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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`ARGENTUM PHARMACEUTICALS LLC
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`Petitioner
`
`v.
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`CIPLA LIMITED
`
`Patent Owner
`
`_____________________
`
`Case No. IPR2017-00807
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`U.S. Patent No. 8,168,620
`_____________________
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`
`
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`PATENT OWNER’S MOTION TO EXCLUDE PETITIONER’S EVIDENCE
`UNDER 37 C.F.R. § 42.64
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`
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`
`
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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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`
`
`
`
`
`IPR2017-00807
`Patent No. 8,168,620
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
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`I.
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`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c), Patent Owner moves to
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`exclude from
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`the record
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`inadmissible evidence submitted by Petitioner.
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`Specifically, the Board should exclude Exhibits 1014, 1026-1032, 1034-1044,
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`1047-1049, 1051, 1052, 1054-1139, 1148-1150, 1152, 1153, 1159-1164, 1168, and
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`1171. In addition, the following paragraphs of Petitioner’s expert declarations
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`should be excluded: (1) paragraphs 1-11, 13-17, 21, 24-31, 42-44, 53, 55, 56, 62,
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`69-71, 77, 84-90, 95, 96, and 104-115 of EX1003; (2) paragraphs 1-13, 16-20, 27,
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`32-34, 40-42, 44-49, 59, and 72-77 of EX1004; (3) paragraphs 1, 20, 26, 32, 38,
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`41, 50, 56-66, 75-85, 87-111, 113, 114, 119, 120, 123, 124, 126, 130, 131, 133,
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`137-139, 142, 146, 149, 151-153 of EX1140; (4) exhibits 1, 2a, 5, and 7 of
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`EX1140; (5) paragraphs 1-6, 10, 16, 42-44, 46-48, and 52-95 of EX1144; and (6)
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`paragraphs 1-6, 12-17, 22, 23, 53, 54, 59-66, 68-70, and 72-84 of EX11451
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`because none of the above are cited in the Petition or Reply.
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`It is not enough for the Board to find that this Motion is moot if the Board
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`does not rely on the inadmissible evidence in reaching its Final Written Decision.
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`If the exhibits identified above remain in the record, Petitioner could continue to
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`1 All objections to EX1145 apply equally to EX1165 because EX1165 is the public
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`version of EX1145.
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`rely on them on appeal to the Federal Circuit, and Patent Owner would be unfairly
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`forced to address them again.
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`Significant portions of the evidence submitted by Petitioner in support of its
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`Petition and Reply should be excluded. For example, Petitioner relies on EX1055
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`as proof of the co-administration of azelastine and fluticasone before the invention
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`date, but this exhibit: (1) is heavily modified; (2) was available to Petitioner before
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`it filed its Petition, and thus is untimely; and (3) relies on a document that is, by
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`definition, not a printed publication. Similarly, at pages 19 and 25 of its Reply,
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`Petitioner relies on EX1037—purportedly, a “Carr” article—which is neither
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`identified in its Exhibit List nor has it been entered in the record in this proceeding.
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`Petitioner also improperly attempts to use its Reply and reply declarations to
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`cure the numerous deficiencies in its Petition. For example, Petitioner’s
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`formulation expert, Dr. Donovan, submitted new motivation arguments in her reply
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`declaration. Her new testimony regarding selection of certain excipients and
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`avoidance of others is (1) nowhere to be found in her original declaration; and (2)
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`contradictory to her previous testimony in the related Apotex litigation.
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`The exhibits identified below should be excluded for the reasons that follow.
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`II. EX1055 AND ¶¶53-54 OF EX1144 SHOULD BE EXCLUDED UNDER
`FRE 801-802, AND 1002 AND 35 U.S.C. § 331(b).
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`Patent Owner moves to exclude EX1055 and paragraphs 53 and 54 of
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`EX1144. EX1055 is purportedly a patient record, but on its face, EX1055 is not the
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`actual patient record but a modified imitation of it. First and foremost, as a doctor’s
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`patient record is subject to HIPAA confidentiality laws, so the underlying record is
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`not a printed publication at the time of the invention. Petitioner has made no effort
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`to show that this document, or the underlying source, was publicly available before
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`the invention date.
