`
`
`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’ RESPONSE TO PATENT OWNERS’ MOTION FOR
`OBSERVATIONS ON CROSS-EXAMINATION OF DR. AGIS
`KYDONIEUS
`
`
`1
`Case IPR2015-00268 has been joined with this proceeding.
`
`
`
`
`
`
`Response to Page 1, ¶ 1: Because a POSA would have known that
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`physostigmine was unstable, Weinstock 1994 (Ex. 2027) only shows at most that
`
`rivastigmine was more stable than a very unstable compound. (Ex. 1049 at 97:17–
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`98:4; Ex. 1031 at ¶¶ 48, 59 n.13.)
`
`In any case, Patent Owners mischaracterize Dr. Kydonieus’ testimony at (Ex.
`
`1049 at 69:6–20), which does not refer to Weinstock 1994, but instead is
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`immediately preceded and followed by questions regarding the Weinstock 1981
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`reference (Ex. 1049 at 68:10–69:5, 69:21–70:16). Dr. Kydonieus opined in his
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`declaration that a POSA would have understood Weinstock 1994 to refer to
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`rivastigmine as having greater in vivo activity than physostigmine “in humans and
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`animals” (a phrase that Dr. Klibanov omitted when quoting the reference in his
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`declaration), not to refer to oxidative stability of rivastigmine. (See Ex. 1031 at ¶
`
`70.)
`
`Dr. Kydonieus testified that Elmalem (Ex. 1009) and Weinstock 1981 (Ex.
`
`2046) are both publications of Professor Weinstock-Rosin’s research group, and
`
`the use of very similar language in Weinstock 1981 to describe the addition of an
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`antioxidant to certain drugs “to prevent oxidation” would not have been understood
`
`by a POSA to be a mere coincidence. (Ex. 1049 at 68:10–71:5.)
`
`Dr. Kydonieus’ testimony is relevant to, and consistent with, his opinion that
`
`the statement in Weinstock 1981(Ex. 2046) that an antioxidant was added to
`
`
`
`1
`
`
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`compositions of morphine and physostigmine, both of which were known to be
`
`susceptible to oxidation, “to prevent oxidation” of these drugs, would have been
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`considered by a POSA in interpreting the statement in Elmalem (Ex. 1009) that an
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`antioxidant was added to drugs, including RA7, “to prevent oxidation” of those
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`drugs. (See Ex. 1049 at 68:10–70:18; Ex. 1031 at ¶¶ 59–60.)
`
`Response to Page 1, ¶ 2: The statement from Enz 1991 to which Patent
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`Owners addressed questioning does not inform the POSA of rivastigmine’s
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`absolute stability, because even if rivastigmine were understood to be more stable
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`than physostigmine, as Dr. Kydonieus testified, that would at most mean it was
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`comparatively more stable than a compound with “very bad chemical stability”
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`that “has very short duration of action.” (Ex. 1049 at 208:1–18.) Further, as Dr.
`
`Kydonieus opined, a POSA considering the statement from Enz 1991 as a whole
`
`would have understood it to refer to duration of action of rivastigmine in the body
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`(in vivo). (Ex. 1031 at ¶ 69.)
`
`Response to Page 2, ¶¶ 1–2 and Page 3, ¶ 1: That rivastigmine has greater
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`claimed stability than physostigmine does not inform the POSA of the absolute
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`stability of rivastigmine, as physostigmine is a very unstable compound that was
`
`known to be subject to both fast hydrolysis and oxidative degradation. (Ex. 1049
`
`at 97:3:14, 17–98:4; Ex. 1031 at ¶¶ 48, 59 n.13; Ex. 2012 at ¶ 48.) Dr. Kydonieus
`
`testified that Rosin (Ex. 1008) states that physostigmine has a short half-life. (Ex.
`
`
`
`2
`
`
`
`1049 at 97:17–98:4.) He also testified that Rosin indicates that physostigmine is
`
`subject to oxidative degradation. (Ex. 1049 at 97:3–14.) Dr. Klibanov admitted
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`that physostigmine is subject to hydrolysis. (Ex. 2012 at ¶ 48.) The testimony
`
`cited by Patent Owners is relevant to, and consistent with, Dr. Kydonieus’ opinion
`
`that physostigmine was known by a POSA to be unstable, with a short 20-40
`
`minute half-life, and with his opinion that Connors (Ex. 1015) lists physostigmine
`
`as a drug that was reported as susceptible to oxidative degradation. (Ex. 1031 at ¶¶
`
`48, 59 n.13.)
