`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`CIPLA LTD.,
`Patent Owner
`_____________________
`
`CASE IPR2017-00807
`Patent 8,168,620
`_____________________
`
`CIPLA LTD.’S
`MOTION FOR OBSERVATIONS ON CROSS-EXAMINATION OF
`PETITIONER’S REPLY WITNESSES: DR. ROBERT SCHLEIMER, DR.
`MAUREEN DONOVAN, AND JOHN C. STAINES, JR
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`IPR2017-00807
`Patent No. 8,168,620
`Patent Owner Cipla Ltd. (“Cipla”) deposed Petitioner’s reply witness, Dr.
`
`Maureen Donovan, on March 27, 2018, and files concurrently the deposition
`
`transcript and a previously unfiled exhibit as exhibits CIP2178 and CIP2177,
`
`respectively. Cipla deposed Petitioner’s reply witness, Dr. Schleimer, on March 30,
`
`2018, and files the deposition transcript concurrently as Exhibit CIP2179. Finally,
`
`Cipla deposed Petitioner’s reply witness, Mr. Staines, on April 4, 2018, and files
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`concurrently the deposition transcript as Exhibit CIP2180 and a previously
`
`unmarked exhibit that was marked by Petitioner as EX1171. Cipla files its Motion
`
`for Observations on Cross-Examination in accordance with Due Date 4 (Paper 36,
`
`1). All emphasis is added unless otherwise noted.
`
`I.
`
`Observation #1: Dr. Schleimer previously offered no evidence of a
`motivation to combine the four references listed in Ground 3.
`
`In CIP2179, at 27:9-32:18, Dr. Schleimer testified that, with the exception of
`
`water, he “did not” discuss in his reply declaration (EX1144) any of the limitations
`
`in claims 42-44, i.e., the claims of Ground 3. Dr. Schleimer further confirmed that
`
`footnote 1 of EX1144 is his sole response to Dr. Carr’s testimony that Dr.
`
`Schleimer’s first declaration (EX1003) failed to mention claims 42-44 or any
`
`motivation to combine the references of Petitioner’s Ground 3. This testimony is
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`relevant to Dr. Schleimer’s obviousness conclusions pertaining to claims 42-44 and
`
`Petitioner’s arguments because it undercuts their position that a motivation existed
`
`in 2002 for a person of ordinary skill to combine the art cited in Ground 3.
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`IPR2017-00807
`Patent No. 8,168,620
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`EX1144, ¶5, n.1; Reply, 15-18.
`
`II. Observation #2: Petitioner and its declarant did not agree on the closest
`prior art.
`
`In CIP2179, at 42:17-44:17, Dr. Schleimer, when asked if Cramer and Segal
`
`are the closest prior art, testified, “[n]o, that’s not correct” but that he “was
`
`convinced that from a legal perspective that Segal and Cramer are perhaps more
`
`persuasive to a patent board than my view.” This testimony is relevant to Dr.
`
`Schleimer’s obviousness conclusions and Petitioner’s arguments because it
`
`undercuts Dr. Schleimer’s credibility and undermines his conclusions that
`
`Dymista® does not exhibit unexpected results compared to the closest prior art.
`
`EX1144, ¶¶52-60; Reply, 18-23. This is also relevant to the weight and credibility
`
`the Board should afford Dr. Schleimer’s testimony.
`
`III. Observation #3: Dr. Schleimer testified that multiple authors concluded
`that co-administration of antihistamines and steroids yielded no clinical
`benefit.
`
`In CIP2179, at 58:3-74:15, Dr. Schleimer testified regarding the various co-
`
`administration studies he cited, as well as meta-analyses published before the
`
`invention date. He testified that Howarth (CIP2041) concluded that there was no
`
`“clinical benefit” to co-administration. He also testified that Nielsen (CIP2042)
`
`found that “[c]ombining antihistamines and intranasal corticosteroids in the
`
`treatment of allergic rhinitis does not provide any additional effect to intranasal
`
`corticosteroids.” This testimony is relevant to Dr. Schleimer’s obviousness
`
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`IPR2017-00807
`Patent No. 8,168,620
`conclusions and Petitioner’s arguments because it undermines Dr. Schleimer’s
`
`credibility by contradicting his testimony regarding the views of skilled artisans
`
`before the invention date and further undermines his conclusions regarding how a
`
`POSA would interpret the co-administration studies he cites. EX1144, ¶¶ 10-39,
`
`52-86; Reply, 3-10, 18-23.
