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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`
`COSMO TECHNOLOGIES LIMITED,
`Patent Owner.
`___________________
`
`
`Case IPR2017-01035
`U.S. Patent No. 9,320,716 B2
`___________________
`
`PATENT OWNER’S OBJECTIONS TO EXHIBITS
`PURSUANT TO 37 C.F.R. § 42.64
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`
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`
`
`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`10345827
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`I.
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`INTRODUCTION
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of Cosmo
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`Technologies Limited (“Patent Owner”), hereby submits the following objections to
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`certain Exhibits filed with Mylan Pharmaceuticals Inc.’s (“Petitioner”) petition for
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`inter partes review of U.S. Patent No. 9,320,716 (the “Petition”). Pursuant to 37
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`C.F.R. § 42.62, Patent Owner’s objections below apply the Federal Rules of
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`Evidence (“FRE”), among other things.
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`II. OBJECTIONS TO EVIDENCE
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`A. OBJECTIONS TO EXHIBIT 1015
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`Patent Owner hereby objects to Ex. 1015, which Petitioner alleges is the
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`“Amendment and Response to Office Action filed on April 29, 2013 in U.S. Patent
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`Appl. No. 13/617,138,” as not relevant under FRE 401 and therefore inadmissible
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`under FRE 402. Indeed, Petitioner does not even cite to this Exhibit, either in its
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`Petition or in the expert report submitted as Exhibit 1006, let alone explain how this
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`exhibit relates to the Petition. If relevant, Patent Owner further objects to this exhibit
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`under FRE 403 because whatever limited probative value it may possess (and Patent
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`Owner maintains that it has no probative value in light of Petitioner’s filings) is
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`substantially outweighed by a danger of unfair prejudice and confusing the issues.
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`B. OBJECTIONS TO EXHIBIT 1022
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`
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`Patent Owner hereby objects to Ex. 1022, which Petitioner alleges is “PCT
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`International Publication No. WO 96/36318,” as not properly authenticated under
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`FRE 901. Petitioner has produced insufficient evidence to support a finding that this
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`exhibit is what Petitioner claims it to be.
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`C. OBJECTIONS TO EXHIBIT 1024
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`Patent Owner hereby objects to Ex. 1024, which Petitioner alleges is “PCT
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`International Publication No. WO 99/39700,” as not properly authenticated under
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`FRE 901. Petitioner has produced insufficient evidence to support a finding that this
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`exhibit is what Petitioner claims it to be.
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`D. OBJECTIONS TO EXHIBIT 1025
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`Patent Owner hereby objects to Ex. 1025, which Petitioner alleges is the
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`“FDA Inactive Ingredient Guide 1996/1997,” as not properly authenticated under
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`FRE 901. Petitioner has produced insufficient evidence to support a finding that this
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`exhibit is what Petitioner claims it to be. Patent Owner further objects to this exhibit
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`as inadmissible hearsay under FRE 802 because Petitioner offers it to prove the truth
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`of the matter asserted. See, e.g., Pet. at 23-24, 33, 56. Patent Owner further objects
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`to this exhibit as not relevant under FRE 401 and therefore inadmissible under FRE
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`402. If relevant, Patent Owner objects to this exhibit under FRE 403 because its
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`probative value is substantially outweighed by a danger of unfair prejudice and
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`confusing the issues.
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`E. OBJECTIONS TO EXHIBIT 1026
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`
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`Patent Owner hereby objects to Ex. 1026, which Petitioner alleges is the
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`“Handbook of Pharmaceutical Excipients (Wade and Weller, eds., 2d ed. 1994),” as
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`not properly authenticated under FRE 901. Petitioner has produced insufficient
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`evidence to support a finding that this exhibit is what Petitioner claims it to be.
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`Patent Owner further objects to this exhibit as inadmissible hearsay under FRE 802
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`because Petitioner offers it to prove the truth of the matter asserted. See, e.g., Pet. at
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`11-12, 14, 23-24, 27, 33-36, 41, 50, 52, 56-58, 61.
