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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC.
`Petitioner
`
`v.
`
`QUALICAPS CO. LTD.
`Patent Owner
`
`Case IPR2017-00203
`Patent No. 6,649,180
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S RESPONSE TO
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`EXHIBIT LIST
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`Exhibit No. Description
`1001
`United States Patent No. 6,649,180
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
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`1010
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`1011
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`1012
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`1013
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`1014
`
`Complaint, Warner Chilcott (US), LLC et al. v. Mylan
`Pharmaceuticals, Inc., et al., Case No. 2:15-cv-01740-JRG-
`RSP (E.D. Texas)
`
`Proof of Service of Complaint, Case No. 2:15-cv-01740-JRG-
`RSP (E.D. Texas)
`
`United States Patent No. 5,756,123 (“Yamamoto”)
`
`The Japanese Pharmacopeia (The Society of Japanese
`Pharmacopeia, 13th ed. 1996) (“Japanese Pharmacopeia”)
`
`United States Patent No. 3,493,407 (“Greminger”)
`
`21 C.F.R. § 172.874 (1998)
`
`National Formulary (American Pharmaceutical Association,
`12th ed. 1965)
`
`Handbook of Pharmaceutical Excipients (1986)
`
`File History of United States Patent No. 6,649,180
`
`Expert Declaration of Arthur H. Kibbe
`
`Shin-Etsu Chemical Co., Ltd. PHARMACOAT Technical
`Information Shin-Etsu Chemical Co., Ltd. TC-5 Technical
`Information
`
`Chichester, C.O., E.M. Mrak, and G.F. Stewart, “Utilization of
`Synthetic Gums in the Food Industry,” Advances in Food
`Research, Volume 12, Technical Center, General Foods
`Corporation, Tarrytown, N.Y., 1963.
`
`Deposition Transcript of Jason T. McConville, Ph.D., Case No.
`2:15-cv-1471-JRG-RSP (E.D. Tex.), July 8, 2016
`
`1
`
`
`
`
`
`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
`
`1026
`
`1027
`
`Declaration Of Mr. Jonathan D. Olinger In Support Of
`Petitioner’s Unopposed Motion For Pro Hac Vice Admission
`Under 37 C.F.R. § 42.10(C)
`United States Patent No. 5,756,123 (“Yamamoto”) (Served but
`not filed, June 14, 2017)
`
`The Japanese Pharmacopeia (The Society of Japanese
`Pharmacopeia, 13th ed. 1996) (“Japanese Pharmacopeia”)
`(Served but not filed, June 14, 2017)
`
`21 C.F.R. § 172.874 (1998) (Served but not filed, June 14,
`2017)
`
`National Formulary (American Pharmaceutical Association,
`12th ed. 1965) (Served but not filed, June 14, 2017)
`
`Handbook of Pharmaceutical Excipients (1986) (Served but not
`filed, August 11, 2017)
`
`Email exchange between counsel July 25, 2017 (Served but not
`filed, August 11, 2017)
`
`Email exchange between counsel August 4, 2017 (Served but
`not filed, August 11, 2017)
`
`Email exchange between counsel August 10, 2017 (Served but
`not filed, August 11, 2017)
`Mylan Pharmaceuticals Inc., Mylan Laboratories Limited, and
`Mylan Inc.’s Amended Notice Of Videotaped Deposition Of
`Representative(s) Of Qualicaps Co., Ltd. Pursuant To Federal
`Rule Of Civil Procedure 30(B)(6) (Served but not filed, August
`11, 2017)
`Email exchange between counsel March 21, 2017 (Served but
`not filed, August 11, 2017)
`
`Email exchange between counsel April 25, 2017 (Served but not
`filed, August 11, 2017)
`
`Amended Docket Control Order, Warner Chilcott (US), LLC v.
`Teva Pharmaceuticals USA, Inc., No. 2:15-cv-1471 (E.D. Tex.
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`2
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`
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`1028
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`1029
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`May 19, 2017), ECF No. 165 (Served but not filed, August 11,
`2017)
`
`Deposition Transcript of Jason T. McConville, Ph.D., August
`17, 2017
`
`Reply Expert Declaration of Arthur H. Kibbe
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`3
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`
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`I.
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`
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`Introduction
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`Petitioner provides the following Response to Patent Owner’s Motion to
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`Exclude certain evidence from the proceedings.
