UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PHARMACOSMOS A/S
`Petitioner
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`v.
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`LUITPOLD PHARMACEUTICALS, INC.
`Patent Owner
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`Patent No. 7,754,702
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`Title: METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
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`Inter Partes Review No. 2015-01490
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`PETITIONER’S RESPONSE TO PATENT OWNER’S OBJECTIONS TO
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(2)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PHARMACOSMOS A/S
`Petitioner
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`v.
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`LUITPOLD PHARMACEUTICALS, INC.
`Patent Owner
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`Patent No. 7,754,702
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`Title: METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON
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`Inter Partes Review No. 2015-01490
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`PETITIONER’S RESPONSE TO PATENT OWNER’S OBJECTIONS TO
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(2)
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`Patent No. 7,754,702
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`IPR2015-01490
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`Petitioner Pharmacosmos A/S (“Petitioner”) hereby submits its Response to
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`Patent Owner Objections to Evidence served on June 27, 2016.
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`PETITIONER’S RESPONSES TO PATENT
`OWNER’S OBJECTIONS TO EVIDENCE
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`PATENT OWNER’S OBJECTION NO. 1 RELATING TO WANG
`(EXHIBIT 1055)
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`Patent Owner objects to Exhibit 1055 under Fed. R. Evid. 401, 402, 801 and
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`802, contending that its lacks relevance and that it is “[h]earsay and hearsay within
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`hearsay.”
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to Wang and maintains
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`that Wang should be admissible in these proceedings because is not inadmissible
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`hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner disagrees with Patent
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`Owner’s objections that Wang is not relevant, as it is properly cited to show the
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`state of the art at or around the time of the purported invention. Petitioner cites to
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`Wang, a review of risk associated with intravenous iron products in the Journal of
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`the American Medical Association, as evidence to refute statements made by
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`Patent Owner that iron dextran was recalled from the market. Wang reports that
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`iron dextran was regularly used at high doses around the filing date of U.S. Patent
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`No. 7,754,702 (“the ‘702 patent”) and at least through 2013. See Paper 34 at pp.
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`21-23. Wang is not relied upon to make Petitioner’s prima facie case. Moreover,
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`the fact that Wang was published after the priority date of the ‘702 patent is
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`immaterial. See Liberty Mutual v. Progressive Casualty Insurance, CBM2012-
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`00002, slip op. at 64 (PTAB January 23, 2014) (Paper 66) (“It is well settled that
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`references that have publication dates after the critical date may be cited to show
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`the state of the art at or around the time of the invention.” (citing Eli Lilly and Co.
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`v. Barr Labs., Inc., 251 F.3d 955, 969-70 (Fed. Cir. 2001))).
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Wang and/or to the extent the
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`Patent Owner seeks to challenge any portions of Wang in any other manner.
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`PATENT OWNER’S OBJECTION NO. 2 RELATING TO THE
`SUPPLEMENTARY CONTENT OF WANG (EXHIBIT 1056)
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`Patent Owner objects to Exhibit 1056 under Fed. R. Evid. 401, 402, 801 and
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`802, contending that its lacks relevance and that it is “[h]earsay and hearsay within
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`hearsay.”
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to the Exhibit 1056 and
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`maintains that Exhibit 1056 should be admissible in these proceedings because is
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`not inadmissible hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner
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`disagrees with Patent Owner’s objections that Exhibit 1056 is not relevant, as it
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`properly cited to show the state of the art at or around the time of the purported
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`invention. Exhibit 1056 is the supplemental content for Wang (Exhibit 1055) and
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`is cited by the Petitioner as further evidence that although iron dextran has been
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`administered at high doses only 0.0307 percent of the 68,305 patients discussed in
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`Wang experienced anaphylaxis. See Paper 34 at p. 21. Exhibit 1056 is not relied
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`upon to make Petitioner’s prima facie case. Moreover, the fact that Exhibit 1056
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`was published after the priority date of the ‘702 patent is immaterial. See Liberty
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`Mutual v. Progressive Casualty Insurance, CBM2012-00002, slip op. at 64 (PTAB
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`January 23, 2014) (Paper 66) (“It is well settled that references that have
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`publication dates after the critical date may be cited to show the state of the art at
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`or around the time of the invention.” (citing Eli Lilly and Co. v. Barr Labs., Inc.,
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`251 F.3d 955, 969-70 (Fed. Cir. 2001))).
