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
`_______________________
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`PAR PHARMACEUTICAL, INC., BRECKENRIDGE PHARMACEUTICAL,
`INC., AND ROXANE LABORATORIES, INC.
`Petitioners
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`v.
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`
`
`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. JORGENSEN’S CROSS EXAMINATION
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`
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`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.
`
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`Entered: January 3, 2017
`
`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. JORGENSEN’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
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`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. 1-7: “I. Yalkowsky would not…” ................................................ 3
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`B. Mot. 7-9: “II. Petitioners have not…lead compound…” ...................... 9
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`C. Mot. 9-14: “III. Petitioners have not…formulation problems…” ...... 10
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`D. Mot. 14: “IV. Petitioners have not…alkylation reactions…” ............. 14
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`E. Mot. 14-15: “V. A POSA would not…activity” ................................. 14
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`i
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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
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`The Board should deny Novartis’s motion for observations of Dr.
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`Jorgensen’s deposition (Paper 55, “Mot.”) in its entirety because Novartis
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`impermissibly argues its case rather than concisely pointing out relevant testimony
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`and its relevance as required by the Trial Practice Guide. 77 Fed. Reg. 48756,
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`48767-68 (Aug. 14, 2012). That is, Novartis’s argumentative observations
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`impermissibly characterize the subject testimony rather than quoting it or
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`accurately summarizing it, address multiple passages (and often extensive—
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`covering 50 pages of testimony) in a single observation, characterize other
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`exhibits, and re-argue old arguments and introduce new ones. Actelion Pharm. v.
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`Icos, IPR2015-00561, Paper 33 at 2-3 (Mar. 18, 2016) (examples of offending
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`observations are 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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`1
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`another 30 pages of briefing after a 15-page reply. Zhongshan Broad Ocean Motor
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`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. Fuels,
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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 one 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 here
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`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).
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`II. Responses to observations
`Novartis’s impermissible arguments and characterizations include all of its
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`headers (e.g., “I. Yalkowsky would not have motivated ….”) and each observation
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`as detailed in the following paragraphs with Petitioners’ responses.
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`2
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`A. Mot. 1-7: “I. Yalkowsky would not…”
`Novartis paraphrases 113:19-115:6 (Mot. 1), impermissibly characterizing
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`nearly two pages of Dr. Jorgensen’s testimony, and along with a half-dozen other
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`observations (Mot. 1-3, 6), impermissibly expanding a single mention of enthalpy
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`at POR 25 into over three pages of new argument. Novartis also impermissibly
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`characterizes and misquotes evidence other than the deposition transcript at hand
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`(e.g., Ex. 1118). In any event, the cited pages of Dr. Jorgensen’s testimony define
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`the components of the formula ΔG=ΔH-TΔS in his supplemental declaration, Ex.
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`1118 ¶ 95. This testimony and Novartis’s arguments and characterizations are
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`relevant to Novartis’s new and expanded enthalpy theories at Reply 9-10 (“Lemke
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`and Yalkowsky together taught that adding flexible side chains (to increase
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`internal entropy) containing polar groups (to increase hydrophilicity) is likely to
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`improve solubility”), 15-16 (“a POSA would have understood the same qualitative
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`effects apply in real and ideal systems” and “[a]lthough a POSA would not have
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`been interested in quantitatively calculating ideal solubility, a POSA would be very
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`interested in the qualitative impact of entropy on solubility”); Ex. 2222, 115:7-21
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`(“one would expect…that a more polar compound will have a more negative
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`enthalpy of solution. So that would be a known factor that would favor enthalpy of
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`solution.”); Ex. 1118 ¶ 15 (Stella “illustrates precisely the impact on rapamycin’s
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`water solubility of modifications with flexible side chains containing polar groups
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`3
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`as taught by Lemke and Yalkowsky”), ¶ 101 (“a POSA who works in the field of
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`drug design would not be interested in calculating the ideal solubility of any drug
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`candidate”), ¶ 102 (“A POSA would have been interested in such qualitative
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`effects when considering the teachings of Yalkowsky on the entropy of fusion: as
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`the entropy increases, the dissolution of the solute is favored.”), Ex. 2091 at 43-45,
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`and Ex. 1003 ¶¶ 77-79, 84.
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`Novartis paraphrases 120:13-122:10 (Mot. 1), characterizing nearly two
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`pages of testimony and another exhibit. Novartis expands a single mention of
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`enthalpy at POR 25 into three pages of new argument. (Mot. 1-3, 6). Novartis also
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`mischaracterizes Petitioners’ position. Petitioners do not contend that “an increase
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`in internal entropy will necessarily lead to an increase in water solubility,” but that
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`an increase in internal entropy is favorable to solubility. Mot. 2 (emphasis added);
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`Reply 14 (“These flexible bonds would have been reasonably expected to increase
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`the internal entropy of fusion as taught by Yalkowsky and favorably influence
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`everolimus’s dissolution.”). Novartis also mischaracterizes the cited testimony. Dr.
