Paper No. ____
`Date Filed: April 28, 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’ MOTION FOR OBSERVATIONS ON
`CROSS-EXAMINATION OF AGIS KYDONIEUS, Ph.D.
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`Date Filed: April 28, 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’ MOTION FOR OBSERVATIONS ON
`CROSS-EXAMINATION OF AGIS KYDONIEUS, Ph.D.
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`
`I.
`
`The Prior Art Taught That Rivastigmine
`Has Greater Chemical Stability In Vitro
`
`At Ex. 1049, page 69, lines 6 to 20, Dr. Kydonieus agreed that “one
`
`reference from the Weinstock Group can aid in the interpretation of other
`
`references from the same scientific group.”2 This testimony is relevant to Dr.
`
`Kydonieus’s erroneous opinion that a POSA would have understood that the
`
`antioxidant was added to RA7 in Elmalem to prevent its oxidation in ¶ 57 of Ex.
`
`1031. The testimony is relevant because, in a subsequent paper—Weinstock
`
`1994—the Weinstock Group did not add an antioxidant to rivastigmine. (Ex. 2012
`
`at ¶¶ 47, 72; Ex. 2027.) A POSA reading Elmalem in light of Weinstock 1994 and
`
`the art as a whole would have concluded that rivastigmine did not require an
`
`antioxidant. (Ex. 2012 at ¶¶ 72, 74.)
`
`At Ex. 1049, page 206, line 16 to page 208, line 18, Dr. Kydonieus admitted
`
`that “chemical stability” refers mostly to in vitro stability. This testimony is
`
`relevant to Enz 1991 and Weinstock 1994, which both report that rivastigmine has
`
`greater “chemical stability” than physostigmine in Ex. 2026 at 272 and Ex. 2027 at
`
`219, and Dr. Kydonieus’s assertion in ¶¶ 68-70 of Ex. 1031 that Dr. Klibanov
`
`2 At Ex. 1049, page 6, line 20 to page 7, line 14, Dr. Kydonieus testified that,
`
`unless he indicated otherwise, the opinions he expressed during cross-examination
`
`applied to both the ’031 and ’023 Patents.
`
`1
`
`
`
`mischaracterized these references as relating to in vitro stability. This testimony is
`
`relevant because it confirms that Enz 1991 and Weinstock 1994 disclose that
`
`rivastigmine has greater “chemical stability” in vitro than physostigmine and that
`
`Dr. Klibanov did not mischaracterize these references. (See Ex. 2012 at ¶ 47.)
`
`At Ex. 1049, page 100, line 10 to page 101, line 12 and page 102, line 6 to
`
`page 103, line 2, Dr. Kydonieus admitted that Rosin states that physostigmine was
`
`chemically unstable in vitro and there was a need for new carbamate derivatives
`
`with greater chemical stability in vitro than physostigmine. This testimony is
`
`relevant to Dr. Kydonieus’s erroneous opinion that the statement in Rosin that the
`
`greater in vivo potency of RA7 over physostigmine may be due to “greater
`
`chemical stability” relates to in vivo, not in vitro, stability in Ex. 1049, page 104,
`
`line 22 to page 105, line 2. This testimony is relevant because it demonstrates that
`
`when Rosin discusses “chemical stability” it relates to in vitro, not in vivo,
`
`stability.
`
`At Ex. 1049, page 110, line 24 to page 111, line 14, Dr. Kydonieus admitted
`
`that, if a drug is stable to hydrolysis inside the body, it would be expected to be
`
`stable to hydrolysis outside the body. This testimony is relevant to Dr.
`
`Kydonieus’s erroneous opinion that the statement in Rosin that the greater in vivo
`
`potency of RA7 over physostigmine may be due to “greater chemical stability”
`
`relates to in vivo, not in vitro, stability in Ex. 1049, page 104, line 22 to page 105,
`
`2
`
`
`
`line 2. Physostigmine was known to degrade in vitro by hydrolysis. (Ex. 2012 at ¶
`
`78.) This testimony is relevant because it demonstrates that, even under Dr.
`
`Kydonieus’s incorrect interpretation of Rosin, a POSA would have understood that
`
`greater chemical stability in vivo also means greater chemical stability in vitro.