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Exhibit 1056 and/or to the extent
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`the Patent Owner seeks to challenge any portions of Exhibit 1056 in any other
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`manner.
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`PATENT OWNER’S OBJECTION NO. 3 RELATING TO THE KEATING
`(EXHIBIT 1057)
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`Patent Owner objects to Exhibit 1057 under Fed. R. Evid. 401, 402, 801 and
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`802 contending that its lacks relevance and that it is hearsay.
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to Exhibit 1057 and
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`maintains that it should be admissible in these proceedings because is not
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`inadmissible hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner
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`disagrees with Patent Owner’s objections that Exhibit 1057 is not relevant, as it is
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`properly cited to show the state of the art at or around the time of the purported
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`invention. Petitioner cites to Exhibit 1057 as evidence that the Beshara reference
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`discloses the properties of VIT-45. See Paper 34 at p. 24. Exhibit 1057 is offered
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`to show that while the title of Beshara indicates that it relates to polymaltose,
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`Beshara discloses the properties of ferric carboxymaltose. Id. As such, while
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`Exhibit 1057 is cited to show the state of the art at or around the time of the
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`invention, it is not relied upon to make Petitioner’s prima facie case.
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Exhibit 1057 and/or to the extent
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`the Patent Owner seeks to challenge any portions of Exhibit 1057 in any other
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`manner.
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`PATENT OWNER’S OBJECTION NO. 4 RELATING TO THE
`PRESENTATION FROM THE GALENICA GROUP (EXHIBIT 1059)
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`Patent Owner objects to Exhibit 1059 under Fed. R. Evid. 401, 402, 801,
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`802 and 901 contending that its lacks relevance, that it is hearsay and that it lacks
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`authentication.
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to the Exhibit 1059 and
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`maintains that Exhibit 1059 should be admissible in these proceedings because is
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`not inadmissible hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner
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`disagrees with Patent Owner’s objections that Exhibit 1059 is not relevant, as it is
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`properly cited to show the state of the art at or around the time of the purported
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`invention. Petitioner cites to Exhibit 1059 to refute statements made by Patent
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`Owner that iron dextran was recalled from the market. Exhibit 1059 is evidence
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`that sales of an iron dextran product, InFed®, have remained steady from August
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`2013 to December 2015, demonstrating that iron dextran products are still
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`currently used. See Paper 34 at p. 21. Exhibit 1059 is not relied upon to make
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`Petitioner’s prima facie case. Moreover, the fact that Exhibit 1059 was published
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`after the priority date of the ‘702 patent is immaterial. See Liberty Mutual v.
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`Progressive Casualty Insurance, CBM2012-00002, slip op. at 64 (PTAB January
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`23, 2014) (Paper 66) (“It is well settled that references that have publication dates
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`after the critical date may be cited to show the state of the art at or around the time
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`of the invention.” (citing Eli Lilly and Co. v. Barr Labs., Inc., 251 F.3d 955, 969-
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`70 (Fed. Cir. 2001))).
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`Petitioner disagrees with Patent Owner’s objections that Exhibit 1059 lacks
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`authentication. Exhibit 1059 is complete, and, it is self-authenticating, or it is what
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`it purports to be. See Fed. R. Evid. 901. Petitioner notes that the Patent Owner has
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`not pointed to any particular defects in the contents of Exhibit 1059.
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Exhibit 1059 and/or to the extent
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`the Patent Owner seeks to challenge any portions of Exhibit 1059 in any other
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`manner.
