Paper No. ____
`Date Filed: May 12, 2015
`
`On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NOVEN PHARMACEUTICALS INC.
`AND MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2014-005501
`
`U.S. Patent 6,335,031
`
`PATENT OWNERS’ OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`Date Filed: May 12, 2015
`
`On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NOVEN PHARMACEUTICALS INC.
`AND MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2014-005501
`
`U.S. Patent 6,335,031
`
`PATENT OWNERS’ OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`
`Pages
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`Exhibit 2059 Is Admissible As An Authenticated Business
`Record ..........................................................................................................1
`
`There Is No Basis To Exclude Dr. Schöneich’s Cross-
`Examination Testimony Related To Ex. 2059...............................................7
`
`Petitioners Have Waived Their Objections To Exhibits 2015
`And 2032 ......................................................................................................8
`
`Exhibits 2053 And 2061 Have Circumstantial Guarantees Of
`Trustworthiness And Thus Are Admissible Under F.R.E. 807......................9
`
`No Part Of Ex. 2012 Or Ex. 1049 Should Be Excluded Because
`The Experts Are Permitted To Rely On Exhibits 2015, 2032,
`2053, And 2061 ..........................................................................................12
`
`VI. No Part Of Exhibit 2012 Should Be Excluded Because Dr.
`Klibanov Was Allowed To Rely On The ’031 Patent For Non-
`Hearsay Purposes........................................................................................14
`
`VII. Conclusion..................................................................................................15
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`200 Kelsey Assocs., LLC v. Delan Enters. Inc.,
`No. 92044571, 2008 WL 2515089 (T.T.A.B. June 11,
`2008) ........................................................................................................... 4
`
`Alpert v. Slatin,
`305 F.2d 891 (C.C.P.A. 1962)...................................................................... 5
`
`Astra Aktiebolag v. Andrx Pharms., Inc.,
`222 F. Supp. 2d 423 (S.D.N.Y. 2002) .......................................................... 6
`
`CaptionCall, L.L.C. v. UltraTec, Inc.,
`IPR2013-00544, Paper 74 (P.T.A.B. Mar. 3, 2015)...............................10, 11
`
`Corning Inc. v. DSM IP Assets B.V.,
`IPR2013-00043, Paper 97 (P.T.A.B. May 1, 2014)...................................4, 5
`
`Corning Inc. v. DSM IP Assets B.V.,
`IPR2013-00049, Paper 88 (P.T.A.B. May 9, 2014)...................................... 8
`
`Hal Roach Studios, Inc. v. Richard Feiner & Co.,
`896 F.2d 1542 (9th Cir. 1990)...................................................................... 4
`
`Halbert v. Schuurs,
`1983 WL 51885 (B.P.A.I. May 23, 1983).................................................... 5
`
`Handi Quilter, Inc. v. Bernina Int’l AG,
`IPR2013-00364, Paper 30 (P.T.A.B. June 12, 2014).................................... 1
`
`Invitrogen Corp. v. Clontech Labs, Inc.,
`429 F.3d 1052 (Fed. Cir. 2005).................................................................... 8
`
`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co.,
`CBM2013-00002, Paper 59 (P.T.A.B. Feb. 24, 2014)...........................13, 15
`
`Monsanto Co. v. David,
`516 F.3d 1009 (Fed. Cir. 2008).............................................................13, 15
`
`Munoz v. Strahm Farms, Inc.,
`69 F.3d 501 (Fed. Cir. 1995)........................................................................ 4
`
`ii
`
`
`
`Neupak, Inc. v. Ideal Mfg. & Sales Corp.,
`41 F. App’x 435 (Fed. Cir. 2002)............................................................... 10
`
`Novartis Pharms. Corp. v. Noven Pharms., Inc.,
`No. 13-cv-00527 (D. Del.)..................................................................7, 9, 12
`
`Novartis Pharms. Corp. v. Watson Labs., Inc.,
`No. 11-cv-1077-RGA (D. Del.) ................................................................. 10
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .................................................. 14
`
`Rorabaugh v. Cont’l Cas. Co.,
`321 F. App’x 708 (9th Cir. 2009)................................................................. 9
`
`S.E.C. v. Jasper,
`678 F.3d 1116 (9th Cir. 2012)...................................................................... 4
`
`Teter v. Kearby,
`169 F.2d 808 (C.C.P.A. 1948)...................................................................... 5
`
`U.S. v. Komasa,
`767 F.3d 151 (2d Cir. 2014)......................................................................... 3
`
`U-Haul Int'l, Inc. v. Lumbermens Mut. Cas. Co.,
`576 F.3d 1040 (9th Cir. 2009)...................................................................... 7
`
