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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioners,
`
`v.
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`ASTRAZENECA AB,
`Patent Owner.
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`
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`
`
`Case: IPR2015-013401
`U.S. Patent No. RE44,186
`
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS REGARDING THE
`CROSS-EXAMINATION OF DAVID P. ROTELLA
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`
`
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`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, Petitioner Aurobindo from IPR2016-01117, and Petitioners Sun/Amneal
`from IPR2016-01104 have been added as Petitioners to this proceeding.
`
`
`
`
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`Patent Owner AstraZeneca AB submits this Motion for Observations
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`Regarding the Cross-Examination of David P. Rotella pursuant to the Scheduling
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`Order (Paper No. 17) and the Joint Notice of Stipulation (Paper No. 57).
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`Observation #1 - In Ex. 2221 at 12:3-13:6, Dr. Rotella testified that the two
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`DPP-4 inhibitors in the clinic at the time of the inventions of the RE’186 patent
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`contained an N-linked P2 group (NVP-DPP728) or no electrophile on the P1 group
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`(P32/98). See Ex. 2226. This testimony is relevant to statements and conclusions
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`in Dr. Rotella’s 2nd declaration and Petitioners’ Reply brief regarding selection of
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`a lead compound (Ex. 1074 ¶¶ 10-16; Reply at 10-13), specifically, to the
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`structural solutions to the known problem of intramolecular cyclization.
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`Observation #2 - In Ex. 2221 at 13:20-24 and 15:3-6, Dr. Rotella testified
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`that Ashworth does not use the term “bulky,” but rather says “beta branched,” to
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`describe P2 groups in Ashworth I (Ex. 1007). This testimony is relevant to
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`assertions in Dr. Rotella’s 2nd declaration regarding Ashworth I (Ex. 1074 ¶ 19),
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`specifically, to his assertion that Ashworth I describes and teaches the advantages
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`of “bulkier” P2 groups.
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`Observation #3 - In Ex. 2221 at 15:13-16:11, Dr. Rotella testified that Ex.
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`2261 correctly depicts Compounds 25 and 28 of Ashworth I (Ex. 1007). This
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`testimony is relevant to statements and conclusions in Dr. Rotella’s 2nd declaration
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`and the Reply brief regarding Compound 28 (Ex. 1074 ¶ 24; Reply at 14-15),
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`1
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`specifically, to the correctness of his assertion that Ashworth I describes and
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`teaches stability advantages of “bulkier” P2 groups, since Compound 28, despite
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`the size of its P2 group, is “clearly less stable compared to Compound 25.”
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`Observation #4 - In Ex. 2221 at 16:21-17:17, Dr. Rotella testified that Ex.
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`2223 correctly depicts the structural differences between a tertiary and quaternary
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`β-carbon. This testimony is relevant to conclusions in Dr. Rotella’s 2nd
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`declaration regarding β-branching (Ex. 1074 ¶ 23), specifically, it demonstrates
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`that the isoleucyl and cyclohexyl derivatives contain a tertiary β-carbon, whereas
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`saxagliptin contains a quaternary β-carbon like the t-butyl derivative.
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`Observation #5 - In Ex. 2221 at 18:7-19:2 and 19:14-20:4, Dr. Rotella
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`testified that Mentlein (Ex. 2096) relates to the natural substrates for DPP-4,
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`molecules that DPP-4 cleaves, and discloses that these substrates contain tyrosine
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`and histidine at the P2 position. This testimony is relevant to conclusions in Dr.
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`Rotella’s 2nd declaration regarding the teachings of Mentlein (Ex. 1074 ¶ 19),
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`specifically, because he admitted that none of the prior art compounds he relied
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`upon used tyrosine (hydroxyphenyl group) or histidine (imidazole group)—which
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`Mentlein referred to as “bulky groups”—in the P2 position.
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`Observation #6 - In Ex. 2221 at 20:22-21:23, Dr. Rotella testified that
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`Villhauer-1998 (Ex. 1008) included adamantyl in one of many hundreds of “even
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`more preferred compounds.” In Ex. 2221 at 22:3-21, Dr. Rotella also testified that
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`2
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`Ex. 2263 correctly depicts the structures of and data for Examples 1, 3, 5, 8, and
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`12, which Villhauer-1998 identifies as its preferred agents. This testimony is
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`relevant to statements and conclusions in Dr. Rotella’s 2nd declaration and the
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`Reply brief regarding modifications of Compound 25 (Ex. 1074 ¶¶ 18, 20; Reply at
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`13-15), specifically, to whether one of ordinary skill would have selected
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`adamantyl over the many hundreds of other even more preferred P2 groups from
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`Villhauer-1998.