`
`IV. Observation #4: The clinical efficacy of co-administered azelastine and
`fluticasone was surprising in 2008.
`
`In CIP2179, at 8:5-13, 80:15-19, and 93:9-98:12, Dr. Schleimer testified the
`
`authors of Ratner 2008 (EX1045) had concluded that co-administration of
`
`azelastine and fluticasone “produced an unanticipated magnitude of improvement
`
`in rhinitis symptoms.” This testimony is relevant to Dr. Schleimer’s obviousness
`
`conclusions and Petitioner’s arguments because it undercuts Dr. Schleimer’s
`
`conclusions regarding the clinical efficacy a POSA would have expected on the
`
`invention date because it confirms the independent views of skilled artisans years
`
`after the date of invention. EX1144, ¶¶ 52-67, 83-86; Reply, 18-21.
`
`V. Observation #5: A POSA could not have known about Han and Corren
`“unless they had a time machine.”
`
`In CIP2179, at 103:13-104:6 and 107:4-109:13, Dr. Schleimer testified that
`
`he could not find any data from before the priority date to support a fast onset of
`
`azelastine, so he cited Han (EX1148) and Corren (EX1160). He further explained
`
`that a POSA as of the invention date could not have been aware of the data
`
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`IPR2017-00807
`Patent No. 8,168,620
`conveyed in those two references “unless they had a time machine.” This
`
`testimony is relevant to Dr. Schleimer’s obviousness conclusions and Petitioner’s
`
`arguments because Dr. Schleimer’s reliance on post-invention publications to
`
`support his reading of onset undermines Dr. Schleimer’s conclusion that POSA in
`
`2002 would have expected Dymista®’s onset of action. EX1144, ¶¶68-73; Reply,
`
`21-22.
`
`VI. Observation #6: Dr. Donovan previously believed that sodium chloride
`and dextrose were obvious tonicity adjustors to use in an azelastine
`hydrochloride/fluticasone propionate combination formulation.
`
`In CIP2178, at 46:7-55:6 and 56:20-57:14, Dr. Donovan stood by her trial
`
`demonstratives from the related proceedings before the the District Court for the
`
`District of Delaware that her trial demonstratives (see CIP2177) that “list as an
`
`obvious tonicity adjuster to use—to include in this combination formulation,
`
`dextrose and sodium chloride.” According to Dr. Donovan, in CIP2178, at 58:17-
`
`59:4, “they [sodium chloride and dextrose] were all materials that – that were
`
`identified as obvious materials to include in a combination formulation” of
`
`azelastine hydrochloride and fluticasone propionate. Dr. Donovan’s direct
`
`testimony demonstratives from the related proceeding are filed concurrently as
`
`CIP2177. CIP2177 and the above cited testimony in CIP2178 are relevant to Dr.
`
`Donovan’s obviousness conclusions and Petitioner’s Reply arguments because
`
`they directly contradict her testimony in the present proceeding that a POSA would
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`IPR2017-00807
`Patent No. 8,168,620
`have sought to “avoid” dextrose and sodium chloride and/or undermine her
`
`credibility. EX1145,1 ¶¶68-69; Reply, 17-18. This testimony is also relevant to the
`
`weight and credibility the Board should afford Dr. Donovan’s conclusions.
`
`VII. Observation #7: Flonase® contains antimicrobial preservatives that have
`been shown to adequately control bacterial growth in the dextrose
`component.