`Wells v. J. C. Penney Co.,
`250 F.2d 221 (9th Cir. 1957)........................................................................ 9
`
`Wojciak v. Nishiyama,
`No. 104,539, 2001 WL 1675462 (B.P.A.I. June 4, 2001)............................. 5
`
`Rules
`
`F.R.E. 106.............................................................................................................. 6
`
`F.R.E. 602.......................................................................................................13, 14
`
`F.R.E. 703.................................................................................................13, 14, 15
`
`F.R.E. 803(6) ..........................................................................................1, 3, 4, 6, 7
`
`F.R.E. 807.............................................................................................9, 10, 11, 14
`
`iii
`
`
`
`F.R.E. 901(b)(1)..................................................................................................... 4
`F.R.E. 901(b)(1) ..................................................................................................... 4
`
`F.R.E. 902(11) ....................................................................................1, 2, 3, 4, 6, 7
`F.R.E. 902(11) .................................................................................... 1, 2, 3, 4, 6, 7
`
`F.R.E. 1006.........................................................................................................6, 7
`F.R.E. 1006 ......................................................................................................... 6, 7
`
`Regulations
`Regulations
`
`37 C.F.R § 42.53(a) ............................................................................................. 11
`37 C.F.R § 42.53(a) ............................................................................................. 11
`
`37 C.F.R. § 42.61(c) ............................................................................................ 14
`37 C.F.R. § 42.61(c) ............................................................................................ 14
`
`37 C.F.R. § 42.64................................................................................................1, 6
`37 C.F.R. § 42.64 ................................................................................................ 1, 6
`
`37 C.F.R. § 42.65................................................................................................... 6
`37 C.F.R. § 42.65 ................................................................................................... 6
`
`iv
`
`iV
`
`
`
`Patent Owners submit this response in opposition to Petitioners’ Motion to
`
`Exclude as authorized by the Board’s Scheduling Order. (Paper 11 at 4.) For the
`
`reasons set forth below, Petitioners’ Motion should be denied.
`
`I.
`
`Exhibit 2059 Is Admissible As An Authenticated Business Record
`Ex. 2059 is an excerpt from the New Drug Application (“NDA”) for
`
`rivastigmine and sets forth the “degradation pathways demonstrated for
`
`Rivastigmine hydrogen tartrate.” (Ex. 2059 at 1.) It is admissible under F.R.E.
`
`803(6) and 902(11) as a self-authenticating certified domestic record of a regularly
`
`conducted activity. In response to Petitioners’ evidentiary objections (Ex. 1051),
`
`Patent Owners provided a replacement Ex. 2059 (Ex. 2062)2 to provide the whole
`
`document and a Rule 902(11) certification (the “Certification”) (Ex. 1052) as
`
`supplemental evidence pursuant to 37 C.F.R. § 42.64(b)(2). Petitioners complain
`
`that Patent Owners did not provide “reasonable written notice of the intent to offer
`
`the record” as required by F.R.E. 902(11). (Paper 47 at 7.) However, F.R.E.
`
`902(11) provides that “[b]efore the trial or hearing, the proponent must give an
`
`2 Because Ex. 2062 (“replacement Ex. 2059”) was timely served on Petitioners
`
`under 37 C.F.R. § 42.64(b)(2) and is offered solely to support the admissibility of
`
`the originally filed Ex. 2059, it was properly filed as supplemental evidence in
`
`response to Petitioners’ Motion to Exclude. See Handi Quilter, Inc. v. Bernina
`
`Int’l AG, IPR2013-00364, Paper 30 at 2-3 (P.T.A.B. June 12, 2014).
`
`1
`
`
`
`adverse party reasonable written notice of the intent to offer the record—and must
`
`make the record and certification available for inspection—so that the party has a
`
`fair opportunity to challenge them” (emphasis added). Patent Owners did just that.
`
`On April 24, 2015, Patent Owners filed—and served on Petitioners—Exhibit
`
`List 5 (Paper 39), which listed Ex. 2059. In response to Petitioners’ objections
`
`(Ex. 1051), on April 28, 2015, Patent Owners further provided Petitioners with
`
`replacement Ex. 2059 (Ex. 2062), the Certification (Ex. 1052), and an Amended
`
`Exhibit List 5, which listed replacement Ex. 2059. Patent Owners thereby
`
`provided Petitioners with the requisite written notice of their intent to rely on Ex.