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`Observation #7 - In Ex. 2221 at 22:23-23:20, Dr. Rotella testified that,
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`though Villhauer-1998’s (Ex. 1008) DPP-4 inhibitors are N-linked, he had no
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`opinion as to whether the P2 groups of N-linked DPP-4 inhibitors will occupy a
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`different position in space than the P2 groups of C-linked DPP-4 inhibitors (see
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`Ex. 2259). This testimony is relevant to statements and conclusions in Dr.
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`Rotella’s 2nd declaration and the Reply brief regarding modifications of
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`Compound 25 (Ex. 1074 ¶¶ 17-24; Reply at 13-15), specifically, to whether he did
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`not consider if there was unpredictability or a reasonable expectation of success in
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`moving the P2 group from a stable N-linked DPP-4 inhibitor to a C-linked DPP-4
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`inhibitor.
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`Observation #8 - In Ex. 2221 at 24:7-16, Dr. Rotella testified that, despite
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`stability being a feature one has to pay attention to, he was not asked to provide
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`opinions or comment on the stability of the compounds disclosed in Villhauer-
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`3
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`1998 (Ex. 1008). This testimony is relevant to statements and conclusions in Dr.
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`Rotella’s 2nd declaration and the Reply brief regarding the selection of a lead
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`compound and modification of Compound 25 (Ex. 1074 ¶¶ 17-24; Reply at 13-15),
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`specifically, to whether he did not consider the known solutions to stability in
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`selecting his lead compound and to whether there was unpredictability or a
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`reasonable expectation of success in moving the P2 group from a stable N-linked
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`DPP-4 inhibitor to a C-linked DPP-4 inhibitor.
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`Observation #9 - In Ex. 2221 at 25:3-27:12, Dr. Rotella testified that he
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`investigated N-linked DPP-4 inhibitors, including those with a cyano group, after
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`the invention of saxagliptin while at Bristol-Myers Squibb (“BMS”). See Ex. 2260.
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`This testimony is relevant to statements and conclusions in Dr. Rotella’s 2nd
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`declaration and the Reply brief regarding selection of a lead compound (Ex. 1074
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`¶¶ 10-16; Reply at 10-13), specifically, to whether he did not consider the N-linked
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`DPP-4 inhibitors in selecting his lead compound.
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`Observation #10 – In Ex. 2221 at 29:19-30:1, Dr. Rotella testified that both
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`Augustyns-1997 (Ex. 2151) and Ashworth II (Ex. 2001) have data indicating that
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`use of a 6-membered ring in a pyrrolidine or cyanopyrrolidine-based DPP-4
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`inhibitor substantially reduces activity. See also Ex. 2221 at 28:16-29:10; Exs.
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`2228 and 2230. In Ex. 2221 at 30:3-31:8 and 32:12-15, Dr. Rotella also testified
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`that a 4,5-cyclopropyl-cyanopyrrolidine is named as a 6-membered ring. See Exs.
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`4
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`2256 and 2258. This testimony is relevant to statements and conclusions in Dr.
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`Rotella’s 2nd declaration and the Reply brief regarding modifications of
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`Compound 25 (Ex. 1074 ¶¶ 35-47; Reply at 16-18), specifically, to the correctness
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`of his assertion that one of ordinary skill would have cyclopropanated Compound
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`25 with a reasonable expectation of success and to whether he did not consider if
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`there was unpredictability.
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`Observation #11 - In Ex. 2221 at 33:3-34:1 and 41:6-9, Dr. Rotella testified
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`that Ashworth characterized the 4-cyanothiazolidine ring of Compound 3 as the
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`optimal P1 group and characterized the stability of Compounds 3 and 5 as “good.”
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`See also Ex. 2221 at 32:17-33:2; Ex. 2231; Ex. 2056 ¶ 166. In Ex. 2221 at 34:18-
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`37:18, Dr. Rotella also testified that he disagreed with characterizing this
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`difference in activity as substantial but acknowledged that he had previously
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`characterized a similar difference in activity within his own work as a “substantial
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`improvement.” See Ex. 2254. This testimony is relevant to statements and
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`conclusions in Dr. Rotella’s 2nd declaration and the Reply brief regarding
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`selection of a lead compound (Ex. 1074 ¶¶ 10-16; Reply at 10-13), specifically, to
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`whether Compound 25 would have been selected as a lead compound in view of
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`Ashworth’s determination of cyanothiazolidines (e.g. Compound 3) as optimal.
