`
`
`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’ MOTION TO EXCLUDE
`
`
`1
`Case IPR2015-00268 has been joined with this proceeding.
`
`
`
`
`

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`TABLE OF CONTENTS
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`
`Page
`
`
`I. 
`II. 
`
`INTRODUCTION .......................................................................................... 2 
`PATENT OWNERS’ DEVELOPMENT DOCUMENTS (EXHIBITS
`2015, 2032 AND 2059) ARE INADMISSIBLE AS
`UNAUTHENTICATED HEARSAY. ............................................................ 4 
`III.  TO THE EXTENT PATENT OWNERS RELY ON EXHIBIT 2059
`TO REBUT ANY OF DR. SCHÖNEICH’S OPINIONS, SUCH
`ARGUMENTS SHOULD BE GIVEN NO WEIGHT. .................................. 9 
`IV.  EXCERPTS OF TESTIMONY BY DR. TIEMESSEN FROM THE
`NOVARTIS V. WATSON TRIAL (EXHIBITS 2053 AND 2061) ARE
`INADMISSIBLE AS HEARSAY. ............................................................... 10 
`V.  DR. KLIBANOV’S DECLARATION (EX. 2012) IMPROPERLY
`RELIES ON HEARSAY. ............................................................................. 12 
`VI.  PATENT OWNERS AND DR. KLIBANOV IMPROPERLY RELY
`ON UNSUPPORTED STATEMENTS AND DATA FROM
`THE ’031 PATENT. ..................................................................................... 13 
`VII.  CONCLUSION ............................................................................................. 15 
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`-i-
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases 
`Corning Inc. v. DSM Assets B.V., IPR2013-00043, Paper 97 (May 1, 2014) ........... 8
`
`Corning Inc. v. DSM Assets B.V., IPR2013-00049, Paper 88 (May 9, 2014) ......... 10
`
`Hal Roach Studios, Inc. v. Richard Feiner and Co., Inc.,
`896 F.2d 1542 (9th Cir. 1990) ............................................................................... 8
`
`Invitrogen Corp. v. Clontech Labs, Inc., 429 F.3d 1052 (Fed. Cir. 2005) .............. 10
`
`Neste Oil OYJ v. Reg Synthetic Fuels, LLC,
`IPR2013-00578, Paper 52 (March 12, 2015) ......................................................... 5
`
`United States v. Irvin,
`682 F.3d 1254 (10th Cir. 2012) ............................................................................. 9
`
`Rules 
`37 C.F.R. § 42.53(a) ................................................................................................. 11
`
`37 C.F.R. § 42.61(a) ...............................................................................................1, 5
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`37 C.F.R. § 42.61(c) ...................................................................................... 1, 13, 14
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`37 C.F.R. § 42.62 ....................................................................................................... 1
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`37 C.F.R. § 42.64(c) ................................................................................................... 1
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`37 C.F.R. § 42.65 ...................................................................................................1, 4
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`37 C.F.R. § 42.65(b) .................................................................................................. 9
`
`Fed. R. Evid. 1006 ............................................................................................ 1, 4, 9
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`Fed. R. Evid. 802 .............................................................................................. 1, 5, 9
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`Fed. R. Evid. 803(6) ................................................................................................... 7
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`Fed. R. Evid. 803(6)(b) .............................................................................................. 8
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`-ii-
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`Fed. R. Evid. 804(b)(1) ADVISORY COMMITTEE NOTES (1972) ............................... 11
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`Fed. R. Evid. 901 ...................................................................................................1, 6
`
`Fed. R. Evid. 901(a) ...............................................................................................5, 9
`
`Fed. R. Evid. 902(11) ................................................................................................. 7
`
`Regulations 
`77 Fed. Reg. 48612 (Aug. 14, 2012) ....................................................................... 14
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`-iii-
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`Pursuant to 37 C.F.R. §§ 42.61(a), 42.62 and 42.64(c), Petitioners Noven
`
`Pharmaceuticals, Inc. (“Noven”) and Mylan Pharmaceuticals Inc. (“Mylan”) move
`
`to exclude Exhibits 2015, 2032, 2053, 2059 and 2061 as hearsay under Federal
`
`Rule of Evidence (“FRE”) 802, and to further exclude Exhibits 2015, 2032, and
`
`2059 as unauthenticated under FRE 901. Petitioners further move to exclude
`
`Exhibit 2059 as a purported summary of test results for which underlying data was
`
`not produced by Patent Owners, under F.R.E. 1006 and 37 C.F.R. § 42.65.
`
`Petitioners also move to exclude Paragraphs 27, 159 and 162-66 of Dr. Klibanov’s
`
`declaration (Ex. 2012) and Sections 157:9-160:19, 171:16-179:10, and 185:24-
`
`189:6 of the April 20, 2015 deposition of Dr. Kydonieus (Ex. 1049) as improper
`
`testimony under FRE 602 and 703, because this declaration and deposition
`
`testimony relies upon either (i) Ex. 2015 or 2032; (ii) hearsay testimony by Dr.
`
`Tiemessen (Ex. 2053 or 2061); or (iii) unsupported statements and data from
`
`the ’031 patent specification without an accompanying affidavit in contravention
`
`of 37 C.F.R. § 42.61(c). Petitioners further move the Board under § 42.61(c) to
`
`exclude Patent Owners’ improper reliance on the ’031 patent specification in their
`
`Response (Paper 25, at 19).
`
`To the extent that Patent Owners rely on Ex. 2059 or Dr. Schöneich’s
`
`testimony regarding the exhibit in their Observations to Dr. Schöneich’s April 18,
`
`2015 deposition, Petitioners respectfully submit that any such Observations are
`
`
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`1
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`

