UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SANOFI-AVENTIS U.S. LLC AND
`REGENERON PHARMACEUTICALS, INC,
`Petitioners
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`
`
`
`Case IPR2015-01624
`U.S. Patent No. 6,331,415
`
`_____________
`
`PETITIONERS' OBJECTION S TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`
`
`720371673
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`Pursuant to 37 C.F.R. § 42.64, Petitioners sanofi-aventis U.S. LLC and
`
`Regeneron Pharmaceuticals, Inc. object to the admissibility of the following
`
`exhibits served by Patent Owners Genentech, Inc. and City of Hope during the
`
`deposition of Jefferson Foote on April 21, 2016.1
`
`I.
`
`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`
`
`Evidence
`Foote Deposition
`Exhibit 1
`(Expert Report of
`Jefferson Foote,
`Ph.D., in Glaxo
`Group vs. Genentech)
`
`Objections
`Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`Improper Impeachment with Extrinsic Evidence: A
`proper foundation was not laid with the exhibit for
`introduction as extrinsic evidence of any prior
`inconsistent statements on non-collateral matters. Fed. R.
`Evid. 613, 611.
`
`
`Relevance: The exhibit is irrelevant to the extent that it
`contains Dr. Foote's statements in a prior litigation
`concerning the validity of U.S. Patent No. 6,331,415 ("the
`'415 patent")—the patent at issue in the instant IPR
`proceeding—on invalidity grounds that are not the same
`or substantially the same as the § 103 invalidity grounds
`currently instituted in the instant proceeding. Fed. R.
`Evid. 402. Secondly, any of the exhibit's probative value
`to the § 103 invalidity grounds instituted in the instant
`proceeding is substantially outweighed by the danger of
`unfair prejudice, confusing the issues, misleading the
`Board as trier of fact, undue delay, wasting time, and
`
`1 Petitioners also objected to the introduction of these exhibits during the deposition. Patent
`owners did not "provide evidence to cure the objection during the deposition," as required by 37
`C.F.R. § 42.64(a).
`
`720371673
`
`1
`
`

`
`Foote Deposition
`Exhibit 2
`(Rebuttal Expert
`Report of Jefferson
`Foote, Ph.D., in
`Glaxo Group vs.
`Genentech)
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`needlessly presenting cumulative evidence. Fed. R. Evid.
`403. Dr. Foote has submitted a Declaration in the instant
`proceeding (Exh. 1006), rendering this exhibit cumulative
`and wasteful of the Board's resources.2
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii).
`Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`Improper Impeachment with Extrinsic Evidence: A
`proper foundation was not laid with the exhibit for
`introduction as extrinsic evidence of any prior
`inconsistent statements on non-collateral matters. Fed. R.
`Evid. 613, 611.
`
`
`Relevance: The exhibit is irrelevant to the extent that the
`exhibit contains Dr. Foote's statements in a prior litigation
`concerning the validity of the '415 patent—the patent at
`issue in the instant IPR proceeding—on invalidity
`grounds that are not the same or substantially the same as
`the § 103 invalidity grounds currently instituted in the
`instant proceeding. Fed. R. Evid. 402. Secondly, any of
`
`2 Relatedly, the B.P.A.I. has explained that "absent a compelling reason," a party may not
`"attempt to inquire on cross-examination into how direct testimony declarations came to be
`prepared," even for the proceeding at issue. Pevarello v. Lan, Patent Interference No. 105,394,
`Paper 85 at 23 (B.P.A.I. January 12, 2007) (citing efficient use of judicial resource among
`reasons to limit scope of cross-examination). Thus, Patent Owner's line of questioning regarding
`deposition exhibits 1-6 inquires into: (1) how Dr. Foote prepared and/or modified vel non his
`expert testimonies in different proceedings; and (2) whether he read his statements in preparation
`for a deposition, is irrelevant. As the B.P.A.I. noted, "it does not matter how a declaration for
`direct testimony is prepared, who suggested what, what changes were made, how drafts and the
`final declaration were transmitted to a witness for signature, etc. If a witness signed a
`declaration, a good starting point is to presume that the witness agrees with the content of the
`declaration apart from who wrote it and how many changes were made or why they were made."
