`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`ARGENTUM PHARMACEUTICALS LLC
`
`Petitioner
`
`v.
`
`CIPLA LIMITED
`
`Patent Owner
`
`_____________________
`
`Case No. IPR2017-00807
`
`U.S. Patent No. 8,168,620
`_____________________
`
`PATENT OWNER’S REPLY TO OPPOSITION TO
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`I.
`
`
`
`IPR2017-00807
`U.S. Patent No. 8,168,620
`
`Petitioner’s objective indicia response was not timely.
`
`In view of the Board’s admonition to “develop a more complete record
`
`during trial,” Paper 11, 24, Cipla’s discovery revealed that Petitioner and its
`
`declarants knew of Cipla’s objective indicia arguments and evidence before filing
`
`its Petition, but did not address them for “strategic reasons.” See Paper 43 at 9-10;
`
`POR at 53-55. Petitioner doesn’t dispute this. Without an opportunity to
`
`substantively respond, Cipla is prejudiced.
`
`Petitioner’s sole rebuttal—that it could not access many of the documents
`
`Cipla relied upon in the Apotex trial—belies the facts. Almost all of these
`
`documents were publicly available from peer-reviewed journals that Petitioner
`
`could find using the public exhibit list from trial. CIP2017, 257-354. Even so,
`
`Petitioner could have addressed the publicly available arguments and evidence, but
`
`failed to meet that low threshold. cf. Amneal Pharm. Inc. v. Supernus Pharm. Inc.,
`
`IPR2013-00368, Paper 2, at 47-48 (June 20, 2013). In any event, EX1174 shows
`
`that Petitioner didn’t contact the Court until February 2018, which does not show
`
`unavailability in February 2017 when the Petition was filed.
`
`II.
`
`Petitioner’s Reply and EX1145 Should be Excluded.
`
`Petitioner claims that its new arguments and evidence are meant to “counter
`
`arguments raised in the POR.” Opp. at 6. But that is not what occurred in
`
`Petitioner’s Reply or EX1145. The Petition and Dr. Donovan’s first declaration
`
`
`
`- 1 -
`
`
`
`
`(EX1004) offered only broad, non-specific motivations for why a POSA would use
`
`
`
`IPR2017-00807
`U.S. Patent No. 8,168,620
`
`the excipients recited in claims 42-44. Pet., 42; EX1004, ¶¶ 57-68. Cipla
`
`deconstructed these arguments, so Petitioner belatedly offered in its Reply and
`
`EX1145 new motivations for a POSA to use those same claimed excipients.1 That
`
`Cipla overcame Petitioner’s and Dr. Donovan’s original motivations in the POR is
`
`not a license to offer brand new motivations in Reply when those new motivations
`
`could, and should, have been raised in the Petition. Allowing Petitioner to inject
`
`these new arguments in Reply renders meaningless 37 C.F.R. § 42.23(b).
`
`Petitioner and Dr. Donovan raised Dr. Govindarajan’s non-confidential
`
`testing (CIP2030) in Reply as “support[ing]” an expectation of success. EX1145,
`
`¶¶30-40. That is a far cry from rebutting Cipla’s reliance on this same information,
`
`which Dr. Donovan attempted separately. EX1145, ¶¶41-49.
`
`Finally, the Federal Circuit has implicitly endorsed inclusion of Rule
`
`42.23(b) arguments in motions to exclude. See Genzyme Therapeutic Prods. Ltd.
`
`Partnership v. Biomarin Pharm. Inc., 825 F.3d 1360, 1368-69 (Fed. Cir. 2016).
`
`III.
`
`Certain cross examination testimony was outside the scope.
`Petitioner’s post hoc justifications for claiming that certain testimony from
`
`1 Petitioner’s attempt to connect its general disclosure of glycine’s “humectant”
`
`properties to its new “comfort” argument is untimely and impermissible in a
`
`motion to exclude.
`
`
`
`- 2 -
`
`
`
`
`Drs. Carr and D’Addio was within the scope of their declaration fails. First,
`
`
`
`IPR2017-00807
`U.S. Patent No. 8,168,620
`
`Petitioner concedes that Dr. Carr didn’t raise the issue of his Astelin and Flonase
`
`prescribing habits in his declaration. Petitioner also implies that Dr. Carr’s
`
`testimony was directed to whether co-administration of Astelin and Flonase
`
`provided a meaningful benefit. But nowhere in EX1142, 6:8-11:15, did Petitioner
`
`question Dr. Carr about such a meaningful benefit.2 Nor did Dr. Carr’s declaration
`
`mention his Dymista® prescribing habits. And the relationship between Dr. Carr’s
`
`prescribing habits and Dymista®’s status as the “gold standard” is tenuous at best,
`
`especially in view of Dr. Carr’s testimony that poor insurance coverage often
`
`prevents more patients from receiving Dymista®. EX1142, 114:16-115:4; 117:3-
`
`11; 117:18-118:7.