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`
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`entitled to no weight. Petitioners held back Ex. 2059, an excerpt from a Novartis
`
`document, preventing any expert (including Patent Owners’ expert, Dr. Klibanov)
`
`from providing testimony regarding the document. Any belated attorney argument
`
`or conjecture in Patent Owners’ Observations regarding Ex. 2059 cannot substitute
`
`for expert testimony and is entitled to no weight.
`
`I.
`
`Introduction
`
`The challenged claims of the ’031 patent are directed to pharmaceutical
`
`compositions comprising rivastigmine and an amount of antioxidant. At issue in
`
`this proceeding is whether a POSA would have had a reasonable expectation that
`
`the rivastigmine molecule undergoes oxidative degradation based on the
`
`combination of structural features that cause a particular carbon-hydrogen bond to
`
`be especially weak and therefore particularly susceptible to oxidation. Patent
`
`Owners contend that the inventors’ observation of rivastigmine’s predictable break
`
`down via oxidation during formulation development was somehow surprising to
`
`the inventors and qualifies them for a patent.
`
`Neither Patent Owners nor their expert has addressed the technical bases for
`
`rivastigmine’s predictable oxidative degradation. Instead they have pieced
`
`together an invention story composed entirely of hearsay statements, and their own
`
`self-serving interpretation of these statements. Patent Owners have not submitted a
`
`declaration from any inventor. The statements likewise lack relevance to the
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`
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`2
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`
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`proceeding because they have no bearing on a POSA’s understanding of
`
`rivastigmine’s predictable susceptibility to oxidation.
`
`Patent Owners rely on the following documents and statements from outside
`
`this proceeding in an attempt to show that the inventors were surprised to learn that
`
`rivastigmine degraded oxidatively, and to demonstrate the efforts undertaken to
`
`determine that the conventional antioxidant tocopherol worked to reduce the
`
`oxidation of rivastigmine in Patent Owners’ transdermal formulation:
`
` Exhibits 2015 and 2032 are each a collection of several purportedly
`
`confidential internal documents regarding the development of Patent Owners’
`
`rivastigmine transdermal patch, Exelon;
`
` Exhibit 2053 is an excerpt of selected hearsay testimony of Dr. Tiemessen, a
`
`named inventor of the ’031 patent, from an August 2013 U.S. district court
`
`trial, Novartis v. Watson, to which Petitioners were not a party;
`
` Exhibit 2059 is a one-page excerpt of a confidential internal Novartis
`
`document bearing the title “4.2 Interpretation of results of stress testing/
`
`degradation pathways”;
`
` Exhibit 2061 is an expanded excerpt of Dr. Tiemessen’s testimony from the
`
`same Novartis v. Watson trial; and
`
` Portions of the April 20, 2015 deposition of Dr. Kydonieus (Ex. 1049) at
`
`which Patent Owners’ attorney read portions of Ex. 2061 into the record.
`
`
`
`3
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`

