UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`
`
`
`
`Case: IPR2015-013401
`U.S. Patent No. RE44,186
`
`
`ASTRAZENECA’S OBJECTIONS TO
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.6
`
`
`
`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, and Petitioner Aurobindo from IPR2016-01117 have been added as
`Petitioners to this proceeding.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`
`
`
`
`Case: IPR2015-013401
`U.S. Patent No. RE44,186
`
`
`ASTRAZENECA’S OBJECTIONS TO
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.6
`
`
`
`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, and Petitioner Aurobindo from IPR2016-01117 have been added as
`Petitioners to this proceeding.
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`
`
`Table of Contents
`
`Transcripts and Related Exhibits - EX1028 to EX1031 and EX1073 ............ 1
`
`
`
`
`I.
`
`II. Declarations and Reports - EX1035, EX1041, EX1060/Ex1060A, and
`EX1074 ............................................................................................................ 3
`
`III. Public Documents - EX1036 to EX1040, EX1043 to EX1059,
`EX1063 to EX1065, and EX1072 ................................................................. 16
`
`IV. Confidential Documents - EX1062/EX1062A and EX1066 to EX1071 ...... 21
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner objects to the
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`
`
`admissibility of the following Exhibits filed by Petitioners on November 7, 2016,
`
`and any reference or reliance on these Exhibits in Petitioners’ Reply, in future
`
`filings, or in any future argument before the Board.
`
`These objections are timely filed and served on November 15, 2016, i.e.,
`
`“within five business days of service,” as November 11, 2016 was a federal
`
`holiday. See 37 C.F.R. §§ 42.2, 42.64(b)(1); 5 U.S.C. § 6103.
`
`Reference to a “Rule” herein means the Federal Rules of Evidence as
`
`modified by 37 C.F.R. § 42.62(c).
`
`I.
`
`TRANSCRIPTS AND RELATED EXHIBITS - EX1028 TO EX1031
`AND EX1073
`
`OBJECTIONS TO EXHIBIT 1028
`
`Exhibit 1028 is a copy of the trial transcript of the cross-examination of Dr.
`
`Lenhard, Patent Owner’s expert declarant in this proceeding. Patent Owner
`
`objections are already of record in the transcript.
`
`
`
`OBJECTIONS TO EXHIBIT 1029
`
`Exhibit 1029 is a copy of the trial transcript of the cross-examination of Dr.
`
`Meyer, Patent Owner’s expert declarant in this proceeding. In addition to the
`
`objections already of record in the transcript per 37 C.F.R. § 42.64(a), pursuant to
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`the parties’ stipulation (Paper 35 at ¶ 6), Patent Owner objects to the following
`
`portions of Exhibit 1029 for being outside the scope of Dr. Meyer’s declaration:
`
`441:2-443:19.
`
`
`
`OBJECTIONS TO EXHIBIT 1073
`
`Exhibit 1073 is a copy of the transcript of the deposition of Dr. Weber,
`
`Patent Owner’s expert declarant in this proceeding. In addition to the objections
`
`already of record in the transcript per 37 C.F.R. § 42.64(a), Patent Owner objects
`
`to Exhibit 1073 for lacking a signed certificate. See 37 C.F.R. § 42.53(f)(6).
`
`Patent Owner further objects to Exhibit 1073 under Rule 106 (incomplete)
`
`and Rule 403 (misleading, confusing, unfair prejudice) to the extent it lacks Dr.
`
`Weber’s errata sheet. Dr. Weber was unable to complete her review of the
`
`transcript prior to submission by Petitioner. Patent Owner understands that
`
`Petitioners have been notified by the Board that the errata sheet can be included.
`
`
`
`OBJECTIONS TO EXHIBITS 1030 AND 1031
`
`Exhibits 1030 and 1031 are 2016 printouts from webpages regarding Januvia
`
`and Tradjenta, respectively. Patent Owner objects to Exhibits 1030 and 1031 under
`
`Rule 402 (lack of relevance) and Rule 403 (misleading, confusing, unfair
`
`prejudice, waste of time, needlessly cumulative). These exhibits have no bearing
`
`
`
`2
`
`
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`Case No. IPR2015-01340
`Patent No. RE44,186
`on the obviousness of the claims of RE 44,186, as each exhibit post-dates the
`
`invention and does not relate to RE 44,186 or the products of the claims, Onglyza
`
`and Kombiglyze XR. Notably, Petitioners elected not to rely on Exhibits 1030
`
`and 1031 in the Reply brief and, thus, the exhibits have no relevance in this IPR.