`
`As for Dr. D’Addio’s testimony, Petitioner makes no attempt to justify how
`
`Meda’s development work with orally administered non-allergy drugs was within
`
`the scope of Dr. D’Addio’s narrowly focused testimony on the facts surrounding
`
`Meda’s azelastine/fluticasone nasal spray formulation work, except to say that it is
`
`“relevant.” This testimony is therefore out of scope.
`
`
`2 Petitioner gratuitously adds to the record by asserting “why would Dr. Carr have
`
`regularly prescribed such a combination?” The answer is: “[t]he practice was not to
`
`administer [Astelin and Flonase] together.” CIP1142, 6:21-7:4.
`
`
`
`- 3 -
`
`
`
`
`
`
`IV.
`
`EX1171 should be excluded.
`
`IPR2017-00807
`U.S. Patent No. 8,168,620
`
`Petitioner failed to respond to several bases for exclusion—that EX1171 was
`
`(1) substantive testimony belatedly filed after the deadline to do so, (2) taking
`
`Petitioner’s viewpoint that the revisions in EX1171 are “clerical,” not relevant
`
`because the revisions “don’t affect the opinions or evidence,” and (3) not properly
`
`introduced on redirect—and therefore has waived them. See Paper 43, 13-15.
`
`Petitioner’s only substantive rebuttal—that citation to 37 C.F.R. § 42.53(d)(3) was
`
`improper—bolsters Cipla’s grounds for exclusion. If EX1171 was not direct
`
`evidence, as Petitioner argues, then it could only have been properly entered on
`
`redirect (it was not). As for prejudice, an additional hour of examination does not
`
`offset the need to restrategize Mr. Staines’s deposition and review at least 237
`
`additional pages of exhibits in the last few hours of the one day Mr. Staines was
`
`available for deposition. See CIP2180, 167:8-15.
`
`V.
`
`EX1055 and Paragraphs 53-43 of EX1144 should be excluded.
`
`Petitioner doesn’t dispute that (1) Cipla timely objected to EX1055 as
`
`incomplete, and (2) EX1055 obscures much of the underlying document. This
`
`missing information is important because that the obscured information likely
`
`contradicts Petitioner. In fact, Dr. Schleimer conceded that “Dr. Accetta’s records
`
`actually frequently said ‘take as needed’” (See CIP2179, 94, 4-7), which, as Dr.
`
`Carr explained, is wholly inconsistent with a fixed-dose combination formulation
`
`
`
`- 4 -
`
`
`
`
`
`
`like the ’620 patent. CIP2147, ¶67.
`
`IPR2017-00807
`U.S. Patent No. 8,168,620
`
`VI.
`
`EX1037 must be excluded under 37 C.F.R. §§ 42.63(a) and (e).
`
`Cipla didn’t waive its objection. It objected to the lack of EX1037 at the first
`
`opportunity (at the Petition stage) and Petitioner never remedied this objection.
`
`Thus, the same deficiency existed at the Reply stage so there was no need for a
`
`duplicative objection from Cipla.3 Petitioner then compounded its deficiency by
`
`filing EX1037 along with its opposition on April 24, 2018. The time for curing
`
`Petitioner’s evidence has passed, and therefore, EX1037 should be excluded.
`
`VII.
`
`Petitioner’s improper incorporation by reference should be rejected.
`
`Petitioner’s opposition cannot overcome one simple but
`
`important
`
`consequence of its incorporation of uncited evidence: incorporation would exceed
`
`the Petition and Reply word limits. See Paper , 8 (citing 37 C.F.R. § 42.24(a), (c)).
`
`Petitioner has offered no legitimate reason for the Board to ignore its own Rules,
`
`and indeed, the hundreds of extra words obtained through this avoidance of the
`
`word limits prejudices Cipla, which did not receive the same benefit.
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`3 Ironically, Petitioner concedes that it did not re-object to the portions of EX1002
`
`it now seeks to exclude. Paper 41, 2. Petitioner’s motion to exclude thus
`
`contradicts its basis for keeping EX1037 in the IPR.
`
`
`
`- 5 -
`
`
`
`
`
`
`
`
`
`
`
`Date: April 30, 2018
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`IPR2017-00807
`U.S. Patent No. 8,168,620
`
`
`
`Dennies Varughese
`Lead Attorney for Patent Owner
`Registration No. 61,868
`
`
`
`- 6 -
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`
`
`The undersigned hereby certifies that the above-captioned “Patent Owner’s
`
`Reply to Opposition to Motion to Exclude Evidence” was served in its entirety on
`
`April 30, 2018, upon the following parties via electronic mail upon the following
`
`counsel of record for the Petitioner:
`
`Michael R. Houston: mhouston@foley.com
`Joseph P. Meara: jmeara@foley.com
`James P. McParland: jmcparland@foley.com
`ARG-dymista@foley.com
`
`FOLEY & LARDNER LLP
`321 North Clark Street
`Suite 2800
`Chicago, IL 60654
`
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
`Dennies Varughese
`Lead Attorney for Patent Owner
`Registration No. 61,868
`
`
`
`Date: April 30, 2018
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`