`
`2059 and replacement Ex. 2059 as self-authenticating evidence at the oral
`
`argument in these proceedings. Moreover, Petitioners served evidentiary
`
`objections to Ex. 2059 (Ex. 1051) and filed a motion to exclude Ex. 2059 (which
`
`also addressed replacement Ex. 2059) and challenged the adequacy of the
`
`Certificate. (Paper 47.) Thus, Petitioners have had a fair opportunity to challenge
`
`both Ex. 2059 and the Certification, satisfying F.R.E. 902(11). Petitioners’
`
`assertion that Patent Owners were required to give notice prior to Dr. Schöneich’s
`
`deposition is unsupported by any authority and makes no sense because the
`
`Certification would not have changed Dr. Schöneich’s testimony on Ex. 2059.
`
`Regardless, the requirement for written notice may be waived where the
`
`adverse party has actual notice of the intent to admit the record and an opportunity
`
`2
`
`
`
`to challenge the Rule 902(11) evidence. U.S. v. Komasa, 767 F.3d 151, 155-56 (2d
`
`Cir. 2014). Here, Petitioners have had actual knowledge of Patent Owners’ intent
`
`to rely on Ex. 2059 since Dr. Schöneich’s April 18, 2015 deposition and—as is
`
`evident from Petitioners’ objections and motion to exclude—Petitioners have had a
`
`fair opportunity to challenge both Ex. 2059 and the Certification. Petitioners also
`
`could have challenged Ex. 2059 through redirect of Dr. Schöneich but chose not to.
`
`The Certification further satisfies F.R.E. 902(11) because it was made by
`
`Peter McArdle, an Executive Director of Drug Regulatory Affairs at Novartis
`
`Pharmaceuticals Corporation, who is the “custodian” of Ex. 2059, and it
`
`establishes that Ex. 2059 complies with F.R.E. 803(6)(A)-(C).3 (Ex. 1052.) It is
`
`Mr. McArdle’s duty to maintain Ex. 2059 to document the pharmaceutical
`
`regulatory approval process, and he is familiar with the manner and process in
`
`which Ex. 2059 is maintained. (Id. at ¶¶ 2-3.) Mr. McArdle confirms that, as part
`
`of Novartis’s regular practice, Ex. 2059 would have been generated at or near the
`
`time of the activity described therein by a person with knowledge, as required by
`
`F.R.E. 803(6)(A). (Id. at ¶ 5.) He further confirms that Ex. 2059 was made, and
`
`kept in the regulatory records archives, as part of Novartis’s regularly conducted
`
`3 The Certification meets the requirements of F.R.E. 803(6)(D), and Petitioners
`
`have not shown, under F.R.E. 803(6)(E), that the source of information or the
`
`method or circumstances of preparing Ex. 2059 indicate a lack of trustworthiness.
`
`3
`
`
`
`business activity, i.e., the pharmaceutical regulatory process, as required by F.R.E.
`
`803(6)(B)-(C). (Id. at ¶¶ 2, 4-6.) Documents created by a company for filing with
`
`a governmental agency are admissible as a record of a regularly conducted activity
`
`pursuant to F.R.E. 803(6). See S.E.C. v. Jasper, 678 F.3d 1116, 1122-23 (9th Cir.
`
`2012) (finding a Form 10-K created to be filed with the Securities and Exchange
`
`Commission admissible as a business record under F.R.E. 803(6)).
`
`Petitioners assert that the Certification must be made by someone having
`
`personal knowledge of the contents of Ex. 2059. (Paper 47 at 7-8.) No such
`
`requirement exists. See Munoz v. Strahm Farms, Inc., 69 F.3d 501, 503-04 (Fed.
`
`Cir. 1995) (“[A] ‘custodian’ under the business records exception need not be the
`
`person who created the records.”); 200 Kelsey Assocs., LLC v. Delan Enters. Inc.,
`
`No. 92044571, 2008 WL 2515089 at *2 (T.T.A.B. June 11, 2008) (finding that a
`
`“qualified witness” need only have “personal knowledge regarding the records and
`
`how they are kept in the regular course of business,” not “personal knowledge of
`
`the contents of the records”). Petitioners’ reliance on Hal Roach Studios (Paper 47
`
`at 8) is misplaced because that case concerned authentication by a witness with
`
`knowledge pursuant to F.R.E. 901(b)(1), not F.R.E. 902(11) at issue here. Hal
`
`Roach Studios, Inc. v. Richard Feiner & Co., 896 F.2d 1542, 1551 (9th Cir. 1990).