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`II. Argument
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`A.
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`Exhibit 1011 – Dr. Kibbe’s Declaration
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`Patent Owner’s entire argument for excluding Ex. 1011 is based on the
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`distorted presumption that Dr. Kibbe copied the Petition instead of the reality that
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`Dr. Kibbe prepared his declaration with the help of counsel for Petitioner, who,
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`needing very little argument to present a strong case of obviousness, made minimal
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`changes to Dr. Kibbe’s work product in drafting the Petition. Dr. Kibbe confirmed
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`this in his deposition and reply declaration.
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`
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`As Petitioner explained in addressing Patent Owner’s character attack on Dr.
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`Kibbe in its Reply, Dr. Kibbe was asked if he had “a copy of the petition while he
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`was working on making changes and edits” to his declaration and he responded, “I
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`don’t think so.” Ex. 2029, 25:21-24. Dr. Kibbe confirmed this in his declaration
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`under penalty of perjury. Ex. 1029, ¶ 3. Patent Owner has no evidence that his
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`original declaration constitutes the hearsay it suggests is excludable. And the cases
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`4
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`Patent Owner cites to suggest the similarity between the declaration and the
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`Petition here automatically makes the declaration hearsay are inapposite.
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`
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`Those cases are from district court proceedings and ignore two guiding
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`principles of Inter Partes Review practice that differ from district court litigation.
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`First, the Board has repeatedly stated that how declarations are prepared is “a
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`waste of time, both for the witness and the Board.” Square, Inc. v. Think
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`Computer Corp., No. CBM2014-00159, Paper No. 47 at pp. 26-27, 2015 WL
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`7695141, at *13 (PTAB Nov. 27, 2015); see also Seoul Semiconductor Co. v.
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`Enplas Corp., 2015 WL 6083576, *3 (PTAB Oct. 15, 2015). Second, the PTAB
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`consistently instructs the bar to not put excess information in declarations that is
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`not addressed in the petition and to not put forth arguments in the petition that lack
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`support in a declaration. See Amazon.com v. Broadcom Corp., 2017 WL 4476704,
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`*2 (Oct. 6, 2017) (“A declaration in support of petition may be proffered as
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`evidence in support of an argument made in the petition. Such a declaration,
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`however, is not a vehicle through which a petitioner may make an argument that
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`should have been made in the petition.”); see also Cisco Sys., Inc. v. C-Cation
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`Techs., LLC, 2014 WL 12580243 (PTAB Aug. 29, 2014) (“This practice of citing
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`the Declaration to support conclusory statements that are not otherwise supported
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`in the Petition also amounts to incorporation by reference.”).
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`5
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`
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`Patent Owner has no evidence to support its claims that the creation of Dr.
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`Kibbe’s declaration mirrored the fact patterns of the cases it cites. Thus, there is
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`no presumption of hearsay. That Dr. Kibbe reviewed the final Petition after
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`preparing his Declaration (Ex. 1011, ¶ 48) is of no moment. This motion should be
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`denied.
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`
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`B.
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`Exhibit 1012 – Shin-Etsu Website Product Descriptions
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`Exhibit 1012 is self-authenticating as bearing a trade inscription for a
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`consumer product. Federal Rule of Evidence 901(b)(4) states evidence can be
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`authenticated by “[t]he appearance, contents, substance, internal patterns, or other
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`distinctive characteristics of the item, taken together with all the circumstances.”
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`Further, Rule 902(7) renders materials bearing trade inscriptions that “indicat[e]
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`origin, ownership, or control” self-authenticating. The committee notes explain
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`why: “Several factors justify dispensing with preliminary proof of genuineness of
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`commercial and mercantile labels and the like. The risk of forgery is minimal.
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`Trademark infringement involves serious penalties. Great efforts are devoted to
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`inducing the public to buy in reliance on brand names, and substantial protection is
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`given them.” (emphasis added).
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`
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`Cases have used these provisions in concert to efficiently dispense with
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`unnecessary authentication steps because the risk of inaccuracy is minimal:
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`“Although all of the examples contained in Rule 902 could be applicable to
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`6
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`computerized records, three in particular have been recognized by the courts to
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`authenticate electronic evidence: 902(5) (official publications); 902(7) (trade
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`inscriptions); and 902(11) (domestic records of regularly conducted activity).”