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`F. OBJECTIONS TO EXHIBIT 1028
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`Patent Owner hereby objects to Ex. 1028, which Petitioner alleges is
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`“Remington: The Science and Practice of Pharmacy, Vol. 1 (1995),” as not properly
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`authenticated under FRE 901. Petitioner has produced insufficient evidence to
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`support a finding that this exhibit is what Petitioner claims it to be. Patent Owner
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`further objects to this exhibit as inadmissible hearsay under FRE 802 because
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`Petitioner offers it to prove the truth of the matter asserted. See, e.g., Pet. at 12, 23-
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`24, 26-28, 32, 58.
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`G. OBJECTIONS TO EXHIBIT 1030
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`Patent Owner hereby objects to Ex. 1030, which Petitioner alleges is
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`“Hawley’s Condensed Chemical Dictionary (John Wiley & Sons, Inc., 13th ed.
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`1997),” as not properly authenticated under FRE 901. Petitioner has produced
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`insufficient evidence to support a finding that this exhibit is what Petitioner claims it
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`to be. Patent Owner further objects to this exhibit as inadmissible hearsay under
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`
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`FRE 802 because Petitioner offers it to prove the truth of the matter asserted. See,
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`e.g., Pet. at 31, 54-55.
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`H. OBJECTIONS TO EXHIBIT 1032
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`Patent Owner hereby objects to Ex. 1032, which Petitioner alleges is the
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`“Entocort® RC Highlights of Prescribing
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`Information,” as not properly
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`authenticated under FRE 901. Petitioner has produced insufficient evidence to
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`support a finding that this exhibit is what Petitioner claims it to be. Patent Owner
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`further objects to this exhibit as inadmissible hearsay under FRE 802 because
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`Petitioner offers it to prove the truth of the matter asserted. See, e.g., Pet. at 64.
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`Patent Owner further objects to this exhibit as not relevant under FRE 401 and
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`therefore inadmissible under FRE 402. If relevant, Patent Owner objects to this
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`exhibit under FRE 403 because its probative value is substantially outweighed by a
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`danger of unfair prejudice and confusing the issues.
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`I.
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`OBJECTIONS TO EXHIBIT 1033
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`Patent Owner hereby objects to Ex. 1033, which Petitioner alleges is a copy
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`of Svennson et al., Hydration of an Amphiphilic Excipient Gelucire 4.14, as not
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`properly authenticated under FRE 901. Petitioner has produced insufficient evidence
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`to support a finding that this exhibit is what Petitioner claims it to be. Patent Owner
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`further objects to this exhibit as inadmissible hearsay under FRE 802 because
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`
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`Petitioner offers it to prove the truth of the matter asserted. See, e.g., Ex. 1006, at 27.
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`J. OBJECTIONS TO EXHIBIT 1047
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`Patent Owner hereby objects to Ex. 1047, which Petitioner alleges is a
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`webpage printout from the “Uceris® website,” as not properly authenticated under
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`FRE 901. Petitioner has produced insufficient evidence to support a finding that this
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`exhibit is what Petitioner claims it to be. Patent Owner further objects to this exhibit
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`as inadmissible hearsay under FRE 802 because Petitioner offers it to prove the truth
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`of the matter asserted. See, e.g., Pet. at 66.
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`K. OBJECTIONS TO EXHIBIT 1048
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`Patent Owner hereby objects to Ex. 1048, which Petitioner alleges is a
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`transcript of remarks made by Santarus, Inc.’s CEO, Gerry Proehl, and others on
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`January 15, 2013, as not properly authenticated under FRE 901. Petitioner has
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`produced insufficient evidence to support a finding that this exhibit is what
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`Petitioner claims it to be. Patent Owner further objects to this exhibit as improper
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`testimony under 37 C.F.R. §§ 1.68, 42.53(a) and 28 U.S.C. § 1746. Patent Owner
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`further objects to this exhibit as inadmissible hearsay under FRE 802 because
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`Petitioner offers it to prove the truth of the matter asserted. See, e.g., Pet. at 66.
