Trials@uspto.gov
`571-272-7822
`
`Paper 81
`Entered: June 6, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ACRUX DDS PTY LTD., ACRUX LIMITED, and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`v.
`KAKEN PHARMACEUTICAL CO., LTD. and VALEANT
`PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`DECISION
`Motions to Strike and to Exclude
`37 C.F.R. § 42.64
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`571-272-7822
`
`Paper 81
`Entered: June 6, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ACRUX DDS PTY LTD., ACRUX LIMITED, and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`v.
`KAKEN PHARMACEUTICAL CO., LTD. and VALEANT
`PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`DECISION
`Motions to Strike and to Exclude
`37 C.F.R. § 42.64
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`
`IPR2017-00190
`Patent 7,214,506 B2
`
`
`Kaken Pharmaceutical Co., Ltd. and Valeant Pharmaceuticals
`International, Inc. (collectively, “Patent Owner”) filed a Motion to Strike,2
`see Paper 46, to which Acrux DDS PTY Ltd. and Acrux Limited
`(collectively, “Petitioner”) filed an opposition, see Paper 48. Patent Owner
`also filed a Motion to Exclude, see Papers 58, to which Petitioner filed an
`opposition, see Paper 63, and Patent Owner filed a reply, see Paper 76.
`Petitioner filed a Motion to Exclude, see Paper 51, to which Patent Owner
`filed an opposition, see Paper 70, and Petitioner filed a reply, see Paper 75.
`
`Patent Owner’s Motion to Strike
`Patent Owner seeks to strike significant portions of three declarations,
`
`Exhibits 1509–1511, which Petitioner submitted with its Reply, and portions
`of Petitioner’s Reply that Patent Owner contends presents new legal theories
`in violation of 37 C.F.R. § 42.23(b). Paper 46, 4–12. Patent Owner
`suggests that the three declarations are an attempt by Petitioner to
`circumvent the word limit for its reply “by pushing most of its evidence and
`argument into declarations that are not cited with particularity. Rather,
`Petitioner [improperly] incorporates by reference into the Reply large
`sections of its declarations without explaining their specific relevance.” Id.
`at 2. Patent Owner also asserts that Petitioner uses these declarations as the
`“sole vehicle” for introducing many of the new exhibits that Patent Owner
`seeks to have struck. Id. Patent Owner also seeks to strike Exhibits 1512
`and 1514–1660 as either not relied upon by Petitioner or only cited in “bulk
`form.” Id. at 9–12. Patent Owner provides a detailed analysis of which
`
`
`2 We authorized Patent Owner to file a motion to strike. See Paper 43, 3.
`2
`
`
`
`
`
`IPR2017-00190
`Patent 7,214,506 B2
`
`paragraphs and exhibits should be struck as either not relied upon by
`Petitioner in its Reply or were cited “in bulk.” Id. at 13–15.
`
`Concerning Petitioner’s alleged new theory of obviousness, Patent
`Owner states:
`
`Petitioner argues in its Reply that earlier Kaken patents
`(Exs. 1007 and 1505) are genus patents covering the use [of]
`efinaconazole in treating mycosis. Petitioner concludes for the
`first time in the Reply that it would be obvious to use
`efinaconazole in treating a species of mycosis—
`onychomycosis—based on the generic disclosure of treating
`any type of mycosis in Exs. 1007 and 1505. Petitioner
`concludes that these earlier patents allegedly undermine
`evidence of commercial success for Jublia®, the marketed
`topical efinaconazole product for treating onychomycosis (see
`Reply at p. 9).
`Paper 46, 11.
`Petitioner responds that the three additional expert declarations are
`properly supported by documentary evidence and “are directly responsive to
`arguments raised by [Patent Owner’s] experts and in the [Patent Owner
`Response].” Paper 48, 1. Petitioner details how its use of the declarations
`and exhibits in its Reply constitutes appropriate rebuttal evidence and its
`Reply contains no new legal theory. See id. at 3–15. Specifically, Petitioner
`states that its rebuttal evidence at issue here includes (1) publications by
`PO’s expert, Dr. Elewski, that Petitioner alleges contradict her declaration
`testimony (Exs. 1512 & 1518); (2) Petitioner’s experts’ rebuttal of new
`issues introduced by Dr. Elewski’s declaration (Exs. 1509–1511), and (3)
`evidence rebutting Patent Owner’s secondary considerations evidence (Exs.
