throbber
Filed on behalf of: Par Pharmaceutical, Inc. et al.
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`Entered: January 3, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PAR PHARMACEUTICAL, INC., BRECKENRIDGE PHARMACEUTICAL,
`INC., AND ROXANE LABORATORIES, INC.
`Petitioners
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`_______________________
`Case IPR2016-000841
`U.S. Patent No. 5,665,772
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`PETITIONERS’ RESPONSE TO PATENT OWNER’S
`MOTION FOR OBSERVATIONS
`ON DR. RATAIN’S CROSS EXAMINATION
`
`
`
`
`1 Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
`
`

`
`IPR2016-00084
`U.S. Patent No. 5,665,772
`
`Table of Contents
`
`I.
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`The Board should deny Novartis’s motion because it exceeds the page
`limits and each observation is excessively long and argumentative ............... 1
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`II.
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`Responses to observations ............................................................................... 2
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`A. Mot. 1: “I. A POSA would not have reasonably expected…” .............. 2
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`B. Mot. 2-4: “II. Petitioners have failed…[co-administration and
`half-life]” ............................................................................................... 3
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`C. Mot. 4-15: “III. Compelling objective indicia…” ................................. 6
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`1. Mot. 5: “A. Everolimus satisfied long-felt needs…” ................. 6
`
`2. Mot. 6-9: “B.1. Everolimus unexpectedly has antitumor
`activity” ....................................................................................... 7
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`3. Mot. 10-15: “B.2. Everolimus unexpectedly has FDA
`approval…” ............................................................................... 11
`
`i
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`I.
`The Board should deny Novartis’s motion because it exceeds the page
`limits and each observation is excessively long and argumentative
`
`The Board should deny Novartis’s motion for observations of Dr. Ratain’s
`
`deposition (Paper 57, “Mot.”) in its entirety because Novartis impermissibly argues
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`its case rather than concisely pointing out relevant testimony and its relevance as
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`required by the Trial Practice Guide. 77 Fed. Reg. 48756, 48767-68 (Aug. 14,
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`2012). That is, Novartis’s argumentative observations impermissibly characterize
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`the subject testimony rather than quoting it or accurately summarizing it, address
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`multiple sections of testimony in a single observation, characterize other exhibits,
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`and re-argue old arguments and introduce new ones. Actelion Pharm. v. Icos,
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`IPR2015-00561, Paper 33 at 2-3 (Mar. 18, 2016) (examples of offending
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`observations in Actelion Ex. 1049 at 14-15); LG Elecs v. ATI Techs, IPR2015-
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`00325, Paper 52 at 3-4 (Jan. 25, 2016); Medtronic v. Nuvasive, IPR2013-00506,
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`Paper 37 at 3-4 (Oct. 15, 2014). What is more, this motion would be improper even
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`if it was an authorized sur-reply because it impermissibly raises new arguments.
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`Novartis also violated the Board’s scheduling order by filing two 15-page
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`motions for observations, one for each expert, rather than a single motion as
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`permitted. Paper 9 at 3, 4, 6; 37 C.F.R. § 42.24. Like a motion to exclude, the
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`Scheduling Order authorizes only one motion for observations, regardless of the
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`number of exhibits addressed in the briefs and there is no good reason to allow
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`another 30 pages of briefing after a 15-page reply. Zhongshan Broad Ocean Motor
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`1
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`v. Nidec Motor, IPR2014-01121, Paper 86 at 32-33 (May 9, 2016) (five-judge
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`panel, with substantively identical scheduling order); Neste Oil v. Reg Synth. Fuel,
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`IPR2013-00578, Paper 29 at 4-5 (Sept. 9, 2014). When the Board desires more
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`than one 15-page motion for observations, it expressly orders it, unlike here. Mylan
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`Pharm. v. Allergan, IPR2016-01127, Paper 9 at 6 (Dec. 8, 2016) (added sentence
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`allowing motion per witness). Although the Board has not typically expunged
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`excess observations sua sponte when the issue is not raised, Petitioners raise it
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`here, and request the Board to do so.
