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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
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`v.
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`CIPLA LTD.,
`Patent Owner.
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`Patent No. 8,168,620
`Issue Date: May 1, 2012
`Title: COMBINATION OF AZELASTINE AND STEROIDS
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`Inter Partes Review No.: IPR2017-00807
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE PETITIONER’S EVIDENCE UNDER 37 C.F.R. § 42.64
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`I.
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`Introduction
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`Petitioner opposes Cipla’s motion to exclude certain evidence (Paper 41,
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`hereafter “Mot.”). In sum, Cipla’s motion fails to identify any rule or statutory
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`basis for the requested exclusions, and similarly fails to identify any prejudice.
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`II. EX1055 and ¶¶ 53 and 54 of Dr. Schleimer’s Second Declaration
`(EX1144) Should Not Be Excluded
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`Exhibit 1055 is an excerpted demonstrative slide from the Apotex trial. It is
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`the only such record that is available to Petitioner. The sponsoring witness at trial,
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`Dr. Accetta, described the underlying, original patient record (DTX-2) in great
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`detail during the Apotex trial, and Cipla had ample opportunity to cross-examine
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`him on this document. See EX2018, 48:11-50:17 (direct testimony); 62:14-65:4
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`(cross-examination). The trial court then allowed exhibit DTX-2 into evidence. Id.
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`at 58:21. Despite this, the original patient record underlying EX1055 remained
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`unavailable to Petitioner, contrary to Cipla’s contention (Mot., 2-3). First, the
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`District Court denied a request for copies of the Apotex trial exhibits. EX1174
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`(Decl. of Tyler Liu), ¶ 2. Petitioner then requested a copy of the exhibit from Cipla,
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`but Cipla refused. See EX1175 (Email From Adam LaRock to Michael Houston).
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`Because EX1055 is the only evidence of the patient record available to Petitioner,
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`it should not be excluded, especially where Cipla has the underlying document.
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`As for timeliness, Cipla fails to identify any reason why EX1055 is not
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`1
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`proper reply evidence.1 See Mot., 2. Exhibit 1055 is responsive at least to Dr.
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`Carr’s opinions that the closest prior art is monotherapy, ignoring the prevalent
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`practice in the art of co-prescribing the two drugs together. See EX1144, ¶¶ 53-54.
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`As for relevance, which is already waived,2 Cipla misstates Dr. Schleimer’s
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`use of the exhibit; his declaration identifies EX1055 to support the fact that
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`“[c]onjunctive use of a fluticasone propionate nasal spray and an azelastine
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`hydrochloride nasal spray was confirmed in the prior Apotex trial” well before the
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`filing date of the ’620 patent. See EX1144, ¶53. Dr. Schleimer is not advancing
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`EX1055 as a printed publication, but instead as evidence to show that doctors did
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`in fact co-prescribe azelastine and fluticasone for adjunctive administration well
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`before the priority date, thus corroborating his testimony regarding the prior art.
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`Turning next to Cipla’s arguments based on FRE 1002, Cipla offers no
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`explanation of how “modification” of the underlying patient record to focus in on
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`1 This scope argument is improper in a motion to exclude. See section IV, below.
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`2 EX1055 was first served on Cipla at the deposition of Dr. Carr on Feb. 7, 2018.
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`Cipla did not make a relevance or hearsay objection, so both have been waived.
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`See Office Trial Practice Guide, 77 Fed. Reg. 48,756, 48,772 (Aug. 14, 2012).
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`Cipla’s later filed objections of Mar. 13, 2018 – more than 5 business days after
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`initial service – are untimely as to this exhibit. See 37 C.F.R. § 42.64(b)(1).
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`2
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`the details relating to co-administration actually affects the probative value of the
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`exhibit. See Mot., 3. The fact that Dr. Carr did not have access to the original
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`patient record during his deposition is not a reason to exclude EX1055, as Dr. Carr
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`was an expert witness in the Apotex trial and had more access to the original
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`patient record than Petitioner. EX1142, 11:22-12:8 (“I was there for pretty much
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`the whole trial…I do remember [Dr. Accetta] testifying.”).