`
`Any future reliance on these exhibits would be, among other things, unduly
`
`prejudicial, misleading, and a waste of the Board’s time.
`
`Finally, Patent Owner further objects to Exhibits 1030 and 1031 under Rules
`
`801/802 (hearsay), 805 (hearsay within hearsay), and 901 (lack of authentication).
`
`Exhibits 1030 and 1031 cite and report alleged facts that constitute hearsay and, to
`
`the extent they are relied on for the truth of those alleged facts, constitute hearsay
`
`themselves. Exhibits 1030 and 1031 have not been authenticated by any witness,
`
`including Dr. Meyer who was questioned on them, and are not self-authenticating.
`
`II. DECLARATIONS AND REPORTS - EX1035, EX1041,
`EX1060/EX1060A, AND EX1074
`
`OBJECTIONS TO EXHIBIT 1035
`
`Exhibit 1035 is a reply report of Dr. Hoffman from the copending district
`
`court litigation. Patent Owner objects to Exhibit 1035 under Rules 801/802
`
`(hearsay) and 805 (hearsay within hearsay) and 37 C.F.R. § 1.68 (lacking
`
`requirements for submission). As Exhibit 1035 is not sworn testimony, it is rank
`
`hearsay. Indeed, despite Petitioners’ attempt to use Exhibit 1035 during the district
`
`court trial, it was not included on the Admitted Trial Exhibit List. Further, as
`3
`
`
`
`
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`Case No. IPR2015-01340
`Patent No. RE44,186
`Exhibit 1035 extensively cites and reports opinions and alleged facts, primarily
`
`based on documents not of record, it constitutes hearsay within hearsay.
`
`Patent Owner also objects to Exhibit 1035 under Rule 402 (lack of
`
`relevance) and Rule 403 (misleading, confusing, unfair prejudice, waste of time,
`
`needlessly cumulative). Notably, Petitioners make no attempt to offer an opinion or
`
`analysis from Exhibit 1035 in the Reply brief, only that someone else had read a
`
`small portion of Exhibit 1035. See Reply at 24. Hence, nearly all, if not the
`
`entirety, of Exhibit 1035 lacks relevance in this IPR. Any future reliance on this
`
`exhibit would be, among other things, unduly prejudicial, misleading, and a waste
`
`of the Board’s time.
`
`As to the specific statements made in the report, Patent Owner offers the
`
`following objections:
`
`Paragraph Nos.
`
`Fed. R. Evid.
`
`Basis for Objection
`
`¶ 36
`
`¶ 43
`
`¶ 46
`
`
`
`403
`
`702 and 703
`
`The graph of paragraph 36 is unduly
`prejudicial, confuses the issues,
`misleads the factfinder, and is a
`waste of time.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why AstraZeneca and
`BMS commissioned the SAVOR
`study.
`
`702 and 703
`
`Improper expert testimony—
`
`4
`
`
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`Case No. IPR2015-01340
`Patent No. RE44,186
`conclusory statements, lacks
`explanation for bases of opinions
`supporting how the FDA warning
`would have impacted prescribing
`behavior had it been present on the
`Onglyza and Kombiglyze labels
`since their launches.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`regarding marketplace dynamics
`and, in particular, opinions that if
`Onglyza was superior, or provided
`meaningful differentiation to
`Januvia, Onglyza should have been
`comparable to (or even surpassed)
`the market share of Januvia.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`regarding the reasons for the decline
`in Janumet prescriptions.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`regarding statement that exclusions
`from formularies is indicative of a
`drug lacking benefits over other
`available treatments in the same
`therapeutic class.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`regarding statement that
`AstraZeneca and BMS are profit
`maximizing entities.
`
`¶ 47
`
`702 and 703
`
`¶¶ 51-52
`
`702 and 703
`
`¶ 58
`
`702 and 703
`
`¶ 66
`
`702 and 703
`
`
`
`5
`
`
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`Case No. IPR2015-01340
`Patent No. RE44,186
`The graphs of paragraph 67 are
`unfairly prejudicial, confuse the
`issues, mislead the factfinder, and
`are a waste of time.