`
`At Ex. 1049, page 103, line 3 to page 104, line 11, Dr. Kydonieus admitted
`
`that “metabolic degradation” refers to degradation inside the body, e.g., by
`
`enzymes, and “excretion” refers to elimination from the body, e.g., by the liver or
`
`kidneys. This testimony is relevant to Dr. Kydonieus’s erroneous opinion that the
`
`statement in Rosin that the greater in vivo potency of RA7 over physostigmine may
`
`be due to “greater chemical stability” relates to in vivo, not in vitro, stability in Ex.
`
`1049, page 104, line 22 to page 105, line 2. This testimony is relevant because Dr.
`
`Kydonieus further admitted that “slower metabolic degradation or/and excretion,”
`
`which refers to in vivo degradation or elimination, is a different reason from
`
`“greater chemical stability” for the greater in vivo potency of RA7 over
`
`physostigmine reported in Rosin. (Ex. 1049, page 104, lines 12 to 21.)
`
`At Ex. 1049, page 9, line 13 to page 10, line 16, Dr. Kydonieus confirmed
`
`that if a drug degrades, the potency of the drug is reduced. This testimony is
`
`relevant to Dr. Kydonieus’s opinion in ¶ 46 of Ex. 1031 that Dr. Klibanov did not
`
`assert that there is a link between in vivo potency and greater oxidative stability
`
`under pharmaceutically relevant conditions. This testimony is relevant because it
`
`3
`
`
`
`demonstrates that there is a link between in vivo potency and greater oxidative
`
`stability under pharmaceutically relevant conditions.
`
`II.
`
`A POSA Would Not Reasonably Have Predicted That
`Rivastigmine Would Oxidatively Degrade Absent Testing
`
`At Ex. 1049, page 43, lines 2 to 17, Dr. Kydonieus admitted that “oxidation
`
`is formulation-dependent.” This testimony is relevant to Dr. Kydonieus’s opinion
`
`that “a POSA would have understood . . . that rivastigmine was likely to undergo
`
`oxidative degradation in any given pharmaceutical formulation” in ¶ 8 of Ex. 1031.
`
`This testimony is relevant because it contradicts that erroneous opinion. It further
`
`confirms that “a POSA would conduct testing to confirm to what extent, if any, the
`
`drug in the formulation oxidatively degrades.” (Ex. 1031 at ¶ 10.)
`
`At Ex. 1049, page 154, line 11 to page 155, line 3, Dr. Kydonieus asserted
`
`that a POSA should “expect” to see degradation of rivastigmine in any
`
`formulation. This testimony is relevant to that opinion. This testimony is relevant
`
`because it is contradicted by Dr. Kydonieus’s opinion that oxidative degradation is
`
`formulation specific and “a POSA would conduct testing to confirm to what extent,
`
`if any, the drug in the formulation oxidatively degrades.” (Ex. 1031 at ¶ 10.)
`
`III.
`
`A POSA Would Not Reasonably Have Predicted That
`Rivastigmine Would Oxidatively Degrade Based On Structure
`
`At Ex. 1049, page 92, line 21 to page 94, line 5, Dr. Kydonieus admitted that
`
`just because a drug is formulated as a salt “doesn’t mean that it will not degrade.”
`
`4
`
`
`
`This testimony is relevant to Dr. Schöneich’s assertion that some of Dr. Klibanov’s
`
`real-world pharmaceutical compounds having structural features in common with
`
`rivastigmine were formulated as salts to reduce oxidative degradation in ¶ 47 of
`
`Ex. 1032. This testimony is relevant because it shows that the mere fact that a
`
`compound is formulated as a salt does not establish that it is “susceptible” to
`
`oxidative degradation or that measures were taken to avoid oxidation.
`
`At Ex. 1049, page 125, line 8 to page 128, line 6, Dr. Kydonieus admitted
`
`that Ansel (Ex. 1016) states that “[o]ne of the most important activities of
`
`preformulation is the evaluation of the physical and chemical stability of the pure
`
`drug substance” and that this refers to an experimental evaluation. This is relevant
`
`to Dr. Kydonieus’s opinion that a POSA would have analyzed the structure of
`
`rivastigmine during preformulation and determined, without testing, that it was
`
`“susceptible” to oxidation in ¶ 25 of Ex. 1031. The testimony is relevant because it
`
`confirms that actual stability tests are an essential part of preformulation and it is
`
`undisputed that no such testing was reported in the prior art. (Ex. 2012 at ¶ 47.)