`1515–1517, 1523–1660). Paper 48, 2.
`Petitioner asserts that it made no new argument to support its
`obviousness grounds because the argument in questions merely “observes
`3
`
`
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`IPR2017-00190
`Patent 7,214,506 B2
`
`the PO’s prior efinaconazole patents recite the same preferred amount of
`antifungal agent as the ’506 patent and the cited art: JP ’639,” a fact that
`Petitioner notes was reflected in the Decision on Instituted. Paper 48, 14,
`(citing Instit. Dec. 9, 16). Finally, Petitioner asserts that its assertions
`regarding to blocking patents is appropriate rebuttal to Patent Owner’s
`proffer of secondary considerations evidence. Id. at 14–15.
`Our rules mandate that a “reply may only respond to arguments raised
`in the corresponding opposition or patent owner response.” 37 C.F.R.
`§ 42.23(b). We agree with Petitioner that its three rebuttal declarations and
`the exhibits that are cited as support in those declarations are appropriate
`rebuttal to the Patent Owner Response. See Paper 48, 11–14 (explaining
`how Petitioner’s experts relied on the challenged exhibits); 37 C.F.R.
`§ 42.65 (stating “[e]xpert testimony that does not disclose the underlying
`facts or data on which the opinion is based is entitled to little or no
`weight”).3 We also agree that Petitioner raises no new legal theory in its
`Reply.
`In reviewing the declarations of Dr. Walters and Dr. Weinberg at
`issue in Patent Owner’s Motion to Strike, both declarants were responding to
`specific assertions made by Dr. Elewski cited as support in the Patent Owner
`Response. See generally Exs. 1509, 1510. For instance, Dr. Walters
`addresses Dr. Elewski’s claim construction and her characterization of the
`teachings of the asserted art. See, e.g., Ex. 1509 ¶¶ 7–71. Dr. Weinberg also
`addresses Dr. Elewski’s characterization of the teachings of the asserted art.
`See, e.g., Ex. 1510 ¶¶ 31–45. In his declaration, Mr. Staines addressed
`
`
`3 Petitioner agrees to withdraw Exhibit 1635 as it was inadvertently
`included. See Paper 48, 11 n.3.
`
`
`
`4
`
`
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`IPR2017-00190
`Patent 7,214,506 B2
`
`Patent Owner’s arguments concerning secondary considerations. See
`generally Ex. 1511. As such, these declarations, along with the evidentiary
`exhibits cited in support, are appropriate rebuttal evidence.
`That is not to say, however, that we will review the declarations and
`exhibits cited therein independent of Petitioner’s reliance on them in its
`Reply. As Petitioner admits “[t]o the extent that both parties’ expert
`declarations contain information not expressly cited, the Board is, of course,
`free to ascribe whatever weight it deems appropriate.” Paper 48, 2.
`We also agree with Petitioner that it has not presented a new legal
`theory in its Reply. Petitioner’s arguments were in direct response to Patent
`Owner’s assertions as to how one of skill in the art would have viewed the
`use of efinaconazole to treat onychomycosis. See Reply 3 (responding to
`PO’s arguments that efinaconazole was a ‘breakthrough’ and that prior art
`topical agents did not work); id. at 9 (citing two of Patent Owner’s patents to
`validate preferred amounts of efinaconazole).
`Therefore, we deny Patent Owner’s Motion to Strike.
`
`Petitioner’s Motion to Exclude
`Petitioner moves to exclude paragraph 9–11 and 20–30 of the
`Declaration of Vincent A. Thomas, CPA, CVA, CFF, ABV (Exhibit 2028)
`and supporting evidence exhibits, Exhibits 2093, 2095, 2098, and 2099.
`Paper 51, 1; see Paper 75. Petitioner moves to exclude these paragraphs of
`Mr. Thomas’ Declaration under Federal Rule of Evidence 702 as conclusory
`and unsupported by sufficient facts or data. Id. Petitioner moves to exclude
`the exhibits because they are “incomplete as providing partial information
`preventing Petitioners from testing the sufficiency of the information
`
`
`
`5
`
`
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`IPR2017-00190
`Patent 7,214,506 B2
`
`provided, hearsay, as lacking authentication, and Exhibits 2093 and 2095 as
`irrelevant.” Paper 51, 10.