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`Lorraine v. Markel Am. Ins. Co., 241 F.R.D. 534, 551 (D. Md. 2007). There, the
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`court noted that “[u]nder Rule 902(7), labels or tags affixed in the course of
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`business require no authentication. Business e-mails often contain information
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`showing the origin of the transmission and identifying the employer-company.
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`The identification marker alone may be sufficient to authenticate an e-mail under
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`Rule 902(7).” Id. at 551-552 (quoting Weinstein at § 900.07[3][c]). Indeed, courts
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`have held that materials presented on company letterhead bearing the company’s
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`identifiers are self-authenticating under Rule 902(7). See Savage v. Federal
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`Express Corp., 856 F.3d 440, 451 n. 2 (6th Cir. 2017). “[A] conclusory
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`foundational challenge made without any ‘sound reason to doubt’ a document’s
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`authenticity . . . may be disregarded . . . .” Strabala v. Zhang, 318 F.R.D. 81, 94
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`(N.D. Ill. 2016) (quoting U.S. v. Cejas, 761 F.3d 717, 724 (7th Cir. 2014)).
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`
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`There is no real challenge to the document’s authenticity put forward by
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`Patent Owner, nor can there be. Patent Owner’s own expert admitted that the
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`Yamamoto patent (Ex. 1004), which is the primary reference for invalidity,
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`confirms that the viscosities for the Shin-Etsu brand HPMCs at issue in this case
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`match the advertised viscosities on the Shin-Etsu branded webpage (Ex. 1012).
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`7
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`
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`Ex. 1028, 170:5-174:5. There is sufficient basis to disregard Patent Owner’s
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`authenticity objection especially when Patent Owner does not even challenge the
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`content.
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`
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`Patent Owner also argues Ex. 1012 is hearsay. To constitute hearsay, the
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`alleged “statement” must be offered for the truth of the matter asserted. Fed. R.
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`Evid. 801(c)(2). As Patent Owner’s Motion to Exclude notes, the purpose for Ex.
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`1012 is to link the generic name used in Ex. 1007 with its tradename. Mot. at 3.
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`Petitioner is not relying on the document to show that what was printed before the
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`critical date, the date of any piece of prior art, or the specifics of the corroborating
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`viscosities. In other words, Ex. 1012 is not being offered as a truth, but rather as
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`foundation for the argument presented in the Petition at pages 30-31. Thus, Ex.
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`1012 is not hearsay but is relevant. . Patent Owner does not dispute the link that
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`the Petition draws at pages 30-31 so its argument that the document that helps
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`establish that link is irrelevant is smoke with no fire.
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`C.
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`Exhibit 1028 – Portions of Patent Owner’s Expert Deposition
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`Patent Owner’s objections to these portions of testimony appear to be a
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`preservation of its arguments that Petitioner must have addressed the Patent
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`Owner’s failure to produce evidence of nexus at the petition stage before Patent
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`Owner made its arguments for nexus in these proceedings. The substantive
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`arguments for why this is incorrect are contained in the supplemental papers the
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`8
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`Board requested and have already been provided. Paper No. 46. Each of these
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`areas are directly responsive to arguments, even if Patent Owner merely tried to
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`presume nexus without producing any evidence, and thus those objections (and
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`these) are meritless.
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`D.
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`Exhibit 1029 – Paragraphs of Dr. Kibbe’s Reply Declaration
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`Patent Owner objects to various paragraphs as being outside the scope of
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`Reply, an issue addressed in Paper No. 46. Patent Owner Motion, p. 7-8 (objection
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`to Paragraphs 5-7, 8, and 9-12 on this basis).
`
`
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`Patent Owner then objects to Paragraph 8 as not being cited in the Reply
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`brief. Patent Owner cites no rule or procedure for this type of exclusion. As is
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`clear, Paragraph 8 of Dr. Kibbe’s Reply Declaration is a conclusion statement to
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`Paragraphs 5-7 relating to the lack of evidence as to suggesting that the inventors
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`solved a problem in the manner Patent Owner theorize and contend demonstrate
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`unexpected results.
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`
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`Patent Owner then objects to Dr. Kibbe’s testimony as not being evidence
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`because it does not cite other evidence in addition to his opinion of what the person
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`of skill in the art would have known or understood. Patent Owner Motion, p. 8-9.