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`Petitioners therefore bring Novartis’s improper motion to the Board’s
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`attention in its response and ask the Board to dismiss or deny it in its entirety
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`without leave to correct. Green Cross v. Shire Human Genetic Therapies,
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`IPR2016-00258, Paper 78 (Dec. 21, 2016) (ordering petitioner to do the same);
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`Zhonghan at 32-33 (no leave to correct); LG Elecs. at 3-4 (also no leave).
`
`II. Responses to observations
`Novartis’s impermissible arguments and characterizations include all of its
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`headers (e.g., “I. A POSA would not have….”) and practically all of its
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`observation as detailed in the following paragraphs with Petitioners’ responses.
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`A. Mot. 1: “I. A POSA would not have reasonably expected…”
`This section is a de facto unauthorized sur-reply on reasonable expectations.
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`2
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`Novartis paraphrases 11:15-24, 14:19-15:6 (Mot. 1), impermissibly
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`characterizing two sections of testimony and its own expert declarations, arguing
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`reasonable expectation of success. Contrary to Novartis’s argument, Petitioners
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`rebutted Novartis’s legal and factual contentions. Reply 17-19 & n.6 (including
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`cited exhibits, as do all citations to Petitioners’ briefs or its experts’ testimony).
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`The cited testimony and Novartis’s arguments are also relevant to Ex. 1119 ¶¶ 26-
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`29, 32-36, 42-44, 47-48, 101-106; Ex. 2223 14:6-17, 16:11-22; 18:4-8; 20:17-21;
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`23:23-24:16, 77:7-15 (Kao ‘678 (Ex. 2130)); 80:13-25; 84:12-25 (Kao ‘447 (Ex.
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`2075)), 85:10-15 (same).
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`Novartis paraphrases 18:9-19:23, 21:18-20 (Mot. 1), characterizing two
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`portions of testimony totaling nearly two pages and further arguing reasonable
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`expectation of success. This testimony and Novartis’s reasonable-expectation
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`arguments are relevant to the items identified in the response above.
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`B. Mot. 2-4: “II. Petitioners have failed…[co-administration and
`half-life]”
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`The section continues Novartis’s sur-reply on reasonable expectations.
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`Novartis paraphrases 204:18-205:19 (Mot. 2), characterizing a page of Dr.
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`Ratain’s testimony and another exhibit (Ex. 2132), and re-arguing its case.
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`Novartis did not attempt to impeach Dr. Ratain with the trial testimony in Ex.
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`2132, but instead impermissibly attempts to do so here—after cross-examination is
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`3
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`over and Dr. Ratain cannot respond. Novartis’s arguments and the cited text are
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`relevant to Reply 25-26; Ex. 1119 ¶¶ 26-29.
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`Novartis paraphrases 206:20-207:3 (Mot. 2), where Dr. Ratain stated that
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`he did not know the dosing schedule “off the top of [his] head” and “would have to
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`look at the…label,” ensuring the accuracy of his testimony. This testimony and
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`Novartis’s arguments are relevant to the items in the response above.
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`Novartis paraphrases 205:20-206:15 (Mot. 3), where Dr. Ratain read the
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`rapamycin label, Ex. 2053 (unlike the previous observation, Novartis did not
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`withhold this label). There is no dispute over the label’s contents, but Novartis
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`argues for the first time, and without any supporting evidence other than the label,
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`that rapamycin and cyclosporine “cannot be co-administered.” POR 57, 68
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`(emphasis added). Novartis’s arguments and the cited text are relevant to the items
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`identified in the first response in subsection B.
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`Novartis paraphrases 212:22-215:7 (Mot. 3), misleadingly characterizing
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`over two pages of Dr. Ratain’s testimony regarding ¶ 47 of his declaration. As Dr.
