`
`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 IPR2014-005501
`
`U.S. Patent No. 6,335,031
`
`
`PETITIONERS’ REPLY IN SUPPORT OF MOTION TO EXCLUDE
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`1 Case IPR2015-00268 has been joined with this proceeding.
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`TABLE OF CONTENTS
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`I. Ex. 2059 is Not Admissible as an Authenticated Business Record Under FRE
`803(6). ........................................................................................................................ 1
`II. Dr. Tiemessen’s Prior Trial Testimony (Ex. 2053, 2061) Is Not Admissible
`Under the Residual Exception, FRE 807. .................................................................. 3
`III. Petitioners Did Not Waive Their Objections to Ex. 2015 and 2032. ............... 4
`IV. FRE 703 Does Not Render Hearsay Documents (Ex. 2015, 2032, 2053,
`2061) Admissible. ...................................................................................................... 5
`V. Reliance on Experimental Results that are Reported in the Patent
`Specification is in Contravention of the Rules. ......................................................... 5
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`i
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`Cases
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`TABLE OF AUTHORITIES
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`Page(s)
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`200 Kelsey Assocs., LLC v. Delan Enters. Inc., et al.,
`No. 92044571, 2008 WL 2515089
`(T.T.A.B. June 11, 2008) ....................................................................................... 2
`Astra Aktiebolag v. Andrx Pharms., Inc.,
`222 F. Supp. 2d 423 (S.D.N.Y. 2002) ................................................................... 3
`Monsanto Co. v. David,
`516 F.3d 1009 (Fed. Cir. 2008).............................................................................. 5
`Munoz v. Strahm Farms, Inc.,
`69 F.3d 501 (Fed. Cir. 1995) .................................................................................. 2
`Rorabaugh v. Cont’l Cas. Co.,
`321 F. App’x 708 (9th Cir. 2009) .......................................................................... 4
`S.E.C. v. Jasper,
`678 F.3d 1116 (9th Cir. 2012) ...........................................................................2, 3
`U-Haul Int'l, Inc. v. Lumbermens Mut. Cas. Co.,
`576 F.3d 1040 (9th Cir. 2009) ............................................................................... 3
`Wells v. J. C. Penney Co.,
`250 F.2d 221 (9th Cir. 1957) ................................................................................. 4
`Rules
`
`Fed. R. Evid. 703 Advisory Committee Notes (2000 Amendments) ....................1, 5
`Fed. R. Evid. 801(d)(2) .............................................................................................. 4
`Fed. R. Evid. 803(6) ................................................................................................... 2
`Fed. R. Evid. 807 ....................................................................................................... 3
`Regulations
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`77 Fed. Reg. 48612 (Aug. 14, 2012) ......................................................................... 5
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`ii
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`Patent Owners have failed to establish that a hearsay exception applies, and
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`FRE 703 does not render underlying hearsay and unauthenticated documents
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`admissible.
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`I.
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`Ex. 2059 is Not Admissible as an Authenticated Business Record Under
`FRE 803(6).
`
`Patent Owners have not cured the double-hearsay nature of Ex. 2059, which
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`on its face purports to “summarize the findings” from elsewhere. (Paper 47 at 7;
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`Paper 49 at 7.) Patent Owners rely solely on unsupported attorney argument that
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`the 29 additional pages of Ex. 2062 are the findings summarized by the single page
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`of Ex. 2059. (Paper 49 at 7.) Even if true, Ex. 2062 suffers from the same
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`hearsay, foundation, and authentication deficiencies as Ex. 2059. And Ex. 2062
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`was served on Petitioners 24 days after Dr. Schöneich’s deposition; and Dr.
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`Schöneich did not have an opportunity to examine it.
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`No expert has opined on Ex. 2062, or original Ex. 2059, for that matter.