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`Regarding hearsay, another waived objection, the crux of Cipla’s argument
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`is that Dr. Schleimer “relies on the out-of-court statements in the underlying,
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`original patent record portrayed in EX1055.” Mot., 4. As a patient record, the
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`original underlying document falls within the exception of FRE 803(4) –
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`“Statement Made for Medical Diagnosis or Treatment.” Here, the statement in the
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`original document was “made for—and is reasonably pertinent to—medical
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`diagnosis or treatment” and “describes medical history; past or present symptoms
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`or sensations; their inception; or their general cause.” FRE 803(4). As for the
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`“second level” of hearsay resulting from EX1055 not being the original document
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`itself, there are no allegations of actual modification of any of the text from the
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`original patient record. That is, Cipla does not contend that the portions of the
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`original patient record shown in EX1055 are anything but that—a copy of at least a
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`portion of the actual record. Thus, this is not a hearsay-within-hearsay situation.
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`Even if it were, because the underlying document is just being reproduced, it “has
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`3
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`equivalent circumstantial guarantees of trustworthiness” and otherwise meets sub-
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`parts (2)-(4) of FRE 807. See FRE 807; 805 (exception of hearsay within hearsay).
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`Further, EX1055 has non-hearsay relevance in terms of corroborating Dr.
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`Accetta’s trial testimony regarding the original patient record, DTX-2, and his
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`prescribing practices in general. That testimony is the primary evidence Petitioner
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`relies on for the underlying facts, as supported by Dr. Schleimer. See EX1144,
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`¶ 41; EX1170, ¶ 2.
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`As for any prejudice to Cipla, there can be none at least because Cipla itself
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`put Dr. Accetta’s testimony in evidence in this proceeding, and Cipla was a party
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`in the Apotex trial where EX1055 was used, and where the original patient record,
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`DTX-2, was admitted into evidence. Cipla also had ample opportunity to cross-
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`examine Dr. Accetta at deposition and during the trial. There simply can be no
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`surprise or prejudice in connection with EX1055.
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`As for declaration paragraphs 53 and 54, Cipla seeks to exclude them
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`wholesale even though their content does not exclusively rely on EX1055. See e.g.,
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`EX1144, ¶ 53 (discussion of closest prior art); ¶ 54 (discussion of Dr. Carr prior
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`admissions). In any event, FRE 703 allows Dr. Schleimer to rely on the contents of
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`EX1055, even if it suffers from the evidentiary flaws alleged by Cipla.
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`III. EX1037 Should Not Be Excluded
`No exhibit numbered 1037 was cited in the Petition, and 1037 was not a
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`4
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`designated exhibit number at that time; thus, Cipla’s sole objection relating to that
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`exhibit (i.e., that it was an exhibit not described in the exhibit list and not filed)
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`was unfounded and there could not have been any correction made at that time. At
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`the reply stage, an article co-authored by Cipla’s own expert, Dr. Carr, was
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`designated as EX1037 and was then cited in Petitioner’s Reply and Dr. Schleimer’s
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`second declaration (EX1144). However, Cipla failed to raise any objection to
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`EX1037 or to portions of the Reply and declaration that cited to it. See Paper 32.
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`Thus, the objections Cipla raises now are waived. See 37 C.F.R. 42.64(b)(1).
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`An error did occur during Petitioner’s reply filing, such that EX1037 and
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`EX1043 (another exhibit introduced for the first time on reply) were inadvertently
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`not filed along with the Reply, which error was the result of confusion caused by
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`using the lower exhibit numbers for these two exhibits. Concurrent with this filing,
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`Petitioner is filing these two exhibits and an updated exhibit list providing a
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`description and an indication these two exhibits have been filed. Petitioner regrets
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`the filing oversight that occurred, but has now remedied the error.
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`In any event, Cipla cannot claim any prejudice regarding EX1037, as it is
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`clearly identified in Dr. Schleimer’s second declaration (EX1144, ¶ 90) in relation
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`to Cipla’s own EX2052 which itself cites EX1037. Dr. Schleimer even provides a
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`quote directly from EX1037. EX1144, ¶ 90. And, EX1037 was also discussed
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`during the Apotex trial during Dr. Carr’s direct testimony. See EX2021, 538:10-
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`5
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`540:8. Given that EX1037 is a paper that Dr. Carr himself authored, there cannot
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`be any surprise regarding EX1037, and Cipla clearly has a copy of it. Also, Cipla
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`could have asked counsel for Petitioner or questioned Dr. Schleimer about the
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`identity of this document if there were any confusion, but Cipla did not once ask
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`about the exhibit, apparently content to sit on its earlier objections directed to
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`exhibits that were nonexistent at the time. EX1037 should not be excluded.