`
`In CIP2178, at 61:4-63:17, Dr. Donovan testified that “in the chemical
`
`manufacturing controls package for an FDA-approved project [sic] that you have
`
`to demonstrate that your antimicrobial preservative for a multidose system is
`
`adequate.” In CIP2178, at 65:1-16, Dr. Donovan confirmed that “by 2002 Flonase
`
`was a multidose nasal spray that was FDA approved” and “contained the
`
`preservatives benzalkonium chloride and phenyl ethyl alcohol.” In CIP2178, at
`
`66:9-19, Dr. Donovan testified: “Flonase contains antimicrobial preservatives that
`
`have been demonstrated to maintain the lack of growth. They kill or – or render
`
`harmless, somewhat harmless, bacteria that – that can enter into that formulation.
`
`So there’s likely no bacteria there to need the dextrose to feed off of.” This
`
`testimony is relevant to Dr. Donovan’s obviousness conclusions and Petitioner’s
`
`Reply arguments because it contradicts her testimony that a motivation existed in
`
`2002 to (1) use the three preservatives as recited in claims 42-44, and (2) avoid
`
`1 Citations to EX1145 also apply equally to EX1165, a public redacted copy of
`
`EX1145.
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`IPR2017-00807
`Patent No. 8,168,620
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`using dextrose. EX1145, ¶¶59-66, 69; Reply, 17-18.
`
`VIII. Observation #8: Dr. Donovan did not know whether azelastine could be
`a di- or trivalent cation.
`
`In CIP2178, at 125:2-16, when asked whether two additional amine
`
`structures in azelastine would be classified as tertiary amines, Dr. Donovan
`
`testified that “identifying functional groups in—in chemical molecules is not
`
`something I’m prepared to do about azelastine or other structures today.” In
`
`CIP2178, at 125:17-126:8, Dr. Donovan further testified: “I haven’t made a
`
`systematic analysis of the other functional groups contained in azelastine to both
`
`name them and be able to tell you what sort of electronic structure contributions
`
`they make.” And in CIP2178, at 127:13-128:1, when asked whether the two
`
`additional amine structures contained in azelastine would protonate to form a di- or
`
`trivalent cation, Dr. Donovan testified: “Well, a formulator acting as a POSA
`
`wouldn’t be the person doing that. I haven’t been asked to provide an opinion on
`
`how a formulator or a chemist would go about doing that. So at this point in time I
`
`am not prepared to – to start describing accurately how that would be
`
`accomplished.” This testimony is relevant to Dr. Donovan’s obviousness
`
`conclusions and Petitioner’s Reply argument because it undercuts her testimony
`
`that azelastine is a monovalent cation. EX1145, ¶¶18-29; Reply, 11-12. This
`
`testimony is also relevant to the weight and credibility the Board should afford Dr.
`
`Donovan’s conclusions.
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`IPR2017-00807
`Patent No. 8,168,620
`IX. Observation #9: Dr. Donovan admits that a “dosage form suitable for
`nasal administration” is a final formulation that must administer the
`dose that was intended to be administered.
`
`In CIP2178, at 138:19-139:2, Dr. Donovan testified that a dosage form is
`
`suitable for nasal administration if it “at the time that it’s administered that it [is]
`
`able to administer the dose that was intended to be administered.” In CIP2178, at
`
`159:10-22, Dr. Donovan admitted that the time a POSA would know that a
`
`formulation delivers the amount of the drug intended to be administered “would
`
`likely be the time at which I’ve decided on my final formulation components, their
`
`final concentrations, my final device, my final – and what my – probably close to
`
`what my manufacturing specifications would be.” In CIP2178, at 163:21-164:17,
`
`Dr. Donovan admitted that to determine whether a multidose drug suspension
`
`administered the amount of drug that was intended to be administered, she would
`
`have to “chemically analyze for the amount of drug that was sprayed into whatever
`
`container I sprayed it into.” This testimony is relevant to the claim construction
`
`issue in Dr. Donovan’s declaration and Petitioner’s Reply because it undermines
`
`Dr. Donovan’s disagreement with Dr. Smyth’s claim construction testimony and
`
`supports Cipla’s proffered claim construction: “pharmaceutical formulations that
`
`are tolerable to patients, that are homogeneous, and that can be suitably deposited
`
`on the nasal mucosa.” EX1145,¶¶7-11; Reply, 1-3. This testimony is also relevant
`
`to Dr. Donovan’s obviousness conclusions and Petitioner’s Reply because it
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`Patent No. 8,168,620
`undermines her claims that Dr. Govindarajan’s recreations of Cramer Example III
`
`were successful. EX1145, ¶¶30-41; Reply, 13-15.
