UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`PATENT OWNER’S EVIDENTIARY OBJECTIONS
`UNDER 37 C.F.R. § 42.64(b)
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`1 Cases IPR2017-00578 and IPR2017-00596 have been joined with this
`proceeding.
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`PATENT OWNER’S EVIDENTIARY OBJECTIONS
`UNDER 37 C.F.R. § 42.64(b)
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`1 Cases IPR2017-00578 and IPR2017-00596 have been joined with this
`proceeding.
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`Pursuant to 37 C.F.R. § 42.64(b), Patent Owner hereby objects as follows to the
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`admissibility of Petitioner’s evidence:
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`EX. 1039: FRE 402/403/602/701/702/703/801/802. EX. 1039 includes opinions
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`that are not admissible under FRE 701, 702, or 703, or Daubert v. Merrell Dow
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`Pharms., Inc., 509 U.S. 579 (1993). Dr. Calman was retained by Petitioner as a
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`“technical expert to provide [his] independent analysis in these proceedings.” EX.
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`1039, ¶ 7. Dr. Calman provides “putative conversions” to the Schirmer Tear Test
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`(with anesthesia) scores reported in Figure 2 of the Sall reference (“Sall”) to
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`generate “inferred raw STT scores” and uses these scores to conclude “no material
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`clinical difference would be expected between the two CsA groups, as again the
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`estimated raw values for the 0.05% and 0.1% CsA treatment groups at 6 months
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`are only roughly half a millimeter apart.” See EX. 1039, ¶¶ 68-71. Dr. Calman’s
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`analyses are inadmissible as they are not based on sufficient facts or data, are not
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`the product of reliable principles and methods, and do not apply reliable principles
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`and methods to the facts of the case. Dr. Calman admits his conversions are
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`inferences and not “literal conversions” to actual raw Schirmer scores. See EX.
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`1039, ¶ 68. Instead, Dr. Calman conducts his analysis by estimating raw Schirmer
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`tear test values (mm) from the categorized Schirmer scores reported in Sall Figure
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`2. Id. For example, Dr. Calman infers a Schirmer score of 4 corresponds to an
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`estimated raw value of 11 mm. See EX. 1039, ¶ 68. But the Sall reference
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`specifically states that the mean categorized Schirmer value of 4 relates to patients
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`with raw values of 11, 12, 13, or 14 mm/5 min. See EX. 1007, at page 635. Dr.
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`Calman’s “opinions” as to whether a person of skill in the art viewing Sall Figure 2
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`would conclude there is no clinically meaningful difference between the 0.05%
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`and 0.10% CsA formulations should be excluded as inadmissible under FRE 702.
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`In addition to relying on his own improper analysis, Dr. Calman also relies
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`on Dr. Bloch’s dubious analysis derived from “gleaning” the mean change from
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`baseline values for each composition in Sall Figure 2 to the nearest hundredth
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`decimal place. As discussed in more detail below, Dr. Bloch’s analysis on
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`unsubstantiated values is improper and unreliable, as it is not based on sufficient
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`facts or data, is not the product of reliable principles and methods, and does not
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`apply reliable principles and methods to the facts of the case. Thus, Dr. Calman’s
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`“opinions” which rely on Dr. Bloch’s improper analysis to conclude that Sall does
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`not disclose any statistically significantly different results between the 0.05% and
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`0.10% CsA formulations (EX. 1039, ¶¶ 67-71) should be excluded as inadmissible
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`under FRE 702, as well as under FRE 801/802 as hearsay and FRE 602 for lack of
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`personal knowledge.
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`Additionally, EX. 1039 includes opinions that are untimely and outside the
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`scope of a proper reply and therefore not admissible under FRE 402 or 403. 37
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`C.F.R. § 42.23(b), governing these proceedings, states that “[a] reply may only
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`respond to arguments raised in the corresponding . . . patent owner response.” Id.
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`at § 42.23(b). The Office Patent Trial Practice Guide states that “[e]xamples of
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`indications that a new issue has been raised in a reply include new evidence
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`necessary to make out a prima facie case for the patentability or unpatentability of
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`an original or proposed substitute claim, and new evidence that could have been
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`presented in a prior filing.” Office Patent Trial Practice Guide, 77 Fed. Reg.
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`48,756 at 48,767 (Aug. 14, 2012). Petitioner chose not to file a declaration from a
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`clinician regarding the clinical results in Sall with its Petition. EX. 1039 is a
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`declaration by Dr. Calman, a clinician, submitted with Petitioner’s reply. Dr.
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`Calman, for the first time, presents evidence that could have (and should have)
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`been presented previously that Petitioner now relies on for a prima facie case of
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`unpatentability. It should not be permitted on reply at this late date in the
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`proceedings.
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`EX. 1040: FRE 402/403/701/702/703. EX. 1040 includes opinions that are not
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`admissible under FRE 701, 702, or 703, or Daubert v. Merrell Dow Pharms., Inc.,
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`509 U.S. 579 (1993). Dr. Bloch provides “statistical analyses for certain data
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`reported in Stevenson, Sall Figures 1-2” and “Allergan’s animal PK
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`[pharmacokinetic] studies testing cyclosporine ophthalmic emulsions as used by
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`Dr. Attar in her Exhibit B to her Declaration presented to the USPTO.” See EX.
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`1040, ¶ 10. Dr. Bloch’s analyses are inadmissible as they are not based on
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`sufficient facts or data, are not the product of reliable principles and methods, and
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`do not apply reliable principles and methods to the facts of the case. Neither
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`Stevenson nor Sall provide data tables of the raw values graphed in the articles.