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`FRE 1002 mandates that an “original writing, recording, or photograph is
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`required in order to prove its contents unless these rules or a federal statute
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`provides otherwise.” The original (or at least an unmodified copy of it) is available
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`from the prescribing clinician, Dr. Donald Accetta, or from the District Court for
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`the District of Delaware, where it was entered into evidence not under seal.
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`Petitioner, however, failed to submit the original record, or an unmodified copy,
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`despite its availability.
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`Petitioner’s failure to provide the original patient record is meaningful
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`because Petitioner questioned Dr. Carr on EX1055 during his deposition but Dr.
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`Carr repeatedly had difficulty
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`testifying about EX1055 given
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`the clear
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`modifications from the original. EX1142, 13:6-7 (“Do you actually have the full
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`document for me to review so that I can appropriately comment on it?”) and 14:2-4
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`(“Well, perhaps, if I may, I could try to read the document behind rather than just
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`what you’ve highlighted.”). Even Petitioner’s expert agreed that the modifications
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`impacted the ability to see the original content. CIP2179, 9:21-10:3 (“That’s
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`correct. It covers the writing underneath.”).
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`Because EX1055 is not an original document, it is also double hearsay.
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`Petitioner’s reliance on EX1055 is not based on what EX1055 itself says, but
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`instead relies on the out-of-court statements in the underlying, original patient
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`record portrayed in EX1055. Petitioner and its declarant, Dr. Schleimer, rely on
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`this document for the truth of the matter asserted, i.e., that physicians did, in fact,
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`co-prescribe azelastine and fluticasone before the invention date. EX1144, ¶¶53-
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`54; Reply, 19. Petitioner has not shown that any exceptions apply under FRE 803
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`or that the residential exception under FRE 807 applies here.
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`Patent Owner timely objected to EX1055 both at Dr. Carr’s deposition and
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`in response to Petitioner’s Reply. See EX1142, 12:21-22; Paper 32, 7.
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`Accordingly, EX1055 should be excluded on either of these grounds.
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`III. EX1037 SHOULD BE EXCLUDED BECAUSE IT VIOLATES 37
`C.F.R. § 42.63(a) AND (e).
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`Petitioner never submitted EX1037, and therefore it should be excluded. The
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`entry for EX1037 in the Exhibit List submitted with the Petition was blank. Patent
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`Owner timely raised this issue. See Paper 14, 3-4. The entry for EX1037 in
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`Petitioner’s current Exhibit List (served on March 27, 2018) is still blank. But
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`Petitioner’s Reply (pp. 5-7, 19-22, 25) and EX1144, ¶¶16, 42, 61-63, 66-67, 77-79,
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`82-84, 90) imply that EX1037 was in fact filed. 37 C.F.R. § 42.63(a) states that
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`“[a]ll evidence must be filed in the form of an exhibit” and subsection (e) provides
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`that “[i]f the exhibit is not filed, the exhibit list should note that fact.” Because
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`EX1037 was not filed and Petitioner’s Exhibit Lists fail to note that EX1037 was
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`not filed, Petitioner violated both requirements. Accordingly, EX1037 and
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`Petitioner’s Reply at pp. 5-7, 19-22, and 25, and EX1144 ¶¶16, 42, 61-63, 66-67,
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`77-79, 82-84, and 90, which cite EX1037, should be excluded.
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`IV. PETITIONER’S REPLY AND EX1145 VIOLATE 37 C.F.R. § 42.23(b)
`BY RAISING NEW ISSUES.