`
`X. Observation #10: Dr. Donovan confirmed that Dr. Govindarajan’s
`recreations of Cramer Example III were not a “dosage form suitable for
`a nasal administration.”
`
`In CIP2178, at 195:3-8, Dr. Donovan testified that Dr. Govindarajan “was
`
`approaching [his recreations of Cramer Example III] as a POSA beginning a
`
`formulation development activity.” In CIP2178, at 197:11-198:9 and 199:2-8, Dr.
`
`Donovan testified that Dr. Govindarajan’s recreation of Cramer Example III “was
`
`not a formulation” but instead was “his first mixing of materials that were listed as
`
`a composition.” And, in CIP2178, at 159:10-22, Dr. Donovan testified that the time
`
`a POSA would know that a formulation delivers the amount of the drug intended to
`
`be administered “would likely be the time at which I’ve decided on my final
`
`formulation components, their final concentrations, my final device, my final – and
`
`what my – probably close to what my manufacturing specifications would be.”
`
`This testimony is relevant to Dr. Donovan’s obviousness conclusions and
`
`Petitioner’s Reply because it undercuts Dr. Donovan’s testimony that Dr.
`
`Govindarajan’s recreations of Cramer Example III were suitable for nasal
`
`administration. EX1145, ¶¶30-40; Reply, 13-15.
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`IPR2017-00807
`Patent No. 8,168,620
`XI. Observation #11: Dr. Donovan did not “call into question” in the related
`district court proceeding the difference in the grades of viscosity of
`HPMC used by Drs. Herpin and Govindarajan.
`
`In CIP2178, at 171:4-20, Dr. Donovan testified that her expert report in the
`
`related Apotex case (see CIP2016) “call[ed] into question” certain aspects of Dr.
`
`Herpin’s recreations of prior art Cramer Example III. Despite this, in CIP2178, at
`
`174:11-175:10, Dr. Donovan admitted that her expert report from the related
`
`Apotex case did not call into question the HPMC viscosity grades used by Dr.
`
`Herpin, despite the fact that the ’620 patent was a part of both this proceeding and
`
`the related Apotex case. This testimony is relevant to Dr. Donovan’s obviousness
`
`conclusions and Petitioner’s Reply because it undermines Dr. Donovan’s
`
`testimony that Dr. Herpin did not recreate Dr. Govindarajan’s recreations of
`
`Cramer Example III. EX1145, ¶¶41-45; Reply, 14-15. This testimony speaks to the
`
`weight and credibility the Board should afford Dr. Donovan’s conclusions.
`
`XII. Observation #12: Dr. Donovan admitted that in aqueous environments
`azelastine hydrochloride dissociates into electrolytes.
`
`In CIP2178, at 117:2-118:19 and 119:16-120:7, Dr. Donovan admitted that,
`
`below the solubility limit of the solution, azelastine hydrochloride will dissociate
`
`into electrolytes when placed in an aqueous environment at a reasonable pH. This
`
`testimony is relevant to Dr. Donovan’s testimony because it undermines her
`
`conclusion that azelastine hydrochloride would not have been viewed by a POSA
`
`as incompatible with MCC/CMC. EX1145, ¶¶18-29; Reply at 11-12.
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`IPR2017-00807
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`XIII. Observation #13: Dr. Donovan admitted that the two-preservative
`combinations in Astelin® and Flonase® were sufficient to inhibit
`bacterial growth.
`In CIP2178, at 207:1-17, Dr. Donovan agreed that Astelin® and Flonase®,
`
`because they were FDA-approved by 2002, “had passed the preservative challenge
`
`test or had sufficiently shown to the FDA that they inhibited bacterial growth.” In
`
`CIP2178, at 208:17-209:8, Dr. Donovan further agreed that given the available
`
`information about Astelin® and Flonase® in 2002, “the person of ordinary skill
`
`would know that those preservatives and those concentrations would be able to
`
`pass a preservative challenge[] test or at least gain FDA approval.” This testimony
`
`is relevant to Dr. Donovan’s obviousness conclusions (see EX1145, ¶¶59-66) and
`
`Petitioner’s Reply (see Reply at 17-18) because it directly contradicts Dr.