`
`At Ex. 1049, page 123, lines 13 to 23, Dr. Kydonieus confirmed that he did
`
`not dispute the statement in Morrison and Boyd that “[t]he properties of one
`
`[functional] group may be modified, of course, by the presence of another
`
`[functional] group.” (See also Ex. 1038 at 45.) This testimony is relevant to Dr.
`
`Kydonieus’s opinion that a POSA would have analyzed the structure of
`
`5
`
`
`
`rivastigmine during preformulation and determined, without testing, that it was
`
`“susceptible” to oxidation in ¶ 25 of Ex. 1031. This testimony is relevant because
`
`it confirms that the structure of the molecule as a whole determines stability.
`
`IV.
`
`A POSA Would Not Have Added An Antioxidant Unless Required
`
`At Ex. 1049, page 9, lines 4 to 12, Dr. Kydonieus confirmed that he opined
`
`in his Reply Declaration that “[b]ecause a POSA would have understood that
`
`rivastigmine was likely to undergo oxidative degradation, the POSA would have
`
`been motivated to take steps to reduce or eliminate the oxidative degradation.”
`
`This testimony is relevant to that opinion. This testimony is relevant because it is
`
`contradicted by Dr. Kydonieus’s opinion that oxidation is formulation specific and
`
`“a POSA would conduct testing to confirm to what extent, if any, the drug in the
`
`formulation oxidatively degrades” (Ex. 1031 at ¶ 10), as well as the teaching in the
`
`prior art not to include an antioxidant in a pharmaceutical formulation unless one
`
`was required (Ex. 2012 at ¶¶ 39-45).
`
`V.
`
`Rosin Does Not Disclose That RA7 Oxidatively Degrades Under
`Pharmaceutically Relevant Conditions Or Requires An Antioxidant
`
`At Ex. 1049, page 10, line 24 to page 11, line 9, Dr. Kydonieus asserted that
`
`the “compounds of the present invention” in Rosin are limited to the three claimed
`
`RA-series compounds. This testimony is relevant to Dr. Kydonieus’s erroneous
`
`opinion that the statement in Rosin that “[p]referred antioxidants for use with the
`
`compounds of the present invention include sodium metabisulphite and ascorbic
`
`6
`
`
`
`acid” pertains to the three claimed RA-series compounds, one of which is RA7, in
`
`¶ 41 of Ex. 1031. (See also Ex. 1049 at 14:5-15:18.) This testimony is relevant
`
`because Rosin defines the “compounds of the invention” as the large class of
`
`carbamate compounds having general formula I (Ex. 1008 at col. 4, ll. 26-53) and
`
`the same statement regarding “preferred antioxidants” appears in the Rosin priority
`
`application, which claimed that large class of carbamate compounds. (Ex. 1049 at
`
`35:23-36:19, 37:16-39:5; Ex. 2058 at 12, 18, 31.) Thus, Dr. Kydonieus is wrong
`
`that a POSA would have believed that the Rosin inventors intended the “preferred
`
`antioxidant” to pertain only to the three RA-series compounds that were ultimately
`
`claimed in Rosin.
`
`At Ex. 1049, page 10, line 24 to page 11, line 6, Dr. Kydonieus testified for
`
`the first time (Ex. 1049 at 13:9-22) that his opinion that the “compounds of the
`
`present invention” are the three RA-series compounds claimed was based on the
`
`Rosin abstract. This testimony is relevant to Dr. Kydonieus’s erroneous opinion
`
`that the statement regarding “[p]referred antioxidants” in Rosin pertains to the
`
`three claimed RA-series compounds, one of which is RA7, in ¶ 41 of Ex. 1031.
`
`(See also Ex. 1049 at 14:5-15:18.) This testimony is relevant because the Rosin
`
`priority application claimed a large class of carbamate compounds and the original
`
`abstract related to that large claimed class. (Ex. 1049 at 37:16-39:5, 47:2-13; Ex.
`
`2058 at 31, 36.) Thus, Dr. Kydonieus is wrong that a POSA would have believed
`
`7
`
`
`
`that the Rosin inventors considered the “present invention” to be only the three
`
`RA-series compounds that were ultimately claimed in Rosin.
`
`At Ex. 1049, page 32, line 12 to page 33, line 6, Dr. Kydonieus agreed that
`
`the “compounds of the invention” in Rosin describes a large class of more than
`
`eight million compounds and that the Rosin inventors could not have had hands-on
`
`experience with all of those compounds. This testimony is relevant to Dr.