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`PATENT OWNER’S OBJECTION NO. 5 RELATING TO THE CHARLES
`RIVER MONOGRAPH FOR C57BL/6 MICE (EXHIBIT 1060)
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`Patent Owner objects to Exhibit 1060 under Fed. R. Evid. 401, 402, 801,
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`802 and 901 contending that its lacks relevance, that it is hearsay and that it lacks
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`authentication.
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to Exhibit 1060 and
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`maintains that it should be admissible in these proceedings because is not
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`inadmissible hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner
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`disagrees with Patent Owner’s objections that Exhibit 1060 is not relevant, as it is
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`properly cited to show the state of the art at or around the time of the purported
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`invention. Petitioner cites to Exhibit 1060 as evidence of the weight of a mouse.
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`See Paper 34 at p. 7. Petitioner has argued that because the proposed substitute
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`claims require administration of at least 0.6 grams of iron as a single unit dose but
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`do not specify the species of the subject being treated, they are not enabled by the
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`specification because the recited amount would have different consequences on
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`different species. See id. at pp. 6-7. Although it is self-evident that different
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`species of animals can have vastly different weights, Exhibit 1060 is cited as
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`further evidence of the weight of one species, a mouse, to illustrate that the
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`administration of at least 0.6 grams of iron as a single unit dose to a mouse would
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`have different consequences than the administration of the same dose to a larger
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`animal such as an elephant. See id. at p. 7. As such, while Exhibit 1060 is cited to
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`show the state of the art at or around the time of the invention, it is not relied upon
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`to make Petitioner’s prima facie case. Moreover, the fact that Exhibit 1060 was
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`published after the priority date of the ‘702 patent is immaterial. See Liberty
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`Mutual v. Progressive Casualty Insurance, CBM2012-00002, slip op. at 64 (PTAB
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`January 23, 2014) (Paper 66) (“It is well settled that references that have
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`publication dates after the critical date may be cited to show the state of the art at
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`or around the time of the invention.” (citing Eli Lilly and Co. v. Barr Labs., Inc.,
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`251 F.3d 955, 969-70 (Fed. Cir. 2001))).
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`Petitioner disagrees with Patent Owner’s objections that Exhibit 1060 lacks
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`authentication. Exhibit 1060 is complete, and, it is self-authenticating, or it is what
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`it purports to be. See Fed. R. Evid. 901. Petitioner notes that the Patent Owner has
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`not pointed to any particular defects in the contents of Exhibit 1060.
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Exhibit 1060 and/or to the extent
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`the Patent Owner seeks to challenge any portions of Exhibit 1060 in any other
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`manner.
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`PATENT OWNER’S OBJECTION NO. 6 RELATING TO THE WEBPAGE
`FOR THE SAN DIEGO ZOO (EXHIBIT 1061)
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`Patent Owner objects to Exhibit 1061 under Fed. R. Evid. 401, 402, 801,
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`802 and 901 contending that its lacks relevance, that it is hearsay and that it lacks
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`authentication.
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to Exhibit 1061 and
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`maintains that it should be admissible in these proceedings because is not
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`inadmissible hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner
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`disagrees with Patent Owner’s objections that Exhibit 1061 is not relevant, as it is
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`properly cited to show the state of the art at or around the time of the purported
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`invention. Petitioner cites to Exhibit 1061 as evidence of the weight of an
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`elephant. See Paper 34 at p. 7. Petitioner has argued that because the claims
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`require administration of at least 0.6 grams of iron as a single unit dose but do not
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`specify the species of the subject being treated, they are not enabled by the
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`specification because the recited amount would have different consequences on
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`different species. See id. at pp. 6-7. Exhibit 1061 is cited as further evidence of
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`the weight of one species, an elephant, to illustrate that the administration of at
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`least 0.6 grams of iron as a single unit dose to an elephant would have different
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`consequences than the administration of the same dose to a smaller animal such as
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`a mouse. See id. at p. 7. As such, while Exhibit 1061 is cited to show the state of
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`the art at or around the time of the invention, it is not relied upon to make
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`Petitioner’s prima facie case. Moreover, the fact that Exhibit 1061 was published
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`after the priority date of the ‘702 patent is immaterial. See Liberty Mutual v.