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`Ratain stated, “The point [of ¶ 47] was…that a POSA would know that analogs are
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`not going to have exactly the same half-life as a parent compound….Clearly, one
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`would have no prior art data…for a drug that had never been given to humans.”
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`213:11-19. Novartis continues, mischaracterizing Petitioners’ position and making
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`4
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`new half-life arguments. POR 68. Novartis’s arguments and the cited text are
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`relevant to items identified in the first response in subsection B.
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`Novartis paraphrases 207:4-20, 211:6-212:23, 207:4-211:5 (Mot. 3-4),
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`mischaracterizing and quoting out of context from three sections of testimony
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`totaling nearly four pages, as well as mischaracterizing three other exhibits and
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`further arguing its case. Dr. Ratain testified that Ex. 1055 is “a study of adherence
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`in transplant patients showing that their adherence….is higher when you to take a
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`medicine once a day as opposed to twice a day, which is common sense.” 207:24-
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`208:5. He further testified that Ex. 1056 showed that “[more] frequent doses
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`resulted in less adherence” and “on average, a single daily dose yields the highest
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`adherence rate.” 209:24-210:8. Dr. Ratain further explained that the differences
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`were not statistically significant because “their data set…[is] too small,” but the
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`results were “exactly what you would expect using commonsense principles, that
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`the fewer times a day you have to remember to take a drug, the more likely you are
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`to take it.” 210:14-211:2. Novartis also argues for the first time that rapamycin is
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`not administered once per day and that doing so would not improve adherence.
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`Novartis’s arguments and the cited testimony are relevant to the items identified in
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`the first response in subsection B and Ex. 2053 (Rapamycin label stating “take
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`once daily by mouth.”).
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`5
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`C. Mot. 4-15: “III. Compelling objective indicia…”
`This section is a de facto unauthorized sur-reply on secondary
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`considerations.
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`Novartis paraphrases 12:11-13:2 (Mot. 4-5), impermissibly characterizing
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`two sections of testimony and its own expert testimony, and further arguing
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`secondary considerations. Contrary to Novartis’s argument, Petitioners rebutted
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`Novartis’s legal and factual contentions. Reply 20-28. Novartis’s arguments are
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`also relevant to Ex. 1119 ¶¶ 25-30 (scope and summary of declaration), ¶¶ 31-44
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`(e.g., expectation that everolimus and rapamycin have similar anti-cancer and other
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`properties), ¶¶ 51-55 (e.g., FDA approval vs. actual properties), ¶¶ 56-61 (e.g.,
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`prior-art teachings of rapamycin’s anti-tumor activity and applicability of models),
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`¶¶ 62-100 (e.g., rapamycin’s efficacy for, e.g., breast cancer, RCC, PNET –
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`includes temsirolimus), ¶¶ 101-108 (e.g., rapamycin and everolimus, like other
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`rapamycins, are mTOR inhibitors), ¶¶ 109-112 (e.g., explaining why “Everolimus
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`did not satisfy any long-felt needs”); Ex. 2223 16:16-22, 20:17-21, 24:7-15, 59:15-
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`23, 60:22-25, 84:12-25, 188:14-189:6, 189:23-190:15, 191:15-192:2, 193:5-18,
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`194:9-14, 198:12-16, 199:9-12.
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`1. Mot. 5: “A. Everolimus satisfied long-felt needs…”
`Novartis paraphrases 187:13-23, 187:24-188:9, 196:11-18, 192:8-10,
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`192:21-25 (Mot. 5), characterizing five portions of Dr. Ratain’s testimony out of
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`6
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`context and arguing long-felt need. Dr. Ratain also testified that a long-felt need
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`for “new, safe and effective therapies” for RCC and breast cancer “still exists,” but
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`were satisfied by rapamycin before everolimus (187:13-23, 188:14-189:6, 191:15-
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`192:2, 193:16-18, 194:11-14), and then later better satisfied by cabozanitib and
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`nivolumab (193:5-10, 194:5-14). Dr. Ratain also testified that drugs require FDA
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`approval to be marketed to treat the approved disease (113:17-20), but “once it’s
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`approved, [it] can be administered to a patient for any reason and any indication.”