`Id. at 21.
`
`720371673
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`2
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`

`
`Foote Deposition
`Exhibit 3
`(Deposition
`Transcript of
`Jefferson Foote,
`Ph.D., in Glaxo
`Group vs. Genentech,
`12/9/11)
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`the exhibit's probative value to the § 103 invalidity
`grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair
`prejudice, confusing the issues, undue delay, wasting
`time, misleading the Board as trier of fact, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403. Dr.
`Foote has submitted a Declaration in the instant
`proceeding (Exh. 1006), rendering this exhibit cumulative
`and wasteful of the Board's resources.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii).
`Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`Improper Impeachment with Extrinsic Evidence: A
`proper foundation was not laid with the exhibit for
`introduction as extrinsic evidence of any prior
`inconsistent statements on non-collateral matters. Fed. R.
`Evid. 613, 611.
`
`
`Relevance: The exhibit is irrelevant to the extent that the
`exhibit contains Dr. Foote's statements in a prior litigation
`concerning the validity of the '415 patent—the patent at
`issue in the instant IPR proceeding—on invalidity
`grounds that are not the same or substantially the same as
`the § 103 invalidity grounds currently instituted in the
`instant proceeding. Fed. R. Evid. 402. Secondly, any of
`the exhibit's probative value to the § 103 invalidity
`grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair
`prejudice, confusing the issues, misleading the Board as
`trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403. Dr.
`Foote has submitted a Declaration in the instant
`
`720371673
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`3
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`

`
`Foote Deposition
`Exhibit 4
`(Expert Report of
`Jefferson Foote,
`Ph.D. in Bristol-
`Myers Squibb vs.
`Genentech)
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`proceeding (Exh. 1006), rendering this exhibit cumulative
`and wasteful of the Board's resources.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii).
`Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`Improper Impeachment with Extrinsic Evidence: A
`proper foundation was not laid with the exhibit for
`introduction as extrinsic evidence of any prior
`inconsistent statements on non-collateral matters. Fed. R.
`Evid. 613, 611.
`
`
`Relevance: The exhibit is irrelevant to the extent that the
`exhibit contains Dr. Foote's statements in a prior litigation
`concerning the validity of the '415 patent—the patent at
`issue in the instant IPR proceeding—on invalidity
`grounds that are not the same or substantially the same as
`the § 103 invalidity grounds currently instituted in the
`instant proceeding. Fed. R. Evid. 402. Secondly, any of
`the exhibit's probative value to the § 103 invalidity
`grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair
`prejudice, confusing the issues, misleading the Board as
`trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403. Dr.
`Foote has submitted a Declaration in the instant
`proceeding (Exh. 1006), rendering this exhibit cumulative
`and wasteful of the Board's resources.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii).
`
`720371673
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`4
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`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
` Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`Improper Impeachment with Extrinsic Evidence: A
`proper foundation was not laid with the exhibit for
`introduction as extrinsic evidence of any prior
`inconsistent statements on non-collateral matters. Fed. R.
`Evid. 613, 611.
`
`
`Relevance: The exhibit is irrelevant to the extent that the
`exhibit contains Dr. Foote's statements in a prior litigation
`concerning the validity of the '415 patent—the patent at
`issue in the instant IPR proceeding—on invalidity
`grounds that are not the same or substantially the same as
`the § 103 invalidity grounds currently instituted in the
`instant proceeding. Fed. R. Evid. 402. Secondly, any of
`the exhibit's probative value to the § 103 invalidity
`grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair
`prejudice, confusing the issues, misleading the Board as
`trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403. Dr.
`Foote has submitted a Declaration in the instant
`proceeding (Exh. 1006), rendering this exhibit cumulative
`and wasteful of the Board's resources.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii).
`Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`Improper Impeachment with Extrinsic Evidence: A
`
`5
`
`Foote Deposition
`Exhibit 5
`(Rebuttal Expert
`Report of Jefferson
`Foote, Ph.D. in
`Bristol-Myers Squibb
`vs. Genentech)
`
`Foote Deposition
`Exhibit 6
`(Opening Expert
`Report of Jefferson
`Foote, Ph.D. in
`Sanofi-Aventis vs.
`Genentech)
`
`720371673
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`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`proper foundation was not laid with the exhibit for
`introduction as extrinsic evidence of any prior
`inconsistent statements on non-collateral matters. Fed. R.
`Evid. 613, 611.
`
`Relevance: The exhibit contains Dr. Foote's statements in
`a separate litigation regarding a patent (U.S. 7,923,221)
`that is not the '415 patent at issue in the instant IPR
`proceeding and therefore is irrelevant to the § 103
`invalidity grounds currently instituted in the instant
`proceeding. Fed. R. Evid. 402. Secondly, any of the
`exhibit's probative value to the § 103 invalidity grounds
`instituted in the instant proceeding is substantially
`outweighed by the danger of unfair prejudice, confusing
`the issues, misleading the Board as trier of fact, undue
`delay, wasting time, and needlessly presenting cumulative
`evidence. Fed. R. Evid. 403. Dr. Foote has submitted a
`Declaration in the instant proceeding (Exh. 1006),
`rendering this exhibit cumulative and wasteful of the
`Board's resources.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii).
`Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`
`Relevance: This exhibit contains the statements of a
`different expert in a prior litigation concerning, inter alia,
`the '415 patent and therefore is irrelevant to the § 103
`invalidity grounds currently instituted in the instant
`proceeding. Fed. R. Evid. 402. More specifically, the
`statements of Dr. Winter concern the invalidity of the '415
`patent primarily for non-enablement and lack of written
`description, with an obviousness-type double patenting
`argument that is irrelevant to the § 103 invalidity grounds
`
`Foote Exhibit 7
`(Expert Report of Sir
`Gregory Winter,
`CBE, FRS,
`Regarding Invalidity
`of U.S. Patent Nos.
`6,331,415 and
`7,923,221, in Eli Lilly
`vs. Genentech)
`
`720371673
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`6
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`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`currently instituted in the instant proceeding. Secondly,
`any of the exhibit's probative value to the § 103 invalidity
`grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair
`prejudice, confusing the issues, misleading the Board as
`trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403. Dr.
`Foote has submitted a Declaration in the instant
`proceeding (Exh. 1006), rendering this exhibit cumulative
`and wasteful of the Board's resources.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii). More specifically, Dr. Foote did not
`consider or rely upon other expert reports or testimonies
`in his Declaration.
`
`Improper Basis for an Expert's Opinion Testimony: A
`proper foundation was not laid with the exhibit to
`demonstrate that it contains statements that an expert
`would reasonably rely upon in forming an opinion. Fed.
`R. Evid. 703.
`Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`
`Relevance: This exhibit contains the statements of a
`different expert in a prior litigation concerning, inter alia,
`the '415 patent and therefore is irrelevant to the § 103
`invalidity grounds currently instituted in the instant
`proceeding. Fed. R. Evid. 402. More specifically, the
`statements of Dr. Winter concern the invalidity of the '415
`patent primarily for non-enablement and lack of written
`description, with an obviousness-type double patenting
`argument that is irrelevant to the § 103 invalidity grounds
`currently instituted in the instant proceeding. Secondly,
`any of the exhibit's probative value to the § 103 invalidity
`
`Foote Deposition
`Exhibit 8
`(Reply Expert
`Report of Sir
`Gregory Winter,
`CBE, FRS,
`Regarding Invalidity
`of U.S. Patent Nos.
`6,331,415 and
`7,923,221, in Eli Lilly
`vs. Genentech)
`
`720371673
`
`7
`
`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair
`prejudice, confusing the issues, misleading the Board as
`trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403. Dr.