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`Patent Owner further objects to this exhibit as not relevant under FRE 401 and
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`therefore inadmissible under FRE 402. If relevant, Patent Owner objects to this
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`exhibit under FRE 403 because its probative value is substantially outweighed by a
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`
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`danger of unfair prejudice and confusing the issues.
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`L. OBJECTIONS TO EXHIBIT 1049
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`Patent Owner hereby objects to Ex. 1049, which Petitioner alleges is a
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`webpage printout detailing the “Uceris® Instant Savings Program” as not properly
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`authenticated under FRE 901. Petitioner has produced insufficient evidence to
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`support a finding that this exhibit is what Petitioner claims it to be. Patent Owner
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`further objects to this exhibit as inadmissible hearsay under FRE 802 because
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`Petitioner offers it to prove the truth of the matter asserted. See, e.g., Pet. at 66.
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`Patent Owner further objects to this exhibit as not relevant under FRE 401 and
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`therefore inadmissible under FRE 402. If relevant, Patent Owner objects to this
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`exhibit under FRE 403 because its probative value is substantially outweighed by a
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`danger of unfair prejudice and confusing the issues.
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`M. OBJECTIONS TO EXHIBIT 1050
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`Patent Owner hereby objects to Ex. 1050, which Petitioner alleges is a
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`transcript of remarks made during the second quarter 2014 earnings conference call
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`for Salix Pharmaceuticals, Ltd., as improperly authenticated under FRE 901.
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`Petitioner has produced insufficient evidence to support a finding that this exhibit is
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`what Petitioner claims it to be. Patent Owner further objects to this exhibit as
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`improper testimony under 37 C.F.R. §§ 1.68, 42.53(a) and 28 U.S.C. § 1746. Patent
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`Owner additionally objects to this exhibit as inadmissible hearsay under FRE 802
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`
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`because Petitioner offers it to prove the truth of the matter asserted. See, e.g., Pet. at
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`66. Patent Owner further objects to this exhibit as not relevant under FRE 401 and
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`therefore inadmissible under FRE 402. If relevant, Patent Owner objects to this
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`exhibit under FRE 403 because its probative value is substantially outweighed by a
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`danger of unfair prejudice and confusing the issues.
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`N. OBJECTIONS TO EXHIBIT 1051
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`Patent Owner hereby objects to Ex. 1051, which Petitioner alleges is “L.W.
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`Doner, Determining Sugar Composition of Food Gum Polysaccharides by HPTLC,
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`Chromatographia 2001, 53, May (No. 9/10), as inadmissible hearsay under FRE 802
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`because Petitioner offers it to prove the truth of the matter asserted. See, e.g., Ex.
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`1006, at 86 n.14. Patent Owner further objects to this exhibit as not relevant under
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`FRE 401 and therefore inadmissible under FRE 402. If relevant, Patent Owner
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`objects to this exhibit under FRE 403 because its probative value is substantially
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`outweighed by a danger of unfair prejudice and confusing the issues.
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`O. OBJECTIONS TO EXHIBIT 1052
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`Patent Owner hereby objects to Ex. 1052, which Petitioner alleges is the
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`“Amendment filed on January 15, 2013 in U.S. Patent Appl. No. 13/617,138,” as not
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`relevant under FRE 401 and therefore inadmissible under FRE 402. Indeed,
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`Petitioner does not even cite to this Exhibit, either in its Petition or in the expert
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`report submitted as Exhibit 1006, let alone explain how this exhibit relates to the
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`
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`Petition. If relevant, Patent Owner further objects to this exhibit under FRE 403
`
`because whatever limited probative value it may possess (and Patent Owner
`
`maintains that it has no probative value in light of Petitioner’s filings) is
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`substantially outweighed by a danger of unfair prejudice and confusing the issues.