`
`Petitioners’ reliance on Corning (Paper 47 at 8) is likewise misplaced. That
`
`case concerned documents reflecting testing conducted after the IPR petitions were
`
`4
`
`
`
`filed and solely to address whether a claim limitation was inherently present in the
`
`prior art. Corning Inc. v. DSM IP Assets B.V., IPR2013-00043, Paper 97 at 3, 5
`
`(P.T.A.B. May 1, 2014). On those facts, the Board found that “[c]onducting
`
`specific and unique scientific experimental work [was] not ‘a regularly conducted
`
`activity’” because such experiments involved “unique events not normally repeated
`
`on a ‘regular’ basis.” Id. at 5.4 Here, however, Ex. 2059 does not reflect specific
`
`and unique scientific experimental work conducted solely to address issues in this
`
`case. Instead, Ex. 2059 is an excerpt from an NDA created and maintained by
`
`Novartis as part of its regularly conducted practice of pursuing pharmaceutical
`
`regulatory approval. (Ex. 1052 at ¶¶ 2-6.) Moreover, where—as here—the
`
`documents reflect experimental work conducted as part of a regularly conducted
`
`practice, such documents are admissible pursuant to F.R.E. 803(6). See Astra
`
`4 The cases cited in Corning, IPR2013-00043, Paper 97 at 5-6, are also
`
`distinguishable. Alpert v. Slatin, 305 F.2d 891, 895-96 (C.C.P.A. 1962), and Teter
`
`v. Kearby, 169 F.2d 808, 816-17 (C.C.P.A. 1948), concern whether an inventor’s
`
`experimental records are independent corroboration of an inventor’s testimony for
`
`the purposes of establishing a reduction to practice in an interference. In Wojciak
`
`v. Nishiyama, No. 104,539, 2001 WL 1675462 at *7 (B.P.A.I. June 4, 2001), and
`
`Halbert v. Schuurs, 1983 WL 51885 at *5-6, 11-12 (B.P.A.I. May 23, 1983), there
`
`was an insufficient foundation to apply the business records exception.
`
`5
`
`
`
`Aktiebolag v. Andrx Pharms., Inc., 222 F. Supp. 2d 423, 522 n.62 (S.D.N.Y. 2002).
`
`Contrary to Petitioners’ assertions (Paper 47 at 7, 8), Ex. 2059 and
`
`replacement Ex. 2059 are not inadmissible because they are undated. Neither
`
`F.R.E. 803(6) nor 902(11) requires a dated document for admissibility as a self-
`
`authenticating certified domestic record of a regularly conducted activity.
`
`Moreover, Patent Owners do not contend that Ex. 2059 is prior art. Instead, Patent
`
`Owners simply rely on Ex. 2059 to show that it is now known that when
`
`rivastigmine oxidizes, it forms an N-oxide. (Paper 44 at 10.)
`
`Ex. 2059 is also not inadmissible because it consists of one page of a larger
`
`document. In their Motion, Petitioners did not object to Ex. 2059 under F.R.E. 106
`
`and thus waived any objection based on completeness. 37 C.F.R. § 42.64(c).
`
`Also, at his deposition, Dr. Schöneich did not claim that he needed any additional
`
`information to confirm that one of the degradation products of rivastigmine shown
`
`in Ex. 2059 is an N-oxide. (Ex. 1048 at 19:10-12.) Regardless, as permitted by 37
`
`C.F.R. § 42.64(b)(2) , Patent Owners timely provided a replacement Ex. 2059 (Ex.
`
`2062), the complete document from which Ex. 2059 was taken. Petitioners cite no
`
`authority to oppose Patent Owners’ properly submitted replacement Ex. 2059.