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`37 C.F.R. § 42.23(b) requires that “[a] reply may only respond to arguments
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`raised in the corresponding opposition, patent owner preliminary response, or
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`patent owner response.” The Patent Trial Practice Guide provides examples of new
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`issues that are improperly raised in reply: “new evidence necessary to make out a
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`prima facie case for the [] unpatentability of a[] . . . claim,” or “new evidence that
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`could have been presented in a prior filing.” Office Patent Trial Practice Guide, 77
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`Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). Petitioner and its declarant Dr. Donovan
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`improperly supplement
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`their obviousness arguments by (1) raising new
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`motivations for the POSA to use the preservatives and isotonicity adjustor recited
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`in claims 42-44, and (2) raising new arguments for why a POSA would have had a
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`reasonable expectation of successfully arriving at the invention of the challenged
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`claims. For example, for the first time in her reply declaration, Dr. Donovan:
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`• Asserts that a POSA would have been motivated to use the three claimed
`
`preservatives in order to pass a preservative challenge test (EX1145,
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`¶¶60-66);
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`• Cites Remington: the Science of Practice of Pharmacy as support of her
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`opinions that the claimed preservatives were obvious (EX1145, ¶¶61-63);
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`• Asserts that EDTA’s use as a chelating agent would have motivated a
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`POSA to use it (EX1145, ¶63);
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`• Asserts that a POSA would “have been motivated to avoid” using sodium
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`chloride and dextrose—the tonicity adjusters used in the prior art
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`Astelin® and Flonase® products (EX1145, ¶¶68-69) (emphasis in
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`original);
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`• Asserts that a POSA would have been motivated to use glycerine to
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`“add[] to the comfort of the nasal spray” (EX1145, ¶70); and
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`• Relies on Dr. Govindarajan’s recreations of Cramer Example III—
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`recreations that Dr. Donovan relied on in the related district court
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`proceeding months before the Petition was filed—to “support a POSA’s
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`reasonable
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`expectation
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`of
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`successfully
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`combining
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`azelastine
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`hydrochloride and fluticasone propionate into an aqueous nasal spray”
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`(EX1145, ¶¶12-17).
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`This testimony is also inconsistent with Dr. Donovan’s opinions in the
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`related Apotex litigation, where she testified that sodium chloride and dextrose
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`were tonicity adjustors to include in an “obvious combination formulation,” but
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`now testifies that a POSA would have been “motivated to avoid” those agents.
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`EX1145, ¶¶68-69; CIP2177, 33; EX2178, 54:3-7.
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`Petitioner’s Reply is built on these same new issues and evidence. See e.g.,
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`Reply, 13, 17-18. These arguments and evidence are newly raised to purportedly
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`support obviousness and were available to Petitioner and Dr. Donovan at the time
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`the Petition was filed. Petitioner therefore was required to submit these arguments
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`and evidence in its case-in-chief. Intelligent Bio-Sys., Inc. v. Illumina Cambridge
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`Ltd., 821 F.3d 1359, 1369-70 (Fed. Cir. May 9, 2016); Wasica Fin. GmbH v.
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`Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. April 4, 2017). Patent
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`Owner timely objected. See Paper 32, 9-10. Petitioner is precluded from raising
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`those issues in its reply papers, and therefore they should be excluded as contrary
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`to 37 C.F.R. § 42.23(b).
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`V. DOZENS OF EXHIBITS AND DECLARATION PARAGRAPHS
`WERE NOT CITED IN THE PETITION OR REPLY AND THEIR
`INCLUSION WOULD VIOLATE 37 C.F.R. § 42.24(c).
`
`Petitioner submitted dozens of exhibits that are cited nowhere in its Petition
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`or its Reply. Exhibits 1014, 1026-1032, 1034-1044, 1047-1049, 1051, 1052, and
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`1054, as well as paragraphs 1-11, 13-17, 21, 24-31, 42-44, 53, 55, 56, 62, 69-71,
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`77, 84-90, 95, 96, and 104-115 of EX1003, and paragraphs 1-13, 16-20, 27, 32-34,
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`40-42, 44-49, 59, and 72-77 of EX1004 were submitted with the Petition, but are
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`cited nowhere in the Petition itself. Similarly, the Reply fails to cite: (1) Exhibits
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`1055-1139, 1148-1150, 1152-1153, 1159-1165, and 1168; (2) paragraphs 1, 20, 26,
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`32, 38, 41, 50, 56-66, 75-85, 87-111, 113-114, 119-120, 123-124, 126, 130-131,
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`133, 137-139, 142, 146, 149, and 151-153 of EX1140; (3) Exhibits 1, 2a, 5, and 7
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`of declaration EX1140; (4) paragraphs 1-6, 10, 43-44, 46-48, 53-54, 72-74, 78, 80,
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`and 94-95 of EX1144; and (5) paragraphs 1-6, 22-23, 53-54, 59, 66, 72-73, 78, and
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`80-81 of EX1145.