`
`Response to Page 3, ¶ 2: The testimony cited by Patent Owners does not
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`demonstrate a link between in vivo potency and oxidative stability, because Patent
`
`Owners confuse in vivo potency with the absolute concentration of drug in a
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`composition. (See Ex. 1049 at 9:13–10:16.)
`
`In any event, the cited testimony does not support Patent Owners’
`
`conclusion, as Dr. Kydonieus testified that Rosin (Ex. 1008) lists four different
`
`reasons that may account for greater in vivo potency of a drug, including higher
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`lipid solubility and more-efficient gastrointestinal adsorption. (Ex. 1049 at
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`104:12–17; Ex. 1008 at 11:26–35.)
`
`Response to Page 4, ¶¶ 1–2 and Page 6, ¶ 1: Patent Owners confuse the
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`predictability of rivastigmine’s oxidative degradation, which was apparent to a
`
`POSA based on its structure, with the testing that a formulator may have conducted
`
`
`
`3
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`
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`to confirm this expectation; Dr. Kydonieus has explained both points and how they
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`relate. (See Ex. 1031 at ¶¶ 8–10.) Dr. Kydonieus testified that a POSA would
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`have understood that rivastigmine was susceptible to oxidative degradation and
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`would likely degrade in any particular formulation unless such degradation was
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`protected against with an antioxidant. (Ex. 1049 at 128:16–129:15.)The formulator
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`would then perform tests, as Dr. Kydonieus testified, to determine “the best
`
`amount of antioxidant you can use to get the best protection.” (Ex. 1049 at 129:9-
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`15.) He also testified that a POSA would not have been surprised to observe
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`degradation of rivastigmine in a particular formulation. (Ex. 1049 at 150:23–
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`151:21.) Dr. Kydonieus also testified that drug degradation is undesirable because
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`it weakens drug potency, and also because the degradation byproducts could be
`
`toxic. (Ex. 1049 at 9:13–10:16.) This testimony is relevant to, and consistent with,
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`Dr. Kydonieus’ opinion that a POSA would have been motivated to add an
`
`antioxidant to a rivastigmine formulation to arrest its expected oxidative
`
`degradation. (See Ex. 1031 at ¶¶ 92–94.)
`
`Response to Page 4, ¶ 3: Dr. Kydonieus testified that salts better resist
`
`oxidative degradation than bases. (Ex. 1049 at 93:18–94:5.) This testimony is
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`relevant to, and consistent with, the opinion of Dr. Schoneich that the salt form of a
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`drug is generally less susceptible to oxidation than the free base form, and in
`
`particular that oxidation is usually substantially reduced when the drug is
`
`
`
`4
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`
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`maintained in its dry form, such as in salt form in a capsule form. (Ex. 1032 at ¶¶
`
`47–48.)
`
`Response to Page 5, ¶ 1: Patent Owners mischaracterize Dr. Kydonieus’
`
`testimony, and omitted his testimony explaining that a POSA would have
`
`understood that rivastigmine was susceptible to oxidation based on its structure,
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`and that a POSA would have undertaken tests to determine the amount of
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`antioxidant that was required in a particular formulation. (Ex. 1049 at 128:7–
`
`129:15.) Further, Dr. Kydonieus testified, consistent with his declaration (Ex.
`
`1031 at ¶¶ 28–30), that a POSA would have understood Ansel (Ex. 1016) to state
`
`that the structure of a compound allowed for the prediction of the likelihood of
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`degradation of that compound. (Ex. 1049, 128:16–130:7.) This testimony is
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`consistent with the disclosure of Ansel, stating that “[i]nitial investigation begins
`
`through knowledge of the drug's chemical structure which allows the
`
`preformulation scientist to anticipate the possible degradation reactions.” (Ex.
`
`1016 at 11; see Ex. 1031 at ¶ 28.)