`
`Finally, Ex. 2059 is not inadmissible under F.R.E. 1006 or 37 C.F.R. § 42.65
`
`because it is not a summary without underlying data. F.R.E. 1006 governs the
`
`admission of summaries prepared for litigation and offered at trial to prove the
`
`6
`
`
`
`content of voluminous writings that cannot be conveniently examined in court. U-
`
`Haul Int’l, Inc. v. Lumbermens Mut. Cas. Co., 576 F.3d 1040, 1043, 1044-45 (9th
`
`Cir. 2009) (holding that F.R.E. 1006 applies to summaries of other evidence
`
`prepared for litigation and not to summaries prepared as records of regularly
`
`conducted business activities, which are admissible under F.R.E. 803(6)).
`
`Replacement Ex. 2059 further provides the data underlying Ex. 2059.
`
`In sum, Ex. 2059 and replacement Ex. 2059 are admissible as authentic
`
`records of a regularly conducted activity under F.R.E. 902(11) and 803(6).
`
`II.
`
`There Is No Basis To Exclude Dr. Schöneich’s
`Cross-Examination Testimony Related To Ex. 2059
`The Board should consider Ex. 2059 and Dr. Schöneich’s deposition
`
`testimony that one of the degradation products of rivastigmine shown in Ex. 2059
`
`is an N-oxide. (Ex. 1048 at 19:10-12.) This testimony is relevant to Dr.
`
`Schöneich’s opinion that the oxidation of rivastigmine is similar to that of olefins
`
`(Ex. 1032 at ¶ 31) because Dr. Schöneich further admitted that when an
`
`unsubstituted olefin oxidizes, it cannot form an N-oxide (Ex. 1048 at 15:12-15).
`
`Ex. 2059 (and replacement Ex. 2059) was produced to the Noven Petitioner
`
`in Novartis Pharms. Corp. v. Noven Pharms., Inc., No. 13-cv-00527 (D. Del.)
`
`(“district court litigation”) on July 18, 2013. Whether or not the Noven Petitioner
`
`chose to discuss Ex. 2059 with Dr. Schöneich does not foreclose Patent Owners
`
`from cross-examining Dr. Schöneich with that document. Moreover, Petitioners
`
`7
`
`
`
`have provided no basis for their assertion that Ex. 2059 should be given no weight
`
`because it is not supported by expert testimony from Dr. Klibanov. (Paper 47 at 9-
`
`10.) And because Ex. 2059 is supported by expert testimony from Dr. Schöneich
`
`(Ex. 1048 at 19:10-12), this case is unlike Invitrogen Corp. v. Clontech Labs, Inc.,
`
`429 F.3d 1052 (Fed. Cir. 2005) and Corning Inc. v. DSM IP Assets B.V., IPR2013-
`
`00049, Paper 88 (P.T.A.B. May 9, 2014), which concerned attorney arguments
`
`made wholly without supporting testimony.
`
`III. Petitioners Have Waived Their Objections To Exhibits 2015 And 2032
`Exs. 2015 and 2032 comprise confidential Patent Owners documents
`
`showing that (a) even the ’031 Patent inventors, who had at least the skill level of a
`
`POSA and years of experience with rivastigmine, did not predict without testing
`
`that rivastigmine would undergo oxidative degradation (Ex. 2015 at 3; Ex. 2032 at
`
`5), (b) consistent with the prior art teaching that an antioxidant should not be added
`
`unless required, the inventors only added an antioxidant to their rivastigmine test
`
`formulations after discovering that rivastigmine degraded in those formulations
`
`(Ex. 2015 at 3; Ex. 2032 at 7-12), and (c) the inventors had to conduct “exhaustive
`
`testing” to determine that the degradation of rivastigmine was oxidative and
`
`required the addition of an antioxidant (Ex. 2015 at 3, 10-13). (Paper 25 at 12, 19.)
`
`Although the Noven Petitioner originally objected to Exs. 2015 and 2032
`
`(Ex. 1050), Petitioners’ expert Dr. Kydonieus subsequently relied on both exhibits
`
`8
`
`
`
`in support of his opinions. (Ex. 1031 at ¶¶ 84 n.19, 128-129.) Because Petitioners
`
`have relied on the same evidence, they have waived their right to object to its
`
`admissibility. See Rorabaugh v. Cont’l Cas. Co., 321 F. App’x 708, 709 (9th Cir.
`
`2009) (defendants waived right to appeal the admission of deposition testimony by
`
`failing to raise objection and by relying on the evidence in their trial
`
`memorandum); Wells v. J. C. Penney Co., 250 F.2d 221, 235 (9th Cir. 1957)
`
`(appellants waived objection by relying on testimony in their brief).