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`Jorgensen did not testify that “an increase in internal entropy can lead to a decrease
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`in water solubility.” Mot. 2 (emphasis added). Rather, Dr. Jorgensen testified that
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`“you could have any combination of enthalpy and entropy” and therefore, for
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`example, “You can make a change to a molecule that resulted in greater solubility,
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`and that can come about by an increase in the entropy of dissolution or a decrease
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`4
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`in the enthalpy or both” and that “any combination of signs with delta H and delta
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`S are possible.” Ex. 2222, 120:17-24, 122:8-10. This observation is relevant to the
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`items identified with respect to the first observation.
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`Novartis characterizes two sections, 120:4-9 and 116:14-25 (Mot. 2), and
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`along with other observations (Mot. 1-3, 6), expands a single mention of enthalpy
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`at POR 25 into three pages of new argument. Novartis also argues what the cited
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`testimony “shows” instead of concisely stating its relevance. The cited testimony is
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`relevant to the items identified with respect to the first observation.
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`Novartis paraphrases 117:4-118:16 (Mot. 2-3), characterizing a page and a
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`half of testimony and along with other observations (Mot. 1-3, 6), expanding a
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`single mention of enthalpy at POR 25 into three pages of new argument. Novartis
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`also impermissibly introduces a new argument regarding Yalkowsky’s Figure 2 as
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`part of its new and expanded enthalpy arguments. The cited testimony is relevant
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`to the same items identified with respect to the first observation. It is also relevant
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`to Reply 13 n.13, 15 & n.4; Ex. 1118 ¶ 82 (“Adding more rotatable bonds increases
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`the number of possible conformations and increases the favorable effect on
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`solubility. This favorable effect is independent of the solvent and merely reflects
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`the available conformations of the solute.”), ¶¶ 82 n.5, 91, 95 (“The fundamental
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`concept illustrated in Figure 2 of Yalkowsky applies to all dissolution processes.”),
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`¶ 110.
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`5
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`Novartis paraphrases 120:10-12 (Mot. 3). There, Novartis asked, “Is the
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`effect of adding flexible groups on enthalpy independent of the solvent?” Dr.
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`Jorgensen responded, “An odd question, but no.” Novartis did not follow up and
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`ask why this was an odd question. Novartis argues what this testimony “shows”
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`instead of concisely stating its relevance and adds to its three pages of new
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`argument regarding enthalpy. (Mot. 1-3, 6).
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`Novartis paraphrases 115:7-116:3 (Mot. 3), characterizing nearly a page of
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`testimony, and further adding to its enthalpy argument. Novartis also
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`mischaracterized the testimony. Dr. Jorgensen did not state that “polar compounds
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`would have a more negative enthalpy of solution.” (emphasis added). In response
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`to Novartis’s question, “Is it possible to predict whether any given chemical
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`modification will be to an increase or decrease in the enthalpy solution?” Dr.
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`Jorgensen responded, “one would expect, but, again, as with most things in
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`chemistry not guaranteed, that a more polar compound will have a more negative
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`enthalpy of solution. So that would be a known factor that would favor enthalpy of
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`solution.” Ex. 2222, 115:7-21 (emphases added); see also 122:25-123:5 (while
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`discussing a hydroxypropoxy group, stating “adding an additional more flexible
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`bond would be a good thing” but “adding a CH2 group, you know, could
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`counteract that some”), 123:11-124:8 (“you have polar pieces…you have added an
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`additional rotatable bond which helps the solubility, but you’ve also added a CH2
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`6
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`group which would likely diminish the favorable solubility effect.”). Dr. Jorgensen
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`also stated that he “didn’t provide prior art references” regarding polar compounds’
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`effect on enthalpy because this “wasn’t part of [his] declaration.” Id. at 115:25-
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`116:3. The testimony is relevant to the items identified in the first observation.
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`Novartis paraphrases 124:18-127:13 (Mot. 4), characterizing nearly three
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`pages of testimony, and introduces a new argument relating to hydrocarbon chain
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`length and solvents that is further developed in three pages of arguments spanning
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`six other observations (Mot. 4-6). It also mischaracterizes the testimony. Dr.