`
`403
`
`¶ 67
`
`
`
`OBJECTIONS TO EXHIBIT 1041
`
`Exhibit 1041 is a declaration of Dr. Tanenberg. Patent Owner objects to
`
`Exhibit 1041 under Rule 402 (lack of relevance) and Rule 403 (misleading,
`
`confusing, unfair prejudice, waste of time, needlessly cumulative). Exhibit 1041
`
`contains opinions of Dr. Tanenberg that Petitioners elected not to rely on in the
`
`Reply brief. See Exhibit 1041 at ¶¶ 14, 17, 22-25, 27-30, 32-34, 36-38, 40-43, 45-
`
`55. Accordingly, those opinions have no relevance in this IPR. Any future
`
`reliance on these opinions would be, among other things, unduly prejudicial,
`
`misleading, and a waste of the Board’s time.
`
`Patent Owner also objects to Exhibit 1041 under Rules 701 (improper lay
`
`opinion) and 702 (improper expert opinion evidence). While Dr. Tanenberg
`
`provided his credentials, he does not assert that he is offering his opinions as a
`
`qualified expert witness and, thus, his opinions should be disregarded as improper
`
`lay testimony. See Exhibit 1041 at ¶¶ 10, 11.
`
`As to the specific statements made in the declaration, Patent Owner offers
`
`the following objections:
`
`
`
`6
`
`
`
`Paragraph Nos.
`
`Fed. R. Evid.
`
`¶ 26
`
`702 and 703
`
`¶ 38
`
`702 and 703
`
`¶ 45
`
`702 and 703
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting what physician
`prescribing practices would have
`been had FDA warning issued in
`2009.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting how FDA-approved DPP-
`4 inhibitors have gained market
`share.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting alleged lack of clinical
`significance of reductions of A1C
`levels resulting from once-daily
`dosing.
`
`
`
`OBJECTIONS TO EXHIBIT 1060/1060A
`
`Exhibit 1060/1060A is a declaration of Dr. McDuff. Patent Owner objects
`
`to Exhibit 1060/1060A under Rule 402 (lack of relevance) and Rule 403
`
`(misleading, confusing, unfair prejudice, waste of time, needlessly cumulative).
`
`Exhibit 1060/1060A contains opinions of Dr. McDuff that Petitioners elected not
`
`to rely on in the Reply brief. See Exhibit 1060/1060A at ¶¶ 15, 17, 20-26, 29-30,
`
`32, 34-36. Accordingly, those opinions have no relevance in this IPR. Any future
`
`
`
`7
`
`
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`Case No. IPR2015-01340
`Patent No. RE44,186
`reliance on these opinions would be, among other things, unduly prejudicial,
`
`misleading, and a waste of the Board’s time.
`
`Patent Owner also objects to Exhibit 1060/1060A under Rules 701
`
`(improper lay opinion) and 702 (improper expert opinion evidence). While Dr.
`
`McDuff provided his credentials, neither he nor Petitioners assert that he is
`
`offering his opinions as a qualified expert witness and, thus, his opinions should be
`
`disregarded as improper lay testimony. See Exhibit 1060/1060A at ¶¶ 6-8; Reply
`
`at 24-26.
`
`As to the specific statements made in the declaration, Patent Owner offers
`
`the following objections:
`
`Paragraph Nos.
`
`Fed. R. Evid.
`
`Basis for Objection
`
`¶ 24
`
`702 and 703
`
`¶¶ 35-37
`
`702 and 703
`
`¶¶ 41-43
`
`702 and 703
`
`
`
`8
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting alleged lack of
`profitability.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting alleged impact of FDA
`warning.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting alleged substantiality of
`discounts for Onglyza and
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`Kombiglyze XR.
`
`Paragraph Nos.
`
`Fed. R. Evid.
`
`
`
`OBJECTIONS TO EXHIBIT 1074
`
`Exhibit 1074 is a declaration of Dr. Rotella. Patent Owner objects to Exhibit
`
`1074 under Rule 402 (lack of relevance) and Rule 403 (misleading, confusing,
`
`unfair prejudice, waste of time, needlessly cumulative). Exhibit 1074 contain
`
`opinions of Dr. Rotella that Petitioners elected not to rely on in the Reply brief.