`

`
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`The above exhibits do not address the prior art references upon which this IPR trial
`
`is based, nor do they pertain to evidence of secondary considerations of
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`nonobviousness (no evidence of which has been offered by Patent Owners).
`
`Petitioners request that the Board exclude Patent Owners’ hearsay exhibits,
`
`the portions of Dr. Klibanov’s declaration (Ex. 2012) and Patent Owners’
`
`Response (Paper 25) that rely upon them, and Patent Owners’ attempt to read
`
`hearsay documents into the record at deposition.
`
`II.
`
`Patent Owners’ Development Documents (Exhibits 2015, 2032 and
`2059) are Inadmissible as Unauthenticated Hearsay.
`
`Patent Owners’ development documents, Ex. 2015, 2032 and 2059 are
`
`inadmissible as unauthenticated hearsay. Ex. 2059 is also inadmissible under
`
`F.R.E. 1006 and 37 C.F.R. § 42.65 as a summary without underlying data.
`
`Patent Owners, and Dr. Klibanov, rely on Ex. 2015 and 2032 for the truth of
`
`the matter asserted therein. (Paper 25 at 12, 19; Ex. 2012 at ¶¶ 162-166.) For
`
`example, Patent Owners rely on hearsay to support the claim that “the inventors
`
`had to conduct ‘exhaustive testing’ to determine that the degradation of
`
`rivastigmine was oxidative in nature and required the addition of an antioxidant to
`
`fix.” (Id. at 19.) In his declaration, Dr. Klibanov relies, for example, on both
`
`exhibits as showing that certain formulations prepared by the inventors during
`
`development included rivastigmine in the form of a free base and in the form of a
`
`hydrogen tartrate salt, and that certain individuals did not predict or expect stability
`
`
`
`4
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`
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`issues. (Ex. 2012 at ¶¶ 163-67.)
`
`Petitioners timely objected to Ex. 2015, 2032 and 2059 as unauthenticated
`
`hearsay, serving written objections to each exhibit. (Ex. 1050 (Noven 1-27-2015
`
`Objections) at 5-6 and 11-12; Ex. 1051 (Noven 4-24-2015 Objections) at 3-4.)
`
`Petitioners also objected to Ex. 2059 during the deposition of Dr. Schöneich. (Ex.
`
`1048 at, e.g., 17:20-24, 18:16-20, 19:23-20:9, objecting that the document was
`
`incomplete and questions pertaining to the document were outside the scope of Dr.
`
`Schöneich’s direct testimony.) Patent Owners did not cure the deficiencies.
`
`Patent Owners provide no testimony purporting to show first-hand
`
`knowledge of the preparation of, or content within, Ex. 2015, 2032 or 2059.
`
`Without such supporting testimony, the documents are inadmissible as hearsay.
`
`FRE 802; 37 C.F.R. § 42.61(a); Neste Oil OYJ v. Reg Synthetic Fuels, LLC,
`
`IPR2013-00578, Paper 52, at 5-8 (March 12, 2015) (excluding a status report, test
`
`reports, and meeting minutes containing hearsay statements).  The documents are
`
`also inadmissible because Patent Owners have not produced evidence to show
`
`what each of the documents that comprise Ex. 2015, 2032 and 2059 actually is.
`
`FRE 901(a) (“To satisfy the requirement of authenticating or identifying an item of
`
`evidence, the proponent must produce evidence sufficient to support a finding that
`
`the item is what the proponent claims it is.”); Neste Oil OYJ v. Reg Synthetic Fuels,
`
`LLC, IPR2013-00578, Paper 52 at 3-5 (March 12, 2015) (excluding exhibits
`
`
`
`5
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`
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`lacking authentication under FRE 901).
`
`Ex. 2015 is unreliable as it is an unexplained compilation of two hearsay
`
`documents—Patent Owners do not explain what the documents are or how they are
`
`related. The first document within Ex. 2015 purports to be meeting minutes. (Ex.
`
`2015 at LTS0042712.) The first page of the document contains unexplained
`
`handwritten comments, and one of the “annex” documents, annex 12, has a hand-
`
`written title. (Id. at LTS0042712, LTS0042732.) The second document within Ex.
`
`2015 lists purported authors “Luethi P, Asche H,” whose identities are not
`
`explained, and are not listed among those on the first page of the first document.
`
`(Id. at LTS0102239.) The second document bears a 2006 date, over ten years later
`
`than the two 1996 dates listed on the face of the first document. (Id.)
`
`Ex. 2032 is also unreliable as it is an unexplained compilation of three
`
`unrelated documents. The first document within Ex. 2032, a purported
`
`development plan, is undated. (Ex. 2032 at 1.) When asked at deposition to
`
`provide a date for the document, Patent Owners’ counsel was unable to do so. (Ex.
`
`1049 (Kydonieus transcript) at 172:21-23, 174:18-175:3.) The document also
`
`contains unexplained handwritten notes above its title. (Ex. 2032 at N0260066.)
`
`The second document within Ex. 2032 purports to be a one-page e-mail dated
`
`December 1997. (Ex. 2032 at N0821943.) The third document within Ex. 2032 is
`
`an unexplained, landscape-formatted series of pages that appears to be a draft
`
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`6
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`
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`because instead of page numbering, the document recites “[page].” (Id. at
`
`N0821944-49.)
`
`As employed at the April 18, 2015 deposition, Ex. 2059 was an unreliable,
`
`unexplained excerpt of a larger document. It consisted of only one page, despite
`
`being stamped “Page 30 of 30,” was undated, and purported to summarize
`
`experimental data not provided in the document (or by Patent Owners at all). (Ex.
`
`2059 at N0002403.) For example, Ex. 2059 contains a section titled “4.2
`
`Interpretation of results of stress testing/ degradation pathways,” and states that
`
`“[f]ollowing degradation pathways demonstrated for Rivastigmine hydrogen
`
`tartrate summarize the findings.” (Id. (emphasis added).)
`
`Patent Owners served a replacement Ex. 2059, along with a purported
`
`“Certification” (Exhibit 1052) on April 28, 2015.2 However, replacement Ex. 2059
`
`remains unauthenticated because the “Certification” does not meet the
`
`requirements of FRE 902(11), which requires that Patent Owners provide
`
`“reasonable written notice of the intent to offer the record,” but Patent Owners
`
`instead used Ex. 2059 without prior notice at the deposition of Dr. Schöneich.
`
`FRE 902(11) also requires that FRE 803(6)(A)-(C) be met, but the “Certification”
`
`does not meet the requirements of 803(6)(A) because the declarant does not have
`
`2 Patent Owners served replacement Ex. 2059 and 2061 on April 28, 2015, and
`
`Petitioners served objections to these replacement exhibits on April 28.
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`
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`7
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`
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`personal knowledge that Ex. 2059 was made by someone with knowledge, at or
`
`near the time of the activity described. See Hal Roach Studios, Inc. v. Richard
`
`Feiner and Co., Inc., 896 F.2d 1542, 1551 (9th Cir. 1990) (attorney without
`
`personal knowledge could not authenticate corporate registration statement).
`
`Patent Owners certification also does not cure Petitioners’ hearsay objection
`
`to Ex. 2059. The Board has held that “[c]onducting specific and unique scientific
`
`experimental work is not ‘a regularly conducted activity’” of a business, and
`
`therefore reports of scientific research and tests do not meet the business record
`
`exception to hearsay of F.R.E. 803(6)(b). Corning Inc. v. DSM Assets B.V.,
`
`IPR2013-00043, Paper 97 at 5-6 (May 1, 2014). Further, even if Ex. 2059 were a
`
`business record, it contains multiple levels of hearsay, as the underlying
`
`experimental records are not included in even the expanded “replacement” version
`
`of Ex. 2059. Of course, efforts to supply an expanded replacement copy of Ex.
`
`2059 are meaningless because the expanded exhibit was not used in the April 18,
`
`2015 deposition.
`
`The replacement Ex. 2059 remains unreliable, unexplained hearsay. It
`
`remains undated and still purports to provide a compilation of data obtained by
`
`methods described in other documents. (Ex. 2059 at N0002374, N0002376-77.)
`
`Because Ex. 2059 and replacement Ex. 2059 are undated excerpts of larger
`
`documents that purport to provide a summary of data recorded elsewhere, they are
`
`
`
`8
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`

