IPR2017-00323
`Patent No. 6,943,166
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________
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`
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`ICOS CORPORATION
`Patent Owner.
`
`______________________
`
`
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`IPR2017-00323
`Patent No. 6,943,166
`
`______________________
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
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`Patent No. 6,943,166
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`ICOS CORPORATION
`Patent Owner.
`
`______________________
`
`
`
`IPR2017-00323
`Patent No. 6,943,166
`
`______________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
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`
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`IPR2017-00323
`Patent No. 6,943,166
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner submits the following
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`
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`objections to evidence served with the Petition for Inter Partes Review of U.S.
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`Patent No. 6,943,166 (Paper No. 2).
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`Exhibit 1008- Patent Owner objects
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`to Exhibit 1008 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, date of the exhibit, or its public availability prior to the
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`critical date. No evidence establishes that Exhibit 1008 is what Petitioner claims it
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`is. Patent Owner objects to Exhibit 1008 as not relevant, a waste of time, and not
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`helpful to trier of fact under FRE 402 and 403 as there is no admissible evidence
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`establishing its public availability prior to the critical date of the ’166 patent.
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`Patent Owner also objects to Exhibit 1008 as hearsay (FRE 802), e.g., offering the
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`out of court statements of various reviewers for the truth of the matters asserted
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`(e.g., 0037, 0052, 0070, 0095, 0126, 0128, 0132, 0139, 0146, 0155, 0173, 0188,
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`0211, 0217, 0223, 0238, 0245, 0251, etc.); and as hearsay within hearsay (FRE
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`805), e.g. offering the out of court statements of the drug sponsor (e.g., 0061, 0317,
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`0359, 0363, 0387), pharmacologists (e.g. 0039) and test subjects (e.g., 0061, 0070,
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`0122, 0125, 0138, 0145, 0150, 0184, 0196, 0203, 0208, 0215, etc.) for the truth of
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`the matters asserted.
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`Exhibit 1010- Patent Owner objects
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`to Exhibit 1010 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`1
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`IPR2017-00323
`Patent No. 6,943,166
`establish the authenticity or date of the exhibit. No evidence establishes that
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`
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`Exhibit 1010 is what Petitioner claims it is. Patent Owner objects to Exhibit 1010
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`as not relevant, a waste of time, and not helpful to trier of fact under FRE 402 and
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`403 as it is dated in 2015 and accessed in 2016, years after the relevant critical date
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`of the ’166 patent. Patent Owner also objects to Exhibit 1010 as hearsay (FRE
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`802), e.g., offering the out of court statements of the author of the document for the
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`truth of the matter asserted.
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`Exhibit 1014- Patent Owner objects
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`to Exhibit 1014 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, date of the exhibit, or its public availability prior to the
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`critical date. No evidence establishes that Exhibit 1014 is what Petitioner claims it
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`is. Patent Owner objects to Exhibit 1014 as not relevant, a waste of time, and not
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`helpful to trier of fact under FRE 402 and 403 as there is no admissible evidence
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`establishing its public availability prior to the critical date of the ’166 patent.
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`Patent Owner also objects to Exhibit 1014 as hearsay (FRE 802), e.g., offering the
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`out of court statements of the author of the document for the truth of the matter
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`asserted.
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`Exhibit 1019- Patent Owner objects
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`to Exhibit 1019 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit, or its public availability prior to
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`2
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`IPR2017-00323
`Patent No. 6,943,166
`the critical date. No evidence establishes that Exhibit 1019 is what Petitioner
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`claims it is. Patent Owner objects to Exhibit 1019 as not relevant, a waste of time,
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`and not helpful to trier of fact under FRE 402 and 403 as there is no admissible
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`evidence establishing its public availability prior to the critical date of the ’166
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`patent. Patent Owner also objects to Exhibit 1019 as hearsay (FRE 802), e.g.,
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`offering the out of court statements of the authors of the document for the truth of
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`the matter asserted.
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`Exhibit 1020- Patent Owner objects
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`to Exhibit 1020 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit, or its public availability prior to
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`the critical date. No evidence establishes that Exhibit 1020 is what Petitioner
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`claims it is. Patent Owner objects to Exhibit 1020 as not relevant, a waste of time,
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`and not helpful to trier of fact under FRE 402 and 403 as there is no admissible
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`evidence establishing its public availability prior to the critical date of the ’166
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`patent. Patent Owner also objects to Exhibit 1020 as hearsay (FRE 802), e.g.,
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`offering the out of court statements of the authors of the document for the truth of
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`the matter asserted; and as hearsay within hearsay (FRE 805), e.g., offering the out
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`of court statements of Eli Lilly and Company, ICOS Corporation, George
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`Rathmann, and August M. Watanabe for the truth of the matters asserted.