`
`See Exhibit 1074 at ¶¶ 11, 14-18, 22, 24-25, 27-30, 32-38, 43-45, 47-51, 53-57.
`
`Accordingly, those opinions have no relevance in this IPR. Any future reliance on
`
`these opinions would be, among other things, unduly prejudicial, misleading, and a
`
`waste of the Board’s time.
`
`As to the specific statements made in the declaration, Patent Owner offers
`
`the following objections:
`
`Paragraph Nos.
`
`Rule
`
`Basis for Objection
`
`¶¶ 13-14
`
`Fed. R. Evid. 702
`and 703
`
`¶ 19
`
`
`
`37 C.F.R. § 42.23;
`see generally In re
`9
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a person of ordinary
`skill in the art would have
`endeavored to modify Ashworth I
`compound 25.
`
`Improper reply—opinions regarding
`(1) the alleged advantage of
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`replacing a smaller sterically less
`bulky alkyl moiety at the 2-position
`of the amino acyl pyrrolidine with a
`bulkier cycloalkyl in order to
`increase stability; and (2) the alleged
`advantage of replacing a smaller
`branched alkyl moiety at the same
`position with a bulkier cycloalkyl
`moiety may also increase potency are
`new and do not appear in Ex. 1003,
`paragraph 117.
`Improper reply—argument that
`Mentlein confirms that a person of
`ordinary skill in the art would have
`read Ashworth I to encourage bulkier
`acyl groups at the 2-position of the
`amino acyl cyanopyrrolidine is a new
`argument that is not responsive to
`Dr. Weber’s positions.
`
`Improper reply— argument that from
`a pairwise comparison, a person of
`ordinary skill in the art would have
`understood that a DPP-4 inhibitor
`would tolerate substitution of an
`adamantyl group for a cyclohexyl
`group on the P2 ring is a new
`argument that is not responsive to
`Dr. Weber’s positions.
`Improper reply—argument that
`Villhauer characterizes as “[e]ven
`more preferred” a genus that includes
`adamantyl, but not unsubstituted
`cyclohexyl is a new argument.
`Improper reply—argument that
`Villhauer teaches a preference for a
`sterically larger group at P2 is a new
`
`Paragraph Nos.
`
`Rule
`NuVasive, Inc., No.
`2015-1672, 2016
`WL 6608999 (Fed.
`Cir. Nov. 9, 2016)
`(“NuVasive”)
`
`¶ 20
`
`37 C.F.R. § 42.23;
`NuVasive
`
`
`
`10
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`argument.
`
`Improper reply—argument that
`Villhauer teaches that the adamantyl
`group is within the medicinal
`chemist’s toolbox for modifying the
`P2 position of a DPP4 inhibitor is a
`new argument.
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why adamantyl, as a
`bridged cyclohexyl group, would be
`seen by a medicinal chemist as the
`natural progression for increasing the
`bulk of a cyclohexyl substituent.
`
`Improper reply—argument that the
`teaching of the art at the time of the
`invention was that bulkier, not more
`branched, alkyl groups were
`preferred is a new argument.
`Improper reply—argument that a
`person of skill in the art would have
`known from Ashworth I and
`Mentlein to select a sterically bulkier
`substituent than cyclohexyl is a new
`argument.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a person of ordinary
`skill in the art could reasonably
`expect to obtain a potent DPP-4
`inhibitor by moving the adamantyl
`group from nitrogen to carbon.
`
`Paragraph Nos.
`
`Rule
`
`¶ 21
`
`37 C.F.R. § 42.23;
`Fed. R. Evid. 702
`and 703; NuVasive
`
`¶ 23
`
`37 C.F.R. § 42.23;
`NuVasive
`
`¶¶ 20-22
`
`Fed. R. Evid. 702
`and 703
`
`
`
`11
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a medicinal chemist
`would expect the favorable solubility
`properties of the amine to be offset
`by the addition of a bulky,
`hydrophobic, adamantyl group.