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`P. OBJECTIONS TO EXHIBIT 1057
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`Patent Owner hereby objects to Ex. 1057, which Petitioner alleges is the
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`“Final Office Action of March 6, 2013 in U.S. Patent Appl. No. 13/617,138,” as not
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`relevant under FRE 401 and therefore inadmissible under FRE 402. Indeed,
`
`Petitioner does not even cite to this Exhibit, either in its Petition or in the expert
`
`report submitted as Exhibit 1006, let alone explain how this exhibit relates to the
`
`Petition. If relevant, Patent Owner further objects to this exhibit under FRE 403
`
`because whatever limited probative value it may possess (and Patent Owner
`
`maintains that it has no probative value in light of Petitioner’s filings) is
`
`substantially outweighed by a danger of unfair prejudice and confusing the issues.
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`Q. OBJECTIONS TO EXHIBIT 1058
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`Patent Owner hereby objects to Ex. 1058, which Petitioner alleges is the
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`“Applicant-Initiated Interview Summary of April 23, 2013 in U.S. Patent Appl. No.
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`13/617,138,” as not relevant under FRE 401 and therefore inadmissible under FRE
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`402. Indeed, Petitioner does not even cite to this Exhibit, either in its Petition or in
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
`the expert report submitted as Exhibit 1006, let alone explain how this exhibit
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`
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`relates to the Petition. If relevant, Patent Owner further objects to this exhibit under
`
`FRE 403 because whatever limited probative value it may possess (and Patent
`
`Owner maintains that it has no probative value in light of Petitioner’s filings) is
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`substantially outweighed by a danger of unfair prejudice and confusing the issues.
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`R. OBJECTIONS TO EXHIBIT 1060
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`Patent Owner hereby objects to Ex. 1060, which Petitioner alleges is a
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`website printout of the “Orange Book Listing of Uceris® (accessed on March 8,
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`2017),” as not properly authenticated under FRE 901. Petitioner has produced
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`insufficient evidence to support a finding that this exhibit is what Petitioner claims it
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`to be.
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`S. OBJECTIONS TO EXHIBIT 1061
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`Patent Owner hereby objects to Ex. 1061, which Petitioner alleges is an
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`excerpt of Hawley’s Condensed Chemical Dictionary (John Wiley & Sons, Inc.,
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`13th ed. 1997), as not properly authenticated under FRE 901. Petitioner has
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`produced insufficient evidence to support a finding that this exhibit is what
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`Petitioner claims it to be. Patent Owner further objects to this exhibit as inadmissible
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`hearsay under FRE 802 because Petitioner offers it to prove the truth of the matter
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`asserted. See, e.g., Pet. at 55-56, 61.
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`III. CONCLUSION
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
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`For at least these reasons, the Patent Owner objects to the Exhibits described
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`above.
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`Date: October 5, 2017
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`Respectfully submitted,
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`/s/ Gary N. Frischling/
`Gary N. Frischling, Reg. No. 35,515 (Lead)
`Yite John Lu, Reg. No. 63,158
`Irell & Manella LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, CA 90067
`Telephone: (310) 277-1010
`Attorneys for Patent Owner
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner’s Objections to Exhibits
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. 42.6, the undersigned certifies that on October 5, 2017,
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`a copy of the foregoing Patent Owner’s Objections to Exhibits have been served
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`in its entirety via e-mail on counsel of record for Petitioners at the following
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`addresses:
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`Jitendra Malik, Ph.D.
`Reg. No. 55,823
`jitty.malik@alston.com
`
`H. James Abe
`Reg. No. 61,182
`james.abe@alston.com
`
`Lance Soderstrom
`Reg. No. 65,405
`lance.soderstrom@alston.com
`
`Joseph M. Janusz
`Reg. No. 70,396
`joe.janusz@alston.com
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`ALSTON & BIRD LLP
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`Dated: October 5, 2017
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`Respectfully submitted,
` /s/Susan Langworthy
`Susan Langworthy
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