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`Observation #12 - In Ex. 2221 at 38:4-9, 38:13-15, and 41:6-14, Dr. Rotella
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`testified that in Ex. 2232, Compound 3 (described as optimal) and Compound 4
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`5
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`both have a sulfur atom in the P1 ring but that Compound 3 has a Ki value
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`approximately four times lower (more potent) than Compound 4. In Ex. 2221 at
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`38:10-12 and 38:16-39:3, Dr. Rotella also testified that he did not know what
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`contributed to that difference but that both P1 rings are the same size. This
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`testimony is relevant to statements and conclusions in Dr. Rotella’s 2nd declaration
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`and the Reply brief regarding modifications of Compound 25 (Ex. 1074 ¶ 40;
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`Reply at 16-180), specifically, to whether Ashworth II teaches that increases in
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`ring size are allowed.
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`Observation #13 - In Ex. 2221 at 43:12-45:15, Dr. Rotella testified that
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`Villhauer proposed using a 4-cyanothiazolidide P1 group with an N-linked P2
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`group, and one of these compounds (Ex. 3) had an IC50 for human or rat plasma
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`DPP-4 of 3 nM. Ex. 2158. He also testified that he was not asked to opine on
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`anything about Novartis’s approach, conclusions, or opinions. This testimony is
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`relevant to statements and conclusions in Dr. Rotella’s 2nd declaration and
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`Petitioners’ Reply brief regarding selection of a lead compound (Ex. 1074 ¶¶ 10-
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`16; Reply at 10-13), specifically, to whether Compound 25 would not have been
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`selected as a lead compound in view of Ashworth’s determination of
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`cyanothiazolidines (e.g. Compound 3) as optimal.
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`Observation #14 - In Ex. 2221 at 49:5-49:16, Dr. Rotella testified that
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`Augustyns-1997 (Ex. 2151) teaches that the pyrrolidine ring would prefer
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`6
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`hydrogen compared to anything else and that only a small substituent such as
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`fluorine is allowed. See also Ex. 2221 at 46:10-47:1, 47:11-13; Ex. 2229. In Ex.
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`2221 at 46:19-51:13 and 51:25-54:15, Dr. Rotella also testified that a substituent at
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`the 3-position on a pyrrolidine ring and at the 4-position on a cyanopyrrolidine ring
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`are at the same location on the ring. Exs. 2257 and 2257A. This testimony is
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`relevant to statements and conclusions in Dr. Rotella’s 2nd declaration and the
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`Reply brief regarding modifications of Compound 25 (Ex. 1074 ¶¶ 35-47; Reply at
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`16-18), specifically, to whether there was unpredictability or a reasonable
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`expectation of success when substituting the cyanopyrrolidine ring of a C-linked
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`DPP-4 inhibitor.
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`Observation #15 - In Ex. 2221 at 58:19-59:11, Dr. Rotella testified that
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`Augustyns-1997 (Ex. 2151) taught that introducing a double bond (e.g., Compound
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`9B) would flatten and rigidify the ring. In Ex. 2221 at 58:8-18, Dr. Rotella also
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`testified that Ex. 2233 correctly depicts the structures and loss in potency resulting
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`from flattening and rigidifying the ring. See also Ex. 2056 ¶ 179. This testimony is
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`relevant to statements and conclusions in Dr. Rotella’s 2nd declaration and the
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`Reply brief regarding modifications of Compound 25 (Ex. 1074 ¶¶ 35-47; Reply at
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`16-18), specifically, to the correctness of his assertion that one of ordinary skill
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`would have cyclopropanated Compound 25 with a reasonable expectation of
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`success and to whether he did not consider if there was unpredictability.
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`7
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`Observation #16 - In Ex. 2221 at 63:23-65:23, Dr. Rotella testified that
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`cyclopropanation of ACE inhibitors did not have a significant impact on activity
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`nor did increasing the ring size from 5 to 6. In Ex. 2221 at 60:12-61:13 and 65:13-
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`23, Dr. Rotella testified that ACE and DPP-4 are mechanistically different
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`enzymes and that it’s reasonable to expect a difference in activity between the two
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`enzymes. In Ex. 2221 at 62:1-63:3, Dr. Rotella also testified that Hanessian
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`reported no significant binding activity of cyclopropanated proline-containing
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`compounds in a whole series of receptors. This testimony is relevant to conclusions
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`in Dr. Rotella’s 2nd declaration regarding modifications of Compound 25 (Ex.