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`Patent Owners chose not to use either document with Dr. Klibanov. Dr. Schöneich
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`did not testify that Ex. 2059 shows a degradation pathway for rivastigmine. He
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`merely agreed that a chemical structure displayed on the face of the exhibit “would
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`be described as an n-oxide.” (Ex. 1048 at 19:5-12.) Patent Owners’ assertion
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`related to Ex. 2059, that “it is now known that when rivastigmine oxidizes, it forms
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`an N-oxide,” is based only on attorney argument and not expert testimony. (Paper
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`1
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`
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`44 at 9-10; Paper 52 at 9.)2
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`Ex. 2059 is also not admissible as a business record. The declaration of Mr.
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`McArdle that Patent Owners rely upon to support Ex. 2059 is inadequate to show
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`that the document is a business record. FRE 803(6) requires a showing that the
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`record was made (i) at or near the time; and (ii) by, or from information
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`transmitted from, a person with knowledge. 200 Kelsey Assocs., LLC v. Delan
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`Enters. Inc., et al., No. 92044571, 2008 WL 2515089, *2 (T.T.A.B. June 11,
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`2008). The declaration merely parrots the language of FRE 803(6)(A) and
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`provides no detail to show that Mr. McArdle knows anything at all about when or
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`how Ex. 2059 was made. (Ex. 1052 at ¶ 5.)
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`In contrast to the McArdle declaration, the declarants in the cases relied
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`upon by Patent Owners had specific personal knowledge to establish when and
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`how the underlying documents were made. In Munoz, the declarant was the
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`photographer who took the photographs at issue. Munoz v. Strahm Farms, Inc., 69
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`F.3d 501, 503 (Fed. Cir. 1995). In 200 Kelsey Associates, the declarant explained
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`in detail at deposition how the company employees got the information contained
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`2 Patent Owners further mischaracterize Dr. Schöneich’s testimony elsewhere.
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`(Paper 49 at 7.) He stated that an unsubstituted olefin (alkene) cannot form an N-
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`oxide and that rivastigmine would be considered a substituted olefin (alkene). (Ex.
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`1048 at 10:24-12:24, 15:12-15.)
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`
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`2
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`
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`in the records at issue. 2008 WL 2515089, *2. In Jasper, the authenticating trial
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`testimony of an interim CFO showed that the 10-K at issue was made at or near the
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`time of the accounting review by persons with knowledge. S.E.C. v. Jasper, 678
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`F.3d 1116, 1122-23 (9th Cir. 2012). In Astra Aktiebolag, the authenticating
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`witness testified as to specific laboratory practices for recording experimental
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`results and signing laboratory notebooks. Astra Aktiebolag v. Andrx Pharms., Inc.,
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`222 F. Supp. 2d 423, 522 n.62 (S.D.N.Y. 2002). In U-Haul, the authenticating
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`testimony was that of a claims manager, who was thoroughly questioned by the
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`judge, as to how and when employees entered claims into a database. U-Haul Int'l,
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`Inc. v. Lumbermens Mut. Cas. Co., 576 F.3d 1040, 1044-45 (9th Cir. 2009).
`
`II. Dr. Tiemessen’s Prior Trial Testimony (Ex. 2053, 2061) Is Not
`Admissible Under the Residual Exception, FRE 807.
`
`Patent Owners may not rely on the residual exception to the hearsay rule to
`
`shield Dr. Tiemessen from deposition in this proceeding; his prior testimony (Ex.
`
`2053, 20613) is hearsay and not admissible under FRE 807. FRE 807 requires
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`Patent Owners to show that Dr. Tiemessen’s testimony is more probative of what
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`the inventors believed than any other evidence that they could obtain through
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`reasonable efforts. FRE 807; see Paper 49 at 11. But Patent Owners do not assert
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`that Dr. Tiemessen is unavailable, and they do not explain why Patent Owners
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`failed to provide a declaration from Dr. Tiemessen, or anyone else with personal
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`3 Ex. 2053 and 2061 do not include any court reporters’ certification.
`3
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`knowledge of the story on which they seek to rely.