`
`Improper reply—argument that a
`person of skill in the art would have
`been motivated to synthesize
`metabolites of early lead compounds
`in order to enhance the
`pharmacodynamic properties of an
`active DPP4 inhibitor is a new
`argument.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a person of ordinary
`skill in the art would have been
`motivated to synthesize metabolites
`and compensate for decreased
`solubility caused by addition of an
`adamantyl group.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why metabolism would
`occur on the adamantyl group.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a person of skill in
`
`Paragraph Nos.
`
`Rule
`
`¶ 26
`
`¶ 27
`
`Fed. R. Evid. 702
`and 703
`
`37 C.F.R. § 42.23;
`NuVasive
`
`¶¶ 25-27
`
`Fed. R. Evid. 702
`and 703
`
`¶ 28
`
`¶ 29
`
`
`
`Fed. R. Evid. 702
`and 703
`
`Fed. R. Evid. 702
`and 703
`
`12
`
`
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`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`the art would expect that the
`adamantyl-modified Ashworth
`compound 25 would be metabolized
`via oxidation at one of its tertiary
`adamantyl carbons.
`
`Improper reply—argument that it
`would have been routine to screen
`each of the small number of
`chemically unique C-H bonds in an
`adamantyl group in order to identify
`potential metabolites is a new
`argument.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting alleged expectation that
`adamantyl groups would be oxidized
`in vivo at a tertiary carbon.
`
`Improper reply—argument that a
`person of skill would have performed
`a routine screen of the limited
`number of possible metabolites, in
`order to increase metabolic stability,
`and in doing so would have arrived
`at the hydroxyl configuration of
`saxagliptin is a new argument.
`
`Improper reply—argument that
`Ashworth II teaches that
`incorporation of sulfur into the 5-
`membered ring is not just tolerated,
`but can produce compounds with
`slightly enhanced potency over their
`carbocyclic counterparts is a new
`argument.
`
`Paragraph Nos.
`
`Rule
`
`¶ 31
`
`¶ 32
`
`¶ 33
`
`¶ 40
`
`
`
`37 C.F.R. § 42.23;
`NuVasive
`
`Fed. R. Evid. 702
`and 703
`
`37 C.F.R. § 42.23;
`NuVasive
`
`37 C.F.R. § 42.23;
`Fed. R. Evid. 702
`and 703; NuVasive
`
`13
`
`
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`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a medicinal chemist
`would understand that a C-S bond is
`longer than a CC bond, making the
`thiazolidine ring larger than a
`pyrrolidine, suggesting while large
`perturbations to the P1 ring are not
`productive (as evidenced by
`Ashworth), small increases in ring
`size are allowed.
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a person of skill in
`the art would understand that
`cyclopropanation preserves the
`saturated five-membered ring.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a person of ordinary
`skill in the art would have been
`motivated to cyclopropanate a DPP-4
`inhibitor.
`
`Improper reply—argument that each
`of the differences between
`saxagliptin and Ashworth compound
`25 reflect further optimizations of the
`same groups that Ashworth was
`optimizing and that a person of skill
`in the art would have had the same
`expectation of success in these
`optimizations as Ashworth had is a
`new argument.
`
`Paragraph Nos.
`
`Rule
`
`¶¶ 38-42
`
`Fed. R. Evid. 702
`and 703
`
`¶ 46
`
`37 C.F.R. § 42.23;
`NuVasive
`
`
`
`14
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`Improper reply—argument that
`Villhauer WO publication suggested
`that adamantyl or 1-
`hydroxymethylcyclohexyl were more
`preferred compared to cyclohexyl at
`the P2 position is a new argument.
`Improper reply—argument that the
`Villhauer patent preferred 3-
`hydroxyadamantyl in the P2 position
`is a new argument.
`Improper reply—argument that
`Ashworth’s sulfur substitution was
`consistent with the art’s knowledge
`that a saturated 5-member ring with
`hydrogen at the 3-position was
`preferred is a new argument.
`Improper reply—argument that
`Hanessian provided an alternate
`approach to modifying the 4-position
`on a proline ring while preserving
`the saturated 5-member ring with a
`free 3-position is a new argument.
`
`Improper reply—argument that
`Magnin 2004 reports computational
`studies that suggest the 4,5-
`methanoproline system is predicted
`to be more stable than other isomers
`is a new argument.