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`1074 ¶ 47), specifically, to the correctness of his assertion that one of ordinary skill
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`would have cyclopropanated Compound 25 with a reasonable expectation of
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`success and to whether he did not consider if there was unpredictability.
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`Observation #17 - In Ex. 2221 at 66:14-71:2 and 71:8-72:8, Dr. Rotella
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`testified that Exs. 2234-2236 correctly depict the structures of and data for
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`Compounds 21, 22, 24, 25, 28, 29, and 30 of Magnin (Ex. 2002), illustrating that
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`the orientation and location of the cyclopropyl group matters for stability and
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`activity. See also Ex. 2056 ¶¶ 189, 227-230. This testimony is relevant to
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`conclusions in Dr. Rotella’s 2nd declaration regarding unexpected results (Ex.
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`1074 ¶ 50), specifically, to whether the results obtained from the cis-4,5
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`configuration were unpredictable, surprising, and unexpected.
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`8
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`Observation #18 - In Ex. 2221 at 73:4-19, Dr. Rotella testified that Magnin
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`(Ex. 2002), as illustrated in Ex. 2237, shows that the nature of the P2 group matters
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`for potency—when combined with cyclopropanation at the cis-4,5 position, a 4-
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`fold decrease in potency results for the tertiary isoleucine Compound 21 but no
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`decrease is observed for the quaternary tert-butyl Compound 29. See also Ex. 2056
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`¶¶ 189, 227-230. This testimony is relevant to conclusions in Dr. Rotella’s 2nd
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`declaration regarding unexpected results (Ex. 1074 ¶ 50), specifically, to whether
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`the results obtained from a quaternary β-carbon in P2 in combination with a cis-4,5
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`cyclopropyl at P1 were unpredictable, surprising, and unexpected.
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`Observation #19 - In Ex. 2221 at 74:22-75:15 and 78:12-79:3, Dr. Rotella
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`testified that Magnin (Ex. 2002) shows that it is possible to increase stability and
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`preserve potency by the combination of an appropriately placed and oriented
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`cyclopropyl and an appropriately selected P2 group. See Ex. 2238; see also Ex.
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`2056 ¶¶ 227-230. This testimony is relevant to conclusions in Dr. Rotella’s 2nd
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`declaration regarding unexpected results (Ex. 1074 ¶ 50), specifically, to whether
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`the effects of a quaternary carbon in the β-position and cis-4,5 cyclopropanation
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`were unpredictable, surprising, and unexpected.
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`Observation #20 - In Ex. 2221 at 77:2-9 and 77:18-23, Dr. Rotella testified
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`that Ex. 2239 correctly depicts the structure of Compound 29 of Magnin (Ex.
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`2002) and saxagliptin, both of which contain a quaternary carbon in the β-position
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`9
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`and a cis-4,5 cyclopropyl pyrrolidine at P1. This testimony is relevant to
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`conclusions in Dr. Rotella’s 2nd declaration regarding unexpected results (Ex.
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`1074 ¶ 50), specifically, to whether saxagliptin’s potency and stability were
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`unpredictable, surprising, and unexpected.
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`Observation #21 - In Ex. 2221 at 81:6-83:7, Dr. Rotella testified that he was
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`unwilling to opine, as outside his expertise, on whether a hydroxyadamantyl group
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`of an N-linked DPP-4 inhibitor will occupy a different position in space or bind
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`differently than a hydroxyadamantyl group of a C-linked DPP-4 inhibitor, as
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`depicted in Ex. 2259A. In Ex. 2221 at 83:19-84:18, Dr. Rotella also testified that,
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`in the DPP-4 field at the time, “there were no crystal structures and so one has no
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`way of knowing how these various groups fit into and interact with the enzyme.”
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`This testimony is relevant to statements and conclusions in Dr. Rotella’s 2nd
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`declaration and the Reply brief regarding modifications of Compound 25 (Ex.
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`1074 ¶¶ 17-24; Reply at 13-15), specifically, to whether his opinions did not
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`address whether a hydroxyadamantyl group of an N-linked DPP-4 inhibitor will
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`occupy a different position in space or bind differently than a hydroxyadamantyl
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`group of a C-linked DPP-4 inhibitor and to whether the effect of moving the N-
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`linked P2 group to the C-linked position would have been unpredictable.