`Petitioner assigns several errors to Mr. Thomas’ methodology in
`determining the commercial success of Jublia®. First, Petitioner asserts that
`Mr. Thomas relied on gross sales without considering costs associated with
`those sales such as marketing and advertising costs or the actual realized
`selling price of Jublia®. Id. at 1, 3–4. Second, Mr. Thomas, Petitioner
`asserts, did not consider factors that drove total prescription numbers for
`Jublia® in determining that it shifted the market for onychomycosis
`treatment from oral to topical therapy. Id. at 1–2, 7–8. Petitioner complains
`that Mr. Thomas did not supervise the collection of the underlying data upon
`which he relied, and did not consider the effect of blocking patents on his
`determination. Id. at 2, 4–7.
`Patent Owner asserts that Petitioner’s complaints about Mr. Thomas’
`declaratory evidence “boils down to an argument over how to best measure
`commercial success—an issue of weight not admissibility.” Paper 70, 1.
`Patent Owner also asserts that none of the objections to contested exhibits
`has merit because “they focus on exhibits Mr. Thomas prepared (Exs. 2098
`and 2099) from spreadsheets provided by Kaken and Valeant (Exs. 2095 and
`2093) that were in turn derived from industry-standard commercial sources:
`IMS Health and Symphony Health, respectively.” Id. at 11 (citing Ex. 1662
`¶¶ 5–6). Patent Owner asserts that Exhibits 2093 and 2095 are authentic and
`qualify for the business record exception to the hearsay rule. Id. at 13–14.
`Patent Owner provided declarations from Mr. Shupenus and Mr. Miyakawa
`that address the authenticity and hearsay objections for Exhibits 2093 and
`2095. Id. (citing Exs. 1661, 1664).
`
`
`
`6
`
`
`
`IPR2017-00190
`Patent 7,214,506 B2
`
`
`As the moving party, Petitioner bears the burden of proof to establish
`that it is entitled to the requested relief: the exclusion of the evidence as
`inadmissible under the Federal Rules of Evidence (“FRE”). See 37 C.F.R.
`§§ 42.20(c), 42,64(a). Here, Petitioner challenges Mr. Thomas’ testimony
`under Federal Rule of Evidence 702(b) asserting that the testimony is not
`based on sufficient facts or data. See Fed. R. Evid 702(b). In essence,
`Petitioner asserts that Mr. Thomas did not perform his analysis correctly
`because he did not rely on the correct evidence concerning sales of Jublia®,
`but he did provide the underlying data on which he relied. We agree with
`Patent Owner that Petitioner’s arguments really test the sufficiency of the
`evidence provided by Mr. Thomas and do not persuade us to exclude such
`evidence. See 37 C.F.R. 42.65(a). We also agree with Patent Owner that
`the declarations provided to explain the data in Exhibits 2093 and 2095 on
`which Mr. Thomas relied is sufficient for authentication and admissibility of
`the evidence. See Exs. 1661 (supporting Ex. 2093), 1664 (supporting
`Exhibit 2095).
`We agree with Patent Owner that Federal Rule of Evidence 106 on
`which Petitioner’s relies to exclude the two exhibits is misplaced. See Paper
`28, 12. The documents are not an incomplete writing that Petitioner is
`seeking to complete; Petitioner is really seeking the underlying data from
`IMS Health or Symphony Health databases to determine the veracity of the
`content of Exhibits 2093 and 2095. See Paper 70, 11–12. We agree that
`Petitioner waived this objection.
`Therefore, we deny Petitioner’s Motion to Exclude.
`
`
`
`7
`
`
`
`IPR2017-00190
`Patent 7,214,506 B2
`
`
`Patent Owner’s Motion to Exclude
`Patent Owner moves to exclude the Ogura reference, Exhibit 1012,
`
`that Petitioner relied upon in its first three grounds on which we instituted an
`inter partes proceeding. Paper 58, 1–4. Because we determined in our Final
`Written Decision that Patent Owner was able to antedate the Ogura
`reference, we need not determine whether Ogura is admissible.
`
`Patent Owner also moves to exclude the Arika Reference, Exhibit
`1513, as unauthenticated and hearsay. Id. at 4–7. Because we do not rely on
`any teaching in Arika in our Final Written Decision, we need not decide the
`admissibility of Arika.