`
`Improper reply—argument that a
`person of ordinary skill familiar with
`Ashworth II and Augustyns would
`have been known to prioritize ring
`fusion at the 4,5-position is a new
`argument.
`
`Paragraph Nos.
`
`Rule
`
`¶ 47
`
`¶ 49
`
`
`
`37 C.F.R. § 42.23;
`NuVasive
`
`37 C.F.R. § 42.23;
`NuVasive
`
`15
`
`
`
`Paragraph Nos.
`
`Rule
`
`¶¶ 43-46, 49
`
`Fed. R. Evid. 702
`and 703
`
`¶¶ 50, 52-53
`
`Fed. R. Evid. 702
`and 703
`
`Fed. R. Evid. 702
`and 703
`
`Fed. R. Evid. 702
`and 703
`
`¶ 55
`
`¶ 56
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why a person of ordinary
`skill in the art would have reasonably
`expected that modulation of the
`cyano position would result in
`increased potency and stability.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why the results of the
`invention were unsurprising.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting alleged drivers of drug
`discovery decisions.
`
`Improper expert testimony—
`conclusory statements, lacks
`explanation for bases of opinions
`supporting why vildagliptin met a
`long-felt need for alternative
`therapies for type-2 diabetes.
`
`III. PUBLIC DOCUMENTS - EX1036 TO EX1040, EX1043 TO EX1059,
`EX1063 TO EX1065, AND EX1072
`
`OBJECTIONS TO EXHIBITS 1036, 1037, 1039, AND 1043
`
`Exhibits 1036 and 1037 are “prescribing information” for Advair and
`
`Cymbalta, respectively. Exhibit 1039 is a 2016 printout of “slides” from the CDC
`
`
`
`16
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`webpage. Exhibit 1043 is a 2015 listing of essential medicines by the WHO.
`
`Patent Owner objects to Exhibits 1036, 1037, 1039, and 1043 under Rule 402 (lack
`
`of relevance) and Rule 403 (misleading, confusing, unfair prejudice, waste of time,
`
`needlessly cumulative). These exhibits have no bearing on the obviousness of the
`
`claims of RE 44,186, as each exhibit post-dates the invention and does not relate to
`
`RE 44,186 or the products of the claims, Onglyza and Kombiglyze XR. See e.g.,
`
`Reply at 4 (acknowledging that Exhibit 1043 does not address either product).
`
`Notably, Petitioners elected not to offer an opinion or analysis regarding Exhibits
`
`1036, 1037, and 1039 in the Reply brief; nor do they cite their declarants’ opinions
`
`regarding these exhibits. Hence, these exhibits are irrelevant to this IPR. Any
`
`future reliance on these exhibits would be, among other things, unduly prejudicial,
`
`misleading, and a waste of the Board’s time.
`
`Patent Owner further objects to Exhibits 1036, 1037, 1039, and 1043 under
`
`Rules 602 (lack of foundation, speculation, and personal knowledge) and 701
`
`(improper lay opinions). To the extent the declarants provided an opinion or
`
`analysis relying on Exhibits 1036, 1037, 1039, and 1043, Petitioners offered no
`
`foundation for such an opinion or analysis. To the extent, the declarant has not
`
`alleged to be providing expert testimony, any opinion on these references is
`
`improper lay testimony.
`
`
`
`17
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Finally, Patent Owner further objects to Exhibits 1036, 1037, 1039, and
`
`1043 under Rules 801/802 (hearsay), 805 (hearsay with hearsay), and 901 (lack of
`
`authentication). Exhibits 1036, 1037, 1039, and 1043 cite and report opinions
`
`and/or alleged facts from other sources that constitute hearsay within hearsay. To
`
`the extent Exhibits 1036, 1037, 1039, and 1043 are relied on for the truth of those
`
`opinions and facts, they constitute hearsay themselves. Exhibits 1036, 1037, 1039,
`
`and 1043 have not been authenticated by any witness with personal knowledge and
`
`are not self-authenticating.