`
`Moreover, pages 22-41 of Ex. 2015 and pages 1-5 of Ex. 2032 were
`
`admitted into evidence during trial in the district court litigation without objection
`
`by the Noven Petitioner. (Ex. 1026 at 430:24-431:6 (admitting PTX242 without
`
`objection), 432:19-433:1 (admitting PTX246 without objection); Novartis, No. 13-
`
`cv-00527, D.I. 150-7 at 10 (identifying PTX242 as bearing Bates Nos.
`
`LTS0102239-58 and PTX246 as bearing Bates Nos. N020066-70). By agreement
`
`between Patent Owners and the Noven Petitioner, the parties may rely in this IPR
`
`on the entirety of the witnesses’ trial testimony from the district court litigation
`
`(Exs. 1025, 1026). Because pages 22-41 of Ex. 2015 and pages 1-5 of Ex. 2032
`
`are part of the evidentiary record from the district court litigation filed in this IPR
`
`without objection, Petitioners have waived their objections to those documents.
`
`IV. Exhibits 2053 And 2061 Have Circumstantial Guarantees Of
`Trustworthiness And Thus Are Admissible Under F.R.E. 807
`Exs. 2053 and 2061 contain the sworn trial testimony of Dr. Tiemessen, one
`
`9
`
`
`
`of the ʼ031 Patent inventors, in Novartis Pharms. Corp. v. Watson Labs., Inc., No.
`
`11-cv-1077-RGA (D. Del.) and are admissible under F.R.E. 807.
`
`First, Dr. Tiemessen’s sworn testimony was subject to cross-examination
`
`during the trial and by the Noven Petitioner during Dr. Tiemessen’s deposition in
`
`the district court litigation, and thus has the “equivalent circumstantial guarantees
`
`of trustworthiness” required by F.R.E. 807(a)(1). See CaptionCall, L.L.C. v.
`
`UltraTec, Inc., IPR2013-00544, Paper 74 at 31-34 (P.T.A.B. Mar. 3, 2015).
`
`Second, Patent Owners rely on Ex. 2053 to show that (a) even the ’031
`
`Patent inventors did not predict in advance of testing that rivastigmine would
`
`undergo oxidative degradation, and (b) consistent with the teaching in the prior art
`
`that an antioxidant should not be added unless required, the inventors did not add
`
`an antioxidant to their rivastigmine test formulations until after they discovered
`
`that rivastigmine degraded. (Paper 25 at 12, 19.) Although an inventor’s efforts
`
`are not relevant to obviousness (i.e., they cannot be used to negate validity), they
`
`can be relevant to non-obviousness (i.e., they can be used to support validity).
`
`E.g., Neupak, Inc. v. Ideal Mfg. & Sales Corp., 41 F. App’x 435, 440 (Fed. Cir.
`
`2002). Patent Owners rely on Ex. 2061 to demonstrate that Petitioners’ expert, Dr.
`
`Kydonieus, was wrong that “[t]he inventors considered oxidative degradation to be
`
`a significant concern during preformulation” and “assigned over a one-third chance
`
`of stability issues.” (Paper 42 at 14-15.) Exs. 2053 and 2061 are thus offered as
`
`10
`
`
`
`evidence of material facts and, because they contain the sworn testimony of an
`
`inventor, they are more probative of the way in which the invention was made and
`
`what the inventors believed than any other evidence that Patent Owners can obtain
`
`through reasonable efforts, as required by F.R.E. 807(a)(2)-(3).5
`
`Third, admitting the trial testimony of Dr. Tiemessen is in the interests of
`
`justice, as it provides as complete a record as possible regarding the way in which
`
`the invention in the ʼ031 Patent was made, as required by F.R.E. 807(a)(4). See
`
`CaptionCall, IPR2013-00544, Paper 74 at 34.
`
`Finally, before the oral argument in these proceedings, Patent Owners
`
`provided Petitioners with reasonable notice of the intent to offer the trial testimony
`
`of Dr. Tiemessen, so that Petitioners have a fair opportunity to meet it, as required
`
`by F.R.E. 807(b). Specifically, Patent Owners and the Noven Petitioner agreed in
`
`the district court litigation that the parties shall be permitted to rely on prior trial
`
`testimony of Dr. Tiemessen from the Watson District Court case, provided it was
`
`5 CaptionCall further indicates that, contrary to Noven’s assertion (Paper 47 at 11),
`
`the use of prior litigation testimony does not run afoul of 37 C.F.R § 42.53(a) and
`
`Patent Owners were not required to submit a declaration from Dr. Tiemessen. See
`
`CaptionCall, IPR2013-00544, Paper 74 at 32-33. Indeed, Petitioners also relied on
`
`deposition testimony of Dr. Tiemessen (Ex. 1036) without providing a declaration.