`
`Response to Page 5, ¶ 2: Patent Owners mischaracterize Dr. Kydonieus’
`
`testimony, and refer to one sentence of Morrison and Boyd (Ex. 1038) that is in a
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`section of the reference that Dr. Kydonieus did not cite or discuss in his
`
`declarations. (Compare Ex. 1031 at ¶ 14 (Dr. Kydonieus’ citation to page 3 of
`
`Morrison and Boyd) with Ex. 1049 at 119:25–122:24 (questions regarding page
`
`
`
`5
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`
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`168 of Morrison and Boyd).) Dr. Kydonieus testified that answering the question
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`posed was “not my expertise and I cannot answer.” (Ex. 1049 at 122:10–24.) Dr.
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`Kydonieus testified as to one specific hydrolysis mechanism that he was aware of,
`
`but he clarified that “I don’t know what else can be modified.” (Id. at 123:13–23.)
`
`In response to Patent Owners’ repeated inquiry on the same point, Dr. Kydonieus
`
`testified that in his work in industry, he relies on an organic chemist, and he
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`explained that “I do not know personally the answer.” (Id. at 124:10–125:7.) This
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`testimony is relevant to Dr. Kydonieus’ reliance on Dr. Schoneich, an organic
`
`chemist, in rendering his opinion that a POSA would have been able to predict
`
`whether a drug molecule is susceptible to oxidative degradation. (Ex. 1031 at ¶
`
`15.) And Dr. Schoneich testified that he analyzed the entire rivastigmine molecule
`
`in determining its likelihood of oxidative degradation. (Ex. 1032 at ¶ 22.)
`
`Response to Page 6, ¶ 2, Page 7, ¶ 1, and Page 8, ¶¶ 1–2: All of the cited
`
`testimony is consistent with Rosin’s disclosure of the use of antioxidant with a
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`select group of RA-series compounds, which Dr. Kydonieus testifies a POSA
`
`would understand to embrace RA7. (Ex. 1049 at 15:7–13, 23:16–24:9.)
`
` Dr. Kydonieus testified that the authors of Rosin (Ex. 1008), Dr.
`
`Weinstock-Rosin’s research group, had tested two antioxidants, sodium
`
`metabisulfite and ascorbic acid, with RA-series compounds, and thus determined
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`that the two antioxidants were preferred antioxidants. (Ex. 1049 at 23:16–24:14.)
`
`
`
`6
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`
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`This testimony is relevant to, and consistent with, Dr. Kydonieus’ opinion that,
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`because Rosin discloses several tables of data for eleven RA-series compounds,
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`and identifies seven of these RA-series compounds (including RA6, RA7, and
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`RA15) as preferred compounds of the RA series, that the authors had determined
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`that these antioxidants worked best with RA7 and the other tested RA-series
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`compounds based on their experiments with those compounds. (See Ex. 1031 at
`
`¶¶ 39–43.)
`
`Response to Page 9, ¶ 1: Dr. Kydonieus calculated the amount of
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`antioxidant contained in the RA7 compositions of Elmalem (Ex. 1009) as both a
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`percentage of the weight of total composition, and as a percentage of the weight of
`
`the drug. (Ex. 1031 at ¶¶ 134–138; Ex. 1010 at ¶ 46; Ex. 1049 at 58:14–61:9,
`
`62:4–20, 62:25–63:19.) And a POSA would have understood from Elmalem (Ex.
`
`1009) that an antioxidant was added to the RA7 composition “to prevent oxidation”
`
`of the RA7, regardless of the particular amount of antioxidant that was added (or
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`whether that amount was expressed as % weight to drug or % weight to
`
`composition). (Ex. 1031 at ¶ 78.)
`
`Dr. Kydonieus testified that the weight percent of antioxidant in a
`
`composition can be stated equivalently as either a percentage of the total weight, or
`
`as a percentage of the drug weight, and that it is a simple, high-school math
`
`exercise to convert between these two expressions of antioxidant weight
`
`
`
`7
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`
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`percentage. (Ex. 1049 at 58:14–61:9, 62:4–20, 62:25–63:19.) For example, Dr.
`
`Kydonieus testified that the RA7 drug solution of Elmalem contains 1 ml of saline.