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`Petitioner’s failure to cite these exhibits and paragraphs in its Petition or
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`Reply demonstrates that these exhibits and paragraphs do not make any fact of
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`consequence more or less probable. See FRE 401, 403. And to the extent that those
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`uncited exhibits were cited in declaration paragraphs subsequently cited in the
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`Petition or Reply, incorporation of the exhibits and/or declarations’ discussion of
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`these exhibits into either the Petition or Reply would result in either document
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`exceeding the word limits set forth in 37 C.F.R. § 42.24(a) and (c). Patent Owner
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`timely objected to these uncited exhibits and paragraphs as violating 35 U.S.C. §
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`331(b). Paper 14, 4-6; Paper 32, 3. The exhibits and declaration paragraphs
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`identified above should thus be excluded for lack of relevance and/or exceeding
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`the word limits of § 42.24.
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`IPR2017-00807
`Patent No. 8,168,620
`VI. PETITIONER’S OBJECTIVE INDICIA EVIDENCE WAS NOT
`TIMELY SUBMITTED.
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`Petitioner’s objective indicia evidence and arguments in reply should be
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`excluded because they were not timely submitted. 35 U.S.C. § 312(a)(3) required
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`Petitioner to submit a petition that identified “with particularity” the grounds of its
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`challenge and the evidence for the challenge. As Petitioner’s Ground 2 and Ground
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`3 are rooted in obviousness under 35 U.S.C. § 103, it is black-letter law that
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`“[o]bjective indicia of nonobviousness must be considered in every case where
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`present.” Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048 (Fed. Cir. 2016)
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`(en banc).2 This means that Petitioner needed to address all of the objective indicia
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`of which it (and its experts) were, or should have been, aware.
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`Petitioner, however, was aware of a host of evidence and arguments that
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`Patent Owner had publicly submitted and discussed less than two months before
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`the Petition was filed. See, e.g., CIP2127, 1; CIP2158, 94:10-96:10; CIP2159,
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`119:12-121:5, 123:7-126:13. Petitioner and its declarants knew of, but did not
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`address: (1) Dymista®’s unexpectedly faster onset of action and reduction in side
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`effects compared to existing fluticasone and azelastine products; (2) Dymista®’s
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`satisfaction of the long-felt need in the U.S. for a more effective, faster, and safer
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`2 Indeed, both Petitioner’s declarants who submitted declarations with the Petition
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`acknowledged this obligation. EX1003, ¶92; EX1004, ¶11.
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`treatment of allergic rhinitis; (3) FDA’s and Meda’s skepticism of the claimed
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`invention; (4) industry praise for Dymista®; (5) failure by at least Meda to
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`formulate an azelastine/fluticasone combination; (6) licensing of the ’620 patent;
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`(7) evidence of copying; or (8) Dymista®’s U.S. commercial success.3 See, e.g.,
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`CIP2127 (“Argentum attended the public portions of the trial and is using the same
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`experts…”); CIP2158, 94:5-96:10 (Dr. Schleimer testifying that he recalled
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`numerous objective indicia from trial that he did not opine on in his opening
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`report); CIP2159, 121:8-124:4 (Dr. Donovan testifying that she was aware of
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`Patent Owner’s evidence of copycat formulations and Meda’s failed efforts to
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`develop an azelastine/fluticasone combination product); CIP2179, 101:4-102:8 and
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`106:7-107:3 (Dr. Schleimer testifying that he relied on the Greiff reference
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`(EX1147) in the Apotex litigation for onset, yet did not cite it for the same
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`proposition in his first declaration here).
