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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,
`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 MOTION TO EXCLUDE EVIDENCE
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`I.
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`INTRODUCTION
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`Pursuant to 37 C.F.R. § 42.64(c), Petitioner Argentum Pharmaceuticals LLC
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`(“Petitioner”) moves to preclude Patent Owner, Cipla Ltd. (“Patent Owner”) or its
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`experts from relying on the factual assertions made by Dr. Geena Malhotra in her
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`declaration (see EX1002, 284-87) that was submitted during the prosecution of
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`U.S. Patent No. 8,168,620 (“the ’620 patent”) as inadmissible hearsay under
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`Federal Rule of Evidence (“FRE”) 802.
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`The prosecution history file for the ’620 patent was submitted by Petitioner
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`as Exhibit 1002. This exhibit contained the declaration of Dr. Geena Malhotra
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`submitted by Patent Owner during the prosecution of the ’620 patent. EX1002,
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`284-87. The Petition cited to Exhibit 1002 to illustrate, for example, the reasons
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`given by the Examiner for allowing the claims, and to discuss various allegations
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`made by Patent Owner during prosecution. See, e.g., Pet. at 6-7, 40-41, 55, 59.
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`These were non-hearsay uses of Exhibit 1002.
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`However, in its Preliminary Response (and again in its formal Response),
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`Patent Owner and its experts attempted to rely on the Malhotra declaration
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`submitted during prosecution for the truth of the statements made by Ms. Malhotra
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`therein reporting certain experiments she allegedly conducted. See, e.g., POPR,
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`10, 14, 25, 41; EX2001 ¶¶27-28; EX2007 ¶¶25, 31, 37, 42, 44, 47. That is, beyond
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`reporting what arguments were made to the Examiner during prosecution as
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`1
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`Petitioner has done for a non-hearsay purpose, Patent Owner and its experts
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`attempted to affirmatively rely on the Malhotra declaration for the truth of the
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`matters asserted therein, thereby going beyond non-hearsay uses of Exhibit 1002.
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`REG Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F. 3d 954, 963-965 (Fed. Cir.
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`2016) (recognizing distinction between admissibility of out-of-court statements for
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`non-hearsay purposes, versus inadmissibility for hearsay purposes); Minemyer v.
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`B-Roc Representatives, Inc., 678 F. Supp. 2d 691, 709-710 (N.D. Ill. 2009) (noting
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`that the hearsay rule is not a bar to admissibility as to a relevant, non-hearsay
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`purpose).
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`Shortly after trial was instituted in this proceeding, Petitioner objected to
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`Patent Owner’s attempt to rely on Exhibit 1002 in this manner. Paper No. 16, Pet.
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`Obj. at 2. Patent Owner failed to address or cure Petitioner’s objection. As
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`explained below, Patent Owner should be precluded from relying on the testimony
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`by Dr. Malhotra in Exhibit 1002, as this hearsay use of Exhibit 1002 is precluded
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`by FRE 802 (the hearsay rule) and improperly circumvents the right to cross-
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`examination in violation of the Board’s rules under 37 C.F.R. § 42.51(b)(1)(ii).
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`Patent Owner’s attempted reliance on this declaration evidence without making
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`Ms. Malhotra available for cross-examination also violates at least the spirit if not
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`the letter of 37 C.F.R. § 42.61(c).
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`2
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`II. ARGUMENT
`A.
`Patent Owner’s Attempted Reliance on Dr. Malhotra’s
`Declaration Testimony Renders Such Testimony Hearsay and
`Subjection to Exclusion under FRE 802.
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`During prosecution, Patent Owner submitted a declaration by Dr. Malhotra,
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`who allegedly tested Cramer’s Example III formulation and, based on that alleged
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`testing, found it to be “unsuitable for nasal administration.” EX1002, 284-287. In
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`this proceeding, Patent Owner goes beyond simply reciting the events that
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`occurred during prosecution, and now attempts to rely on Dr. Malhotra’s
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`declaration to argue that Dr. Malhotra’s testing of Cramer affirmatively establishes
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`a lack of reasonable expectation of success to combine azelastine and fluticasone
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`into a combination formulation. See POPR, 10, 14, 25, 41; EX2001 ¶¶27-28;
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`EX2007 ¶¶25, 31, 37, 42, 44, 47; see also POR, 9, 28, 32-36, EX2147 ¶¶27-28;
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`EX2176 ¶¶23, 31, 36, 38, 40-43.
