`
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`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
`_____________________
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S 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
`
`
`
`
`
`
`IPR2017-00807
`Patent No. 8,168,620
`
`I.
`
`INTRODUCTION
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`Petitioner’s motion to exclude (Paper 41) a portion of the prosecution history
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`of the ’620 patent is meritless. Patent Owner used the subject evidence—the
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`prosecution declaration of Geena Malhotra (EX1002, 284-87, hereinafter
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`“Malhotra Declaration”)—to support Patent Owner’s arguments made during
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`prosecution, and to show the consistency between Ms. Malhotra’s statements and
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`later-conducted testing by two independent experts, both of whom attempted
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`recreations of the prior art that fall well outside the proper scope of the claim terms
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`“nasal spray” and “suitable for nasal administration.”
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`As explained below, neither of these uses constitutes hearsay, as Petitioner
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`wrongly contends. But, even if they did, each of these uses is excepted from the
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`hearsay rule under either: (i) Fed. R. Evid. 803(15) (statements pertaining to
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`property); or (ii) the residual exception of Fed. R. Evid. 807. And in any event,
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`Petitioner’s request to preclude Patent Owner’s experts from relying on the
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`Malhotra Declaration is misplaced because experts may rely on hearsay evidence
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`in formulating their opinions. Accordingly, the Board should deny Petitioner’s
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`motion to exclude definitive evidence confirming that Cramer (EX1011), and thus
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`Segal (EX1012)—Petitioner’s primary obviousness reference—does not teach a
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`“nasal spray” that is “suitable for nasal administration” within the meaning of the
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`challenged claims.
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`- 1 -
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`IPR2017-00807
`Patent No. 8,168,620
`II. THE MALHOTRA DECLARATION SHOULD NOT BE EXCLUDED.
`Contrary to Petitioner’s unsupported assertion, Patent Owner never
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`“attempted to rely on the Malhotra declaration … for the truth of the statements”
`
`made therein. Paper 41, 1. Rather, Patent Owner has used the Malhotra Declaration
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`for two purposes only: (i) for purposes of claim construction based on the
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`arguments Patent Owner made during prosecution; and (ii) for comparison to the
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`testing of Drs. Govindarajan and Herpin, both of which confirmed the problems
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`with the prior art described in the Malhotra Declaration. Petitioner’s motion to
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`exclude should be denied because (A) the Malhotra Declaration is not hearsay; (B)
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`even if it was, it falls within exceptions to the hearsay rule and thus should not be
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`excluded.
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`A.
`
` The Malhotra Declaration is not hearsay.
`Neither Patent Owner’s Response nor Patent Owner’s experts rely on the
`
`Malhotra Declaration for the truth of the matters asserted therein. The Malhotra
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`Declaration is cited four times in Patent Owner’s Response, none for its truth.
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`The first two citations to the Malhotra Declaration in the Response appear in
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`the claim construction section (Paper 21, 8) explaining that the applicant during
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`prosecution had amended the claims to explicitly require a dosage form “suitable
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`for nasal administration” and a “nasal spray” based on the findings described in the
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`Malhotra Declaration. Ms. Malhotra had recreated the formulation described in
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`- 2 -
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`IPR2017-00807
`Patent No. 8,168,620
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`what the Examiner deemed to be the “closest prior art”—Cramer Example III—
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`and demonstrated it to be unacceptable as a formulation suitable for nasal
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`administration, within the meaning of the claims, because it exhibited (1)
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`unacceptable settling and difficulty re-suspending the active ingredients (2) an
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`unacceptable jet rather than a mist spray, and (3) an unacceptable osmolality.
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`EX1002, 286-87.
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`Patent Owner relies on the findings in the Malhotra Declaration in
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`conjunction with the Applicant’s claim amendments and arguments made during
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`prosecution as intrinsic evidence of the meaning of the “suitable for nasal
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`administration” and “nasal spray” claim terms. Paper 21, 7-10. This is no different
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`than relying on any office action or response thereto made during prosecution to
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`support a claim construction position. The Malhotra Declaration, submitted during
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`prosecution, is a part of the permanent prosecution history of the ’620 patent and a
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`public record. 37 C.F.R. § 1.132. Petitioner has provided no support for its
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`remarkable proposition that the Board should exclude relevant intrinsic evidence,
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`such as the Malhotra Declaration, from its claim construction determination.