`Foote has submitted a Declaration in the instant
`proceeding (Exh. 1006), rendering this exhibit cumulative
`and wasteful of the Board's resources.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii). More specifically, Dr. Foote did not
`consider or rely upon other expert reports or testimonies
`in his Declaration.
`
`Improper Basis for an Expert's Opinion Testimony: A
`proper foundation was not laid with the exhibit to
`demonstrate that it contains statements that an expert
`would reasonably rely upon in forming an opinion. Fed.
`R. Evid. 703.
`Hearsay: The exhibit sets forth inadmissible hearsay
`offered for the truth of the matters asserted therein and is
`not subject to any exceptions. Fed. R. Evid. 801, 802,
`803. Furthermore, the exhibit does not contain any non-
`hearsay statements under Fed. R. Evid. 801(d).
`
`
`Relevance: This exhibit contains the statements of a
`different expert in a prior litigation concerning, inter alia,
`the '415 patent and therefore is irrelevant to the § 103
`invalidity grounds currently instituted in the instant
`proceeding. Fed. R. Evid. 402. More specifically, the
`statements of Dr. Winter concern the invalidity of the '415
`patent primarily for non-enablement and lack of written
`description, with an obviousness-type double patenting
`argument that is irrelevant to the § 103 invalidity grounds
`currently instituted in the instant proceeding. Secondly,
`any of the exhibit's probative value to the § 103 invalidity
`grounds instituted in the instant proceeding is
`substantially outweighed by the danger of unfair
`
`Foote Deposition
`Exhibit 9
`(Deposition
`transcript of Sir
`Gregory Winter -
`Volume 1, 1/19/15 in
`Eli Lilly vs.
`Genentech)
`
`720371673
`
`8
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`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`prejudice, confusing the issues, misleading the Board as
`trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403. Dr.
`Foote has submitted a Declaration in the instant
`proceeding (Exh. 1006), rendering this exhibit cumulative
`and wasteful of the Board's resources.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(ii). More specifically, Dr. Foote did not
`consider or rely upon other technical expert reports or
`testimonies in his Declaration.
`
`Improper Basis for an Expert's Opinion Testimony: A
`proper foundation was not laid with the exhibit to
`demonstrate that it contains statements that an expert
`would reasonably rely upon in forming an opinion. Fed.
`R. Evid. 703.
`Relevance: This exhibit is a prior art patent that was not
`used, relied upon or referenced, or cited by Dr. Foote in
`his Declaration. The patent does not have any nexus with
`any instituted grounds of the proceeding and does not
`establish that any fact in issue in the proceeding is either
`more or less likely to be true, and is therefore irrelevant.
`Fed. R. Evid. 402. Secondly, any of the exhibit's
`probative value to the § 103 invalidity grounds instituted
`in the instant proceeding is substantially outweighed by
`the danger of unfair prejudice, confusing the issues,
`misleading the Board as trier of fact, undue delay, wasting
`time, and needlessly presenting cumulative evidence. Fed.
`R. Evid. 403.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R. 42.53(d)(5)(ii).
`More specifically, Dr. Foote did not consider U.S. Patent
`No. 3,996,345 in his direct testimony.
`Relevance: This exhibit is a prior art patent that was not
`used, relied upon or referenced, or cited by Dr. Foote in
`
`9
`
`Foote Deposition
`Exhibit 10
`(Ullman et al. U.S.
`Patent No. 3,996,345)
`
`Foote Deposition
`Exhibit 11
`
`720371673
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`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`his Declaration. The patent does not have any nexus with
`any instituted grounds of the proceeding and does not
`establish that any fact in issue in the proceeding is either
`more or less likely to be true, and is therefore irrelevant.
