fed. Cir. 1992) ..................................................................................................... 3
`
`Liberty Mutual v. Progressive Casualty Insurance, CBM2012-00002, Paper 66
`(PTAB January 23, 2014) ..................................................................................... 1
`
`Lorraine v. Market American Insurance Co., 241 F.R.D. 534 (D. Md. 2007) ......... 4
`
`St. Luke's Cataract and Laser Institute PA v. Sanderson, 2006 WL 1320242 (M. D.
`Fla. 2006) .............................................................................................................. 4
`
`Susemihl v. United Steamship Co. (Bahamas) Ltd., 859 F.2d 150 (4th Cir. 1988) ... 3
`
`37 C. F. R. § 42.64(c) ................................................................................................. 5
`
`STATUTES
`
`
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`4845-6875-6023.2
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`
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`ii
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`IPR2015-01490
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`Reply to Opposition to Motion to Exclude
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`I.
`
`INTRODUCTION
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`No witness for Petitioner has testified about the exhibits challenged in the
`
`motion to exclude and Petitioner served no supplemental evidence in response to
`
`Patent Owner’s objections. There is no testimony at all about authentication or
`
`whether the exhibits satisfy any hearsay exception. Instead, Petitioner’s opposition
`
`offers only attorney argument. The bases for admission have not been met.
`
`II. Exs. 1055, 1056, 1057, 1059, 1060, 1061 Are Not Relevant
`Exhibits 1055, 1056, 1057, and 1059 all have copyright and publication
`
`dates some 10 years after the filing date of January 2006. In Liberty Mutual v.
`
`Progressive Casualty Insurance (Opp. 4, 8), the post-filing references were
`
`published two or three years after the filing date but were still relevant to the state
`
`of the art at or around the time of filing because both references expressly cited
`
`information known before the filing date. CBM2012-00002, Paper 66, p. 64-65
`
`(PTAB January 23, 2014). Here, in contrast, the identified exhibits are not from
`
`around the time of filing date but nearly a decade later! They are too late to be
`
`relevant and they do not purport to cite information known before the filing date.
`
`Petitioner argues the data in Exs. 1055 and 1056 (Opp. 4) but provides no
`
`evidence these data were known to a POSITA at the time of filing. Indeed, Ex.
`
`1055 seems to be the first publication of data from this cohort. Ex. 1055, p. 2 ¶3.
`
`Petitioner asserts that Ex 1060 and 1061 are bases for “specific comparisons
`1
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`4845-6875-6023.2
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`IPR2015-01490
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`Reply to Opposition to Motion to Exclude
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`to the claimed value” (Opp. 10), whatever that means. However, Petitioner
`
`provides no evidence that these weights of the animals are authentic or
`
`generalizable for this purpose. And, both references are dated so far after the filing
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`date. Petitioner is using random data to try to discount the data originally
`
`presented in the patent.
`
`III. Exs. 1055, 1056, 1057, 1059, 1060, 1061, 1063 Are Inadmissible Hearsay
`Petitioner claims that the exhibits are cited for “what [they] describe” rather
`
`than “the truth of the matters asserted.” Opp. 5,7, 8, 13, 14. This is contradicted
`
`by Petitioner’s own statements which show they are certainly being used for their
`
`alleged truth! Ex. 1055 and 1056 are cited as reporting that “iron dextran was
`
`regularly used at high doses around the filing date” and that “iron dextran has been
`
`administered at high doses,” respectively (Opp. 4); Ex. 1057 is cited as evidence
`
`that “Beshara discloses the properties of VIT-45” (Opp. 6) ; Ex. 1059 is cited as
`
`“demonstrating that iron dextran products are still currently used” (Opp. 8); Ex.
`
`1060 is cited as “evidence of the weight of a mouse” (Opp. 10); Ex. 1061 is cited
`
`as “evidence of a weight of an elephant” (Opp. 12); Ex. 1063 is cited to prove that
`
`“only a single iron dextran product, Imferon ®, was recalled by the FDA” (Opp.
`
`14). Petitioner’s own statements show these references are cited for asserted facts
`
`not mere description. Joy Techs, Inc. v. Manbeck (Opp. 3) does not support
`
`Petitioner’s argument. 751 F.Supp 225, 233 n.2 (D.D.C. 1990) (art cited under 35
`2
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`4845-6875-6023.2
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`IPR2015-01490
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`Reply to Opposition to Motion to Exclude
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`U.S.C. §102(a) is relevant for the embodiments it describes not their veracity),
`
`aff’d 959 F.2d 226 (Fed. Cir. 1992).
`
`With respect to only Ex. 1060, Petitioner argues that, since the exhibit is a
`
`market report or similar commercial publication, it is excepted from the hearsay
`
`rule under FRE 803(17). Opp. 10-11. But Petitioner does not provide any
`
`testimony or supplemental evidence to establish that Ex. 1060 it is generally relied
`
`on by the public or persons in particular occupations as required in this exception.
`
`See FRE 803(17); Advisory Committee Notes to FRE 803(17). On this record,
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`there is no evidentiary basis for Petitioner’s conclusion that Ex. 1060 was
`
`“produced by trustworthy sources” or offered by “a reputable company.” Opp. 5.