`
`(Ex. 1049 at 49:17–51:3, 52:22–55:16.) This testimony is relevant to, and
`
`consistent with, Dr. Kydonieus’ opinion that the amount of antioxidant disclosed in
`
`the two RA7 solutions by Elmalem can be expressed not only as equal to the
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`amount of the weight of the drug, but also as 0.3% and 0.6% weight of the
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`composition, which is within the Handbook range of 0.1–1% for sodium
`
`metabisulfite. (Ex. 1031 at ¶¶ 77–78, 134–138.)
`
`Response to Page 10, ¶ 1: Dr. Kydonieus confirmed at deposition that he
`
`disagreed that Weinstock 1981 is distinguishable from Elmalem based on
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`differences in the experiment. (Ex. 1049 at 83:19–25.) Dr. Kydonieus offered to
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`further explain his opinion at deposition, but Patent Owners’ attorney declined.
`
`(Ex. 1049 at 84:2–8.) This testimony is relevant to Dr. Kydonieus’ opinion that a
`
`POSA’s understanding of Elmalem’s statement that an antioxidant was added “to
`
`prevent” oxidation of RA7 and other drugs would have been informed by the fact
`
`that the same research group had published an earlier paper, Weinstock 1981, in
`
`which they indicated that an antioxidant was added “to prevent oxidation” of
`
`morphine and physostigmine, both of which would have been understood by a
`
`POSA to be susceptible to oxidative degradation. (See Ex. 1031 at ¶¶ 59–60.)
`
`
`
`8
`
`
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`Response to Page 10, ¶ 2 and Page 11, ¶ 1: There is no evidence of a
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`“stock solution” in Elmalem; Dr. Kydonieus testified that Elmalem does not
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`mention any “stock solution,” and that a scientific publication would be expected
`
`to explain the composition of a stock solution if one were used, or at the very least
`
`mention its use. (Ex. 1049 at 71:6–72:17.) This testimony is relevant to Dr.
`
`Kydonieus’ opinion that the Elmalem reference contains no mention of a “stock
`
`solution,” and that Dr. Klibanov, who asserts that an unidentified stock solution
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`was used, provided no support for his opinion that use of a stock solution was
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`“conventional practice.” (See Ex. 1031 at ¶ 63.)
`
`Response to Page 11, ¶ 2: Dr. Kydonieus provided the structures of three
`
`compounds disclosed in Sasaki in his declaration, while also pointing out that
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`Sasaki also more generally disclosed several types of amine-based compounds to
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`which the invention of adding an antioxidant to prevent oxidation were applicable.
`
`(Ex. 1031 at ¶¶ 80–81.) Consistent therewith, Dr. Kydonieus testified that Sasaki
`
`includes broader disclosures of examples of amine-based compounds, including
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`ethanolamine based antihistamine drugs, and ethylene diamine based antihistamine
`
`drugs. (Ex. 1049 at 144:17–145:14.) Dr. Kydonieus also confirmed at deposition
`
`that, as he stated in his reply declaration, Sasaki discloses three examples of
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`compounds that contain a tertiary amine. (Ex. 1049 at 145:15–23.) This testimony
`
`is relevant to Dr. Kydonieus’ opinion that Dr. Klibanov was incorrect to state that
`
`
`
`9
`
`
`
`Sasaki discloses “just two amine-containing compounds in a single formulation.”
`
`(Ex. 1031 at ¶ 80.) Accordingly, Dr. Kydonieus did not mischaracterize Sasaki.
`
`This testimony is also relevant to Dr. Kydonieus’ opinion that Sasaki discloses a
`
`three-month stability study conducted with and without antioxidants that illustrated
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`the drug breakdown rate of amine-containing compounds in composition with an
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`acrylic adhesive. (Ex. 1031 at ¶ 82.)
`
`Response to Page 11, ¶ 3: The testimony cited by Patent Owners does not
`
`demonstrate an erroneous opinion of Dr. Kydonieus. Whether commercial
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`formulations contained a reported antioxidant would not inform a POSA as to the
`
`oxidative susceptibility of the API to degradation. (Ex. 1031 at ¶¶ 90–91.) Dr.
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`Kydonieus testified of other methods to prevent oxidative degradation, such as by
`
`eliminating free radicals and oxygen, other than adding an antioxidant, and that the
`
`manufacturers of commercial formulations of nicotine may have taken such steps.