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`Petitioner opted to instead address some—but not all—of this evidence.
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`Petitioner’s Petition argues that “blocking patents” (EX1009, EX1007) negate any
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`“commercial success” or “long-felt need.” Petition, at 56-58. But because EX1009
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`and EX1007 are issued U.S. patents, they can only block U.S. commercial success
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`3 To the extent documents were marked as confidential, those documents were
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`discussed in open court and were not submitted under seal.
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`or long-felt need—which is what Patent Owner presented in open court before the
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`Petition was filed. Moreover, Petitioner argued in the Petition that EX1007 is not
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`limited to medicaments consisting solely of azelastine and its physiologically
`
`acceptable salts. Petition, at 57. This argument only makes sense in view of Patent
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`Owner’s public argument months before the Petition that the claims of EX1007
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`were limited to azelastine-only medicaments due to the presence of the Markush
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`group in the claims of EX1007. EX2017, 117-118, 695. That is, Petitioner’s
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`arguments confirm that it was aware of Patent Owner’s objective indicia arguments
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`and evidence when it filed the Petition.
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`“Unlike district court litigation, where parties have greater freedom to revise
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`and develop their arguments over time and in response to newly discovered
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`material, the expedited nature of IPRs bring with it an obligation for petitioners to
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`make their case in their petition to institute.” Intelligent Bio-Sys., 821 F.3d at 1369.
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`This obligation required Petitioner to address in its Petition objective indicia of
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`nonobviousness it was aware of, rather than strategically avoiding those issues in
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`the first instance, only to raise them in reply to Patent Owner’s prejudice. See, e.g.,
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`CIP2158, 98:8-17 (Dr. Schleimer testifying that Petitioner did not address publicly
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`available objective indicia for “strategic reasons”). Accordingly, because “[t]he
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`Board will not attempt to sort proper from improper portions of the reply,”
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`paragraphs 52-93 of EX1144, paragraphs 73-84 of EX1145, the entirety of
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`EX1140, Exhibits 1037, 1055-1138, 1147-1168, and pages 18-29 of Petitioner’s
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`Reply should be excluded. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
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`48,767 (Aug. 14, 2012). Patent Owner timely raised this objection. Paper 32, 9-11.
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`VII. CROSS-EXAMINATION TESTIMONY OF PATENT OWNER’S
`DECLARANTS WAS OUTSIDE THE SCOPE OF THE DIRECT AND
`THEREFORE IS NOT RELEVANT.
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`37 C.F.R. § 42.53(d)(5)(ii) states that “the scope of the [cross]-examination
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`is limited to the scope of the direct testimony.” Petitioner’s Reply cites to the
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`cross-examination testimony of Patent Owner’s declarants Dr. Warner Carr
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`(EX1142) and Dr. Alexander D’Addio (EX1141) which were not within the scope
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`of their direct testimony, as follows:
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`• EX1142 at 6:8-11:15: relating to Dr. Carr’s prescribing habits;
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`• EX1142 at 109:7-115:4, 114:16-121:20, and 196:22-198:1: relating to
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`Dr. Carr’s prescribing habits of Dymista® after it was commercially
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`available in 2012;
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`• EX1141 at 44:13-45:8: relating to Dr. D’Addio’s development of tannate
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`pharmaceutical compositions which no declarant asserted as relevant to
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`the challenged claims;
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`• EX1141 47:15-48:6: relating to Meda’s (the exclusive licensee of the
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`’620 patent) development times for drugs for which no declarant has
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`asserted are relevant to the challenged claims; and
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`• EX1141 62:17-64:7: relating
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`to work Meda and Patent Owner
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`contemplated well after 2002.
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`This testimony does not make any fact of consequence more or less probable
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`because it bears no relation to Dr. Carr’s and Dr. D’Addio’s direct testimony.
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`Given its low probative value, this testimony is outweighed by the prejudice to
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`Patent Owner of irrelevant and non-prior art information being used to invalidate
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`the challenged claims, and the risk of confusing the issues. See FRE 401 and 403.