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`The third citation, at page 33 of the POR, explains that Cramer Example III
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`“was shown not to be ‘suitable for nasal administration’ both during original
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`prosecution and again in litigation.” This statement, again, does not rely on the
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`truth of the Malhotra Declaration. Rather, it highlights that this argument was
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`- 3 -
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`IPR2017-00807
`Patent No. 8,168,620
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`made by the Applicant, and accepted by the Examiner, during prosecution. Patent
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`Owner’s comparison of the statements in the Malhotra Declaration to later testing
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`and findings by Drs. Govindarajan and Herpin—neither of which are subject to a
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`motion to exclude—does not require Ms. Malhotra’s statements to be true; it
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`merely requires them to exist. That is not hearsay.
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`The fourth citation to the Malhotra Declaration in the POR appears in a
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`discussion of the testing conducted by Dr. Govindarajan, the scientist whose
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`testing was recommended by Dr. Donovan—Petitioner’s formulation expert in this
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`IPR as well as Apotex’s formulation expert in the related district court case—and
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`relied upon by Apotex in the related district court litigation. See id., 34; EX2178,
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`167:12-22. The sentence which the Malhotra Declaration is cited to support
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`describes Dr. Govindarajan’s testing, which was intended to reproduce the testing
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`process described in the Malhotra Declaration. Id.
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`The purpose here was to highlight that Dr. Govindarajan sought to recreate
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`the experiment described in the Malhotra Declaration; not to establish the truth of
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`the statements in the Malhotra Declaration itself. Rather, what matters is that Dr.
`
`Govindarajan recreated the testing described therein and his testing confirmed the
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`deficiencies described in the Malhotra Declaration. This is not hearsay.
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`Patent Owner’s experts likewise did not rely on the Malhotra Declaration for
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`the truth of the matter. The sole citation to the Malhotra Declaration in Dr. Carr’s
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`- 4 -
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`IPR2017-00807
`Patent No. 8,168,620
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`Second Declaration is for purposes of claim construction and thus does not rely on
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`the declaration for its truth. See CIP2147, ¶27. Similarly, Dr. Smyth cites to the
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`Malhotra Declaration for: (1) intrinsic supporting evidence for claim construction
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`(CIP2150, ¶23); (2) for what Ms. Malhotra said in her declaration (id., ¶¶31, 36);
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`or (3) discussions of the Govindarajan and Herpin testing, which recreated and
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`confirmed what was stated in the Malhotra Declaration. See id., ¶¶36-38, 42. None
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`of these discussions rely on the facts underlying the Malhotra Declaration, and thus
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`they do not constitute hearsay.1
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`1.
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`Even Petitioner’s cited authority confirms that the
`Malhotra Declaration is admissible for claim construction
`purposes.
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`First and foremost, Petitioner cannot credibly argue that the Malhotra
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`1 Even assuming the Malhotra Declaration was hearsay, it is well settled that
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`experts may rely on hearsay evidence provided that the evidence is of a type
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`reasonably relied on by experts in the field. Fed. R. Evid. 703. Notably, the
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`Malhotra Declaration contains substantial formulation information, including
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`manufacturing steps, ingredient concentrations, and formulation details—precisely
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`the kind of information that an expert would rely on to ascertain how a formulation
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`was made and to determine whether or not a given formulation is suitable for
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`administration to a patient.
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`- 5 -
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`IPR2017-00807
`Patent No. 8,168,620
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`Declaration is inadmissible for claim construction because it is a part of the
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`permanent part of the prosecution history, and where the Applicant made both
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`claim amendments and arguments for patentability expressly citing to it. The
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`Malhotra Declaration is highly relevant to claim construction because it illustrates
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`how Patent Owner and the Examiner understood the terms of the patent claims
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`confirming their patentability and leading to their issuance. See Phillips v. AWH
`
`Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005) (en banc) (“the prosecution history
`
`provides evidence of how the PTO and the inventor understood the patent.”).