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`Patent Owners also cite no legal authority in support of their argument that
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`revealing Ex. 2061 for the first time at the April 20 deposition of Dr. Kydonieus
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`was reasonable notice, given that it contained different testimony of Dr. Tiemessen
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`than was cited in Patent Owners’ January 20 response. (Paper 49 at 11-12.)
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`III. Petitioners Did Not Waive Their Objections to Ex. 2015 and 2032.
`Petitioners have not waived their objections to Ex. 2015 and 2032.
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`Petitioners may freely rely on the documents because Patent Owners’ documents
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`are not hearsay when used by Petitioners. FRE 801(d)(2). Further, Patent Owners’
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`cases are readily distinguishable. In Rorabaugh, the party failed to make the
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`objection at issue at trial. Rorabaugh v. Cont’l Cas. Co., 321 F. App’x 708, 709
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`(9th Cir. 2009). In Wells, the party intentionally relinquished the original objection
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`at issue on the record. Wells v. J. C. Penney Co., 250 F.2d 221, 235 (9th Cir.
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`1957).
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`Patent Owners disingenuously attempt to justify their use of Ex. 2015 and
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`2032 in this proceeding based on the district court litigation, because Ex. 2015 and
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`2032 were not admitted into evidence at trial. Rather, each is a collection of
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`several unrelated documents, and Patent Owners assert only that one document
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`from each composite exhibit was admitted into evidence at trial. And while the
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`parties did agree that the trial transcript (Ex. 1025-27) may be used in this
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`4
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`proceeding, thereby avoiding the need for certain depositions, the parties never
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`agreed that any document admitted at trial is thereby exempt from the rules of
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`evidence governing hearsay in this proceeding, and Patent Owners have provided
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`no authority in support of this argument.
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`IV. FRE 703 Does Not Render Hearsay Documents (Ex. 2015, 2032, 2053,
`2061) Admissible.
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`Dr. Klibanov may not act as a vehicle to present inadmissible hearsay. FRE
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`703 Advisory Committee Notes (2000 Amendments) (“Rule 703 has been
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`amended to emphasize that when an expert reasonably relies on inadmissible
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`information to form an opinion or inference, the underlying information is not
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`admissible simply because the opinion or inference is admitted.”) (emphasis
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`added). In Monsanto, cited by Patent Owners, the court decided that admission of
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`a hearsay report was harmless error on the facts of that case, not that its admission
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`was proper. Monsanto Co. v. David, 516 F.3d 1009, 1016 n.4 (Fed. Cir. 2008).
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`V. Reliance on Experimental Results that are Reported in the Patent
`Specification is in Contravention of the Rules.
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`The Board’s rules and policies make it clear that Patent Owners cannot rely
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`on the patent specification for hearsay purposes. E.g., 77 Fed. Reg. 48612, 48624
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`(Aug. 14, 2012). Patent Owners cite no authority for the proposition that FRE 703
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`overrides the Board’s clear directive that a patent specification may not be relied
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`upon to prove the truth of what it discloses. Paper 49 at 15.
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`5
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`Dated: May 19, 2015
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`Respectfully submitted,
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`/Michael K. Levy/
`Steven J. Lee (Reg. No. 31,272)
`Michael K. Levy (Reg. No. 40,699)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: 212-425-7200
`Fax: 212-425-5288
`
`Counsel for Petitioner Noven Pharmaceuticals,
`Inc.
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`6
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`CERTIFICATE OF SERVICE
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` I
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` certify pursuant to 37 C.F.R. §42.6(e) that a copy of the foregoing
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`Petitioners’ Reply in Support of Motion to Exclude was served electronically on
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`May 19, 2015 to counsel for Patent Owners at the following email address:
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`ExelonPatchIPR@fchs.com.
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`Dated: May 19, 2015
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`/Michael K. Levy/
`Michael K. Levy (Reg. No. 40,699)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: 212-425-7200
`Fax: 212-425-5288
`Counsel for Petitioner Noven Pharmaceuticals,
`Inc.
`
`1
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