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`IV. Petitioner’s Reply and Dr. Donovan’s Second Declaration (EX1145) Are
`Correctly Limited to Proper Reply Evidence and Argument
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`The Board has held that “[a] motion to exclude is neither a substantive
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`surreply, nor a proper vehicle for arguing whether a reply or supporting evidence is
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`of appropriate scope.” Kyocera Corp. v. Softview LLC, IPR2013-00007, Paper 51
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`at 34 (PTAB March 27, 2014). Yet here, Cipla’s motion does just that, seeking to
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`exclude because “Petitioner and its declarant Dr. Donovan improperly supplement
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`their obviousness arguments” and that “[t]hese arguments and evidence are newly
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`raised to purportedly support obviousness and were available to Petitioner and Dr.
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`Donovan at the time the Petition was filed.” Mot. 5, 7. These assertions are
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`improper for a motion to exclude and should not be considered.
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`Further, the Federal Circuit has explained that a Petition is not required to
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`preemptively address every possible argument, and that a Reply may counter
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`arguments raised in the POR. See Idemitsu Kosan Co., Ltd. v. SFC Co. Ltd., 870 F.
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`3d 1376, 1380-81 (Fed. Cir. 2017). This is precisely what Petitioner has done in
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`6
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`connection with its proper reply expert evidence, which is responsive to Cipla’s
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`Response; each bullet point at page 6 of the Motion is addressed below:
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`1) As discussed in her first declaration, it was well known to a POSA in
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`2002 that multi-dose nasal spray formulations must be preserved against microbial
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`contamination. EX1004, ¶52. In addition, Dr. Donovan’s discussion in ¶¶60-66 is
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`responsive to Cipla’s assertion that there was no design need or market pressure to
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`use the claimed three-preservative combination (POR at 41-44).
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`2) The citation to Remington’s is responsive to Cipla’s assertions that a
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`POSA would not focus on EDTA, BKC, and phenyl ethyl alcohol (“PEA”) (POR,
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`41-44; EX2150, ¶¶53-54), and that preservatives would be avoided all together
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`based on Segal (id., ¶ 52). Remington’s is cited in Segal (EX1012, 4:1-3), and Dr.
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`Donovan uses it to illustrate why a POSA would have limited their preservative
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`options, while finding EDTA, BKC, and PEA very promising (EX1145, ¶¶60-66).
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`3) Dr. Donovan’s discussion of EDTA’s chelating properties as further
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`motivation for its use is responsive to Cipla’s argument that a POSA would not
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`have been motivated to use EDTA (id.) as well as Dr. Smyth’s assertion that a
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`POSA “would not have had a good reason” to include EDTA in a nasal spray
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`suspension (EX2150, ¶ 54).
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`4) Dr. Donovan’s assertions regarding the use of sodium chloride and
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`dextrose as tonicity agents respond to Dr. Smyth’s assertion that there was a “clear
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`7
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`preference in the art for sodium chloride and dextrose” and that “there was no
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`reason for a POSA to pursue glycerin” (EX2150, ¶¶ 56, 58), as well as Cipla’s
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`assertion that there was no “good reason to pursue glycerine” (POR at 46).
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`5) In the Petition and in Dr. Donovan’s first declaration, the use of glycerine
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`as a humectant and the use of humectants to provide nasal formulations
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`comfortable for the use is expressly described. Pet. at 44; EX1004, ¶¶ 56, 72.
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`Because humectants “effect moisturization” (EX1004, ¶ 56, EX1012, 4:8-10)
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`among other things, Dr. Donovan’s assertion is not new to the Reply. Petitioner
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`and Dr. Donovan’s discussion of using glycerine to add to the comfort of a nasal
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`spray is also responsive to Cipla’s assertion that a POSA would not have been
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`motivated to use glycerine (POR at 3, 40, 44-46; EX2150, ¶ 55).
