UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`
`Filed: March 31, 2016
`
`PETITIONER’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`
`Filed: March 31, 2016
`
`PETITIONER’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`
`TABLE OF CONTENTS
`INTRODUCTION ........................................................................... 1
`PETITIONER TIMELY OBJECTED ........................................... 3
`ARGUMENT ................................................................................... 4
`Exhibits 2266, 2267 and 2268 and Related Testimony During
`Dr. Laskar’s Cross-Examination Should Be Excluded as
`Violations of the Board’s Own Ruling and Under Fed. R. Evid.
`801–802............................................................................................. 4
`i.
`Exhibits 2266 and 2268 and related testimony......................... 5
`ii.
`Exhibit 2267 and related testimony.......................................... 7
`Exhibits 2247-2263 Should be Excluded as Untimely Under 37
`C.F.R § 42.64(b).............................................................................. 10
`The Preservative Efficacy Testing Reported in Exhibits 2126
`and 2128 Should Be Excluded as Unsupported and Unreliable
`Under Fed. R. Evid. 702 .................................................................. 12
`CONCLUSION .............................................................................. 15
`
`I.
`II.
`III.
`
`IV.
`
`A.
`
`B.
`
`C.
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Ericsson Inc. v. Intellectual Ventures I LLC,
`IPR2014-01149, 2015 WL 8651563 (PTAB, Dec. 9, 2015)...............................4
`Google, Inc. v. Michael Meiresonne,
`IPR2014-01188, Paper No. 37 (PTAB, Jan. 20, 2016) .....................................10
`Handi-Quilter, Inc. v. Bernina Int’l AG,
`IPR2013-00364, Paper 30 at 3 (PTAB, June 12, 2014) ....................................11
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`711 F.3d 1348 (Fed. Cir. 2013)..................................................................13, 15
`Rembrandt Vision Techs., L.P. v. Johnson & Johnson Vision Care,
`Inc.,
`282 F.R.D. 655 (M.D. Fla. 2012) aff'd, 725 F.3d 1377 (Fed. Cir.
`2013) ...............................................................................................................15
`Toshiba Corp. v. Optical Devices, LLC,
`IPR2014-01447, Paper 34 at 45–47 (PTAB, Mar. 9, 2016)..............................12
`RULES
`Fed. R. Evid. 702 .................................................................................. 3, 12, 13, 15
`Fed. R. Evid. 801, 802 ..............................................................................4, 5, 7, 10
`OTHER AUTHORITIES
`37 C.F.R. § 42.5(b) .................................................................................................4
`37 C.F.R. § 42.53(c) ...............................................................................................6
`37 C.F.R § 42.64.........................................................................................3, 10, 12
`37 C.F.R. § 42.65..................................................................................................13
`37 C.F.R. § 42.123................................................................................ 3, 11, 12, 13
`
`ii
`
`
`
`I.
`
`INTRODUCTION
`Patent Owner repeatedly and improperly attempts to introduce evidence into
`
`the record by failing to observe this Board’s procedural rules and by taking actions
`
`contrary to this Board’s Order. Accordingly, pursuant to 37 C.F.R. § 42.64(c) and
`
`the Scheduling Order (Paper 20) as modified by stipulation (Paper 29),
`
`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc.,
`
`InnoPharma LLC, Mylan Pharmaceuticals Inc., and Mylan Inc. (collectively,
`
`“Petitioner”) respectfully moves to exclude (1) Exhibits 2266–2268, (2) Exhibits
`
`2247-2263, and (3) Exhibits 2126 and 2128 submitted by Senju Pharmaceutical
`
`Co., Ltd., Bausch & Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp.
`
`(collectively “Patent Owner”).1
`
`Patent Owner’s Exhibits 2266, 2267, and 2268 were introduced during the
`
`cross-examination of Dr. Paul Laskar, Petitioner’s expert, on March 25, 2016 in an
`
`effort to backdoor alleged sur-reply evidence into the record, even though this
`
`1 Petitioner notes that Patent Owner has not yet filed Patent Owner’s Exhibits
`
`2266-2268 and 2247-2263 as of the filing of this motion. The transcript of Dr.
`
`Laskar’s cross-examination on March 25, 2016 has not been filed yet as of the
`
`filing of this motion, however, Patent Owner has stated that it will be filed as
`
`EX2272.