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`Observation #22 - In Ex. 2221 at 85:12-86:21, Dr. Rotella testified that Ex.
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`2241 correctly depicts that the hydroxyadamantyl group of saxagliptin binds
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`10
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`differently than the hydroxyadamantyl group of vildagliptin. This testimony is
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`relevant to conclusions in Dr. Rotella’s 2nd declaration regarding unexpected
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`results (Ex. 1074 ¶ 53), specifically, to whether there is unexpectedly favorable
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`binding interactions between saxagliptin and the DPP-4 enzyme and
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`unpredictability of such interactions in the absence of a crystal structure.
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`Observation #23 - In Ex. 2221 at 87:23-89:16, Dr. Rotella testified that Ex.
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`2244 correctly depicts the metabolism of vildagliptin and that vildagliptin’s major
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`metabolite does not involve hydroxylation of the adamantyl group. In Ex. 2221 at
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`89:17-90:3, Dr. Rotella also testified that saxagliptin’s major metabolite involves a
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`second hydroxylation of the adamantyl group. This testimony is relevant to
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`conclusions in Dr. Rotella’s 2nd declaration regarding unexpected results (Ex.
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`1074 ¶ 52), specifically, to his alleged motivation to modify Compound 25 and the
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`unpredictability of metabolism.
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`Observation #24 - In Ex. 2221 at 90:4-92:17, Dr. Rotella testified that he did
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`not have an opinion on whether saxagliptin’s major metabolite is an active DPP-4
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`inhibitor or is present in higher concentrations than saxagliptin over a longer
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`period of time (see Ex. 2243). This testimony is relevant to conclusions in Dr.
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`Rotella’s 2nd declaration regarding unexpected results (Ex. 1074 ¶ 52),
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`specifically, to whether he considered the biological consequences of saxagliptin’s
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`active metabolite and the unpredictable and unexpected pharmacodynamic
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`11
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`properties of saxagliptin.
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`Observation #25 - In Ex. 2221 at 92:18-93:23, Dr. Rotella testified that
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`saxagliptin is approximately 10x more potent than vildagliptin and that
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`saxagliptin’s major metabolite is approximately 5x more potent than vildagliptin.
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`In Ex. 2221 at 93:24-94:24, Dr. Rotella also testified that the half-life of the
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`binding interaction between saxagliptin and DPP-4 is approximately 14x longer
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`than that of vildagliptin and that the half-life of the binding interaction between
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`saxagliptin’s major metabolite and DPP-4 is approximately 7x longer than that of
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`vildagliptin. This testimony is relevant to conclusions in Dr. Rotella’s 2nd
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`declaration regarding unexpected results (Ex. 1074 ¶ 52), specifically, to whether
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`there was unpredictable and unexpected slow, tight binding kinetics observed for
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`saxagliptin and its active metabolite and to whether the structure-function
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`correlation for DPP-4 in humans was unpredictable.
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`Observation #26 - In Ex. 2221 at 94:23-96:1, Dr. Rotella testified that he did
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`not have an opinion on whether saxagliptin and its binding interactions provide a
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`longer pharmacodynamic half-life than pharmacokinetic half-life. This testimony is
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`relevant to conclusions in Dr. Rotella’s 2nd declaration regarding unexpected
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`results (Ex. 1074 ¶ 52), specifically, to whether he considered the unpredictable
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`and unexpected, extended pharmacodynamic profile observed for saxagliptin in
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`vivo.
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`12
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`Observation #27 - In Ex. 2221 at 99:24-101:4, Dr. Rotella testified that he
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`did not have an opinion as to whether once daily dosing is a benefit particularly in
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`treating patients with type 2 diabetes. This testimony is relevant to conclusions in
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`Dr. Rotella’s 2nd declaration regarding unexpected results (Ex. 1074 ¶ 53),
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`specifically, to the unpredictability of saxagliptin’s clinical properties and to
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`whether it met a long felt need.
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`Observation #28 - In Ex. 2221 at 102:14-104:1, Dr. Rotella testified that, as
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`illustrated in Ex. 2246, there was a great deal of activity in the field of DPP-4
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`inhibitors prior to the invention of saxagliptin that did not yield an FDA-approved
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`inhibitor. In Ex. 2221 at 104:12-14, Dr. Rotella also testified that he was not asked
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`to consider the question of FDA approval as a part of his opinion. This testimony is
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`relevant to conclusions in Dr. Rotella’s 2nd declaration regarding failures of others
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`(Ex. 1074 ¶¶ 54-55), specifically, to whether failure of others prior to the invention
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`of saxagliptin to yield an FDA-approved DPP-4 inhibitor supports non-
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`obviousness.