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`Progressive Casualty Insurance, CBM2012-00002, slip op. at 64 (PTAB January
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`23, 2014) (Paper 66) (“It is well settled that references that have publication dates
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`after the critical date may be cited to show the state of the art at or around the time
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`of the invention.” (citing Eli Lilly and Co. v. Barr Labs., Inc., 251 F.3d 955, 969-
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`70 (Fed. Cir. 2001))).
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`Petitioner disagrees with Patent Owner’s objections that Exhibit 1061 lacks
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`authentication. Exhibit 1061 is complete, and, it is self-authenticating, or it is what
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`it purports to be. See Fed. R. Evid. 901. Petitioner notes that the Patent Owner has
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`not pointed to any particular defects in the contents of Exhibit 1061.
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Exhibit 1061 and/or to the extent
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`the Patent Owner seeks to challenge any portions of Exhibit 1061 in any other
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`manner.
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`PATENT OWNER’S OBJECTION NO. 7 RELATING TO EGELI
`(EXHIBIT 1062)
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`Patent Owner objects to Exhibit 1062 under Fed. R. Evid. 401, 402, 801 and
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`802, contending that its lacks relevance and that it is hearsay.
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to the Exhibit 1062 and
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`maintains that Exhibit 1062 should be admissible in these proceedings because is
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`not inadmissible hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner
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`disagrees with Patent Owner’s objections that Exhibit 1062 is not relevant, as it is
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`properly cited to show the state of the art at or around the time of the purported
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`invention. Petitioner cites to Exhibit 1062 as evidence that iron carbohydrate
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`complex supplementation is used in veterinary medicine, and that prior to the filing
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`date of the ‘702 patent, iron dextran was administered subcutaneously to day-old
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`piglets. See Paper 34 at p. 7. Exhibit 1062 is provided to illustrate that the
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`proposed substitute claims do not specify the species of subject being treated,
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`because Exhibit 1062 is evidence of veterinary use of iron carbohydrate complexes
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`prior to the filing date of the ‘702 patent. Id. While Exhibit 1062 is cited to show
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`the state of the art at or around the time of the invention, it is not relied upon to
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`make Petitioner’s prima facie case.
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Exhibit 1062 and/or to the extent
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`the Patent Owner seeks to challenge any portions of Exhibit 1062 in any other
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`manner.
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`PATENT OWNER’S OBJECTION NO. 8 RELATING TO DOCUMENT
`REGARDING IMFERON®’S RECALL (EXHIBIT 1063)
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`Patent Owner objects to Exhibit 1063 under Fed. R. Evid. 401, 402, 801,
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`802 and 901 contending that its lacks relevance, that it is hearsay and that it lacks
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`authentication.
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to the Exhibit 1063 and
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`maintains that Exhibit 1063 should be admissible in these proceedings because is
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`not inadmissible hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner
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`disagrees with Patent Owner’s objections that Exhibit 1063 is not relevant, since it
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`is properly cited to refute statements made by the Patent Owner that iron dextran
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`was recalled from the market. Exhibit 1063 is provided as evidence that only a
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`single iron dextran product, Imferon®, was recalled by the FDA. See Paper 34 at
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`p. 22. As such, while Exhibit 1063 is cited to show the state of the art at or around
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`the time of the invention, it is not relied upon to make Petitioner’s prima facie
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`case.
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`Petitioner disagrees with Patent Owner’s objections that Exhibit 1063 lacks
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`authentication. Exhibit 1063 is complete, and, it is self-authenticating, or it is what
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`it purports to be. See Fed. R. Evid. 901. Petitioner notes that the Patent Owner has
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`not pointed to any particular defects in the contents of Exhibit 1063.