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`Jorgensen did not state that “the ‘qualitative effect’ on solubility of increasing
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`chain length will vary depending on the solvent” (emphasis added). Rather, he
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`testified that “the entropy effect discussed by Yalkowsky would certainly be
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`operable in water and that would be a favorable effect on solubility with increasing
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`chain length” and “the effect that Yalkowsky is addressing is operable in any
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`solvent.” Ex. 2222, 127:16-128:2. For the particular compounds in Schwartz, “the
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`data [is] interesting” because the prediction “wasn’t clear because you have two
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`competing effects. You have the favorable entropy effect with increasing the chain
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`length versus the unfavorable effect of adding CH2 groups. And for these
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`particular compounds, the latter was the dominant effect.” Id. at 134:2-11; see also
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`133:18-22 (“For these compounds where you’re increasing the length of a
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`hydrocarbon chain, an alkyl chain, there is decrease in solubility with increase in
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`7
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`chain length, which is consistent with our previous discussions.”). This testimony
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`is relevant to Dr. Jorgensen’s other testimony regarding competing effects of
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`hydrophobicity and flexibility. Ex. 2091, 58:22-59:4, 108:14-24.
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`Novartis paraphrases 133:7-134:11 (Mot. 4), characterizing nearly a page
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`of testimony regarding a new document (Yalkowsky 1972) first introduced by
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`Novartis during this post-Reply deposition, and adding to the hydrocarbon chain
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`arguments at Mot. 4-6. Novartis impermissibly includes nearly a page of new
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`argument regarding hydrocarbon (or alkyl) side chains, characterizes other
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`exhibits, and misstates Petitioners’ position. Petitioners do not contend that adding
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`flexible side chains always increases solubility in all solvents. The cited testimony
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`is relevant to items in the previous response.
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`Novartis paraphrases 128:6-129:17 and 134:20-135:11 (Mot. 5),
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`characterizing two pages of testimony, and further adding to the three-page
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`hydrocarbon chain/solvent arguments at Mot. 4-6. The cited testimony is relevant
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`to the items in the above response to 124:18-127:13.
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`Novartis paraphrases 69:16-24 and 127:14-128:5 (Mot. 6), adding to its
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`chain (Mot. 4-6) and enthalpy arguments (Mot. 1-3) discussed above. The cited
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`testimony is relevant to the previously identified items for both arguments.
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`Novartis paraphrases 69:25-71:17 and 74:8-75:15 (Mot. 6), characterizing
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`three pages of testimony and impermissibly arguing that POSA would not combine
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`8
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`the references. Dr. Jorgensen also testifies that “the flexible chain part
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`of…Yalkowsky…is implicit in…Lemke.” Ex. 2222, 67:3-6; see also 66:5-67:2,
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`67:3-68:20. This testimony is relevant to Reply 9-16.
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`B. Mot. 7-9: “II. Petitioners have not…lead compound…”
`This section adds two pages of new and repeated arguments to Novartis’s
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`lead compound case set forth at POR 47-50.
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`Novartis points to 5:14-6:2 (Mot. 7) and re-argues its lead-compound case.
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`This observation is relevant to Reply 3-5; Pet. 6, 26-27, 39, 41-42.
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`Novartis paraphrases 9:14-16:7 and 104:20-105:12 (Mot. 7-8),
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`characterizing eight pages of testimony to set forth a new lead-compound argument
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`that Stella was assigned to American Home Products. This observation is relevant
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`to the same items identified above.
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`Novartis points to 16:16-17:5 (Mot. 8), where Dr. Jorgensen testified that
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`“high dose[s]” of rapamycin were toxic to monkeys and baboons, and re-argues its
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`lead-compound case. The sizes of the doses are discussed at 18:8-19:22 (discussing
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`Morris (Ex. 1005) at 59-60). This testimony is relevant to Ex. 1118 ¶ 20, Ex. 2091
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`at 133:11-13, 183:11-23, 184:7-11,185:11-23, 202:8-10 and 204:15-18, 206:2-19,
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`260:25-261:10, and the items identified in the first paragraph of this subsection. It
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`is also relevant to Novartis’s assertion at Mot. 11-12 that a POSA interested in
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`immunosuppressants would be concerned only with lower doses.
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`9
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`Novartis paraphrases 19:23-20:18 (Mot. 8-9), characterizing a page of
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`testimony and further re-arguing its lead-compound case. This observation is
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`relevant to the items listed in the previous paragraphs in this subsection.
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`C. Mot. 9-14: “III. Petitioners have not…formulation problems…”
`Here, Novartis adds five pages of new and repeated arguments to POR 50-
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`54, where it contended rapamycin’s solubility was not a problem or a POSA would
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`have addressed it using a formulation approach.