`

`
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`unauthenticated hearsay. FRE 802, 901(a).
`
`Even if Patent Owners intend Ex. 2059 to serve as a summary of other
`
`experiments, Patent Owners are still required to lay a foundation based on
`
`admissible evidence to prove the contents of those experiments. F.R.E. 1006; 37
`
`C.F.R. § 42.65(b); see United States v. Irvin, 682 F.3d 1254, 1261 (10th Cir. 2012)
`
`(materials summarized by Rule 1006 evidence must themselves be admissible, a
`
`contrary result would inappropriately allow parties to avoid the hearsay rule).
`
`Because Patent Owners have neither produced admissible evidence by a
`
`person with first-hand knowledge of the documents contained within Ex. 2015,
`
`2032 and 2059, nor even provided testimony explaining what these various
`
`documents are, the documents are inadmissible as unauthenticated hearsay.
`
`III. To the Extent Patent Owners Rely on Exhibit 2059 to Rebut Any of Dr.
`Schöneich’s Opinions, Such Arguments Should Be Given No Weight.
`
`To the extent Patent Owners, in their Observations to Dr. Schöneich’s April
`
`18, 2015 deposition, attempt to rebut any of Dr. Schöneich’s opinions by relying
`
`on Ex. 2059 (or Dr. Schöneich’s testimony relating thereto), Petitioners
`
`respectfully submit that such attorney argument should be given no weight by the
`
`Board. Patent Owners provided no testimony on Ex. 2059—not even from their
`
`expert, Dr. Klibanov—and instead are attempting to rely on this exhibit at the
`
`eleventh hour by introducing it as an exhibit during the Reply deposition of
`
`Petitioner’s expert Dr. Schöneich. There is no testimony explaining what Ex. 2059
`
`
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`9
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`