`
`Patent Owner also moves to exclude the following exhibits offered by
`Petitioner for lack of authenticity: 1512, 1522, 1524, 1525, 1527–1549,
`1551, 1553, 1554, 1555, 1557–1560, 1566, 1569, 1576, 1577, 1580–1585,
`1588, 1594, 1599, 1603–1605, 1607, 1609, 1613, 1617, 1619, 1621, 1623,
`1626–1629, 1632–1635, 1638–1645, 1658, and 1660. Id. at 7–9. Patent
`Owner contends that these are unauthenticated web pages. Patent Owner
`admits that “Petitioner has proffered declaration testimony that these
`exhibits are correct copies downloaded from the respective websites.” Id. at
`8. Such an admission shows that the web pages are authentic, or in other
`words, the evidence is “sufficient to support a finding that the item is what
`the proponent claims it is” as required by Federal Rule of Evidence 901(a).
`
`Patent Owner asserts, however, that these declarations are insufficient
`to prove the website’s contents. Patent Owner is making, in essence, a
`hearsay objection to the truth of the matters asserted in the web pages. It
`does not appear that Patent Owner preserved such objection. Paper 58, 8
`
`
`
`8
`
`
`
`IPR2017-00190
`Patent 7,214,506 B2
`
`(citing Paper 39, 8–10, 12, 14, 17–19 (stating objection to lack of
`authentication)).
`
`Also, Patent Owner has not shown sufficiently how each of these
`exhibits is being relied upon by Petitioner. It is unclear from Patent Owner’s
`discussion that Petitioner is relying on these webpages for the truth of the
`content of each of these exhibits, necessitating a hearsay exception. See
`Paper 58, 7–9. Thus, Patent Owner has not carried its burden to have us
`exclude these exhibits.
`
`Finally, Patent Owner seeks to exclude portions of Dr. Walters’
`Declarations, Exhibits 1005 and 1509, because he is not qualified in the
`pertinent art. Id. at 9–14. Patent Owner contends that in defining the
`relevant field for one of skill in the art, we required “experience in
`specifically treating nail infections and not just designing formulations for
`use with skin drugs.” Id. at 11. Patent Owner concludes that “[a] person of
`ordinary skill in the art, as defined by the Board, would therefore recognize
`the specialized nature of treating onychomycosis and need to have a specific
`background in treating nail and its pathologies beyond just having
`knowledge of dermatophytosis and formulations for skin more generally.”
`Id. at 11–12 (citations omitted).
`As explained in our Final Written Decision, Patent Owner’s
`arguments concerning the qualifications of one of skill in the art stems from
`an overly narrow interpretation of the claim terms “onychomycosis” and
`“nail.” See Final Written Dec. 15–17. Further, as we explain in the Final
`Written Decision, the relevant field of art is not limited to fungal infections
`of the nail plate or nail bed, but may include knowledge of fungal infections
`of the skin. Id. at 15. Further, whether Dr. Walters has hands-on experience
`
`
`
`9
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`IPR2017-00190
`Patent 7,214,506 B2
`
`with treating nail infections in a clinical or experimental setting goes to the
`weight accorded his testimony rather than its admissibility. Therefore, we
`will not exclude Dr. Walter’s testimony.
`
`ORDER
`In consideration of the foregoing, it is
`ORDERED that Patent Owner’s Motion to Strike (Paper 46) is
`denied;
`FURTHER ORDERED that Petitioner’s Motion to Exclude (Paper
`51) is denied; and
`FURTHER ORDERED that Patent Owner’s Motion to Exclude
`(Paper 58) is denied.
`
`
`
`
`
`
`
`
`10
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`
`
`IPR2017-00190
`Patent 7,214,506 B2
`
`PETITIONER:
`
`E. Anthony Figg
`Aydin H. Harston
`ROTHWELL FIGG, ERNST & MANBECK, P.C.
`effig@rothwellfigg.com
`aharston@rothwellfigg.com
`litigationparalegals@rothwellfigg.com
`
`Teresa Rea
`Shannon Lentz
`CROWELL & MORING LLP
`trea@crowell.com
`slentz@crowell.com
`
`Tyler Liu
`AGENTUM PHARMACEUTICALS, LLC
`tliu@agpharm.com
`
`
`For PATENT OWNER:
`
`John D. Livingstone
`Naoki Yoshida
`Anthony Hartman
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`John.livingstone@finnegan.com
`Nakoi.yoshida@finnegan.com
`hartmana@ffinnegan.com
`
`
`Toan P. Vo
`Valeant Pharmaceuticals North America LLC
`Toan.vo@bausch.com
`
`
`
`
`11
`
`
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