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`Observation #29 - In Ex. 2221 at 104:2-23, Dr. Rotella testified that Ex.
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`2245 depicts the four FDA-approved DPP-4 inhibitors, including saxagliptin, and
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`that the structures of these DPP-4 inhibitors are unrelated. See also Ex. 2056 ¶¶
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`133-136. This testimony is relevant to conclusions in Dr. Rotella’s 2nd declaration
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`regarding failures of others (Ex. 1074 ¶¶ 54-55), specifically, it demonstrates that
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`13
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`there is no common structural motif for the four FDA-approved DPP-4 inhibitors
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`and is relevant to the unpredictability of structure-function relationships in this
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`field.
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`Observation #30 - In Ex. 2221 at 106:3-108:4, Dr. Rotella testified that Ex.
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`2247 accurately depicts the information in ¶ 253 of Dr. Weber’s declaration (Ex.
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`2056) which reports a number of compounds that came into the literature after the
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`invention of saxagliptin, which also failed to obtain FDA approval as a DPP-4
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`inhibitor. This testimony is relevant to conclusions in Dr. Rotella’s 2nd declaration
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`regarding failures of others (Ex. 1074 ¶¶ 54-55), specifically, to whether failure of
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`others to develop an FDA-approved DPP-4 inhibitor supports non-obviousness.
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`Observation #31 - In Ex. 2221 at 109:2-13, Dr. Rotella testified that he first
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`worked on DPP-4 inhibitors while at BMS subsequent to the discovery of
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`saxagliptin. In Ex. 2221 at 113:7-116:21, Dr. Rotella also testified that during this
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`time he worked with the co-inventors of the RE’186 patent—Drs. Hamann,
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`Magnin, Augeri, and indirectly Dr. Robl (Dr. Hamann’s supervisor)—on the
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`saxagliptin backup program. In Ex. 2221 at 109:14-113:6, Dr. Rotella also testified
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`that he was given Ashworth I (Ex. 1007), Hanessian (Ex. 1010), and Villhauer-
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`1998 (Ex. 1008) by BMS when he began work on this program. This testimony is
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`relevant to conclusions in Dr. Rotella’s 2nd declaration (Ex. 1074), specifically, to
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`whether his analysis constitutes hindsight.
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`14
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`Observation #32 - In Ex. 2221 at 117:19-23, Dr. Rotella testified that he was
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`involuntarily separated from BMS as part of a reduction in force. This testimony is
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`relevant to conclusions in Dr. Rotella’s 2nd declaration (Ex. 1074), specifically, to
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`his bias.
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` Respectfully submitted,
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`Dated: December 12, 2016
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`By: / Anthony A. Hartmann /
`Anthony A. Hartmann, Reg. No. 43,662
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington DC 20001
`Counsel for Patent Owner
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`15
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that copies of the foregoing PATENT OWNER’S
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`MOTION FOR OBSERVATIONS REGARDING THE CROSS-
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`EXAMINATION OF DAVID P. ROTELLA was served electronically via e-
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`mail on December 12, 2016, in its entirety to the following:
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`Counsel for Petitioner Mylan Pharmaceuticals Inc.:
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`Steven W. Parmelee
`sparmelee@wsgr.com
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`Richard Torczon
`rtorczon@wsgr.com
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`Jad A. Mills
`jmills@wsgr.com
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`Douglas H. Carsten
`dcarsten@wsgr.com
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`Counsel for Petitioner Wockhardt BIO AG.:
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`Patrick Gallagher
`PCGallagher@duanemorris.com
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`Gary Speier
`gspeier@carlsoncaspers.com
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`Iain McIntyre
`imcintyre@carlsoncaspers.com
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`16
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`Counsel for Petitioner Teva Pharmaceuticals U.S.A., Inc..:
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`Counsel for Petitioner Aurobindo Pharma U.S.A., Inc..:
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`Sailesh K. Patel
`SPatel@schiffhardin.com
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`George Yu
`GYu@schiffhardin.com
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`Samuel Park
`SPark@winston.com
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`Andrew Sommer
`ASommer@winston.com
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`By: /Lauren K. Young/
`Lauren K. Young
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
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`17
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`Dated: December 12, 2016
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`Counsel for Petitioners Sun/Amneal:
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