`Fed. R. Evid. 402. Secondly, any of the exhibit's
`probative value to the § 103 invalidity grounds instituted
`in the instant proceeding is substantially outweighed by
`the danger of unfair prejudice, confusing the issues,
`misleading the Board as trier of fact, undue delay, wasting
`time, and needlessly presenting cumulative evidence. Fed.
`R. Evid. 403.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R. 42.53(d)(5)(ii).
`More specifically, Dr. Foote did not consider U.S. Patent
`No. 4,299,916 in his direct testimony.
`Relevance: This exhibit is a prior art patent that was not
`used, relied upon or referenced, or cited by Dr. Foote in
`his Declaration. The patent does not have any nexus with
`any instituted grounds of the proceeding and does not
`establish that any fact in issue in the proceeding is either
`more or less likely to be true, and is therefore irrelevant.
`Fed. R. Evid. 402. Secondly, any of the exhibit's
`probative value to the § 103 invalidity grounds instituted
`in the instant proceeding is substantially outweighed by
`the danger of unfair prejudice, confusing the issues,
`misleading the Board as trier of fact, undue delay, wasting
`time, and needlessly presenting cumulative evidence. Fed.
`R. Evid. 403.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R. 42.53(d)(5)(ii).
`More specifically, Dr. Foote did not consider U.S. Patent
`No. 4,193,983 in his direct testimony.
`Relevance: This exhibit is a prior art patent that was not
`used, relied upon or referenced, or cited by Dr. Foote in
`his Declaration. The patent does not have any nexus with
`any instituted grounds of the proceeding and does not
`
`10
`
`(Litman et al. U.S.
`Patent No. 4,299,916)
`
`Foote Deposition
`Exhibit 12
`(Ullman et al. U.S.
`Patent No. 4,193,983)
`
`Foote Deposition
`Exhibit 13
`(Zuk et al. U.S.
`Patent No. 4,208,479)
`
`720371673
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`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`establish that any fact in issue in the proceeding is either
`more or less likely to be true, and is therefore irrelevant.
`Fed. R. Evid. 402. Secondly, any of the exhibit's
`probative value to the § 103 invalidity grounds instituted
`in the instant proceeding is substantially outweighed by
`the danger of unfair prejudice, confusing the issues,
`misleading the Board as trier of fact, undue delay, wasting
`time, and needlessly presenting cumulative evidence. Fed.
`R. Evid. 403.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R. 42.53(d)(5)(ii).
`More specifically, Dr. Foote did not consider U.S. Patent
`No. 4,308,479 in his direct testimony.
`Relevance: The exhibit does not depict relevant
`information and does not otherwise have any nexus with
`the § 103 invalidity grounds instituted in the instant
`proceeding. Fed. R. Evid. 401, 402. Furthermore, the
`exhibit distorts or misrepresents and/or does not fairly and
`accurately represent the real object in the underlying
`evidence as of the priority filing date of the '415 patent.
`Any probative value of the exhibit to the § 103 invalidity
`grounds instituted in the instant proceeding is therefore
`substantially outweighed by the danger of unfair
`prejudice, confusing the issues, misleading the Board as
`trier of fact, undue delay, wasting time, and needlessly
`presenting cumulative evidence. Fed. R. Evid. 403.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R. 42.53(d)(5)(ii).
`
`Improper Summary: The diagram was substantially
`prepared by the examining attorney and merely
`summarized other exhibits that Patent Owners seek to
`introduce into evidence. Fed. R. Evid. 1006, 611
`Relevance: The exhibit does not have any nexus with the
`§ 103 invalidity grounds instituted in the instant
`proceeding. Fed. R. Evid. 402. Furthermore, the exhibit's
`
`11
`
`Foote Deposition
`Exhibit 14
`(Diagram drawn at
`deposition)
`
`Foote Deposition
`Exhibit 15
`(Bujard et al. U.S.
`
`720371673
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`

`
`Patent No. 4,495,280
`History File)
`
`Foote Deposition
`Exhibit 16
`(European Patent
`Specification, EP 1
`532 260 B1)
`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`probative value to the § 103 invalidity grounds instituted
`in the instant proceeding is substantially outweighed by
`the danger of unfair prejudice, confusing the issues,
`misleading the Board as trier of fact, undue delay, wasting
`time, and needlessly presenting cumulative evidence. Fed.