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`In this regard, Patent Owner’s reliance on the Malhotra Declaration is
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`analogous to the evidence discussed in REG Synthetic Fuels, LLC v. Neste Oil Oyj,
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`841 F.3d 954 (Fed. Cir. 2016), upon which Petitioner relies. See Paper 41, 2. In
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`that case, the Federal Circuit found that the Board erred by excluding evidence
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`relevant to what the inventor believed he had invented. Id. at 964. The Federal
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`Circuit explained that “a statement was not hearsay if the communication (as
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`opposed to the truth) had legal significance.” Id. (internal quotations and
`
`amendments omitted). That case is dispositive, and compels denial of Petitioner’s
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`motion to exclude. Here, Patent Owner’s arguments during prosecution, which
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`were premised on the Malhotra Declaration, have legal significance for claim
`
`construction without regard to the truth of the matter because they evidence how
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`both the inventor (Ms. Malhotra) and the Examiner understood the claims.
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`- 6 -
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`IPR2017-00807
`Patent No. 8,168,620
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`2.
`
`Petitioner’s cited authority also confirms that the Malhotra
`Declaration is admissible for purposes of comparing
`unopposed testimony to Ms. Malhotra’s findings.
`
`Second, Petitioner cannot plausibly argue that a comparison of later-
`
`conducted testing of Cramer Example III, conducted by Drs. Govindarajan and
`
`Herpin and not subject to a motion to exclude, to Ms. Malhotra’s statements during
`
`prosecution in any way relies on the truth of Ms. Malhotra’s statements. Here, the
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`relevant facts are (1) the unopposed data from Drs. Herpin and Govindarajan; (2)
`
`the statements in the Malhotra Declaration, as opposed to their truth; and (3) the
`
`consistency between the data derived from Drs. Herpin and Govindarajan on the
`
`one hand, and Ms. Malhotra’s statements on the other. The truth of Ms. Malhotra’s
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`statements is not the focus of this comparison.
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`Patent Owner’s reliance on the Malhotra Declaration here once again
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`satisfies Neste Oil’s “legal significance” test. The comparisons between Ms.
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`Malhotra’s statements and the data of Drs. Govindarajan and Herpin do not require
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`proof of the truth of Ms. Malhotra’s statements. Rather, they evidence (1) that the
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`Malhotra Declaration attempts to demonstrate that the formulations claimed in the
`
`’620 patent were “nasal spray” formulations that were “suitable for nasal
`
`administration” while the prior art formulations were not; and (2) later-conducted
`
`testing by two separate scientists confirmed that the formulations disclosed in the
`
`prior art did not satisfy the “nasal spray” or “suitable for nasal administration”
`
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`- 7 -
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`IPR2017-00807
`Patent No. 8,168,620
`
`limitations of the ’620 patent’s claims. In other words, Patent Owner relied on Ms.
`
`Malhotra’s statements only to show the meaning of the claims and to compare
`
`unopposed testing to her statements to show that none of the testing met the
`
`meaning she ascribed to the terms “nasal spray” and “suitable for nasal
`
`administration.”
`
`B.
`
`
`
`Even if the Malhotra Declaration is Hearsay, it is admissible
`under the Fed. R. Evid. 803(15) and 807 Exceptions.
`
`Even assuming the Malhotra Declaration qualifies as hearsay, the
`
`declaration is admissible under at least two exceptions: Fed. R. Evid. 803 and Fed.