`
`1
`
`
`
`Board had already denied Patent Owner’s request to file a sur-reply.2 See EX2272
`
`at 119:19–22, 134:20–22, 138:9–12, 141:15–18. Notwithstanding the disregard of
`
`the Board’s rules and Order, Patent Owner’s Exhibits 2266, 2250, and 2268 must
`
`be excluded as hearsay.
`
`Patent Owner’s Exhibits 2247–2257 were untimely served on Petitioner on
`
`February 12, 2016, and Patent Owner’s Exhibits 2258–2263 were untimely served
`
`2 The same Patent Owner in the related joinder proceedings perpetrated this
`
`egregious behavior showing that Patent Owner has no regard for the Board’s rules
`
`and Order by defying them when its suits its purpose. See Lupin, Ltd. v. Senju
`
`Pharma. Co., Ltd., IPR2015-01087, IPR2015-01099, IPR2015-01100, IPR2015-
`
`01105, EX1087 at 178:9–203:6 (counsel for Patent Owner handing Patent Owner’s
`
`expert his reply expert report from the district court litigation and asking him to
`
`read his Reply onto the IPR record during Patent Owner’s redirect). Petitioner
`
`Lupin and InnoPharma will file the appropriate motion to exclude when the time is
`
`ripe in proceedings IPR2015-01087, -01099, -01100, -01105. Nevertheless, Patent
`
`Owner’s conduct shows a repeated pattern of abuse, consistent with its actions at
`
`the cross-examination of Dr. Laskar. Patent Owner’s conduct during Dr. Laskar’s
`
`cross-examination is not the only instance of abusive conduct.
`
`2
`
`
`
`on February 16, 2016, both well after this proceeding was instituted and Patent
`
`Owner’s Response was filed. See Papers 49, 50. Patent Owner’s Exhibits 2247–
`
`2263, which contain alleged evidence of preservative efficacy and stability testing
`
`and attempt to supplement Patent Owner’s previously-filed exhibits, must be
`
`excluded for failing to comply with 37 C.F.R. § 42.123(b).
`
`Finally, Patent Owner’s Exhibits 2126 and 2128, the declarations of Patent
`
`Owner’s experts Dr. Adam C. Myers and Dr. Daryl S. Paulson, and specifically the
`
`alleged preservative efficacy testing contained therein, must also be excluded as
`
`unreliable pursuant to Fed. R. Evid. 702.
`
`II.
`
`PETITIONER TIMELY OBJECTED
`Timely objections were made to Exhibits 2266, 2267, and 2268 during the
`
`deposition of Dr. Laskar as hearsay and as not of record in the proceeding.
`
`EX2272 at 119:19–22, 134:20–22, 138:9–12, 141:15–18. Patent Owner gave
`
`Petitioner a standing objection on the record as to those exhibits. Id. at 120:1–3,
`
`135:1–2, 141:19–20.
`
`Petitioner timely objected to Exhibits 2247–2263 as untimely on February
`
`17, 2016 pursuant to 37 C.F.R. § 42.64(b)(1). See Paper 51 at 1–4. Petitioner
`
`objected to the deficiencies relating to the preservative efficacy testing reported in
`
`Exhibits 2126 and 2128 during the deposition of Dr. Myers on February 24, 2016
`
`after confirming the deficiencies with both Dr. Paulson and Dr. Myers. See
`
`3
`
`
`
`EX1083 at 41:3–17.3
`
`III. ARGUMENT
`A.
`Exhibits 2266, 2267 and 2268 and Related Testimony During Dr.
`Laskar’s Cross-Examination Should Be Excluded as Violations of
`the Board’s Own Ruling and Under Fed. R. Evid. 801–802
`Patent Owner’s introduction of Exhibits 2266–2268 is a clear attempt to
`
`circumvent the Board’s denial of the Patent Owner’s request to file a sur-reply
`
`(EX1154 (the Board ruling in an email to the Parties dated March 21, 2016 that
`
`“Patent Owner’s request to file a sur-reply in each proceeding to address allegedly
`
`new arguments presented in the Reply briefs is denied.”) (emphasis in original)).
`
`Tellingly, during the cross-examination of Dr. Laskar, the principle use of these
`
`exhibits by counsel for Patent Owner was merely reading into the record portions
`
`of these exhibits (sometime as much as three pages) to improperly introduce its
`
`arguments into the record, and Patent Owner did not use the exhibits to ask Dr.
`
`Laskar any substantive questions regarding the argument that counsel for Patent
`
`Owner read into the record. See e.g. EX2272 at 119:7–121:12, at 141:7–144:20.