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`As the above citations show, Patent Owner objected to this testimony at the
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`time it occurred and subsequently filed formal objections. Paper 32, 8-9.
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`Accordingly, this testimony should be excluded as irrelevant.
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`VIII. EX1171 IS UNTIMELY, OUTSIDE THE SCOPE OF THE CROSS-
`EXAMINATION, AND IRRELEVANT.
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`Seventeen hours before the deposition of Petitioner’s declarant, John C.
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`Staines, Petitioner’s counsel emailed to Patent Owner’s counsel a list of errata to
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`Mr. Staines’s declaration (EX1140). See CIP2180, at 105:16-106:8. This exhibit
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`was brought into the record by Petitioner’s counsel, in direct contravention of the
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`requirement that, “[i]n the case of direct testimony,” Petitioner was required to
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`serve a copy of this document “at least ten days prior to the deposition.” 37 C.F.R.
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`§ 42.53(d)(3). Petitioner failed to meet this deadline.
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`Despite the deadline for Petitioner to file declaration evidence passing 29
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`days earlier, Petitioner attempted to make substantive changes to Mr. Staines’s
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`testimony. For example, one of Mr. Staines’s revisions
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`is
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`to change
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`“corticosteroids” to “oral corticosteroids,” a change Mr. Staines testified was made
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`because his prior testimony was “inaccurate or vague.” EX1171 (emphasis added),
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`EX1140, ¶49 FN. 97; CIP2180, 123:13-124:3. Further, Mr. Staines sought to
`
`change the language “It does address the relevant…” to “It does not address the
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`relevant...” because without the change his prior testimony was “misleading.”
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`EX1171 (emphasis added), EX1140, ¶121; CIP2180, 124:21-125:21.
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`EX1171 also modifies the factual support to several statements. EX1171,
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`entries for pages 16, 51, 61, 73, 90, 91, 92, 98, 99, 101, 110, 112, 113, 114.
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`Regarding the revisions to Mr. Staines’s cited exhibits, he testified that these
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`revisions were not errors, but instead that he had found exhibits that “gave better
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`support, more—not better, but more support”. CIP2179, at 143:18-145:21.
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`Petitioner’s testimonial evidence is untimely as it was filed well after the
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`March 6, 2018 deadline for filing reply evidence. Paper 26, 2. Had Petitioner
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`wanted to file EX1171, it needed to follow the protocol for filing supplemental
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`information by obtaining authorization from the Board, explaining why the
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`information reasonably could not have been obtained earlier, and showing that the
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`interests-of-justice favored considering the information. See 37 C.F.R § 42.123(c).
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`EX1171 should also be excluded because it was marked as an exhibit on
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`redirect when the witness had not been asked about EX1171, nor had the witness
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`referred to it during his cross-examination. Because EX1171 had no bearing on the
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`questions or answers in cross-examination, marking EX1171 during redirect was
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`outside the scope of the cross-examination, and should therefore be excluded. 37
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`C.F.R. § 42.53 (d)(5)(ii).
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`Finally, EX1171 is not relevant. Petitioner’s counsel characterized the
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`changes reflected in EX1171 as “clerical” CIP2180, at 91:17-20, 94:21-95:7.
`
`Indeed, Mr. Staines testified that EX1171 “do[es]n’t affect the opinions or the
`
`evidence, but [] make them more accurate.” CIP2180, at 132:11-14. Thus, pursuant
`
`to FRE 401 and 403 and 37 C.F.R. § 42.53(d)(3), EX1171 does not make any fact
`
`more or less probable and is untimely, especially given the prejudice caused to
`
`Patent Owner’s deposition preparation efforts. Patent Owner timely objected to
`
`EX1171. CIP2180, 90:10-16, 94:6-20, 104:17-119:2.
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`Date: April 10, 2018
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`
`Dennies Varughese
`Lead Attorney for Patent Owner
`Registration No. 61,868
`
`
`
`- 15 -
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Motion to
`
`Exclude Petitioner’s Evidence Under 37 C.F.R. § 42.64” was served in its entirety
`
`on April 10, 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 10, 2018
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`
`
`
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