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`6) Dr. Donovan’s discussion of Dr. Govindarajan’s successful examples
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`(which were submitted by Cipla to begin with) is directly responsive to Cipla and
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`Dr. Smyth’s false assertion that those examples “failed” and were “(i)
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`unacceptably acidic; (ii) unstable, leading to significant caking of azelastine; and
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`(iii) unable to consistently deliver proper doses” (POR at 34; EX2150, ¶¶ 37-41).
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`Not only is none of the foregoing inconsistent with Dr. Donovan’s trial
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`testimony, even if it were that would not justify exclusion from the proceeding.
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`Thus, neither the portions of Dr. Donovan’s second declaration identified by Cipla
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`nor Petitioner’s Reply are improper.
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`8
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`V. Evidence Need Not Be Cited In Papers To Remain In The Record
`The Board has held that “[i]t is better to have a complete record of the
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`evidence submitted by the parties than to exclude particular pieces of evidence.”
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`Biomarin Pharm. Inc. v. Genzyme Therapeutic Prods. L.P., IPR2013-00537, Paper
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`79 at 25 (PTAB February 23, 2015). With that policy in mind, while certain of
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`Petitioner’s exhibits are not referenced directly in the Petition or the Reply, the
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`vast majority of the exhibits identified by Cipla that were not intentionally blank or
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`a public version of another exhibit are cited in at least one of Petitioner’s expert
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`declarations (112 of 117).3 Further, Cipla’s motion provides no explanation of how
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`the Board would be prejudiced by the identified exhibits, particularly given their
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`content such as EX1014 (a U.S. patent publication), EX1051 (Dr. Schleimer’s
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`CV), and EX1139 (Mr. Staines’ CV). See Hughes Network Systems, LLC, et al. v.
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`3 Exhibits 1062-63, 1080, and 1086 were provided by Mr. Staines, but were
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`ultimately not cited in his declaration (a copy of his CV (EX1139) is appended to
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`Mr. Staines’ declaration). However, exhibits 1030-31, 1034-43, 1047, 1051, 1055,
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`1148, 1150, and 1159-1164 were cited by Dr. Schleimer; exhibits 1014, 1027,
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`1048-49, 1052, 1054, 1056, 1149, 1152-53, and 1168 were cited by Dr. Donovan;
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`and exhibits1057-61, 1064-1079, 1081-1085, 1087-1138 were cited by Mr.
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`Staines. Exhibits 1026, 1028-29, 1032, and 1044 were intentionally left
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`blank/unused. Exhibit 1165 is simply a public version of 1145.
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`9
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`Cal. Inst. of Tech., IPR2015-00059, Paper 42 at 40 (PTAB April 21, 2016)
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`(denying motion to exclude where “the listed exhibits are all discussed, relied upon
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`and cited either in the Petition, Reply or supporting declarations” and where
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`movant had failed to identify any prejudice).
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`The fact that certain paragraphs of the expert declarations are not cited in the
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`Petition or the Reply also does not support their exclusion from the record.4 This is
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`demonstrated by their actual content, such as paragraphs 1-11 of EX1003 – Dr.
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`Schleimer’s first declaration – which describes his retention and expert
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`qualifications. Similar to the non-declaration exhibits, Cipla only cursorily
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`addresses alleged irrelevancy and lack of probative value, and fails to identify any
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`actual prejudice, which the Board has found insufficient to support exclusion from
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`the record. See Cisco Systems, Inc. v. TQ Delta, LLC, IPR2016-01760, Paper 35 at
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`4 Cipla misrepresents the record regarding many of the challenged expert
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`declaration paragraphs. Mot., 7-8. For example, paragraph 53 of EX1003 is cited in
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`the Petition at page 37. A listing of all such citations is as follows: Petition:
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`EX1003, ¶¶53(37), 55(37), 70(36), 84(37,43), 88-90(56), 95(56), 115(40);
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`EX1004, ¶¶27(12,14), 41(49), 44-45(23), 59(18,45,47); Reply: EX1003, ¶¶53(8),
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`62(8), 84-90(6); EX1004, ¶¶27(15), 32(2,15), 34(15), 59(10); EX1140, ¶¶50(25),
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`114(25), 137(27), 149(26); EX1144, ¶¶53-54(19), 72-73,78,80(21-22); EX1145,
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`¶¶22-23(10-12,17), 53-54(10-11,17), 59(17), 72(17-18), 73,78,80,81(26).