`
`Such egregious conduct in violation of the Board’s Order should not be permitted,
`
`and such improper exhibits should be excluded on these bases alone. Furthermore,
`
`3 See 37 C.F.R. § 42.5(b); Ericsson Inc. v. Intellectual Ventures I LLC, IPR2014-
`
`01149, Paper 50 at 9 (PTAB, Dec. 9, 2015).
`
`4
`
`
`
`Exhibits 2266–2268 should also be excluded under Fed. R. Evid. 801–802 as
`
`constituting impermissible hearsay.4
`
`Exhibits 2266 and 2268 and related testimony
`i.
`Exhibit 2266 is a transcript of the videotaped deposition of Dr. Clayton
`
`Heathcock taken on February 19, 2016. Dr. Heathcock is not a declarant in this
`
`proceeding—he is an expert witness for the Defendants in connection with the
`
`related district court infringement litigation. Exhibit 2268 is a copy of the
`
`transcript of the deposition of Dr. Robert Cykiert taken on February 26, 2016, who
`
`also is not a declarant in this proceeding. Dr. Cykiert is another expert witness for
`
`the Defendants in connection with the same district court infringement litigation.
`
`Patent Owner improperly introduced these exhibits during the March 25,
`
`4 As a further illustration of Patent Owner pattern of abusive conduct, in a related
`
`inter partes review by Patent Owner asked its expert (Mr. Jarosz), over fervent
`
`objections by Petitioner, to read that expert’s reply report from a district court
`
`proceeding onto the record during redirect. See Lupin, Ltd., IPR2015-01087, -
`
`01099, -01100, -01105, EX1087 at 178:9 – 203:6. This improper testimony
`
`spanned nearly twenty-five (25) pages. Id. Petitioner Lupin and joinder petitioner
`
`InnoPharma will file the appropriate motion when allowed to do so in IPR2015-
`
`01087, -01099, -01100, -01105 based on Patent Owner’s conduct.
`
`5
`
`
`
`2016 cross-examination of Dr. Laskar despite the fact that Drs. Heathcock and
`
`Cykiert have offered no testimony in the present inter partes review. Patent
`
`Owner’s attorney simply read portions of Exhibits 2266 and 2268 into the record
`
`without even bothering to ask whether Dr. Laskar had any knowledge of the
`
`testimony or opinions of those witnesses from the district court action. See e.g.
`
`EX2272 at 119:7–121:12 (reading portions of Exhibit 2266, Dr. Heathcock’s
`
`deposition transcript from the district court proceeding), at 141:7–144:20 (reading
`
`portions of Exhibit 2268, Dr. Cykiert’s deposition transcript from the district court
`
`proceeding).
`
`Because Drs. Heathcock and Cykiert have not provided testimony in this
`
`inter partes review, and because neither person was being cross-examined on
`
`March 25, 2016, Petitioner was not given the opportunity to conduct redirect
`
`examination of either person to clarify the hearsay statements that counsel for
`
`Patent Owner read into the record. See 37 C.F.R. § 42.53(c). As a result, the
`
`record has been tainted with hearsay statements that are devoid of context, and
`
`Petitioner was not given the opportunity to address them. Indeed, Patent Owner
`
`has made a pattern of introducing surprise exhibits in the form of extraneous expert
`
`opinions or testimony from the related district court action. See Lupin, Ltd,
`
`IPR2015-01087, -01099, -01100, -01105, EX1087 at 178:9–203:6. Patent
`
`Owner’s actions are thus in clear derogation of the Board’s rules, and should
`
`6
`
`
`
`therefore result in exclusion of this purported evidence.
`
`Additionally, Exhibits 2266 and 2268 are inadmissible hearsay and should
`
`be excluded, along with related testimony, pursuant to Fed. R. Fed. 801–802.
`
`Neither Dr. Heathcock nor Dr. Cykiert have testified in the instant proceeding, and
`
`Patent Owner introduced both Dr. Heathcock’s and Dr. Cykiert’s testimony for the
`
`truth of the matter asserted by simply reading portions of Exhibits 2266 and 2268
`
`into the record. EX2272 at 119:7–121:12, at 141:7–144:20. The Board has
`
`previously held that exhibits containing hearsay statements made by individuals
`
`who are not declarants testifying in the proceeding at issue must be excluded—
`
`Exhibits 2266 and 2268 are no different, and all testimony elicited from Dr. Laskar
`
`in connection with these improper exhibits must also be excluded since Patent
`
`Owner gave Petitioner a standing objection. See, e.g., Google, Inc. v. Michael
`
`Meiresonne, IPR2014-01188, Paper No. 37, 10–11 (PTAB, Jan. 20, 2016) (holding
`
`that exhibits consisting of statements made by declarants not testifying in the
`
`proceeding were hearsay must be excluded); Fed. R. Evid. 801–802. Specifically,
`
`in addition to the exhibits themselves, the testimony and the statements by counsel
`
`for Patent Owner at the following transcript citations must be excluded: EX2272
`
`at 119:7–121:12, 127:18–129:1, 141:7-145:21.