`
`Kydonieus’s erroneous opinion that the Rosin inventors must have had hands-on
`
`experience with the claimed compounds because they identify “[p]referred
`
`antioxidants for use with the compounds of the present invention” in ¶ 43 of Ex.
`
`1031. This testimony is relevant because the same statement regarding “preferred
`
`antioxidants” appears in the Rosin priority application, which claimed a large class
`
`of carbamate compounds. (See also Ex. 1049 at 35:23-36:19, 37:16-39:5; Ex.
`
`2058 at 18, 31.) Dr. Kydonieus is thus wrong that a POSA would have believed
`
`that the Rosin inventors had hands-on experience with the preferred antioxidants
`
`and the claimed “compounds of the present invention.”
`
`At Ex. 1049, page 15, line 19 to page 23, line 4, Dr. Kydonieus testified that,
`
`it was his belief, that the compounds claimed in Rosin are RA7, RA12 and RA14,
`
`and that RA6 and RA15 are not claimed in Rosin. This testimony is relevant to Dr.
`
`Kydonieus’s opinion that “the RA-series compounds (RA6, RA7, and RA15)
`
`[tested in Elmalem] were disclosed by Rosin to be paired with ‘preferred’
`
`8
`
`
`
`antioxidants, from which a POSA would have inferred that they were susceptible
`
`to oxidative degradation” in ¶ 58 of Ex. 1031. Under Dr. Kydonieus’s
`
`interpretation of Rosin (Ex. 1031 at ¶ 41; Ex. 1049 at14:5-15:18), because RA6
`
`and RA15 are not claimed, the disclosure of “preferred” antioxidants does not
`
`relate to them. This testimony is relevant because it demonstrates that, even under
`
`Dr. Kydonieus’s interpretation, Rosin does not disclose that all of the compounds
`
`tested in Elmalem were “susceptible” to oxidative degradation.
`
`VI.
`
`Elmalem Does Not Disclose That RA7 Oxidatively Degrades Under
`Pharmaceutically Relevant Conditions Or Requires An Antioxidant
`
`At Ex. 1049, page 59, lines 9 to 20, Dr. Kydonieus admitted that the
`
`Handbook gives a range of weight percents of antioxidant used in pharmaceutical
`
`formulations, which is calculated based on the total weight of the composition, not
`
`on the weight of the API in the composition. This testimony is relevant to Dr.
`
`Kydonieus’s erroneous opinion that the amount of antioxidant added in Elmalem
`
`was equal to the weight of the drug in the formulation in ¶¶ 71-72 of Ex. 1031.
`
`This testimony is relevant because Dr. Kydonieus further admitted that he had not
`
`identified a single reference in which the amount of antioxidant was calculated
`
`based on the weight of the API in the formulation.3 (Ex. 1049 at 64:7-18.) Dr.
`
`3 Although Dr. Kydonieus originally identified Sasaki as a reference in which the
`
`amount of antioxidant was based on the weight of the API (Ex. 1049 at 62:4-20),
`
`9
`
`
`
`Kydonieus’s reading of Elmalem is thus inconsistent with the Handbook and the
`
`prior art generally.
`
`At Ex. 1049, page 83, line 19 to page 84, line 12, Dr. Kydonieus admitted
`
`that he did not recall addressing the differences between the Elmalem and
`
`Weinstock 1981 studies in his Reply Declaration. This testimony is relevant to Dr.
`
`Klibanov’s opinion that there are stark differences between the purposes and
`
`designs of the Elmalem and Weinstock 1981 studies, and thus Weinstock 1981
`
`does not suggest that the antioxidant in Elmalem was added to prevent the
`
`oxidation of RA7 in ¶¶ 111-118 of Ex. 2012. This testimony is relevant because it
`
`demonstrates that Dr. Klibanov’s opinions are unrebutted.
`
`At Ex. 1049, page 73, lines 9 to 25, Dr. Kydonieus agreed that Weinstock
`
`1981 reports that formulations were made up freshly “for each experiment” but
`
`Elmalem does not. This testimony is relevant to Dr. Kydonieus’s opinion that no
`
`stock solution was prepared in Weinstock 1981 or Elmalem in ¶ 63 of Ex. 1031.