`
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`is or how the exhibit, if at all, relates to any issue in this proceeding.
`
`Moreover, Patent Owners were aware of Ex. 2059 (which is a Novartis
`
`document) and their attempt to interject this exhibit at this late hour prevented any
`
`meaningful testimony by either parties’ experts. If Ex. 2059 truly rebutted any of
`
`Dr. Schöneich’s opinions, Patent Owners could have had their expert, Dr. Klibanov,
`
`explain the significance of the document and Dr. Schöneich would have had the
`
`opportunity to address such testimony in his Reply declaration. Any belated
`
`attorney argument or conjecture on this exhibit, which was not considered by any
`
`expert in this IPR proceeding cannot rebut Dr. Schöneich’s opinions and should be
`
`accorded no weight by the Board. Invitrogen Corp. v. Clontech Labs, Inc., 429
`
`F.3d 1052, 1068-70 (Fed. Cir. 2005) (“Unsubstantiated attorney argument
`
`regarding the meaning of technical evidence is no substitute for competent,
`
`substantiated expert testimony.”); Corning Inc. v. DSM Assets B.V., IPR2013-
`
`00049, Paper 88 at 23-24 (May 9, 2014) (attorney argument regarding test results
`
`cannot substitute for expert testimony explaining the tests).
`
`IV. Excerpts of Testimony by Dr. Tiemessen from the Novartis v. Watson
`Trial (Exhibits 2053 and 2061) are Inadmissible as Hearsay.
`Exhibits 2053 and 2061, two different excerpted versions of Novartis v.
`
`Watson trial testimony by inventor Dr. Tiemessen, are both inadmissible hearsay.
`
`Patent Owners rely on Ex. 2053 for the truth of the information asserted in the
`
`transcript, and Ex. 2061 is merely an expanded version of Ex. 2053. Patent
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`
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`10
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`
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`Owners’ Response cites Ex. 2053 in support of factual assertions. (Paper 25 at 12,
`
`19.) In his Declaration, Ex. 2012, Dr. Klibanov relies on the Watson trial
`
`testimony of Dr. Tiemessen for the truth of the matter asserted by Dr. Tiemessen,
`
`such as the assertion that the listed inventors “didn’t expect stability issues.” (Ex.
`
`2012 at ¶¶ 162, 164-165.)
`
`Patent Owners have no basis to rely on these hearsay transcripts. Petitioners
`
`were not a party in the Novartis v. Watson trial and are not related to Watson.
`
`Patent Owners also have not shown that Dr. Tiemessen was unavailable to provide
`
`a declaration in this proceeding. Therefore Dr. Tiemessen’s testimony from the
`
`Watson trial is hearsay as against Noven, even if the testimony was given under
`
`oath. FRE 804(b)(1); ADVISORY COMMITTEE NOTES (1972) to FRE 801(b)(1)(“So
`
`far as concerns the oath, its mere presence has never been regarded as sufficient to
`
`remove a statement from the hearsay category”). The excerpts are selected pages
`
`of testimony of Dr. Tiemessen, who is an employee of Novartis, but he did not
`
`submit a declaration in this proceeding. Patent Owners were required to submit a
`
`declaration if they wished to rely upon testimony by Dr. Tiemessen in this inter
`
`partes review proceeding. 37 C.F.R. § 42.53(a).
`
`Petitioners timely objected to Patent Owners’ attempt to use this hearsay
`
`testimony. Petitioners timely objected to the original exhibit, Ex. 2053. (Ex. 1050
`
`(Noven 1-27-2015 objections) at 20-21.) When Patent Owners read portions of Ex.
`
`
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`11
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`
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`2061, a second, expanded transcript excerpt from the same trial, into the deposition
`
`record at the April 20, 2015 deposition of Dr. Kydonieus, Petitioners objected to
`
`Ex. 2061 as hearsay, and Petitioners further timely objected to Ex. 2061 on April
`
`24, 2015, within five business days after that deposition. (Ex. 1049 at, e.g.,
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`175:21-22, 176:17-18, 177:12-14, 21-23, 178:9-10, 179:5-7, 186:18-19, 188:24-25;
`
`Ex. 1051 (Noven 4-24-2015 objections) at 5.) Patent Owners provided a
`
`replacement Ex. 2061 containing additional testimony, which does not cure
`
`Petitioners’ hearsay objection.
`
`V. Dr. Klibanov’s Declaration (Ex. 2012) Improperly Relies on Hearsay.
`Dr. Klibanov aims to draw from an alleged invention development story in
`
`support of his assertion that the inventors “unexpectedly discovered that
`
`rivastigmine underwent oxidative degradation only after exhaustive testing.” (Ex.
`
`2012 at ¶ 161.) Dr. Klibanov synthesizes his own narrative based on these select
`