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Exhibit 1063 and/or to the extent
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`the Patent Owner seeks to challenge any portions of Exhibit 1063 in any other
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`manner.
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`PATENT OWNER’S OBJECTION NO. 9 RELATING TO GEISSER 1991
`(EXHIBIT 1065)
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`Patent Owner objects to Exhibit 1065 under Fed. R. Evid. 401, 402, 801 and
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`802, contending that its lacks relevance and that it hearsay.
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`PETITIONER’S RESPONSE
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`Petitioner disagrees with Patent Owner’s objections to the Exhibit 1065 and
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`maintains that Exhibit 1065 should be admissible in these proceedings because is
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`not inadmissible hearsay. See Fed. R. Evid. 801, 803, 807. Further, Petitioner
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`disagrees with Patent Owner’s objections that Exhibit 1065 is not relevant, as it is
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`properly cited as exemplary prior art. Petitioner cites to Exhibit 1065 as evidence
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`that iron carbohydrate complexes were administered in veterinary medicine and
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`that Anaemex®, an iron dextran complex, was administered intramuscularly to
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`calves at a single dose of 1600-2400 mg iron prior to the filing date of the ‘702
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`patent. Paper 34 at pp. 21-22. Exhibit 1065 is provided as a piece of prior art and
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`as exemplary of a class of veterinary prior art which Patent Owner has improperly
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`not considered in the context of its proposed substitute claims. As such, Exhibit
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`1065 is not relied upon to make Petitioner’s prima facie case.
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`Petitioner reserves the right to respond further to Patent Owner’s objections
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`in the event that Patent Owner seeks to exclude Exhibit 1065 and/or to the extent
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`the Patent Owner seeks to challenge any portions of Exhibit 1065 in any other
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`Respectfully submitted,
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`BAKER BOTTS L.L.P.
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`/s/ Lisa Kole
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`ATTORNEYS FOR
`PHARMACOSMOS
`
`Lisa Kole (PTO Reg. No. 35,225)
`Steven Lendaris (PTO Reg. No. 53,202)
`Paul Ragusa (PTO Reg. No. 38,587)
`Jennifer Tempesta (PTO Reg. No. 59,021)
`Baker Botts L.L.P.
`30 Rockefeller Plaza
`New York, NY 10112
`Telephone: (212) 408-2500
`Facsimile: (212) 408-2501
`Email: lisa.kole@bakerbotts.com
`steven.lendaris@bakerbotts.com
`paul.ragusa@bakerbotts.com
`jennifer.tempesta@bakerbotts.com
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`manner.
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`July 11, 2016
`Date
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`IPR2015-01490
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`Patent No. 7,754,702
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`CERTIFICATE OF SERVICE ON PATENT OWNER
`UNDER 37 C.F.R. § 42.105(a)
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`The undersigned hereby certifies that the foregoing PETITIONER’S
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`RESPONSE TO PATENT OWNER’S OBJECTIONS TO EVIDENCE
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`PURSUANT TO 37 C.F.R § 42.64(b)(2) is being served on July 11, 2016 by filing
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`through the Patent Review Processing System and delivering a copy via email to
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`the counsel for Patent Owner at the addresses of record:
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`Respectfully submitted,
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`/s/ Lisa Kole
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`Lisa Kole (PTO Reg. No. 35,225)
`Baker Botts L.L.P.
`30 Rockefeller Plaza
`New York, NY 10112
`Telephone: (212) 408-2500
`Facsimile: (212) 408-2501
`Email: lisa.kole@bakerbotts.com
`
`George E. Quillin
`Michael D. Kaminski
`Foley & Lardner L.L.P
`3000 K Street, N.W., Suite 600
`Washington, D.C. 20007
`Email: gquillin@foley.com
`mkaminski@foley.com
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`Dated: July 11, 2016
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`Active 26663846.2
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