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`Novartis paraphrases 77:10-81:18, 90:5-92:9, 98:6-11, and 112:23-
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`113:15 (Mot. 9), characterizing seven pages of testimony and raising a new
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`argument that formulation considerations for use as an immunosuppressant are
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`different than those for use as an anti-tumor agent. Novartis also re-argues that
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`rapamycin’s poor solubility was not a problem, and if it was, a POSA would have
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`attempted only a formulation approach. See POR 50-53. Novartis also
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`mischaracterizes Petitioners’ position and Dr. Jorgensen’s opinions. The cited text
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`and Novartis’s arguments are relevant to Pet. 11, 17 (a POSA “would have known
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`that rapamycin’s relatively poor solubility in water places it on the very low end of
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`the acceptable spectrum for formulation”), 41-42 (a POSA “would have
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`understood that improving rapamycin’s solubility would have increased the drug’s
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`bioavailability which would allow for use in oral formulations”); Reply 2, 5-6
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`(“even modest improvements in rapamycin’s poor solubility would have practical
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`10
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`advantages,” a POSA “would have sought to address the source of the problem—
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`the compound itself,” and noting problems with formulations), 8; Ex. 1003 ¶¶ 75-
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`76 (“Stella specifically identified the need for making rapamycin derivatives that
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`have improved solubility to construct satisfactory pharmaceutical formulations.”),
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`¶¶ 138-140 (a POSA would have known that “improving the solubility of a poorly
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`soluble drug, one can improve the drug’s bioavailability”); Ex. 1118 ¶¶ 8-9, 25-35,
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`38 (“Both formulation and prodrug solutions are viewed as a last resort when
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`chemical modification to solve ADME (absorption, distribution, metabolism,
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`excretion) issues has failed.”); Ex. 2091, 182:23-183:23, 187:2-15,187:22-188:15,
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`193:14-17, 195:21-196:2, 202:19-205:5; Ex. 2222, 64:3-11, 76:9-14; 77:10-19
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`(“it’s understood to a person of ordinary skill that comes as part of the package
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`when you have very low water solubility, you're going to have difficulties with
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`formulation”); 88:10-89:4 (“A person of ordinary skill understands poor solubility
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`and formulation problems go hand in hand.… [T]he implied formulation problem
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`doesn’t have to be explicitly laid out every time one has a solubility problem.”);
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`98:15- 99:3, 100:10-18, 101:20-102:14. Also, footnote 3 is an improper
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`observation (and mischaracterization) of Dr. Ratain’s deposition testimony.
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`Novartis paraphrases 85:3-86:25 (Mot. 10), characterizing two pages of
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`testimony and expanding its unexplained mention of rapamycin’s IND at POR 51
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`11
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`U.S. Patent No. 5,665,772
`to an argument of nearly a page. The observation is relevant to the items identified
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`in the first observation in this subsection.
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`Novartis paraphrases 89:5-90:13 and 96:13-16 (Mot. 11), characterizing a
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`page and a half of testimony and adding to its solubility argument. In the cited
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`section, Dr. Jorgensen also states that his “focus” was on what a POSA “would do
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`faced with rapamycin that was known to have poor solubility,” and that there were
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`“formulation problems, which is completely consistent with having poor
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`solubility,” and then sets forth a POSA’s approach to that problem. 89:16-90:4.
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`Novartis also mischaracterizes Petitioners’ position and Dr. Jorgensen’s testimony:
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`both conclude that a formulation approach was less preferable than modifying
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`rapamycin itself. The observation is relevant to the items identified in the first
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`observation in this subsection.
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`Novartis paraphrases 90:14-92:9 (again), 92:13-93:7, 4:21-5:2, 17:22-
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`18:4, and 19:16-22 (Mot. 11-12), characterizing almost four pages of testimony
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`and continuing a new anti-tumor formulation argument discussed in the first
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`observation of this subsection. Novartis also mischaracterizes Petitioners’ position.
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`Petitioners do not assert that Fiebig suggests that all development of rapamycin
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`stopped, only that Fiebig’s stopped. Reply 6. The observation is relevant to the
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`items identified in the first observation in this subsection and to Novartis’s
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`12
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`U.S. Patent No. 5,665,772
`assertion at Mot. 8 that a POSA interested in immunosuppressants would also be
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`concerned with high doses.