`
`R. Evid. 807(a). First, Rule 803(15) excepts from hearsay statements in documents
`
`that purport to establish or affect a property interest “if the matter stated was
`
`relevant to the document’s purpose.” The Malhotra Declaration falls squarely
`
`within this exception. First, it is well-established that patents are property. See,
`
`e.g., 35 U.S.C. § 261 (“patents shall have the attributes of personal property.”);
`
`Transparent-Wrap Mach. Corp. v. Stokes & Smith Co., 329 U.S. 637, 643 (1947)
`
`(patents are “of the same dignity as any other property.”); see also Oil States
`
`Energy Servs., LLC v. Greene’s Energy Group, LLC, 584 U.S. ___, slip op. at 17
`
`(Apr. 24, 2018). And here, Ms. Malhotra’s statements were made in a document
`
`(the prosecution history, EX1002) that affects an interest in property, namely, the
`
`scope of Patent Owner’s patent (property) right. There are no dealings inconsistent
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`- 8 -
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`IPR2017-00807
`Patent No. 8,168,620
`
`with the truth of the statement; in fact, all of the relevant later statements (i.e., the
`
`testing by Drs. Herpin and Govindarajan) confirm Ms. Malhotra’s statements.
`
`Accordingly, the Malhotra Declaration satisfies each requirement of Rule 803(15).
`
`Second, the so-called residual exception, Fed. R. Evid. 807, also excepts
`
`from hearsay any statement which: (1) has circumstantial guarantees of
`
`trustworthiness; (2) is offered as evidence of a material fact; (3) is more probative
`
`on the point than any other evidence that can be obtained; and (4) the admission of
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`which will best serve the purposes of the rules and the interests of justice.
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`Subsection (b) further provides that the statement is admissible “only if, before the
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`trial or hearing, the proponent gives an adverse party reasonable notice of the
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`intent to offer the statement and its particulars, including the declarant’s name and
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`address, so that the party has a fair opportunity to meet it.”
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`The Malhotra Declaration meets each of these requirements. First, it has
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`three separate circumstantial guarantees of trustworthiness. Ms. Malhotra’s
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`declaration contains an oath and was submitted to a federal agency, see, e.g.,
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`EX1002, 287, and the substance of her statement was later confirmed by the testing
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`of each of Drs. Govindarajan and Herpin. See CIP2030, CIP2029. Second, the
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`Malhotra Declaration, along with the prosecution arguments based on it, are
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`evidence of a material fact in this case: that the inventors defined the claim terms
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`“nasal spray” and “suitable for nasal administration” to require operability—a
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`- 9 -
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`IPR2017-00807
`Patent No. 8,168,620
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`characteristic missing from the prior-art Cramer Example III and Segal references.
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`Third, the Malhotra Declaration is the most probative evidence on the claim
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`construction point because Patent Owner’s arguments during prosecution were
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`based upon the statements in that declaration. Finally, the admission of this
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`evidence will serve both the purpose of the Federal Rules of Evidence and the
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`interests of justice by ensuring that the Board has a complete record and also by
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`ensuring that Petitioner cannot escape the fact that its cited prior art does not teach
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`the “nasal spray” or “suitable for nasal administration” limitations of each
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`challenged claim. And finally, the notice provision of subsection (b) is satisfied
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`because Petitioner itself brought the Malhotra Declaration into the case, and
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`moreover because Ms. Malhotra’s address appears on the very next page of the
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`prosecution history. See EX1002, 288. Notably, Patent Owner also relied on the
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`Malhotra Declaration in its Patent Owner’s Preliminary Response before trial was
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`instituted, so Petitioner cannot legitimately claim any surprise at this stage.
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`III. CONCLUSION
`The Board should deny Petitioner’s motion to exclude the Malhotra
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`Declaration. Petitioner has no legitimate basis to seek its exclusion, but instead
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`hopes to remove a key piece of claim construction evidence from this case because
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`it has not shown in the Petition or Reply that the art taught how to achieve a fixed-
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`dose antihistamine/steroid “nasal spray” combination formulation that is “suitable
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`- 10 -
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`
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`for nasal administration.”
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`
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`IPR2017-00807
`Patent No. 8,168,620
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`Date: April 24, 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
`
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`- 11 -
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`
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Patent Owner’s
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`Opposition to Petitioner’s Motion to Exclude Evidence” was served in its entirety
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`on April 24, 2018, upon the following parties via electronic mail upon the
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`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 24, 2018
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`
`
`
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