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`10
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`42 (PTAB March 12, 2018) (“We are not persuaded by Patent Owner’s cursory
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`argument that evidence not cited in Petitioner’s Reply is irrelevant or lacks
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`probative value outweighed by its prejudice.”). Similarly, Cipla has failed to
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`explain how the uncited paragraphs would result in confusion, delay, or wasted
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`time, and would not instead just cause confusion by selectively excluding some
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`paragraphs from the declarations for no apparent benefit. See id.
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`Lastly, as to the allegations regarding page lengths and incorporation by
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`reference, the Board has previously held that “not every statement made by an
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`expert need be repeated in a brief to avoid incorporation by reference; otherwise,
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`separate expert declarations would be unnecessary.” Sumitomo Elec. Indus., Ltd. v.
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`United Technologies Corp., IPR2017-00966, Paper 7 at 11 (PTAB Sept. 13, 2017).
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`The Board has also recognized that uncited portions of expert declarations can
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`provide context and support for testimony elsewhere in the declaration. See Google
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`Inc. v. Intellectual Ventures II LLC, IPR2014-01031, Paper 41 at 13-14 (PTAB
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`December 7, 2015).
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`VI. Petitioner’s Rebuttal Evidence on Secondary Considerations Is Timely
`Petitioner’s ability to address secondary considerations evidence has already
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`been addressed by the Board. See Paper 11, 22-26. The Board recognized many
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`distinctions over the Robert Bosch IPR, including that “Petitioner was not a party
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`to the [] trial and therefore did not have an opportunity in that case to response to
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`11
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`Patent Owner’s evidence” and that “the Board relied upon the Administrative
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`Judge’s determination in the corresponding ITC proceeding.” Id., 25. The Board
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`further noted that the prosecution history was the only fixed record at that time,
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`and that the POPR offered “testimony and evidence from different declarants” to
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`which “Petitioner has not yet had an opportunity to respond.” Id., 25-26.
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`Thus, the Board held that “a better course of action is to permit the parties to
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`develop a more complete record during trial before considering Patent Owner’s
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`evidence of objective indicia of nonobviousness” (id., 24), which is precisely what
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`Petitioner did with its timely submissions directed to secondary considerations
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`raised in the POR. This makes logical sense because the traditional way to develop
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`such a record is for a Patent Owner to first raise the issues it intends to raise, and
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`then allow Petitioner to appropriately respond. See Petroleum Geo-Services Inc. v.
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`Westerngeco LLC, IPR2014-01477, Paper 18 at 32 (PTAB March 17, 2015)
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`(finding Petition not deficient where Petitioner was not a named defendant in a
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`prior litigation, and stating “evidence of secondary indicia of non-obviousness
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`must be first developed in this proceeding by Patent Owner”).
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`This approach is even more critical here because, as noted above, Petitioner
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`attempted to gain access to the Apotex trial record and was denied by both the
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`District Court and Cipla. EX1174, ¶ 2; EX1175. Thus, Petitioner did not know at
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`the Petition stage which arguments from the prior litigation Cipla would raise here,
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`12
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`nor did Petitioner have access to the evidence underlying those arguments.
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`Moreover, Dr. Donovan explained in her deposition that some litigation materials
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`were subject to a protective order that barred her from discussing such information
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`in this proceeding. See EX2159, 125:16-19.
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`Cipla should not be allowed to exclude evidence and arguments that
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`Petitioner could realistically only have submitted in its Reply papers. Requiring
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`anything more from Petitioner beyond addressing the arguments from the
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`prosecution history would simply be unfair and not in the interests of justice,
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`especially given that Cipla could have requested to file a sur-reply, but chose not
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`to. See, e.g., Campbell Soup Co., et al. v. Gamon Plus, Inc., IPR2017-00087, Paper
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`37 at 3-4 (PTAB Nov. 17, 2017) (granting sur-reply on secondary considerations).
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`Lastly, Cipla requests to exclude numerous exhibits for which an objection
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`as to timeliness was not asserted. See Paper 32, 9-11 (not identifying exhibits 1037,
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`1057-1138, 1147-48, 1150, 1157-58, and 1163-65).