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`For example, Patent Owner argues that Paragraph 17 of Dr. Kibbe’s Reply
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`Declaration cites no evidence to support that viscosity was known to be important.
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`But Dr. Kibbe does cite evidence. He cites the Methocel Catalog that Patent
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`9
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`
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`Owner relies so heavily on (Kibbe Reply Dec. ¶ 17 (“Specifically, at Ex. 2017 at
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`45/86-50/86 the Catalog discusses the impact on viscosity.”)) and Yamamoto (Id.
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`(“Yamamoto explains how viscosity is relevant to the use of gels to make films for
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`capsules)). Patent Owner then argues that no evidence is cited for the proposition
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`that “the Methocel Catalog expressly describes predictably blending HPMC to
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`obtain desire[d] viscosity.” Motion at 5. The same section of Ex. 2017 that Dr.
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`Kibbe cites two sentences earlier contains the table showing predictable blending.
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`Ex. 2017 at 48/86.
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`
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`Patent Owner then objects to Paragraph 20 because there is allegedly no
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`support in Dr. Kibbe’s Declaration for the routineness of mixing two or more types
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`of HPMC. Motion at 9. But Dr. Kibbe cites the Yamamoto patent (Ex. 1004 at
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`Cols. 3 and 4) that describe blending various types of HPMC with no further
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`explanation. And Dr. Kibbe then opines, as is his province as an unchallenged
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`expert -- Patent Owner has not challenged Dr. Kibbe’s expertise and Patent
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`Owner’s ignorance that Dr. Kibbe relies on his “own experience and expertise in
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`the relevant technologies and systems that were already in use” (Ex. 1011, ¶ 5) –
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`that “[n]o further explanation is needed because . . . [it] is a matter of routine
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`benchwork . . . .” Ex. 1029, ¶ 20.
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`
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`Accordingly, there is no basis to exclude these Paragraphs of Dr. Kibbe’s
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`Reply Declaration.
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`10
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`E.
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`Exs. 2064, 2067-2072 – Tanjoh Deposition and Documents
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`Patent Owner’s objection is difficult to follow. It appears that because
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`Petitioner cited the references “in passing . . . but does not cite any material from
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`these exhibits” they must be excluded. This ignores the usefulness of these
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`exhibits and why there is no specific material within the documents to cite to.
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`Patent Owner holds the burden of producing evidence to support its claim for
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`nexus and secondary considerations. And while Petitioner holds the ultimate
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`burden of persuasion, part of fulfilling that burden is the critique on the strength of
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`the nexus claim based on the absence of evidence. Exhibits 2064 and 2067-2072
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`are the technical documents created by the inventors that are the alleged basis for
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`the claimed invention. In those technical documents, there is no evidence that
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`supports Patent Owner’s unsupported claim of presumed nexus. Thus, the lack of
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`evidence in those documents to supportPatent Owner’s claims is precisely why the
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`documents are relevant and responsive to (1) Petitioner’s challenge to secondary
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`considerations began in the Petition and (2) directly responsive to Patent Owner’s
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`unsupportable nexus claim.
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`Dated: November 10, 2017
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`
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`Respectfully submitted,
`
`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
`
`
`
`11
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`
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`Lead Counsel
`Mitchell G. Stockwell
`Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`
`
`
`
`Back-Up Counsel
`D. Clay Holloway
`Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`12
`
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`
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on November 10, 2017 a copy of the
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`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Response to Patent Owner’s
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`Motion to Exclude Evidence was served by electronic mail by agreement of the
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`parties on the following counsel of record for Patent Owner.
`
`Jessica L. Parezo (jparezo@cov.com)
`Andrea G. Reister( areister@cov.com)
`Scott E. Kamholz (skamholz@cov.com)
`Michael N. Kennedy (mkennedy@cov.com)
`Megan P. Keane (mkeane@cov.com)
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`
`MaryAnne Armstrong (maa@bskb.com)
`Lynde F. Herzbach (lynde.herzbach@bskb.com)
`Birch, Stewart, Kolasch & Birch, LLP
`8110 Gatehouse Road, Suite 100 East
`Falls Church, VA 22042
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`Dated: November 10, 2017
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`
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`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
`
`
`13
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`
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