`
`
`
`OBJECTIONS TO EXHIBITS 1038, 1040, 1063 TO 1065, AND 1072
`
`Exhibits 1038 to 1040 and 1063 to 1065 are post-filing publications from
`
`2005 to 2016. Exhibit 1072 is a 1993 publication. Patent Owner objects to
`
`Exhibits 1063 to 1065 under Rule 402 (lack of relevance) and Rule 403
`
`(misleading, confusing, unfair prejudice, waste of time, needlessly cumulative).
`
`These exhibits have no bearing on the obviousness of the claims of RE 44,186, as
`
`each exhibit post-dates the invention and does not relate to RE 44,186 or the
`
`products of the claims, Onglyza and Kombiglyze XR. Indeed, while Exhibits 1063
`
`to 1065 address R&D cost of drugs, they do not address Onglyza and Kombiglyze
`
`XR or other types of diabetes drugs. Notably, Petitioners elected not to offer an
`
`opinion or analysis regarding Exhibits 1038 to 1040, 1063 to 1065, and 1072 in the
`
`
`
`18
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Reply brief; nor do they cite their declarants’ opinions regarding these exhibits.
`
`Hence, these exhibits are irrelevant to this IPR. Any future reliance on these
`
`exhibits would be at least unduly prejudicial, misleading, and a waste of the
`
`Board’s time.
`
`Patent Owner further objects to Exhibits 1038 to 1040, 1063 to 1065, and
`
`1072 under Rules 602 (lack of foundation, speculation, and personal knowledge)
`
`and 701 (improper lay opinions). To the extent the declarants provided an opinion
`
`or analysis relying on Exhibits 1038 to 1040, 1063 to 1065, and 1072, Petitioners
`
`offered no foundation for such an opinion or analysis. To the extent, the declarant
`
`has not alleged to be providing expert testimony, any opinion on these references is
`
`improper lay testimony.
`
`Finally, Patent Owner further objects to Exhibits 1038 to 1040, 1063 to
`
`1065, and 1072 under Rules 801/802 (hearsay) and 805 (hearsay within hearsay).
`
`Exhibits 1038 to 1040, 1063 to 1065, and 1072 cite and report opinions and/or
`
`alleged facts from other sources that constitute hearsay within hearsay. To the
`
`extent Exhibits 1038 to 1040, 1063 to 1065, and 1072 are relied on for the truth of
`
`those opinions and facts, they constitute hearsay themselves.
`
`
`
`
`
`19
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`
`OBJECTIONS TO EXHIBITS 1044 TO 1059
`
`Exhibits 1044-1059 are alleged to be annual reports of Novartis and Merck.
`
`Patent Owner objects to Exhibits 1044-1059 under Rule 402 (lack of relevance)
`
`and Rule 403 (misleading, confusing, unfair prejudice, waste of time, needlessly
`
`cumulative). These exhibits have no bearing on the obviousness of the claims of
`
`RE 44,186, as each exhibit post-dates the invention and does not relate to RE
`
`44,186 or the products of the claims, Onglyza and Kombiglyze XR. Notably,
`
`Petitioners elected not to offer an opinion or analysis regarding Exhibits 1045,
`
`1046, 1048, 1050, 1052-1059 in the Reply brief; nor do they cite their declarants’
`
`opinions regarding these exhibits. Indeed, Petitioners admit that the Merck annual
`
`reports (Exhibits 1052-1059) have even less relevance than the few Novartis
`
`annual reports cited by Dr. McDuff. See Ex. 1060 at fn 28. Hence, these exhibits
`
`are irrelevant to this IPR. Any future reliance on these exhibits would be at least
`
`unduly prejudicial, misleading, and a waste of the Board’s time.
`
`Patent Owner further objects to Exhibits 1044-1059 under Rules 602 (lack of
`
`foundation, speculation, and personal knowledge) and 701 (improper lay opinions).
`
`To the extent the declarants provided an opinion or analysis relying on Exhibits
`
`1044-1059, Petitioners offered no foundation for such an opinion or analysis. To
`
`the extent the declarant has not alleged to be providing expert testimony, any
`
`opinion on these references is improper lay testimony.
`
`
`
`20
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Finally, Patent Owner further objects to Exhibits 1044-1059 under Rules
`
`801/802 (hearsay), 805 (hearsay within hearsay), and 901 (lack of authentication).