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`In attempting to rely on Dr. Malhotra’s out-of-court statements for their
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`truthfulness, i.e., trying to show a lack of expectation of success by assuming Dr.
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`Malhotra’s statements/tests to in fact be true, Dr. Malhotra’s declaration testimony
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`falls squarely within the hearsay definition under FRE 801(c), and therefore is
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`subject to exclusion for hearsay purposes, per FRE 802. US Endodontics, LLC v.
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`Gold Standard Instruments, LLC, PGR2015-00019 (Paper 54), at *38-42 (P.T.A.B.
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`Dec. 28, 2016) (refusing to admit a declaration under FRE 807 (residual exception)
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`3
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`that was submitted during ex parte prosecution and noting that “a declaration from
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`[declarant] in this proceeding would have been more probative than the declaration
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`[from the ex parte proceeding] because a declaration in this proceeding would have
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`subjected [declarant] to cross-examination by Petitioner as a matter of routine
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`discovery under the rules governing this proceeding”).
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`B.
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`Petitioner Timely Objected to Patent Owner’s Attempted Hearsay
`Use of Dr. Malhotra’s Declaration Testimony
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`On September 5, 2017, Petitioner timely objected to Patent Owner’s attempt
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`to rely on Exhibit 1002 in a hearsay manner. See Paper 16, Pet. Obj. at 2.
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`Specifically, Petitioner’s objections called out Exhibit 1002, and recited numerous
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`places where Patent Owner was attempting to rely on the exhibit in a hearsay
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`manner, in violation of FRE 802. Id. Petitioner’s objections further pointed out
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`that Petitioner has not had the opportunity to subject the declarant to cross
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`examination. Id.
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`Petitioner’s objections were timely, having been served within ten business
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`days of institution. 37 C.F.R. 42.64(b)(1). In response to Petitioner’s September
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`5, 2017 objections, Patent Owner made no attempt to submit supplemental
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`evidence or to otherwise address Petitioner’s objection.
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`4
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`C.
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`Patent Owner Refused To Make Dr. Malhotra Available for
`Deposition
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`Beyond just failing to respond to Petitioner’s objections, Patent Owner went
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`further and expressly refused to make Dr. Malhotra available for cross-
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`examination. On December 27, 2017, Petitioner affirmatively requested that
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`Patent Owner make Dr. Malhotra available for cross-examination, among other
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`witnesses. EX1172 (Email from Mike Houston to Adam LaRock). Patent Owner
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`responded on January 4, 2018 that it did not intend to make Dr. Malhotra available.
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`EX1173 (Email from Adam LaRock to Mike Houston). Thus, despite attempting
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`to secure a deposition of Dr. Malhotra, a named inventor on the ’620 patent,
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`Petitioner was rebuffed and therefore has had no opportunity to cross-examine Dr.
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`Malhotra in this IPR (or any other proceeding).
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`Patent Owner’s failure to offer Dr. Malhotra for deposition deprived
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`Petitioner of an opportunity to obtain testimony from Dr. Malhotra on issues raised
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`in her declaration. One example is that Petitioner was not given the opportunity to
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`explore with Dr. Malhotra how her recreation of Cramer’s Example III had an
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`“undesirable” osmolality. See EX1002, 287(C). Nor has Petitioner been given an
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`opportunity to ask Dr. Malhotra how her recreation of Example III was
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`representative of the routine modifications a POSA would have undertaken or why
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`she did not attempt to modify: (i) the HPMC used by assessing multiple
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`commercial grades of HPMC; (ii) the amount of HPMC used, (iii) the amount of
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`5
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`sodium chloride used; or (iv) the type of spray device employed to generate a
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`successful formulation.