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`VII. Cross-Examination Questioning Was Properly Within The Scope
`Petitioner’s cross-examination questioning of Drs. Carr and D’Addio was
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`within the scope of their declarations; each of Cipla’s points raised at pages 12-13
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`of the Motion are addressed below:
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`1) Cross-examination relating to Dr. Carr’s prescribing habits of Astelin and
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`Flonase administered sequentially was within the scope of his opinion that “a
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`13
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`POSA would have known that co-administration of antihistamines and steroids
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`provided no meaningful benefit as compared to steroids alone” and that “the art did
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`not motivate a POSA to combine azelastine and fluticasone into a fixed dose
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`combination.” See EX2147, ¶¶ 45-64 and 80-95. That is, if there were no
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`meaningful benefits, and there was otherwise no motivation, why would Dr. Carr
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`have regularly prescribed such a combination?
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`2) Cross-examination relating to Dr. Carr’s prescribing habits of Dymista®
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`was within the scope of his opinions that Dymista® is “the new gold standard for
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`the treatment of AR” and has “unexpectedly reduced side effects as compared to
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`either azelastine or fluticasone monotherapies.” See EX2147, ¶¶ 148-49, 122-29.
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`That is, Dr. Carr’s frequency and conditions of prescription are relevant to whether
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`Dymista really is “the gold standard,” and his experiences with side-effects are
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`relevant to his opinion regarding “unexpectedly reduced side effects.”
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`3), 4), and 5) Cross-examination that identified (i) the months-long efforts
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`to develop compositions in the ’206 patent, (ii) general new product development
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`times of “probably months,” and (iii) further formulation work that took days just
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`to make a “minor variation” to the final Cipla formula was relevant to and within
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`the scope of Dr. D’Addio’s testimony regarding Meda’s alleged “efforts” to
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`formulate a composition of azelastine and fluticasone that hardly spanned more
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`than a day (see EX2148, ¶¶ 20-25), which Cipla characterizes as a “failure by
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`14
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`others” (POR at 60-61).
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`VIII. EX1171 Should Not Be Excluded
`While Cipla characterizes the corrections Mr. Staines identified in EX1171
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`as Petitioner’s, they were clearly those independently identified by Mr. Staines
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`during his deposition preparation efforts. EX2180, 119:7-121:8, 166:9-20. Cipla’s
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`reference to 37 C.F.R. § 42.53(d)(3) is misplaced, as that rule is not directed to the
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`situation here were a declarant has already submitted direct testimony in a
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`declaration. Cipla was afforded the opportunity to question Mr. Staines about
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`EX1171, including time to review notes and assistance in printing any exhibits
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`needed. See EX2180, 121:9-14; 167:1-20. Notably, while Cipla’s Counsel claimed
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`there were five “new exhibits” cited in EX1171 (i.e., 1069, 1092, 1133, and 1136-
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`37), all of those exhibits were cited in Mr. Staines’ original declaration. See,
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`EX1140, FN 240 (EX1069); FN 122 (EX1092); FN 252 (EX1133); FN 286
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`(EX1136); FN 289 (EX1137). Cipla’s additional examination lasted one-hour, and
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`only covered two of the five “new exhibits.” See EX2180, 121:18 (start time of
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`2:57pm); 167:21 (end time of 3:56pm); 4:14-15. Thus, Cipla cannot claim any real
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`prejudice, and EX1171 should thus not be excluded from the record.
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`Dated: April 24, 2018
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`Respectfully submitted,
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`By: /Michael R. Houston/
`Michael Houston
`Registration No. 58,486
`FOLEY & LARDNER LLP
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`321 North Clark Street, Suite 2800
`Chicago, Illinois 60654
`Telephone: 312-832-4500
`Facsimile: 312-832-4700
`mhouston@foley.com
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`Counsel for Petitioner
`Argentum Pharmaceuticals LLC
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`16
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`CERTIFICATION OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
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`EXCLUDE PETITIONER’S EVIDENCE UNDER 37 C.F.R. § 42.64 was
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`served on April 24, 2018, on Counsel for Patent Owner via electronic mail to the
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`following:
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`Dated: April 24, 2018
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`dvarughe-PTAB@skgf.com
`dsterlin-PTAB@skgf.com
`alarock-PTAB@skgf.com
`ueverett-PTAB@skgf.com
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`By: /Michael R. Houston/
`Michael Houston
`Registration No. 58,486
`Counsel for Petitioner
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