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`Novartis paraphrases 93:15-19, 95:23-97:3, and 97:4-98:5 (Mot. 12),
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`characterizing over two pages of testimony, continuing its formulation re-
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`argument. In doing so, Novartis mischaracterizes Dr. Jorgensen’s testimony. He
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`did not testify that all rapamycin development stopped, only Fiebig’s. Novartis also
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`mischaracterizes Petitioners’ positions. Petitioners did not contend that resorting to
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`formulation approaches would be a failure, but that a medicinal chemist would
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`consider it a failure; Petitioners do not rely solely on Fiebig’s Cremophor example;
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`and, Petitioners do not contend that “all formulation solutions” would be
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`ineffective. Reply 5-6. The observation is also relevant to the items identified in
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`the first observation in this subsection.
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`Novartis paraphrases 100:19-101:19 (Mot. 12-13), characterizing a page
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`of testimony and continuing its formulation argument. The observation is relevant
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`to the items in this subsection’s first observation.
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`Novartis points to 102:6-14 (Mot. 13), continuing its formulation
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`arguments. The observation is relevant to the items identified in the first
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`observation in this subsection, including 101:20-102:14 (“formulations given to the
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`same animal can have different outcomes [and] different biological activity” and
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`13
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`U.S. Patent No. 5,665,772
`“different formulations [can] cause a compound to perhaps be isolated, more or
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`less, in one tissue versus another”).
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`Novartis paraphrases 105:13-106:18 (Mot. 13-1), characterizing a page of
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`testimony and re-arguing its solubility motivation argument. The observation is
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`relevant to the items identified in the first observation in this subsection and Reply
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`7 (listing problems with prodrugs and salts, which Stella did not address); Ex. 1118
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`¶¶ 36-43 (same); Ex. 1115 at 9-16.
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`D. Mot. 14: “IV. Petitioners have not…alkylation reactions…”
`Novartis paraphrases 33:2-25 (Mot. 14), making a new argument that the
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`prior art does not teach performing an alkylation reaction specifically to
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`rapamycin’s hydroxyls. Although Dr. Jorgensen could not recite on the spot an
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`example of applying an undisputedly well-known alkylation reaction specifically
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`to a rapamycin hydroxyl, Novartis’s observation is relevant to Hughes (Ex. 1009,
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`2:43-60, using a carbine-mediated alkylation with the diazo compound from an
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`ester of acetic acid) and Pet. 39, 44, 46 (undisputedly routine modifications); Ex.
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`1003 ¶¶ 64-66, 77, 87-88, 138, 142, 153; Ex. 1118 ¶¶ 5 (hydroxyls easiest to
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`modify), 70 (undisputedly well-known alkylation reactions).
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`E. Mot. 14-15: “V. A POSA would not…activity”
`Novartis paraphrases 25:18-28:2 (Mot. 14-15), characterizing over two
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`pages of testimony addressing Kao ’447 (Ex. 2075) and making a new argument
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`14
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`regarding Hughes (Ex. 2009), which is not discussed in the cited testimony and
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`barely mentioned in the deposition at all. Novartis’s observation is relevant to Pet.
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`7, 18, 34-35, 48-51; Ex. 1003 ¶¶ 57, 64-65, 89, 93-100, 125, 166-172; Ex. 1118 ¶¶
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`23, 103, 105; Id. at ¶¶ 53, 56, 103, 106; Ex. 2091 at 128, 134, 225-242.
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`Novartis paraphrases 55:2-56:4 (Mot. 15), mischaracterizing a page of
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`testimony and making a new reasonable expectation argument. See POR 56-57.
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`The cited testimony should be read in context, from 50:14-56:12, where Dr.
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`Jorgensen explains how a POSA decides whether to go forward with a compound,
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`and Ex. 2091, 207:25-211:16, where Novartis plowed this same ground in Dr.
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`Jorgensen’s earlier deposition. Novartis’s observation is also relevant to Pet. 18,
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`27-32, 42-44; Reply 8-9, 18-19; Ex. 1003 ¶¶ 101-126, 141-145, 166-171; Ex. 1118
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`¶¶ 46, 48, 50-59, 62-63, 68, 69, 103-108; Ex. 2091 at 102, 133, 136, 185, 188.
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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)
`
`Counsel for Petitioner
`Par Pharmaceutical, Inc.
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`/Matthew L. Fedowitz/
`By:
`Matthew L. Fedowitz
`(Reg. No. 61,386)
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`15
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`Dated: January 3, 2017
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`Merchant & Gould P.C.
`1900 Duke Street, Ste. 600
`Alexandria, VA 22314
`703-684-2500; 703-684-2501 (Fax)
`
`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)
`
`Counsel for Petitioner
`Roxane Laboratories, Inc.
`
`IPR2016-00084
`U.S. Patent No. 5,665,772
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`16
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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.
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`JORGENSEN’S CROSS EXAMINATION was served by electronic mail on
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`Patent Owner’s lead 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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