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`Patent Owner’s deliberate strategy of relying on Dr. Malhotra’s prior
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`prosecution declaration, while refusing to make her available for deposition,
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`deprived Petitioner of an opportunity to explore Dr. Malhotra’s bases for her
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`testimony, and/or to confront her with evidence and issues not raised during
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`prosecution.
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`D.
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`Patent Owner’s Attempted Reliance on Dr. Malhotra’s Testimony
`Should Be Precluded
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`Pursuant to 37 C.F.R. § 42.62(a), the FEDERAL RULES OF EVIDENCE apply in
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`Inter Partes Review proceedings. Here, the contents of Dr. Malhotra’s declaration
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`are out-of-court statements that Patent Owner is now attempting to rely on for their
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`truth, establishing the declaration as hearsay under FRE 801(c). Dr. Malhotra was
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`never made available for deposition in this IPR (or in any other proceeding to
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`which Petitioner was a party), thus subjecting the declaration to exclusion under
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`FRE 802. Accordingly, Patent Owner should be precluded from relying on Dr.
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`Malhotra’s declaration testimony because doing so violates FRE 802 as well as the
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`applicable regulations governing this proceeding, which require that affidavit
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`testimony be subject to cross examination under 37 C.F.R. § 42.51(b)(1)(ii).
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`Accord 37 C.F.R. § 42.61(c) (explaining that data in a patent specification or
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`drawing upon which a party intends to rely to prove the truth of the data must be
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`6
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`supported by an affidavit from an individual having first-hand knowledge of how
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`the data was generated, which in turn requires that affiant be made available for
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`cross-examination per § 42.51(b)(1)(ii)).
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`Petitioner appreciates that because the prosecution history of the ’620 patent
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`could be relevant to this proceeding for non-hearsay purposes, it may not be
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`appropriate to “exclude” the Malhotra declaration in Exhibit 1002 from the record
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`altogether. As an alternative, where a party relies on prior testimony without
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`making that witness available for deposition as required by the Board’s rules, the
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`Board has repeatedly held that the testimony is entitled to no weight. See
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`Coalition for Affordable Drugs V LLC v. Biogen MA Inc., IPR 2015-01993, Paper
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`34 at 3 (P.T.A.B. Apr. 19, 2016) (explaining that in order for a declaration
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`submitted during patent prosecution to “be given any weight” in an IPR, the
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`declarant/affiant must be made available for cross-examination in the manner
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`specified in 37 C.F.R. § 42.51(b)(1)(ii)); Altaire Pharm., Inc. v. Paragon Bioteck,
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`Inc., PGR2015-00011, Paper 29 at 3 (P.T.A.B. Apr. 1, 2016) (warning that no
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`weight will be given to a declaration if the declarant is not made available for
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`cross-examination).
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`By relying on Dr. Malhotra’s factual assertions without making her available
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`for cross-examination, Patent Owner has violated the Board’s rules. Therefore, the
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`testimony of Dr. Malhotra on pages 284-287 of Exhibit 1002 should be “excluded”
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`7
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`as to the hearsay purposes for which Patent Owner attempts to rely upon the
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`declaration. Instead, the declaration should be given no weight as to the factual
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`statements therein, and Patent Owner and its experts should likewise be precluded
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`from relying on the Malhotra declaration for the truth of the statements made
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`therein.
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`III. CONCLUSION
`For the foregoing reasons, Petitioner respectfully requests that the Board
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`preclude Patent Owner from relying on the factual assertions in Dr. Malhotra’s
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`declaration contained in Exhibit 1002 at pages 284-287.
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`Dated: April 10, 2018
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`Respectfully submitted,
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`By: /Michael Houston/
`Michael Houston
`Registration No. 58,486
`FOLEY & LARDNER LLP
`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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`8
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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 MOTION TO EXCLUDE EVIDENCE was served on April
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`10, 2018, on Counsel for Patent Owner via electronic mail to the following:
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`Dated: April 10, 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 Houston/
`Michael Houston
`Registration No. 58,486
`Counsel for Petitioner
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