`
`Donovan’s testimony that a person of ordinary skill would seek to use three
`
`preservatives instead of the two-preservative combinations found effective in
`
`Astelin® and Flonase®. EX1145, ¶¶59-66; Reply, 17-18.
`
`XIV. Observation #14: Dr. Donovan failed to rely on any prior art to support
`a pH of 3 or below being “suitable for nasal administration.”
`
`In CIP2178, at 165:9-166:6, Dr. Donovan confirmed that she cited to no
`
`prior art to support her conclusion in EX1145, ¶46 that a pH of 3 or below was
`
`“suitable for nasal administration.” This testimony is relevant to Dr. Donovan’s
`
`obviousness conclusions and Petitioner’s Reply because it raises a concern about
`
`whether Dr. Donovan conducted a proper obviousness analysis. EX1145, ¶46;
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`Reply, 15. This testimony speaks to the weight and credibility the Board should
`
`afford Dr. Donovan’s conclusions about whether a POSA would have had a
`
`reasonable expectation of arriving at a dosage form “suitable for nasal
`
`administration” as claimed.
`
`XV. Observation #15: Dr. Donovan admitted that Dr. Govindarajan’s visual
`observations alone are insufficient to show a uniform suspension.
`
`In CIP2178, at 195:3-8, Dr. Donovan confirmed that Dr. Govindarajan used
`
`visual observations to assess his recreations of Cramer Example III, rather than
`
`analytical tests. In CIP2178, at 197:11-199:8, Dr. Donovan agreed that Dr.
`
`Govindarajan’s visual observations alone did not foreclose the possibility that his
`
`recreations were not in fact uniform when analyzed further. This testimony is
`
`relevant to Dr. Donovan’s obviousness conclusions (EX1145, ¶¶ 30-40) and
`
`Petitioner’s Reply (Reply at 13-15) because it undermines her testimony that Dr.
`
`Govindarajan’s recreations of Cramer Example III were a “dosage form suitable
`
`for nasal administration.”
`
`XVI. Observation #16: Mr. Staines could not identify the proportion of
`Dymista® sales that were attributable to rebates and copayment
`programs.
`
`In CIP2180, at 18:5-19:8, Mr. Staines testified: “I don’t think I could,
`
`attribute, you know, quantitatively what proportion of the sales were due to”
`
`Dymista®’s rebate program. Similarly, in CIP2180, at 21:17-22:13, Mr. Staines
`
`testified that he did not look to see whether copayment programs were offered for
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`competing products and that he could not “estimate a precise percentage, or even a
`
`general percentage” of the sales attributable to Dymista®’s copayment card
`
`program. This testimony is relevant to Mr. Staines’s commercial success
`
`conclusions and Petitioner’s Reply because it undercuts Mr. Staines’s credibility
`
`and undermines his conclusions that rebates and copayment card programs were
`
`primary drivers of Dymista®’s sales. EX1140, ¶¶119-125; Reply, 23-24, 27-28.
`
`XVII. Observation #17: Dr. Staines admitted that the evidence he relied on did
`not actually contain the information he said it did.
`
`In CIP2180, at 32:11-36:1 and 37:20-40:4, Mr. Staines conceded that the
`
`documents he relied upon to conclude that Meda’s salesforce was constrained from
`
`selling to primary care physicians but not to allergy and asthma specialists whom
`
`Meda was targeting, did not say that. Indeed, Mr. Staines agreed that “there’s no
`
`discussion of that” in two Meda documents (CIP2074 and CIP2064) he relied
`
`upon, and that he was “mistaken” in thinking that CIP2053 provided that
`
`information. This testimony is relevant to Mr. Staines’s commercial success
`
`conclusions and Petitioner’s Reply because it undercuts Mr. Staines’s credibility
`
`and undermines his conclusion that Meda’s salesforce and its increased share of
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`voice were a primary driver of Dymista®’s sales. EX1140, ¶¶126-135; Reply at 23-
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`24, 27-28.