`R. Evid. 403.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R.
`42.53(d)(5)(f)(ii). More specifically, Dr. Foote did not
`consider the Bujard Patent's file history in his direct
`testimony.
`
`Completeness: The exhibit does not contain the complete
`prosecution file history for the Bujard patent, the
`remainder of which is necessary to explain the exhibit, to
`place the exhibit in context, to avoid misleading the Board
`as trier of fact, and/or to insure a fair and impartial
`understanding of the exhibit. Fed. R. Evid. 106.
`
`No Basis for Expert Testimony: Dr. Foote was not
`shown to be qualified to provide opinion testimony on the
`contents of the exhibit insofar as his testimony was
`outside the established scope of his expertise. Fed. R.
`Evid. 702.
`Relevance: This exhibit is a non-prior-art foreign patent
`filed and published after the priority filing date of the '415
`patent and was not used, relied upon or referenced, or
`cited by Dr. Foote in his Declaration. The patent does not
`have any nexus with any instituted grounds of the
`proceeding and does not establish that any fact in issue in
`the proceeding is either more or less likely to be true, and
`is therefore irrelevant. Fed. R. Evid. 402. Fed. R. Evid.
`402. Secondly, any of the exhibit's probative value to the
`§ 103 invalidity grounds instituted in the instant
`proceeding is substantially outweighed by the danger of
`unfair prejudice, confusing the issues, misleading the
`Board as trier of fact, undue delay, wasting time, and
`needlessly presenting cumulative evidence. Fed. R. Evid.
`
`720371673
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`12
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`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`
`403.
`
`Scope: The contents of this exhibit are outside the scope
`of the direct testimony and thus are impermissible under
`the Rules. Fed. R. Evid. 611(b); 37 C.F.R. 42.53(d)(5)(ii).
`More specifically, Dr. Foote did not consider European
`Patent No. 1 532 260 B1 in his direct testimony.
`
`
`
`II.
`
`CONCLUSION
`
`To the extent Patent Owners fail to correct the defects identified above,
`
`Petitioners may file a motion to exclude under 37 C.F.R. § 42.64(c) pursuant to the
`
`Scheduling Order (Paper 16) in this case.
`
`
`Respectfully submitted,
`
`
`
`
`
`
`By:
`Richard McCormick (Reg. No. 55,902)
`Lisa M. Ferri (pro hac vice)
`Brian W. Nolan (Reg. No. 45,821)
`MAYER BROWN LLP
`1221 Avenue of the Americas
`New York, NY 10020-1001
`Attorneys for Petitioners sanofi-aventis U.S.
`LLC and Regeneron Pharmaceuticals, Inc.
`
`13
`
`
`
`
`Dated: April 28, 2016
`
`
`
`
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`720371673
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`

`
`IPR2015-01624
`Petitioners’ Objections to Evidence
`CERTIFICATE OF SERVICE
`
`I hereby certify that true and correct copies of the foregoing was served on
`April 28, 2016, via UPS OVERNIGHT service (courtesy by email) to counsel for
`Patent Owners at the following addresses:
`
`David L. Cavanaugh
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue, NW
`Washington, DC 20006
`
`Jeffrey P. Kushan
`Sidley Austin LLP
`1501 K Street, N.W.
`Washington, D.C. 20005
`
`Adam R. Brausa
`Durie Tangri LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`
`
`
`
`
`
`
`
`
`
`/Richard J. McCormick/
`Richard J. McCormick, (No. 55,902)
`rmccormick@mayerbrown.com
`MAYER BROWN LLP
`1221 Avenue of the Americas
`New York, NY 10020-1001
`Telephone: (212) 506-2382
`Fax: (212) 849 5682
`
`
`
`
`
`
`
`
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`720371673
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