`
`Exhibit 2267 and related testimony
`ii.
`Exhibit 2267 is a copy of the Reply Expert Report of Dr. Stephen G. Davies,
`
`7
`
`
`
`Patent Owner’s expert, dated February 15, 2016 and prepared in connection with
`
`the district court infringement litigation. Patent Owner improperly introduced this
`
`exhibit during the March 25, 2016 cross-examination of Dr. Laskar by reading
`
`pages of Dr. Davies’ reply report onto the record, constituting numerous pages of
`
`the transcript. Then, in order to ask the witness a question, Patent Owner simply
`
`asked Dr. Laskar whether he had asked petitioner’s counsel whether Dr. Davies
`
`had expressed any opinions contradicting Dr. Laskar’s opinions. EX2272 at
`
`134:15–138:19.
`
`Patent Owner’s conduct is in direct violation of the Board’s Order denying
`
`Patent Owner’s request to file a sur-reply in the instant proceeding. Indeed, on
`
`March 21, 2016, the parties received an Order from the Board via email stating that
`
`“Patent Owner’s request to file a sur-reply in each proceeding to address allegedly
`
`new arguments presented in the Reply briefs is denied.” EX1154 (emphasis in
`
`original). As such, Patent Owner’s reading into the record portions of Exhibit
`
`2267 is an attempt by Patent Owner to circumvent an Order of the Board by
`
`attempting to backdoor its sur-reply evidence into the record. Accordingly,
`
`Exhibit 2267 and all related testimony must be excluded.
`
`Patent Owner should not be permitted to circumvent the Board’s ruling and
`
`well-established rule that sur-replies are not allowed by simply reading into
`
`evidence the substance of what essentially would have been its sur-reply
`
`8
`
`
`
`declaration from its expert (Dr. Davies) during cross-examination of a Reply
`
`declarant (in this case, Petitioner’s expert, Dr. Laskar). Dr. Davies submitted a
`
`declaration in this proceeding when proper to do so (EX2105), and Patent Owner
`
`was well-aware under the Board’s Rules that Dr. Davies’ original declaration was
`
`the proper vehicle by which Dr. Davies was to make his complete opinion known.
`
`Consistent with this panel’s decision denying Patent Owner a sur-reply,
`
`other panels also have denied submission of sur-replies. For example, in Kyocera
`
`Corp. v. Softview LLC, the Board denied the Patent Owner’s request to file a sur-
`
`reply even without determining whether the Petitioner’s Reply was drawn to new
`
`issues or evidence. IPR2013-00004, Paper No. 32, 3 (PTAB, Oct. 8, 2013). In so
`
`holding, the Board stated:
`
`The rules do not provide for a surreply should the Board decide that
`Petitioners’ Consolidated Reply does not raise new issues or introduce
`new evidence. If the Board determines Petitioner’s Consolidated
`Reply is not responsive to the Patent Owner Response and raises new
`issues or introduces new evidence, the Board will not consider the
`Consolidated Reply. In that case, there will be no need for a surreply
`because the Consolidated Reply will not be considered. In either
`circumstance a surreply to Petitioners’ Consolidated Reply is not
`appropriate.
`
`Id. Thus, Patent Owner’s introduction of Exhibit 2267 is improper and must be
`
`excluded.
`
`Furthermore, Exhibit 2267 and all elicited testimony must be excluded as the
`
`exhibit is impermissible hearsay. Again, the reply report of Dr. Davies was
`
`9
`
`
`
`prepared and served in relation to the district court infringement litigation and was
`
`only introduced in order for Patent Owner to circumvent the Board’s denial of its
`
`request to file a sur-reply. The Rules of this Board (and the Board’s Order denying
`
`a sur-reply) do not give Patent Owner license to freely read in an expert report
`
`from a different district court litigation for the truth of the matters asserted therein.
`
`See Google, Inc., IPR2014-01188, Paper No. 37, 10–11; Fed. R. Evid. 801–802.