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`(115:18-20, 130:5-10). Novartis’s arguments and cited text are also relevant to the
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`items identified in the first response in subsection C and 114:1-4, 121:13-17,
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`122:6-11, 165:3-7, 168:21-169:5, 182:14-18, 195:5-7, 215:16-216:20.
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`Novartis paraphrases 190:17-191:6, 130:17-21 (Mot. 5), characterizing
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`Dr. Ratain’s deposition and declaration testimony regarding human testing and
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`FDA approval, and further arguing long-felt need. Novartis’s arguments and cited
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`text are relevant to the items identified in the previous response.
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`2. Mot. 6-9: “B.1. Everolimus unexpectedly has antitumor
`activity”
`Novartis points to 198:7-10 (Mot. 6) of Dr. Ratain’s testimony,
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`characterizes another exhibit and re-argues its case. Novartis’s arguments and cited
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`testimony are also relevant to testimony at 82:18-20, 85:10-14, 87:22-25 the items
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`identified in the first response in subsection C. Also, Novartis did not attempt to
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`impeach Dr. Ratain with the cited trial testimony during the deposition (Ratain
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`7
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`Decl. ¶¶ 58-60 is on point), but instead improperly attempts to do so here in
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`observations, when he cannot respond.
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`Novartis paraphrases 67:14-21 (Mot. 6), taking Dr. Ratain’s testimony
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`regarding the use of a citation to an old personal communication out of context. Dr.
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`Ratain continued, “My criticism of Dr. Burris was twofold: One, that he’s using a
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`statement from 1985 that’s not supported by any data to conclude what someone
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`would have believed in 1992….Second of all,…there’s a seven-year time gap. I
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`mean, usually personal communications are used for specific reasons, sometimes
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`to give credit….And it may be that Randall Johnson said that he thinks rapamycin
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`is a DNA synthesis inhibitor in 1985. That may have been his opinion, but it
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`certainly is not a reliable…basis to conclude what a POSA would have believed in
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`1992...[because] the lack of supportive data and the seven-year time gap, and lack
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`of supportive data both in the primary article and in any subsequent articles.”
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`(68:3-69:8). Novartis also impermissibly characterizes three other exhibits,
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`including Ex. 2160, which was not even presented during the deposition.
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`Novartis’s arguments and cited text are also relevant to the items identified in the
`
`previous response.
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`Novartis paraphrases 27:17-28:7, 70:7-19 (Mot. 6-7), mischaracterizing
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`Dr. Ratain’s testimony and characterizing four other exhibits (including two not
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`presented during the deposition, Exs. 2160 and 1034) and presenting a complicated
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`8
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`new argument. Novartis incorrectly presents the cited testimony as explaining the
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`differences in meanings of “cytostatic” vs. “cytotoxic” as would have been known
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`in 1992. But Dr. Ratain was pointed to Ex. 1103, a 2004 publication, and asked to
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`define cytostatic and cytotoxic as used therein. 24:19, 25:9, 26:7, 27:2-28:6. He
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`was later asked if it was known in 1992 that “doxorubicin is a cy[to]toxic
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`chemotherapy agent,” and he said yes and agreed that he meant cytotoxic with “the
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`meaning you told me before.” Tr. 70:7-19. The cited text and Novartis’s new
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`argument are relevant to the items identified in the previous response.
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`Novartis paraphrases 37:6-10, 41:3-8, 43:3-11, 52:21-24, 62:21-63:23,
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`64:2-66:17, 9:13-16 (Mot. 7), characterizing seven different sections totaling five
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`pages of Dr. Ratain’s testimony. This is a continuation of Novartis’s argument
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`already presented as an observation of 67:14-21 (Mot. 6), and is addressed above.