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`See EX. 1040, ¶ 26. In the absence of such data, Dr. Bloch conducts his analysis
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`by allegedly “glean[ing] through precise measurements of the y-axis and bars
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`within each bar graph.” Id. For example, from Figure 1 of Sall, which contains a
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`y-axis that measures change in baseline in corneal staining to the tenth decimal
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`place, Dr. Bloch “gleans” the mean change from baseline values for each
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`composition tested to the hundredth decimal place, and conducts his analysis on
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`these unsubstantiated values and improper analysis. See EX. 1040, ¶¶ 33, 35-38.
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`Dr. Bloch’s analysis of Exhibit B of Dr. Attar’s Declaration is equally suspect.
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`Despite Dr. Attar’s testimony that she combined the upper and lower conjunctiva
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`data from the 98-074 study to compare against the same data from the 00-163
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`study, Dr. Bloch nevertheless bases his analysis on the data from the lower
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`conjunctiva in the 98-074 study. See EX. 1038, 167:8-169:24; EX. 1040, ¶¶ 65-68.
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`After “simply magnifying the scale of Dr. Attar’s exhibit,” and drawing a set of
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`rudimentary lines across the figure (which has a y axis with intervals of 0.5), Dr.
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`Bloch goes on to conclude that Dr. Attar “did the wrong ‘thing’ (analysis) when
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`she created her Exhibit B,” because of a purported three-hundredth point
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`difference in values (0.29 compared to 0.32) that he states is “clear” evidence that
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`she used the incorrect data. EX. 1040, ¶ 68. Dr. Bloch’s methods are unreliable
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`and unsubstantiated in light of Dr. Attar’s testimony. Therefore, his “opinions” as
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`to whether Stevenson, Sall or Exhibit B of Dr. Attar’s Declaration disclose any
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`statistically significantly different results between the 0.05% and 0.10% CsA
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`formulations should be excluded as inadmissible under FRE 702.
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`Additionally, EX. 1040 includes opinions that are untimely and outside the
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`scope of a proper reply and therefore not admissible under FRE 402 or 403. 37
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`C.F.R. § 42.23(b), governing these proceedings, states that “[a] reply may only
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`respond to arguments raised in the corresponding . . . patent owner response.” Id.
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`at § 42.23(b). The Office Patent Trial Practice Guide states that “[e]xamples of
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`indications that a new issue has been raised in a reply include new evidence
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`necessary to make out a prima facie case for the patentability or unpatentability of
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`an original or proposed substitute claim, and new evidence that could have been
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`presented in a prior filing.” Office Patent Trial Practice Guide, 77 Fed. Reg.
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`48,756 at 48,767 (Aug. 14, 2012). Petitioner chose not to file a declaration from a
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`statistician regarding the clinical results in Sall with its Petition. EX. 1040 is a
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`declaration by Dr. Bloch submitted with Petitioner’s reply. Dr. Bloch, for the first
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`time, presents evidence that Petitioner could have (and should have) presented in
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`its opening statement that Petitioner relies on for a prima facie case of
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`unpatentability. It should not be permitted on reply at this late date in the
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`proceedings.
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`EX. 1041: FRE 402/403. EX. 1041 includes opinions that are untimely and
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`outside the scope of a proper reply and therefore not admissible under FRE 402 or
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`403. Mr. Hofmann provides analyses of “certain claimed objective indicia of
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`nonobviousness, specifically commercial success and nexus.” EX. 1041, ¶ 9. 37
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`C.F.R. § 42.23(b), governing these proceedings, states that “[a] reply may only
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`respond to arguments raised in the corresponding . . . patent owner response.” Id.
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`at § 42.23(b). The Office Patent Trial Practice Guide states that “[e]xamples of
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`indications that a new issue has been raised in a reply include new evidence
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`necessary to make out a prima facie case for the patentability or unpatentability of
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`an original or proposed substitute claim, and new evidence that could have been
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`presented in a prior filing.” Office Patent Trial Practice Guide, 77 Fed. Reg.
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`48,756 at 48,767 (Aug. 14, 2012). Petitioner chose not to file a declaration
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`regarding these objective indicia of non-obviousness with its Petition. EX. 1041 is
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`a declaration by Mr. Hofmann submitted with Petitioner’s reply. Mr. Hofmann,
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`for the first time, presents evidence that Petitioner could have presented in its
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`opening statement that Petitioner relies on for a prima facie case of unpatentability.
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`It should not be permitted on reply at this late date in the proceedings.
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`Respectfully submitted,
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`/Dorothy P. Whelan/
`Dorothy P. Whelan
`Reg. No. 33,814
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`Date: July 10, 2017
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`Customer Number 26171
`Fish & Richardson P.C.
`Telephone: (612) 337-2508
`Facsimile: (612) 288-9696
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
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`that on July 10, 2017, a complete and entire copy of this Patent Owner Allergan,
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`Inc.’s Objections to Evidence was provided via electronic service, to the Petitioner
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`by serving the correspondence address of record as follows:
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`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`Wendy L. Devine
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`wdevine@wsgr.com
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`Michael R. Dzwonczyk
`Azy S. Kokabi
`Travis B. Ribar
`Sughrue Mion, PLLC
`2100 Pennsylvania Ave., NW, Suite 800
`Washington, DC 20037
`mdzwonczyk@sughrue.com
`akokabi@sughrue.com
`tribar@sughrue.com
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`Gary J. Speier
`Mark D. Schuman
`Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, Minnesota 55402
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`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
`IPRCyclosporine@carlsoncaspers.com
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` /Jessica K. Detko/
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`Jessica K. Detko
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(612) 337-2516
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