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`Further, Ex. 1060 is distinguishable from the commercial publication of Susemihl
`
`v. United Steamship Co., 859 F.2d 150 (4th Cir. 1988) (unpublished). In Susemihl,
`
`the commercial publication was cited for evidence of commercial availability not
`
`for facts regarding the commercial product, as Ex. 1060. Id. at 150. Thus, Ex.
`
`1060 remains inadmissible hearsay.
`
`IV. Exs. 1059, 1060, 1061, and 1063 Are Not Properly Authenticated
`Petitioner alleges that Ex. 1059, 1060, 1061, and 1063 are authenticated
`
`because they are purportedly printouts of websites. Opp. 8, 9, 11, 13, 14.
`
`Petitioner asserts that such printouts are “admissible” citing Lorraine v. Market
`
`American Insurance Co.. 241 F.R.D. 534 (D. Md. 2007). Opp. 8. But Petitioner
`3
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`4845-6875-6023.2
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`IPR2015-01490
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`Reply to Opposition to Motion to Exclude
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`misreads Lorraine which held that the proffered evidence was not admissible
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`because the “complete absence of authentication stripped the exhibits of any
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`evidentiary value.” Id. at 562. In St. Luke's Cataract and Laser Institute PA v.
`
`Sanderson, 2006 WL 1320242, at *3-4 (M. D. Fla. 2006), the court held that “[t]o
`
`authenticate printouts from a website, the party proffering the evidence must
`
`produce ‘some statement or affidavit from someone with knowledge [of the
`
`website].’” See also, EMC Corp. v. PersonalwebTechs., LLC, IPR2013-0084,
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`Paper 64 at p. 45 (PTAB May 15, 2014) (quoting St. Luke’s). Here, where
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`Petitioner has no such statement or affidavit, the webpage printouts cannot be
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`“sufficiently authenticated.”
`
`For Ex. 1060 and 1063, Petitioner does not provide a web address or date the
`
`document was accessed even to satisfy Petitioner’s own incorrect standard.
`
`Petitioner also alleges that Ex. 1059, 1060, 1061, and 1063 are authenticated
`
`because they include a copyright symbol. Opp. 8, 9, 11, 13, 14. For Ex. 1059,
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`Petitioner further argues that the copyright symbol is a trade inscription, but that is
`
`not correct. In order for a trade inscription to be self-authenticating, it needs “to
`
`have been affixed in the course of business and indicating origin, ownership, or
`
`control.” FRE 902(7). A mere copyright symbol on a website does provide any
`
`evidence of “origin, ownership or control.” These exhibits should be excluded.
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`4845-6875-6023.2
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`4
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`IPR2015-01490
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`Reply to Opposition to Motion to Exclude
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`V. Ex. 1054 Is Mischaracterized
`Petitioner alleges that Patent Owner did not timely object, but ignores the
`
`multiple objections raised by Patent Owner during Dr. Manzi’s deposition. As
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`required by the rules, Patent Owner sought to preserve the objections in the motion
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`to exclude. 37 C. F. R. § 42.64(c). Even in the Opposition, Petitioner truncates
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`Dr. Manzi’s testimony to incorrectly characterize Beshara as disclosing the
`
`properties of VIT-45. Opp. 3. Petitioner also incorrectly attributes the properties
`
`described in an example in the ’702 patent to the iron polymaltose of Beshara. In
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`the same breath, Petitioner incongruently states that Dr. Manzi’s testimony was
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`“not relied upon.” Opp. 3.
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`VI. CONCLUSION
`Patent Owner urges the Board to exclude exhibits Exs. 1055, 1056, 1057,
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`1059, 1060, 1061, and 1063, and the objected-to portions of Ex. 1054, as well as
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`the arguments that rely on these exhibits.
`
`Respectfully submitted,
`
`/George E. Quillin/
`George E. Quillin
`Registration No. 32,792
`
`Michael D. Kaminski
`Registration No. 32,904
`
`
`
`5
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`Date: August 30, 2016
`
`
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`Foley & Lardner LLP
`3000 K Street, N.W., Suite 600
`Washington, D.C. 20007
`Counsel for Patent Owner
`
`4845-6875-6023.2
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`
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`IPR2015-01490
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` Reply to Opposition to Motion to Exclude
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the Reply to Opposition to Motion
`
`to Exclude is being served on August 30, 2016, by filing it through the PTAB E2E
`
`System as well as delivering copies via email to the following counsel for the
`
`Petitioner:
`
`
`
`Lisa Kole
`Baker Botts L.L.P.,
`30 Rockefeller Plaza, 45th Floor,
`New York, NY 10112
`E-mail: lisa.kole@bakerbotts.com
`
`Steven Lendaris
`Baker Botts L.L.P.,
`E-mail: steven.lendaris@bakerbotts.com
`
`Paul Ragusa
`Baker Botts L.L.P.,
`E-mail: paul.ragusa@bakerbotts.com
`
`
`/George E. Quillin/
`George E. Quillin
`Registration No. 32,792
`Counsel for Patent Owner
`
`
`
`4845-6875-6023.2
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