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`3
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`Exhibit 1021- Patent Owner objects
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`IPR2017-00323
`Patent No. 6,943,166
`to Exhibit 1021 as
`lacking
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`
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit, or its public availability prior to
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`the critical date. No evidence establishes that Exhibit 1021 is what Petitioner
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`claims it is. Patent Owner objects to Exhibit 1021 as not relevant, a waste of time,
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`and not helpful to trier of fact under FRE 402 and 403 as there is no admissible
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`evidence establishing its public availability prior to the critical date of the ’166
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`patent. Patent Owner also objects to Exhibit 1021 as hearsay (FRE 802), e.g.,
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`offering the out of court statements of the author of the document for the truth of
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`the matter asserted; and as hearsay within hearsay (FRE 805), e.g., offering the out
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`of court statements of ICOS Corp., “former collaborators,” and unknown others
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`(e.g. “[t]wo phase II studies, in 175 and 300 patients, have now been reported as
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`completed”) for the truth of the matters asserted.
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`Exhibit 1026- Patent Owner objects
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`to Exhibit 1026 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit, or its public availability prior to
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`the critical date. No evidence establishes that Exhibit 1026 is what Petitioner
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`claims it is. Patent Owner objects to Exhibit 1026 as not relevant, a waste of time,
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`and not helpful to trier of fact under FRE 402 and 403 as there is no admissible
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`4
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`IPR2017-00323
`Patent No. 6,943,166
`evidence establishing its public availability prior to the critical date of the ’166
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`
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`patent.
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`Exhibit 1030- Patent Owner objects
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`to Exhibit 1030 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit, or its public availability prior to
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`the critical date. No evidence establishes that Exhibit 1030 is what Petitioner
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`claims it is. Patent Owner objects to Exhibit 1030 as not relevant, a waste of time,
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`and not helpful to trier of fact under FRE 402 and 403 as it is dated years after the
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`relevant critical date of the ’166 patent.
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`Exhibit 1031- Patent Owner objects
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`to Exhibit 1031 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit, or its public availability prior to
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`the critical date. No evidence establishes that Exhibit 1031 is what Petitioner
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`claims it is. (See Paper 12 at 10 n.5.) Patent Owner objects to Exhibit 1031 as not
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`relevant, a waste of time, and not helpful to trier of fact under FRE 402 and 403 as
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`it was accessed in 2016, years after the relevant critical date of the ’166 patent.
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`Patent Owner also objects to Exhibit 1031 as hearsay (FRE 802), e.g., offering the
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`out of court statements of an author of the document for the truth of the matter
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`asserted (e.g., relying on the “Date created” date as a fact). See ServiceNow, Inc. v.
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`Hewlett-Packard Co., IPR2015-00707, Paper 12 at 16 (PTAB Aug. 26, 2015).
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`5
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`Exhibit 1032- Patent Owner objects
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`IPR2017-00323
`Patent No. 6,943,166
`to Exhibit 1032 as
`lacking
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`
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit, or its public availability prior to
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`the critical date. No evidence establishes that Exhibit 1032 is what Petitioner
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`claims it is. Patent Owner objects to Exhibit 1032 as not relevant, a waste of time,
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`and not helpful to trier of fact under FRE 402 and 403 as there is no admissible
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`evidence establishing its public availability prior to the critical date of the ’166
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`patent. Patent Owner also objects to Exhibit 1032 as hearsay (FRE 802), e.g.,
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`offering the out of court statements of Robert Temple, M.D. in the document for
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`the truth of the matter asserted (e.g., the approval of NDA 20-895, the March 27,
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`1998 date).
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`Exhibit 1033- Patent Owner objects
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`to Exhibit 1033 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit (document containing dates from
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`2007 and 1998), or its public availability prior to the critical date. No evidence
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`establishes that Exhibit 1033 is what Petitioner claims it is. Patent Owner objects
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`to Exhibit 1033 as not relevant, a waste of time, and not helpful to trier of fact
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`under FRE 402 and 403 as it was accessed in 2016 and dated in 2007, years after
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`the relevant critical date of the ’166 patent. Patent Owner also objects to Exhibit
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`1033 as hearsay (FRE 802), e.g., offering the out of court statements of the author
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`6
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`IPR2017-00323
`Patent No. 6,943,166
`of the document for the truth of the matter asserted (e.g., the FDA’s approval of
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`
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`Viagra, the March 27, 1998 date); and as hearsay within hearsay (FRE 805), e.g.,
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`offering the out of court statements of “men on Viagra” for the truth of the matters
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`asserted.