`documents separate from his role in assisting the PTAB on how a POSA would
`
`have understood technical information at the time of the alleged invention.
`
`To support his narrative, Dr. Klibanov improperly relies on hearsay
`
`statements from Ex. 2015, 2032 and 2053 in paragraphs 162-166 of his declaration
`
`(Ex. 2012). In paragraph 162, he relies on Ex. 2015, 2032 and 2053 to explain the
`
`inventors’ experience. In paragraph 163, he relies on Ex. 2015 and 2032 for his
`
`statements of what the inventors did. In Paragraph 164, he relies on testimony
`
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`12
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`
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`from Ex. 2053 to show the expectations of the inventors. In Paragraph 165, he
`
`relies on Ex. 2032 and 2053 to show what types of stability problems the inventors
`
`expected. In Paragraph 166, Dr. Klibanov relies on Ex. 2015 to show what test
`
`results the inventors observed and what testing they conducted, and he also
`
`improperly cites to unsupported reports of alleged experimental work and test
`
`results in the ’031 patent (discussed below in Section VI).
`
`Dr. Klibanov has identified no basis for knowledge of hearsay documents Ex.
`
`2015 and 2032 other than Dr. Tiemessen’s testimony. (Ex. 2012 at ¶¶ 161-166.)
`
`Dr. Klibanov admitted he was not present for Dr. Tiemessen’s testimony (Ex. 1026
`
`at 533:5-7), and he does not assert that he has ever spoken with Dr. Tiemessen
`
`about Ex. 2015, 2032 or 2053. The portions of Dr. Klibanov’s declaration that rely
`
`on hearsay for retelling the purported invention story should be excluded.
`
`VI. Patent Owners and Dr. Klibanov Improperly Rely on Unsupported
`Statements and Data from the ’031 Patent.
`
`Patent Owners, and Dr. Klibanov, improperly rely on unsupported
`
`statements and data from the ’031 patent specification, without providing a
`
`declaration from a person with first-hand knowledge of the alleged experiments
`
`and test results. Noven timely objected under § 42.61(c) (Ex. 1050 (Noven 1-27-
`
`2015 Objections) at 3), but Patent Owners did not cure the deficiency.
`
`The ’031 patent specification states that a rivastigmine transdermal
`
`formulation has been found to degrade, and provides experimental results,
`
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`13
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`
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`asserting the results were obtained via “exhaustive testing.” (Ex. 1001 at 1:22-28,
`
`see 4:20-30, 7:19-54.) Patent Owners and Dr. Klibanov rely on the report of these
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`experiments in the ’031 patent specification (Paper 25 at 19; Ex. 2012 at ¶¶ 27, 159,
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`166), but Patent Owners have failed to provide a declaration from a person with
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`first-hand knowledge of the experiments, as required by 37 C.F.R. § 42.61(c).
`
`As stated in the Rules of Practice for Trials Before the Patent Trial and
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`Appeal Board, “[t]he rule addresses a recurring problem in which a party
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`mistakenly relies on a specification to prove a fact other than what the specification
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`says.” 77 Fed. Reg. 48612, 48624 (Aug. 14, 2012). This rule is intended to
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`address the use of exactly the type of hearsay that Patent Owners attempt here:
`
`United States patents present hearsay issues when offered to prove the
`truth of the matters they disclose. As an example, the disclosure of
`test data in a patent is hearsay when offered in a trial to prove what
`was tested and what the results were. To make this distinction clear,
`the rule states that the specification and drawings of a United States
`patent or patent application are admissible evidence only to prove
`what they describe.
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`77 Fed. Reg. 48612, 48645 (Aug. 14, 2012) (Response to Comment 174).
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`Thus, the ’031 patent disclosure of experiments and test results cannot be
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`relied upon to prove that these experiments occurred and that these results were
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`obtained, in the absence of an affidavit from an individual with first-hand
`
`knowledge of how the data was generated and how the conclusions were arrived at.
`14
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`