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`Novartis points to 28:9-14, 29:14-20 (Mot. 7-8), characterizing two
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`portions of Dr. Ratain’s testimony (and thus three exhibits) and his declaration
`
`testimony, and making a new argument relating to when rapamycin’s activity was
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`first reported. Novartis’s argument and the cited text is relevant to Ex. 1005,
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`Morris 42 (Table 1, identifying first allograft rejection in 1989 and in vivo use for
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`immunosuppression of autoimmune disease in 1977).
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`Novartis paraphrases 88:4-10, 89:7-15, 67:22-69:8 (Mot. 8), taking three
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`portions of Dr. Ratain’s testimony out of context, characterizing another exhibit,
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`9
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`and continuing its argument first presented as an observation of 67:14-21 (Mot. 6),
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`which is addressed above.
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`Novartis paraphrases 91:11-16, 92:6-13, 22:5-15, 23:19-24:16 (Mot. 8),
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`characterizing four portions of Dr. Ratain’s testimony and two other exhibits and
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`presenting a new argument related to FK506. Novartis also mischaracterizes Dr.
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`Ratain’s declaration testimony at ¶ 36. Novartis’s new argument and the cited
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`testimony are relevant to the items identified in the first response in subsection C.
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`Novartis paraphrases 72:6-18, 80:3-25, 81:3-24, 82:3-6, 86:15-21, 86:23-
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`87:3, 87:16-88:2 (Mot. 9), mischaracterizing seven portions Dr. Ratain’s testimony
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`totaling three pages to argue that the discussed patents do not have cancer test data.
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`Dr. Ratain repeatedly testified that his opinion relied on the inventor’s statements
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`in the patents, not data (73:21-74:6, 77:7-15, 80:13-25, 82:18-20; 84:12-25, 85:9-
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`14, 87:22-25). Novartis’s new argument and cited testimony are also relevant to
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`the items identified in the first response in subsection C.
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`Novartis paraphrases 70:4-6, 70:20-23 (Mot. 9), characterizing two
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`portions of Dr. Ratain’s testimony and two other exhibits and making an argument
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`relating to esorubicin and doxorubicin. In his own declaration at ¶¶ 37-44, Dr.
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`Ratain addressed the Burris declaration paragraphs Novartis cites here, but instead
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`of cross-examining him, Novartis makes a new argument here relevant to the items
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`addressed in the previous response.
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`10
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`3. Mot. 10-15: “B.2. Everolimus unexpectedly has FDA
`approval…”
`
`Novartis paraphrases 186:13-23 and 130:17-21 (again) (Mot. 10), taking a
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`short quote from two portions of Dr. Ratain’s testimony out of context and
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`characterizing two other exhibits to further argue unexpected results and the wrong
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`legal standard. Read in its entirety, Dr. Ratain correctly stated that a finding of
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`unexpected results requires an identification of a difference and “whether or not
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`that difference” would have been unexpected. Novartis removed the word “that”
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`and improperly argues predictability. See Ex. 1119 ¶ 19, Reply 20-22 (both
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`explaining the legal standard). Also, Novartis did not attempt to impeach Dr.
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`Ratain with the cited trial testimony, but instead improperly attempts to do so here.
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`Novartis’s arguments and the cited testimony are also relevant to 113:17-20,
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`114:1-4, 115:18-20, 121:13-17, 122:6-11, 130:5-10, 215:16-216:20, and the items
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`identified in the first response in subsection C.
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`Novartis paraphrases 187:4-7, 215:16-23 (Mot. 10), characterizing two
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`portions of testimony and several other exhibits to further argue unexpected FDA
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`approvals. See also POR 63-65; 164:19-20, 165:3-7, 168:21-25. Novartis’s
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`arguments are relevant to items identified in the response above.
