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