`
`11
`
`
`
`designated, and the testimony in Exs. 2053 and 2061 was so designated. Novartis,
`
`No. 13-cv-00527, D.I. 50 at ¶ 60, D.I. 50-9 at 13. Patent Owners further provided
`
`Petitioners with reasonable notice of the intent to offer Ex. 2053 by citing the
`
`exhibit in the Patent Owners’ Response. (Paper 25 at 12, 19.) Petitioners’ expert
`
`Dr. Kydonieus addressed Patent Owners’ reliance on Dr. Tiemessen’s testimony in
`
`his Reply Declaration (Ex. 1031 at ¶¶ 124-127, 129-132) and Petitioners cited
`
`excerpts from Dr. Tiemessen’s deposition from the Watson District Court case (Ex.
`
`1036), thereby confirming they had a fair opportunity to meet this evidence. Patent
`
`Owners also provided Petitioners with reasonable notice of the intent to offer Ex.
`
`2061 by using it to cross-examine Dr. Kydonieus. (Ex. 1049 at 156:17-157:25.)
`
`Petitioners redirected Dr. Kydonieus concerning Ex. 2061 (Ex. 1049 at 212:21-
`
`213:20), thereby confirming that they had a fair opportunity to meet this evidence.
`
`V.
`
`
`
`No Part Of Ex. 2012 Or Ex. 1049 Should Be Excluded Because The
`Experts Are Permitted To Rely On Exhibits 2015, 2032, 2053, And 2061
`In Ex. 2012 at ¶¶ 161-166, Dr. Klibanov explains that the ʼ031 Patent
`
`inventors did not predict stability problems with rivastigmine and discovered a
`
`stability problem only after testing, which confirms that a POSA would not
`
`reasonably predict that rivastigmine undergoes oxidative degradation under
`
`pharmaceutically relevant conditions or requires an antioxidant. Contrary to
`
`Petitioners’ assertions (Paper 47 at 1, 12-13), these paragraphs are not improper
`
`under F.R.E. 602 because that rule “does not apply to a witness’s expert testimony
`
`12
`
`
`
`under Rule 703.” See also Monsanto Co. v. David, 516 F.3d 1009, 1015 (Fed. Cir.
`
`2008) (“[T]he Federal Rules of Evidence establish that an expert need not have
`
`obtained the basis for his opinion from personal perception.”).
`
`Moreover, F.R.E. 703 provides that “[a]n expert may base an opinion on
`
`facts or data in the case . . . .” Because Exs. 2015, 2032 and 2053 are admissible in
`
`the case (supra at Sections III, IV), they are a proper basis for Dr. Klibanov’s
`
`opinions. (Contra Paper 47 at 12-13.) Even if Exs. 2015, 2032 and 2053 were
`
`inadmissible, “Rule 703 expressly authorizes the admission of expert opinion that
`
`is based on ‘facts or data’ that themselves are inadmissible, as long as the evidence
`
`relied upon is ‘of a type reasonably relied upon by experts in the particular field in
`
`forming opinions.’” F.R.E. 703; Monsanto, 516 F.3d at 1016; Liberty Mut. Ins.
`
`Co. v. Progressive Cas. Ins. Co., CBM2013-00002, Paper 59 at 38 (P.T.A.B. Feb.
`
`24, 2014) (recognizing that exhibits need not themselves be admissible for
`
`testimony of the expert to be admissible because they were of the type that experts
`
`in the pertinent field reasonably would rely on to form their opinions). It is
`
`reasonable for Dr. Klibanov to rely on documents and inventor testimony showing
`
`how the ʼ031 Patent invention was made in forming an opinion that the experience
`
`of the inventors is inconsistent with Petitioners’ obviousness allegations. See
`
`Monsanto, 516 F.3d at 1016 (finding that experts may reasonably rely on scientific
`
`test results under F.R.E. 703). Petitioners have not alleged the contrary.