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`Observation #18: Mr. Staines was not sure whether Dymista®’s
`XVIII.
`23% and 31% rebates were atypical in the pharmaceutical market.
`In CIP2180, at 66:19-70:11, when asked to compare Dymista®’s 23% rebate
`
`in 2012 and 31% rebate in 2013 to the typical rebates in the pharmaceutical market
`
`in 2012, Mr. Staines testified that he had not “formed an opinion on that” and
`
`would need to “study it a little more” to determine whether those rebates were
`
`typical. This testimony is relevant to Mr. Staines’s commercial success conclusions
`
`and Petitioner’s Reply because it undercuts Mr. Staines’s credibility and undercuts
`
`his conclusions that Dymista’s 47% rebate in 2015 was atypical. EX1140, ¶¶63,
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`124, Ex. 2a; Reply, 23-24, 27-28.
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`XIX. Observation #19: Mr. Staines does not know what a “blocking patent”
`is.
`
`In CIP2180, at 86:11-87:21, Mr. Staines testified that his blocking patent
`
`argument “is not my opinion” and, when asked if he knew what a blocking patent
`
`was, said “I don’t think I really do.” Further in CIP2180, at 88:6-90:15, Mr. Staines
`
`testified: “I don’t have an opinion on whether they [EX1007 and EX1009] actually
`
`do block or not” and that it “seem[ed] reasonable” that competitors could have
`
`developed
`
`and
`
`received
`
`regulatory
`
`approval
`
`for
`
`a
`
`combination
`
`azelastine/fluticasone product in 2012. This testimony is relevant to Mr. Staines’s
`
`commercial success conclusions and Petitioner’s Reply because it undercuts Mr.
`
`Staines’s credibility and undermines his conclusions that blocking patents negate a
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`commercial success. EX1140, ¶108; Reply at 23-24, 27-29.
`
`XX. Observation #20: Mr. Staines admitted that he did not know the novel
`features of the claimed invention for his nexus analysis.
`
`In CIP2180, at 61:21-63:12 and 83:19-84:17, Mr. Staines explained his
`
`nexus analysis as follows: “[i]f there is an alternative [product] that can do the
`
`same thing [as Dymista®], then I would consider that not a novel feature.” In
`
`CIP2180, at 83:19-86:7, Mr. Staines further testified that (1) he did not know what
`
`the novel features of the claimed invention were, (2) he “assumed that all of the
`
`features of Dymista [were] in some way or form claimed in the patent,” and (3) he
`
`had “no opinion” on the novel features of the invention from a legal sense. This
`
`testimony is relevant to Mr. Staines’s commercial success conclusions and
`
`Petitioner’s Reply because it undermines Mr. Staines’s conclusions that the novel
`
`features of the claimed invention were not primary drivers of Dymista®’s sales.
`
`EX1140, ¶¶109-135; Reply at 23-24, 27-28.
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`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`Dennies Varughese (Reg. No. 61,868)
`Lead Attorney for Patent Owner
`
`
`Date: April 10, 2018
`1100 New York Avenue, N.W.
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`Washington, D.C. 20005-3934
`(202) 371-2600
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`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the above-captioned "CIPLA LTD.'S
`
`MOTION FOR OBSERVATIONS ON CROSS-EXAMINATION," was served in
`
`its entirety on April 10, 2018, upon the following party via electronic mail:
`
`Michael R. Houston: mhouston@foley.com
`Joseph P. Meara: jmeara@foley.com
`James P. McParland: jmcparland@foley.com
`Andrew R. Cheslock: acheslock@foley.com
`Tyler C. Liu: TLiu@agpharm.com
`ARG-dymista@foley.com
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
` Dennies Varughese (Reg. No. 61,868)
`Date: April 10, 2018
` Lead Attorney for Patent Owner
`
`
`
`
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005 - 3934
`(202) 371-2600
`
`
`
`
`
`
`
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