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`Exhibit 1034- Patent Owner objects
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`to Exhibit 1034 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit (document containing dates from
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`2004 and 1998), or its public availability prior to the critical date. No evidence
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`establishes that Exhibit 1034 is what Petitioner claims it is. Patent Owner objects
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`to Exhibit 1034 as not relevant, a waste of time, and not helpful to trier of fact
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`under FRE 402 and 403 as it was accessed in 2016 and dated in 2004, years after
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`the relevant critical date of the ’166 patent. Patent Owner also objects to Exhibit
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`1034 as hearsay (FRE 802), e.g., offering the out of court statements of the author
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`of the document for the truth of the matter asserted (e.g., the FDA’s approval of
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`Viagra, the March 27, 1998 date); and as hearsay within hearsay (FRE 805), e.g.,
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`offering the out of court statements of the FDA, Arvind Desai, William C. Steere,
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`Joseph Feczko, and Pfizer for the truth of the matters asserted.
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`Exhibit 1035- Patent Owner objects
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`to Exhibit 1035 as
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`lacking
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`authentication under FRE 901 because sufficient evidence has not been provided to
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`establish the authenticity, the date of the exhibit, or its public availability prior to
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`7
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`IPR2017-00323
`Patent No. 6,943,166
`the critical date. No evidence establishes that Exhibit 1035 is what Petitioner
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`
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`claims it is. Patent Owner objects to Exhibit 1035 as not relevant, a waste of time,
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`and not helpful to trier of fact under FRE 402 and 403 as there is no admissible
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`evidence establishing its public availability prior to the critical date of the ’166
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`patent. Patent Owner also objects to Exhibit 1035 as hearsay (FRE 802), e.g.,
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`offering the out of court statements of the author of the document for the truth of
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`the matter asserted.
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`Exhibit 1002- Patent Owner objects to paragraphs 10, 28, 46, 48, 49, 50, 51,
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`62, 63, 66, 71, 73, 75-79, 81, 82, 85, 94, 102, and 108 of Exhibit 1002, the
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`Declaration of Dr. George Grass, Pharm.D., Ph.D. under FRE 901 and 802 as
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`relying on unauthenticated and hearsay evidence. Patent Owner also objects to
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`paragraphs 75, 77, 79, 82, 98-100, and 106-107 as improper expert testimony
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`under FRE 702 and 703 as the calculations and graphs included and relied on
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`therein are not based on sufficient facts or data, are not the products of reliable
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`principles or methods, and provide no help for the trier of fact to evaluate the
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`expert opinion. Patent Owner also objects to the above-identified paragraphs as not
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`relevant and more prejudicial than probative as being based on inadmissible
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`evidence or lacking reliability and support (FRE 401, 402, 403).
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`Exhibit 1004- Patent Owner objects to paragraphs 31, 33, 35, 41, 42, 45, 49,
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`50, 52, 54 of Exhibit 1004, the Declaration of Dr. Muta Issa, M.D., under FRE 901
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`8
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`IPR2017-00323
`Patent No. 6,943,166
`and 802 as relying on unauthenticated and hearsay evidence. Patent Owner also
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`objects to the above-identified paragraphs as not relevant and more prejudicial than
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`probative as being based on inadmissible evidence (FRE 401, 402, 403).
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`Dated: June 26, 2017
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`Respectfully submitted,
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`By:
`
`/Mark J. Feldstein /
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`
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`Mark J. Feldstein, Reg. No. 46,693
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
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`9
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`CERTIFICATE OF SERVICE
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`IPR2017-00323
`Patent No. 6,943,166
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S OBJECTIONS TO EVIDENCE was served on June 26, 2017, via
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`electronic mail directed to counsel of record for the Petitioner at the following:
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`Steven W. Parmelee
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100, Seattle, WA 98104-7036
`sparmelee@wsgr.com
`
`Michael T. Rosato
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100, Seattle, WA 98104-7036
`mrosato@wsgr.com
`
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100, Seattle, WA 98104-7036
`jmills@wsgr.com
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`Petitioner has agreed to electronic service.
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`Dated: June 26, 2017
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`By: /Maureen D. Queler /
`Maureen D. Queler
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`10
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