`
`Patent Owner’s introduction of Dr. Davies’ reply is in clear violation of this
`
`panel’s ruling and the exhibit is impermissible hearsay pursuant to Fed. R. Evid.
`
`801-802. Accordingly, Exhibit 2267 should be excluded along with all of Dr.
`
`Laskar’s testimony elicited from the introduction of the exhibit since Patent Owner
`
`gave Petitioner a standing objection. Specifically, the testimony and the statements
`
`by counsel for Patent Owner at the following transcript citations must be excluded:
`
`EX2272 at 134:13–139:19, 177:3–179:15, and 183:5–17.
`
`B.
`
`Exhibits 2247-2263 Should be Excluded as Untimely Under 37
`C.F.R § 42.64(b)
`Exhibits 2247–2263 all relate to Patent Owner’s preservative efficacy and
`
`stability testing of Patent Owner’s Prolensa product. The exhibits purportedly
`
`supplement the preservative efficacy and stability testing reported in Exhibits 2126
`
`and 2128, the declarations for Dr. Myers and Dr. Paulson that Patent Owner served
`
`on December 28, 2015. Patent Owner served Exhibits 2247–2257 on February 12,
`
`2016, and Exhibits 2258–2263 on February 16, 2016, over six months after trial was
`
`10
`
`
`
`instituted and approximately a month and a half after Patent Owner filed its
`
`Response.
`
`Patent Owner failed to seek authorization under 37 C.F.R. § 42.123(b) for its
`
`late submission of supplemental information. See Handi-Quilter, Inc. v. Bernina
`
`Int’l AG, IPR2013-00364, Paper 30 at 3 (PTAB June 12, 2014) (noting that
`
`supplemental information “may only be filed if a § 123 motion is both authorized
`
`and granted.”).5 Specifically, 37 C.F.R. § 42.123(b) mandates that a party must first
`
`seek authorization from the Board to file a motion to submit supplemental
`
`information, and that any authorized motion to submit information more than one
`
`month after trial is instituted “must show why the supplemental
`
`information
`
`reasonably could not have been obtained earlier . . . .” Id.
`
`In addition to its failures in seeking authorization and filing a motion to submit
`
`the supplemental information, Patent Owner has provided no justification for its late
`
`submission, nor has Patent Owner provided an explanation for why such
`
`supplemental information could not have been obtained and disclosed earlier, as
`
`5 Petitioner recognizes that Patent Owner did not file the exhibits identified herein
`
`and only served such exhibits, while filing Updated Exhibit Lists. But such
`
`procedural maneuvering should not be allowed to evade the mandates of 37 C.F.R.
`
`§ 42.123.
`
`11
`
`
`
`required under § 42.123(b).
`
`In particular, each of the above-identified exhibits
`
`pertain to testing of Patent Owner’s own product. Patent Owner’s own product has
`
`been available to Patent Owner for testing long before the Petitioner even filed its
`
`Petition in this proceeding.
`
`The Board should exclude these untimely exhibits that fail to comply with §
`
`42.64(b) or § 42.123, just as it has done before. See Toshiba Corp. v. Optical
`
`Devices, LLC, IPR2014-01447, Paper 34 at 45–47 (granting motion to exclude
`
`Petitioner’s untimely exhibits, noting that “[u]nnecessary delay in the presentation
`
`of arguments or evidence by either party impedes the Board in fulfilling its mandate
`
`to secure a just, speedy, and inexpensive resolution of every proceeding” and that
`
`“Petitioner made no apparent effort to take advantage of the available procedures”).
`
`C.
`
`The Preservative Efficacy Testing Reported in Exhibits 2126 and
`2128 Should Be Excluded as Unsupported and Unreliable Under
`Fed. R. Evid. 702
`Exhibits 2126 and Exhibit 2128 are the declaration of Patent Owner’s experts
`
`Dr. Myers and Dr. Paulson, respectively. Both declarations contain appendices that
`
`purportedly show preservative efficacy test results for Patent Owner’s Prolensa
`
`product. However, the preservative efficacy test data that it reports is incomplete
`
`and cannot support any reliable results. See EX2128 at 11, 16–19 (no data for 28
`
`day timeframe); EX2126 at 10, 15–16 (same); EX1082, 54:21–55:14 (Dr. Paulson
`
`admitting that the test is incomplete); EX1083, 34:17–35:4.