`
`This testimony is relevant because it demonstrates that Weinstock 1981 made clear
`
`that an antioxidant-containing stock solution of saline was not used for “all drugs,”
`
`unlike in Elmalem. (Ex. 2012 at ¶ 117; Ex. 1009 at 1060 (stating that “[a]ll drugs
`
`he subsequently confirmed that Sasaki calculates the amount of antioxidant based
`
`on the weight of the adhesive in the formulation (Ex. 1049 at 146:20-147:9).
`
`10
`
`
`
`were made up freshly in sterile saline”).)
`
`At Ex. 1049, page 80, line 14 to page 83, line 18, Dr. Kydonieus admitted
`
`that he had not provided a single reference which discusses the preparation of a
`
`stock saline solution, despite believing that there would be hundreds of such
`
`references. This testimony is relevant to Dr. Kydonieus’s opinion that “if a
`
`scientist uses a stock solution, they will indicate this in the publication describing
`
`the experiment” in ¶ 63 of Ex. 1031. This testimony is relevant because it
`
`demonstrates that Dr. Kydonieus’s opinion is unsupported.
`
`VII. Dr. Kydonieus Mischaracterized The Art In His Reply Declaration
`
`At Ex. 1049, page 145, line 15 to page 146, line 3, Dr. Kydonieus admitted
`
`that Sasaki only names three tertiary amines and that the only data in Sasaki is in
`
`Table 1. This testimony is relevant to Dr. Kydonieus’s opinion that Sasaki lists
`
`“numerous amine-based compounds” in ¶ 80 of Ex. 1031. This testimony is
`
`relevant because it demonstrates that Dr. Kydonieus mischaracterizes Sasaki.
`
`At Ex. 1049, page 45, lines 14 to 24, Dr. Kydonieus agreed that he produced
`
`no evidence that any of the nicotine transdermal devices commercially available as
`
`of 1998 was reported to contain an antioxidant. This testimony is relevant to Dr.
`
`Kydonieus’s opinion that “[a] POSA would not understand the disclosure of Ebert
`
`to be limited solely to one manufacturing method” in ¶ 109 of Ex. 1031. The
`
`testimony is relevant because it demonstrates that Dr. Kydonieus is wrong; the
`
`11
`
`
`
`disclosure of Ebert regarding the addition of an antioxidant to a nicotine
`
`transdermal device was not applied to any of the commercially available nicotine
`
`transdermal devices.
`
`At Ex. 1049, page 201, line 17 to page 202, line 22, Dr. Kydonieus admitted
`
`that he did not cite any document, other than his prior trial testimony, in support of
`
`his opinion that aqueous transdermal formulations were well known in the prior
`
`art. This testimony is relevant to that opinion in ¶ 103 of Ex. 1031. This testimony
`
`is relevant because it demonstrates that Dr. Kydonieus’s opinion is unsupported. It
`
`is also contradicted by Dr. Kydonieus’s prior trial testimony that transdermals do
`
`not contain water. (Ex. 1025 at 186:11-24.)
`
`At Ex. 1049, page 195, line 23 to page 198, line 2, page 199, line 23 to page
`
`200, line 9 and page 202, line 23 to page 206, line 15, Dr. Kydonieus admitted that
`
`Exs. 1033-1035, 1041-1042, 1044-1045, as well as the trial opinion from Novartis
`
`v. Watson (Ex. 2002), would not have been available to a POSA as of January
`
`1998. This testimony is relevant to Dr. Kydonieus’s obviousness opinions based
`
`on those exhibits in ¶¶ 55 n.10, 59 n.12, 88, 89, 105, 110 n.23, 120 of Ex. 1031.
`
`This testimony is relevant because it demonstrates that Dr. Kydonieus’s opinions
`
`are improperly based on non-prior art documents.
`
`At Ex. 1049, page 201, lines 9 to 16, Dr. Kydonieus admitted that he did not
`
`cite any prior art document in support of his opinion that a formulation may
`
`12
`
`
`
`contain unreported antioxidants. This testimony is relevant to that opinion in ¶ 91
`
`of Ex. 1031. This testimony is relevant because it demonstrates that Dr.
`
`Kydonieus’s opinion is unsupported.