`
`Exhibits 1044-1059 cite and report opinions and/or alleged facts from other
`
`sources that constitute hearsay within hearsay. To the extent Exhibits 1044-1059
`
`are relied on for the truth of those opinions and facts, they constitute hearsay
`
`themselves. Exhibits 1044-1059 have not been authenticated by any witness with
`
`personal knowledge.
`
`IV. CONFIDENTIAL DOCUMENTS - EX1062/EX1062A AND EX1066
`TO EX1071
`
`OBJECTIONS TO EXHIBITS 1062/1062A
`
`Exhibits 1062/1062A is an attachment to Dr. McDuff’s declaration. Patent
`
`Owner objects to Exhibit 1062/1062A to the extent it relies on other Exhibits
`
`objected to here.
`
`As to the specific attachments, Patent Owner offers the following objections:
`
`Attachment Nos.
`
`Fed. R. Evid.
`
`Basis for Objection
`
`B-3
`
`B-9
`
`
`
`403
`
`401, 402, and 403
`
`Attachment B-3 is unduly
`prejudicial, confuses the issues,
`misleads the factfinder, and is a
`waste of time.
`
`Lack of relevance—net sales
`adjustments for Novartis’s
`pharmaceutical products are
`irrelevant to the commercial success
`of Onglyza and Kombiglyze.
`Attachment B-9 is also unfairly
`
`21
`
`
`
`Attachment Nos.
`
`Fed. R. Evid.
`
`B-10b
`
`403
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`Basis for Objection
`prejudicial, confuses the issues,
`misleads the factfinder, and is a
`waste of time.
`
`Attachment B-10b is unfairly
`prejudicial, confuses the issues,
`misleads the factfinder, and is a
`waste of time.
`
`
`
`OBJECTIONS TO EXHIBITS 1066 TO 1071
`
`Exhibits 1066 to 1071 appear to be analytical reports by third parties. Patent
`
`Owner objects to Exhibits 1066 to 1071 under Rules 602 (lack of foundation,
`
`speculation, and personal knowledge) and 701 (improper lay opinions). To the
`
`extent the declarants provided an opinion or analysis relying on Exhibits 1066 to
`
`1071, Petitioners offered no foundation for such an opinion or analysis. To the
`
`extent, the declarant has not alleged to be providing expert testimony, any opinion
`
`on these references is improper lay testimony.
`
`Finally, Patent Owner further objects to Exhibits 1066 to 1071 under Rules
`
`801/802 (hearsay), 805 (hearsay with hearsay), and 901 (lack of authentication).
`
`Exhibits 1066 to 1071 cite and report opinions and/or alleged facts from other
`
`sources that constitute hearsay within hearsay. To the extent Exhibits 1066 to
`
`1071 are relied on for the truth of those opinions and facts, they constitute hearsay
`
`
`
`22
`
`
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`themselves. Exhibits 1066 to 1071 have not been authenticated by any witness
`
`with personal knowledge and are not self-authenticating.
`
`Respectfully submitted,
`
`
`
`By: / Anthony A. Hartmann /
`
`Anthony A. Hartmann
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
`901 New York Avenue, NW Washington,
`DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
`IPR2015-01340
`
`
`
`Dated: November 15, 2016
`
`
`
`23
`
`
`
`CERTIFICATE OF SERVICE
`
`Case No. IPR2015-01340
`Patent No. RE44,186
`
`The undersigned certifies that copies of the foregoing ASTRAZENECA’S
`
`
`
`
`OBJECTIONS TO EVIDENCE PURSUANT TO 37 C.F.R. § 42.6 was served
`
`electronically via e-mail on November 15, 2016, in its entirety to the
`
`following:
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.:
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`Steven W. Parmalee
`sparmalee@wsgr.com
`
`Richard Torczon
`rtorczon@wsgr.com
`
`Jad A. Mills
`jmills@wsgr.com
`
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`Douglas H. Carsten
`dcarsten@wsgr.com
`
`
`
`Counsel for Petitioner Wockhardt BIO AG.:
`
`
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`
`
`Counsel for Petitioner Teva Pharmaceuticals U.S.A., Inc..:
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`Patrick Gallagher
`PCGallagher@duanemorris.com
`
`Gary Speier
`gspeier@carlsoncaspers.com
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`
`Iain McIntyre
`imcintyre@carls
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