`
`(Ex. 1049 at 43:23–44:7.) Dr. Kydonieus’ testimony is relevant to his opinion that
`
`a POSA would have understood Ebert (Ex. 1006) to include the disclosure that
`
`nicotine will oxidize when exposed to oxygen, and that an antioxidant prevents this
`
`oxidation. (Ex. 1031 at ¶ 109.) His testimony is also relevant to his opinion that,
`
`based on the structural analysis of Dr. Schoneich, this teaching of Ebert would
`
`have been understood by a POSA to be applicable to rivastigmine. (Ex. 1031 at
`
`¶ 109; Ex. 1010 at ¶ 76.) Further, Dr. Kydonieus’ testimony is relevant to Dr.
`
`
`
`10
`
`
`
`Klibanov’s admission that it is irrelevant whether a commercial formulation
`
`contains a reported antioxidant.
`
`(Ex. 1026 at 5 5 1 :4—5 52: 16.)
`
`Response to Page 12, 11 1: A POSA would not have been dissuaded from
`
`combining prior art references based on the mode of drug administration taught in
`
`each reference.
`
`(EX. 1031 at 11 96.) In any case, Dr. Kydonieus testified that his
`
`opinion that aqueous transdermal formulations were well—known in the prior art is
`
`supported by his personal experience preparing such formulations in the 1980’s.
`
`(Ex. 1049 at 20212—22.) Dr. Kydonieus also testified at trial that prior-art
`
`disclosures of RA7 in solution (e.g., Elmalem (Ex. 1009) and Rosin (Ex. 1008)) are
`
`relevant to transdermal formulations because a drug in a transdermal product must
`
`be in solution, in order for it to diffuse through the skin to the patient. (Ex. 1025 at
`
`1 86 26—24.)
`
`Response to Page 12, 11 2: Dr. Kydonieus properly relied on the documents
`
`cited by Plaintiffs. Dr. Kydonieus relied on Novartis internal documents Ex.
`
`1033—35 to rebut Dr. Klibanov’s assertions that were based on Novartis internal
`
`documents or to show that positions taken by Dr. Klibanov are inconsistent with
`
`the inventors’ experience that Dr. Klibanov relies upon. (See Ex. 1031 at 1111 130—
`
`33.) Dr. Kydonieus testified, for example,—
`
`11
`
`
`
`— (EX. 1049 at 18620—18826; see EX. 1031 at 1111 130—33.)
`
`Response to Page 12, 11 3: Dr. Kydonieus relies on the trial opinion from
`
`Novartis v. Watson to show that Novartis asserted that the Watson product
`
`infringed based on the presence of an antioxidant that was not reported by Watson.
`
`(EX. 1031 at 11 91.)
`
`Response to Page 13, 11 1: Dr. Kydonieus testified that while a rivastigmine
`
`transdermal product certainly could have been developed, a manufacturer would
`
`have been blocked from selling the rivastigmine product due to Patent Owners’
`
`(now—expired) patent that covers the rivastigmine molecule, the ’ 176 patent (EX.
`
`1024).
`(EX. 1049 at 141 :9—14323.) This testimony is consistent with his opinion
`that the prior art rendered the claimed subject matter obvious. (See EX. 1031 at 11
`
`92.)
`
`Response to Page 13, 11 2: The testimony cited by Patent Owners is
`
`consistent with Dr. Kydonieus’ opinion that a POSA would not have understood
`
`the disclosure of Rosin to be limited solely to injectable formulations, even if
`
`Rosin does not mention transdermals explicitly. (Ex. 1031 at 1111 99, 101—102.)
`
`Transdermal delivery would have been understood by a POSA to be a conventional
`
`route of administration.
`
`(EX. 1031 at 11 53.)
`
`12
`
`
`
`Response to Page 13, ¶ 3: Dr. Kydonieus testified consistently with his
`
`declaration that, because a drug can form toxic materials upon degradation
`
`generally, a POSA would be motivated to eliminate drug degradation. (Ex. 1049 at
`
`9:13–10:16; see Ex. 1031 at ¶ 94.) The fact that a prior-art reference MODERN
`
`PHARMACEUTICS (EX. 1017) disclosed the potential toxicity of drug degradation
`
`products as a reason that stability of drug dosage forms was important would have
`
`motivated a POSA to add an antioxidant to a formulation that contained an API
`
`that was susceptible to oxidative degradation. (Ex. 1031 at ¶ 94; Ex. 1017 at 3
`
`(page 227).)