`
`Indeed, Dr. Paulson
`
`12
`
`
`
`could barely recognize his declaration during cross-examination. (EX1082, 52:18-
`
`54:10, 55:16-60:14). This incomplete test data renders the preservative efficacy
`
`testing reported in Dr. Paulson’s and Dr. Myer’s declaration unsupported under Fed.
`
`R. Evid. 702(b). See Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`
`711 F.3d 1348, 1374 (Fed. Cir. 2013) (holding that district court abused its discretion
`
`in admitting expert testimony based on insufficient data).6
`
`In addition, the preservative efficacy testing reported in Dr. Paulson’s and Dr.
`
`Myers’ declarations should be excluded because it is not reliable under Fed. R. Evid.
`
`702. Rule 702 requires that “the testimony is the product of reliable principles and
`
`methods” and that “the expert has reliably applied the principles and methods to the
`
`facts of the case.” Patent Owner asserts that the ’290 Patent requires that the
`
`ophthalmic product meet
`
`the preservative efficacy requirements of European
`
`Pharmacopeia Criteria B (“EP B”). See EX2082 at ¶ 44.
`
`The EP B provides standardized procedures for ascertaining whether a
`
`product meets the criteria. Patent Owner’s expert admits, however, that the
`
`6 Furthermore, the late-served and unfiled Exhibits (EX2247-2263) cannot
`
`supplement the incomplete preservative efficacy test results or retroactively allow
`
`the declarations to satisfy 37 C.F.R. § 42.65 because they are improper under 37
`
`C.F.R. § 42.123(b).
`
`13
`
`
`
`preservative efficacy testing of Patent Owner’s Prolensa product suffered from a
`
`litany of deviations from EP B procedures: that the initial inoculum concentrations
`
`for P. aeruginosa and S. aureus were nearly double the maximum allowable initial
`
`concentrations allowed by EP chapter 5.1.3 (EX1082 at 106:5–107:6); that for the
`
`neutralization validation tests higher than designated concentrations of inoculum
`
`were used on the control and test plates (EX1082 at 206:16–209:9); that S. aureus
`
`and P. aeruginosa were incubated for at least 4 days during the neutralization
`
`validation studies when EP B provides for only 3 days of incubation (EX1082 at
`
`126:15–133:18); that the temperature of the molten agar was too high at 46 °C when
`
`EP B requires the temperature to be no higher than 45 °C (EX1082 at 137:13–
`
`140:1);7 that the same growth and recovery media were used for all microorganisms
`
`(TSA+ media) during neutralization validation testing even where different media
`
`are required for different species (i.e. SDA+ for C. albicans) (EX1082 at 152:15–
`
`153:15).
`
`Moreover, Dr. Paulson did not verify that these deviations did not affect the
`
`validity of the preservative efficacy testing—at most he merely speculated there was
`
`7 This is a particularly serious deviation given that studies show that elevated
`
`temperatures, even as low as 46 °C, can lower bacterial resistance to antibacterials.
`
`See EX1077.
`
`14
`
`
`
`no effect. Reliance on such “speculative leaps” is not reliable, so Dr. Paulson’s
`
`declaration in this regard falls short of the admissibility standard of Rule 702. Power
`
`Integrations, 711 F.3d at 1373 (excluding testimony where expert made two
`
`speculative assumptions); see also Rembrandt Vision Techs., L.P. v. Johnson &
`
`Johnson Vision Care, Inc., 282 F.R.D. 655, 667 (M.D. Fla. 2012) aff'd, 725 F.3d
`
`1377 (Fed. Cir. 2013) (excluding expert testimony as unreliable because “his testing
`
`contained serious deviations from the applicable scientific standards.”).
`
`IV.
`
`CONCLUSION
`For the foregoing reasons, Petitioner respectfully requests that the Board
`
`grant the instant Motion to Exclude and exclude Exhibits 2266–2268, 2247–2263,
`
`2128, 2126 and the identified testimony elicited and statements made by counsel
`
`for Patent Owner from the introduction of these exhibits.
`
`Date: March 31, 2016
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Lead Counsel for Petitioner
`
`15
`
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 31st day of March, 2016, a complete copy of the foregoing
`
`Petitioner’s Motion to Exclude was served on counsel of record for the Patent
`
`Owner:
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`bryan.skelton@alston.com
`
`16
`
`
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz
`Reg. No. 70396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing
`LLC, InnoPharma Inc., InnoPharma
`LLC, Mylan Pharmaceuticals Inc., and
`Mylan Inc.
`
`17
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