`
`VIII. A POSA Would Not Have Been
`Motivated To Select And Combine The Art
`
`At Ex. 1049, page 141, line 9 to page 143, line 15, Dr. Kydonieus opined
`
`that a POSA would have been discouraged from developing the rivastigmine
`
`transdermal formulation in Enz because of the existence of the ’176 Patent, which
`
`includes claims to rivastigmine transdermal formulations. This testimony is
`
`relevant to Dr. Kydonieus’s opinion that a POSA would have been motivated to
`
`develop the rivastigmine transdermal device in Enz in ¶ 25 of Ex. 1031. This
`
`testimony is relevant because it contradicts that opinion.
`
`At Ex. 1049, page 39, lines 15 to 25, Dr. Kydonieus agreed that Rosin does
`
`not mention transdermals. (See also Ex. 1025 at 186:6-10.) This testimony is
`
`relevant to Dr. Kydonieus’s opinion that Rosin teaches that RA7 could be
`
`administered transdermally and would have motivated a POSA to add an
`
`antioxidant to the rivastigmine transdermal device in Enz in ¶¶ 53, 101 of Ex.
`
`1031. This testimony is relevant because it contradicts those opinions.
`
`At Ex. 1049, page 147, lines 11 to 23, Dr. Kydonieus admitted that he had
`
`not produced any prior art literature suggesting that rivastigmine degrades to form
`
`potentially harmful degradation products. This testimony is relevant to Dr.
`
`13
`
`
`
`Kydonieus’s opinion that “[a]n additional motivation for adding an antioxidant
`
`would be to prevent the formation of potentially harmful degradation products” in
`
`¶ 94 of Ex. 1031. This testimony is relevant because it demonstrates that a POSA
`
`would not have been motivated to add an antioxidant to rivastigmine to prevent the
`
`formation of potentially harmful degradation products. (See also Ex. 1010 at ¶ 27.)
`
`IX.
`
`Dr. Kydonieus Mischaracterizes The Way The Invention Was Made
`
`At Ex. 1049, page 169, line 13 to page 171, line 4, Dr. Kydonieus admitted
`
`that he did not consider the trial testimony of Dr. Harry Tiemessen, an inventor of
`
`the ʼ023 and ʼ031 Patents, in forming his opinions 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.”
`
`This testimony is relevant to those opinions in ¶ 129 of Ex. 1031. This testimony
`
`is relevant because those opinions are contradicted by Dr. Tiemessen’s trial
`
`testimony that, in the assessment of technical hurdles (Ex. 2032 at 5), (a) “Stability
`
`/ Quality of Base” refers to “the stability, the quality, as well as the manufacturing
`
`of the base” and “stability” was not limited to oxidative stability but included
`
`chemical and physical stability in general, (b) the inventors considered 15% to be a
`
`“very low” probability of encountering a problem with the “Stability / Quality of
`
`Base,” and (c) “Stability of Patch” refers to “the chemical as well as the physical
`
`stability of the patch,” including the adhesion properties. (Ex. 1049 at 157:9-20,
`
`14
`
`
`
`171:8-174:5, 175:4-177:2, 177:19-179:10; Ex. 2061 at 765:15-23, 766:17-24,
`
`767:1-5, 770:12-17, 767:11-17, 768:7-20.)
`
`At Ex. 1049, page 182, line 15 to page 185, line 23, Dr. Kydonieus admitted
`
`that the inventors
`
`. This testimony is
`
`relevant to Dr. Kydonieus’s opinion that the inventors
`
`in ¶ 130 of Ex. 1031. This testimony is relevant because it contradicts that
`
`opinion. Additionally, Dr. Tiemessen testified that the initial use of an antioxidant
`
`was as a “diagnostic tool” because if oxidation were occurring, they would have
`
`expected the antioxidant to have some effect. (Ex. 1049 at 185:24-188:7; Ex. 2061
`
`at 778:5-9.)
`
`At Ex. 1049, page 198, line 3 to page 199, line 22, Dr. Kydonieus admitted
`
`that the inventors concluded that
`
`(See also Ex. 1035 at 3.) This testimony is relevant to Dr.
`
`Kydonieus’s opinion that the inventors’ work is
`
`compounds in ¶ 89 of Ex. 1031. This testimony is relevant because it demonstrates
`
`that Dr. Kydonieus’s opinion is inconsistent with the inventors’ conclusion.
`
`15
`
`
`
`Dated: April 28, 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’ MOTION FOR
`
`OBSERVATIONS ON CROSS-EXAMINATION OF AGIS KYDONIEUS, Ph.D.
`
`was served on April 28, 2015 by causing them 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: April 28, 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
`
`
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