`
`Response to Page 14, ¶ 1:2 Dr. Kydonieus did consider the testimony of
`
`Dr. Tiemessen in forming his opinion, and he confirmed at deposition that the
`
`testimony did not change his opinion. (Ex. 1049 at 180:20–181:8, 181:21–182:10.)
`
`Dr. Kydonieus testified that he had previously considered, and discounted, the
`
`testimony of Dr. Tiemessen. (Ex. 1049 at 180:20–181:8, 181:21–182:10.) Dr.
`
`Kydonieus rejects Dr. Tiemessen’s testimony because Dr. Tiemessen is not an
`
`organic chemist and would not have had a POSA’s training to analyze
`
`
`2 Petitioners have moved to exclude the hearsay testimony of Dr. Tiemessen
`
`that Patent Owners read into the record during the deposition of Dr. Kydonieus,
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`including the testimony that Patent Owners refer to in this paragraph. (Paper 47.)
`
`
`
`
`
`13
`
`
`
`rivastigmine’s chemical structure for likelihood of oxidation. (Ex. 1049 at 189:12-
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`23.) According to Dr. Kydonieus, any surprise of Dr. Tiemessen’s to the oxidation
`
`of rivastigmine, would not have been shared by a POSA. (Ex. 1049 at 18924-
`
`190210.) Dr. Kydonieus also testified that his opinion was unchanged based on the
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`prior testimony of Dr. Tiemessen to which Patent Owners directed his attention.
`
`(Ex. 1049 at 213:5—20.)
`
`Response to Page 15, 11 1:3 There was no mischaracterization of the
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`Novartis internal documents by Dr. Kydonieus, and he testified consistently with
`
`his opinionthat—
`
`(Ex. 1031 at 11 130.) Dr. Kydonieus testified that Ex. 1033,—
`
`_ (Ex. 1049 at 182215—18416, 185:7—12,
`
`186:17—18826’.) Further, Dr. Kydonieus testified that the report, Ex. 1033,
`
`— (Ex-1049
`
`at 183:16——184:6.)
`
`3 Petitioners have moved to exclude the hearsay testimony of Dr. Tiemessen.
`
`(Paper 47.)
`
`14
`
`
`
`Also, Patent Owners mischaracterize the confusing testimony of Dr.
`
`Tiemessen (Exhibit 2061) by improperly paraphrasing it in a manner unsupported
`
`by the original text. (See Ex. 2061 at 778:6—9.) When directed to that testimony,
`
`Dr. Kydonieus testified that he did not understand what it meant. (Ex. 1049 at
`
`186:9—18826.)
`
`Response to Page 15, 1} 2: Patent Owners did not establish the foundation
`
`for anyone to assert what “conclusion the inventors reached,” and Patent Owners
`
`did not produce an inventor declaration for this Inter Partes review proceeding. Dr.
`
`Kydonieus testified that he did not agree with the statements read by Patent
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`Owners at page 198, line 3 to page 99, line 22. Dr. Kydonieus testified that
`
`mums—
`
`(Ex. 1049 at 19825—13.) This is consistent with Dr. Kydonieus” explanation of the
`
`teaching of Sasaki, which is that an acrylic adhesive (such as the adhesive used in
`
`Example 2 of Enz) would cause oxidative degradation when used in a formulation
`
`with an amine-containing compound (like rivastigmine). (Ex. 1031 at W 80—82, 89,
`
`133.)
`
`15
`
`
`
`Dated: May 12, 2015
`
`
`
`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
`
`
`
`CERTIFICATE OF SERVICE
`
` I
`
`
`
` certify pursuant to 37 C.F.R. §42.6(e) that a copy of the foregoing
`
`Petitioners’ Response to Patent Owners’ Motion for Observations on Cross-
`
`Examination of Dr. Agis Kydonieus was served electronically on May 12, 2015 to
`
`counsel for Patent Owners at the following email address:
`
`ExelonPatchIPR@fchs.com.
`
`
`
`Dated: May 12, 2015
`
`
`
`
`
`
`
`
`
`
`
`
`/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.
`
`
`
`
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