`

`
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`VII. Conclusion
`Patent Owners failed to submit an affidavit from a witness with knowledge
`
`of the drug development on which Patent Owners rely, and instead Patent Owners
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`rely on hearsay, whether via non-affidavit testimony, hearsay documents, or
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`statements from the ’031 patent specification itself that are also hearsay. Patent
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`Owners also failed to submit an affidavit from a witness with knowledge of drug
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`degradation/stress testing of rivastigmine, and instead Patent Owners rely on
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`unauthenticated hearsay. Petitioners respectfully request that the Board (i) exclude
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`Ex. 2015, 2032, 2053, 2059 and 2061 and also paragraphs 27, 159 and 162-66 of
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`Dr. Klibanov’s declaration (Ex. 2012), and sections 157:9-160:19, 171:16-179:10,
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`and 185:24-189:6 of the April 20, 2015 deposition of Dr. Kydonieus; and (ii)
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`prevent Patent Owners from relying on hearsay from the patent specification as
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`they seek to do on page 19 of Paper 25.
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`To the extent that Patent Owners rely on Ex. 2059, or Dr. Schöneich’s
`
`testimony regarding the exhibit, in their Observations to Dr. Schöneich’s April 18,
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`2015 deposition, Petitioners respectfully submit that any such Observations are
`
`entitled to no weight because Patent Owners belated use of this document cannot
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`be a substitute for expert testimony.
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`15
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`

`

`
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`Dated: April 28, 2015
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`
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`
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`Respectfully submitted,
`
`/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.
`
`16
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`

`

`CERTIFICATE OF SERVICE
`
` 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’ Motion to Exclude was served electronically on April 28, 2015 to
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`counsel for Patent Owners at the following email address:
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`ExelonPatchIPR@fchs.com.
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`
`
`Dated: April 28, 2015
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`
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`
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`
`
`
`
`/Christopher J. Coulson/
`Christopher J. Coulson (Reg. No. 61,771)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: 212-425-7200
`Fax: 212-425-5288
`Counsel for Petitioner Noven Pharmaceuticals,
`Inc.
`
`NY01 2920082 v1
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`