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`Novartis paraphrases 159:15-19, 159:20-24, 162:14-17, 141:20-25,
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`153:15-20, 100:16-101:15, 104:19-105:6, 119:7-120:17 (Mot. 11-12 & n.2),
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`characterizing six other exhibits and eight portions of testimony totaling four pages
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`11
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`to argue that everolimus does not have the same clinical efficacy as rapamycin or
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`temsirolimus. Novartis mischaracterizes Dr. Ratain’s explanation of efficacy, and
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`concludes by misleadingly switching from effectiveness to clinical efficacy. Dr.
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`Ratain testified that “a significant shrinkage in one patient” would indicate
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`“efficacy in that disease” that “might be in a small subset of people with that
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`disease” and that he might be interested in investigating further. 104:19-105:6. Dr.
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`Ratain also stated that “clinical efficacy” means “that the drug has caused the
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`tumor to get smaller or regress or prevent the tumor from growing in some
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`patients.” 101:16-22. Regarding the various exhibits, Dr. Ratain testified: Acevedo
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`(Ex. 2177) is a Phase II study “report[ing] of rapamycin’s activity in treating breast
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`cancer” (157:6-12); Chan (Ex. 1086) is a “well-done” “randomized Phase II” trial
`
`for temsirolimus (160:17, 161:22-23); Duran (Ex. 2174) was a temsirolimus Phase
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`II trial in neuroendocrine carcinomas that, had it been performed on everolimus,
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`would have resulted in the same conclusions (136:8-13, 137:5-138:4, 138:23-
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`139:20); Gonzalez (Ex. 2173) is a Phase I trial where “the authors determined there
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`was evidence of activity in kidney cancer, mesothelioma, and neuroendocrine
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`tumor,” “there’s certainly at least 19 patients where one can draw, obtain some
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`data regarding whether…nab-rapamycin has activity; and if so, what dose levels
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`might be appropriate,” and concluded “this is a positive study that shows evidence
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`of activity of nab-rapamycin.” (148:10, 149:3-5, 149:21-25, 151:15-17; see also
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`12
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`150:8-12, 22-24, 151:7-14). Regarding Ex. 1105, Dr. Ratain testified that “Dr.
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`Sabatini is not a physician; he’s an oncologist. And he makes a statement that
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`rapamycin analogs are not active in breast cancer and that’s because he doesn’t
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`have the context to really understand the clinical trial that was done.” 172:12-17.
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`Novartis’s arguments are also relevant to the items identified in the first response
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`in subsection C.
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`Novartis paraphrases 142:2-14 (Mot. 12), which is counsel reading Dr.
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`Ratain’s declaration testimony into the record. Novartis impermissibly
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`characterizes his declaration and attempts to impeach him with his trial testimony
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`here, after the deposition has closed and he cannot answer. Novartis’s arguments
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`are relevant to the items identified in the response above.
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`Novartis paraphrases 32:13-18, 36:5-9, 168:5-11 (Mot. 12), characterizing
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`three portions of Dr. Ratain’s testimony to re-argue the weight of Ex. 2178,
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`Bhattacharyya. Although an abstract, Bhattacharyya has “been heavily cited”
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`(156:12) and came out when rapamycin was “generic or very close to generic.”
`
`(165:11-13; see also 164:19-20, 165:3-7, 168:21-25). Novartis’s arguments are
`
`also relevant to the items identified in the first response of subsection C.
`
`Novartis paraphrases 154:5-25 (Mot. 12-13), characterizing Dr. Ratain’s
`
`testimony and the Burris declaration (Ex. 2095) to re-argue the weight the Board
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`13
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`should give Bhattacharyya. Novartis’s arguments are relevant to the items
`
`identified in the previous response.
`
`Novartis paraphrases 141:15-19 (Mot. 13), misleadingly characterizing Dr.
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`Ratain’s testimony and his declaration (by switching between single-agent and
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`treatments in combination) to further argue Bhattacharyya’s weight. Novartis’s
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`argument is relevant to the items identified in the previous response.