`
`13
`
`
`
`Likewise, the excerpts of Dr. Kydonieus’s deposition concerning Ex. 2061
`
`(Ex. 1049 at 157:9-160:19, 171:16-179:10, 185:24-189:6) are not improper under
`
`(i) F.R.E. 602 because the rule does not apply to expert testimony, or (ii) under
`
`F.R.E. 703 because Ex. 2061 is admissible. (Supra at Section IV.) Even if Ex.
`
`2061 were inadmissible, F.R.E. 703 permits Dr. Kydonieus to consider the
`
`testimony demonstrating that he was wrong that “[t]he inventors considered
`
`oxidative degradation to be a significant concern during preformulation” and
`
`“assigned over a one-third chance of stability issues with a rivastigmine patch.”
`
`(Compare Ex. 1031 at ¶ 131 with Ex. 1049 at 171:16-179:10.)
`
`Finally, Patent Owners rely on the excerpts of Dr. Kydonieus’s deposition
`
`concerning Ex. 2061 not simply for the truth of the matters therein but to
`
`demonstrate that Dr. Kydonieus’s opinions are not credible because he failed to
`
`consider the inventor testimony concerning the documents on which Dr.
`
`Kydonieus based his opinions. (Paper 42 at 14-15.)
`
`VI. No Part Of Exhibit 2012 Should Be Excluded Because Dr. Klibanov
`Was Allowed To Rely On The ’031 Patent For Non-Hearsay Purposes
`In Ex. 2012 at ¶ 27, Dr. Klibanov relied on the specification to construe the
`
`ʼ031 Patent claims. Contrary to Petitioners’ assertions (Paper 47 at 14), such
`
`reliance was proper for a non-hearsay purpose consistent with 37 C.F.R.
`
`§ 42.61(c). See Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en
`
`banc). Likewise, Dr. Klibanov’s reliance on the ʼ031 Patent in ¶ 159 of Ex. 2012
`
`14
`
`
`
`was not for a hearsay purpose but to demonstrate that the teaching in Sasaki was
`
`directly contrary to the teaching in the ’031 Patent. See Liberty Mut., CBM2013-
`
`00002, Paper 59 at 38-39 (reliance on a document for what it would have taught a
`
`POSA is not a hearsay purpose). Ex. 2012 ¶ 159 thus should not be excluded.
`
`As set forth above, F.R.E. 703 expressly provides that an expert can rely on
`
`hearsay facts or data that are inadmissible, as long as the evidence is of a type
`
`reasonably relied upon by experts in the particular field. Monsanto, 516 F.3d at
`
`1016. It was reasonable for Dr. Klibanov to rely in ¶ 166 of Ex. 2012 on the ʼ031
`
`Patent in forming his opinion regarding how the invention was made. See id.
`
`Indeed, at trial in the district court litigation Dr. Klibanov cited the very same
`
`section of the ʼ031 Patent without any objection from the Noven Petitioner. (Ex.
`
`1026 at 433:22-435:4.) Thus ¶ 166 of Ex. 2012 should also not be excluded.
`
`(Contra Paper 47 at 1, 13-14.) Additionally, neither ¶ 166 of Ex. 2012 nor page 19
`
`of Patent Owners’ Response (Paper 25) should be excluded because the ʼ031
`
`Patent was not the only evidence to demonstrate that it was only through
`
`exhaustive testing that the inventors determined that the degradation problem with
`
`rivastigmine was oxidative in nature and could be reduced using an antioxidant.
`
`VII. Conclusion
`Patent Owners respectfully request that Petitioners’ Motion be denied.
`
`15
`
`
`
`Dated: May 12, 2015
`
`Respectfully submitted,
`
`/s/ Raymond R. Mandra
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`16
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing PATENT OWNERS’ OPPOSITION
`
`TO PETITIONERS’ MOTION TO EXCLUDE EVIDENCE was served on May
`
`12, 2015 by causing it to be sent by email to counsel for Petitioners at the
`
`following email addresses:
`
`Steven J. Lee (slee@kenyon.com)
`
`Michael K. Levy (mlevy@kenyon.com)
`
`Chris Coulson (ccoulson@kenyon.com)
`
`Joseph M. Reisman (BoxMylan2@knobbe.com)
`
`Jay R. Deshmukh (BoxMylan2@knobbe.com)
`
`William R. Zimmerman (BoxMylan@knobbe.com)
`
`Dated: May 12, 2015
`
`/s/ Raymond R. Mandra
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`1
`
`
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