`
`Novartis paraphrases 162:22-25, 163:14-164:5, 165:20-166:24 (Mot. 13-
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`14), characterizing three portions of testimony and five other exhibits to further
`
`argue Bhattacharyya’s weight and rapamycin’s clinical efficacy. Two of the
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`exhibits (Exs. 1084 and 1085) and a quoted portion of a third (Mot. 14, Ex. 1081
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`abstract) were not even presented at the deposition. Novartis is required to impeach
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`Dr. Ratain during cross examination, not after it has closed and he cannot respond.
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`Novartis’s arguments are relevant to the items identified in the response above.
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`Novartis paraphrases 178:25-179:20, 184:25-185:19, 176:19-177:2,
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`179:21-180:20, 18:2-11 (Mot. 14-15), characterizing five portions of testimony
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`covering over three pages and four exhibits and making new arguments regarding
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`rapamycin’s effectiveness. Novartis also again misleadingly switches between
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`efficacy and effectiveness. Dr. Ratain stated, “I don’t have the expertise to
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`comment on [effectiveness],” gave an illustrative example, and then concluded
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`“I’m not [putting it forward as evidence of effectiveness]. I’m putting it forward as
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`14
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`evidence of activity.” 179:5-20. Also, Novartis did not provide two of the exhibits
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`(Exs. 1093 and 1094) at the deposition despite Dr. Ratain’s request. 173:23-174:17
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`(asking for Ex. 1094), 176:24-177:2 (“If you want to ask me my opinion about the
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`limitations of the trial, I’d be happy to comment with the exhibit [1093] in front of
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`me.”). Novartis’s arguments are also relevant to the items identified in the first
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`response in subsection C.
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`Novartis paraphrases 71:9-12, 70:20-23 (again), 170:12-171:15 (Mot. 15),
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`misleadingly characterizing three portions of testimony, his declaration, and
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`another exhibit, and continuing its argument relating to esorubicin and doxorubicin
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`first raised at Mot. 9 as an observation to 70:4-6, 70:20-23. Novartis’s arguments
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`are relevant to the items already identified in that response. Also, when asked if
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`there is more to learn, Dr. Ratain stated, “There’s more to learn about every drug”
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`and “[t]here’s more to learn about everything.” 171:4-15.
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`Novartis paraphrases 71:20-23, 70:20-23 (again) (Mot. 15), characterizing
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`two portions of Dr. Ratain’s testimony and continuing its esorubicin/doxorubicin
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`argument already addressed. Petitioners’ response is the same as the one above.
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`Dated: January 3, 2017
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`Respectfully submitted,
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`/Daniel G. Brown/
`By:
`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
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`15
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`Counsel for Petitioner
`Par Pharmaceutical, Inc.
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`/Matthew L. Fedowitz/
`By:
`Matthew L. Fedowitz
`(Reg. No. 61,386)
`Merchant & Gould P.C.
`1900 Duke Street, Ste. 600
`Alexandria, VA 22314
`703-684-2500; 703-684-2501 (Fax)
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`Counsel for Petitioner
`Breckenridge Pharmaceutical, Inc.
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`/Keith A. Zullow/
`By:
`Keith A. Zullow (Reg. No. 37,975)
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`212-813-8846; 646-558-4226 (Fax)
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`Counsel for Petitioner
`Roxane Laboratories, Inc.
`
`IPR2016-00084
`U.S. Patent No. 5,665,772
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`16
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`

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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 3rd day of January,
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`2017, a true and correct copy of the foregoing PETITIONERS’ RESPONSE TO
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`PATENT OWNER’S MOTION FOR OBSERVATIONS ON DR. RATAIN’S
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`CROSS EXAMINATION was served by electronic mail on Patent Owner’s lead
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`and backup counsel at the following email address:
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`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Peter J. Waibel (Reg. No. 43,228)
`Christina Schwarz (pro hac vice)
`Charlotte Jacobsen (pro hac vice)
`Susanne L. Flanders (pro hac vice)
`Jared L. Stringham (pro hac vice)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`By: /Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
`
`Counsel for Petitioner
`Par Pharmaceutical, Inc.

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