IN THE 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.
`__________________
`
`IPR2015-00902 (Patent 8,669,290 B2)
`__________________
`
`BEFORE FRANCISCO C. PRATS, ERICA A. FRANKLIN, and GRACE
`KARAFFA OBERMANN, Administrative Patent Judges
`
`PETITIONER’S OBJECTION TO EVIDENCE
`UNDER 37 C.F.R. § 42.64(b)(1)
`
`
`__________________
`
`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.
`__________________
`
`IPR2015-00902 (Patent 8,669,290 B2)
`__________________
`
`BEFORE FRANCISCO C. PRATS, ERICA A. FRANKLIN, and GRACE
`KARAFFA OBERMANN, Administrative Patent Judges
`
`PETITIONER’S OBJECTION TO EVIDENCE
`UNDER 37 C.F.R. § 42.64(b)(1)
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner files and serves the following
`
`objections to evidence submitted by Patent Owner after trial was instituted. These
`
`objections are timely presented as they are filed and served within five business days
`
`of service of the evidence objected to. See id. Petitioner reserves the right to file a
`
`motion to exclude the evidence identified herein as improper and any supplemental
`
`evidence that Patent Owner may offer in an attempt
`
`to correct
`
`the noted
`
`improprieties. See id. § 42.64(b)(1)-(2). Petitioner asks the Patent Trial and Appeal
`
`Board to deny the admission and consideration of the following exhibits on the bases
`
`provided herein:
`
`Exhibit
`Number
`Exhibit 2247
`Exhibit 2248
`
`Exhibit 2249
`
`Exhibit 2250
`
`Exhibit 2251
`
`Exhibit 2252
`
`Exhibit 2253
`
`Description
`
`SSCI Lab Notebook
`SSCI, “Chromatographic Data from the Stability Evaluation of
`Bromfenac Sodium Drug Product Samples for Potency,” Report
`Date: 1/12/2016
`BioScience Laboratories, Inc., Testing for Study #151142-203,
`“A Non-GLP Antimicrobial Preservatives Effectiveness
`Evaluation of Six Products When Challenged with Four
`Microorganisms Species based on European Pharmacopoeia
`Method 5.1.3,” January 7, 2016
`Incubator Log Forms,
`BioScience Laboratories,
`Inc.,
`Refrigerator Log Form, Product Receipt Log Form, Sample
`Submission Form, Product-Tracking Form for Study # 151142-
`203
`Confidential BioScience Laboratories, Inc., Standard Operating
`Procedure No. E-0003, January 14, 2016
`Confidential BioScience Laboratories, Inc., Standard Operating
`Procedure No. E-0017, August 24, 2015
`Confidential BioScience Laboratories, Inc., Standard Operating
`Procedure No. E-0005, October 20, 2015
`
`1
`
`
`
`Exhibit 2254
`
`Exhibit 2255
`
`Exhibit 2256
`
`Exhibit 2257
`
`Exhibit 2258
`
`Exhibit 2259
`
`Exhibit 2260
`
`Exhibit 2261
`
`Exhibit 2262
`
`Exhibit 2263
`
`BioScience Laboratories, Inc., “Protocol and/or SOP Deviation
`Recording Form,” Protocol Number: #151142-203, January 19,
`2016
`Confidential Supplemental Expert Report of Robert O.
`Williams,
`III, Ph.D., Senju Pharm. Co., Ltd. et al. v.
`InnoPharma Licensing, Inc. et al., No. 14-cv-00667 (D.N.J.),
`served January 12, 2016
`Confidential Supplemental Expert Report of Adam C. Myers,
`Ph.D., Senju Pharm. Co., Ltd. et al. v. InnoPharma Licensing,
`Inc. et al., No. 14-cv-00667 (D.N.J.), served January 11, 2016
`Confidential Supplemental Expert Report of Daryl S. Paulson,
`Ph.D., M.A., M.S., M.B.A., Senju Pharm. Co., Ltd. et al. v.
`InnoPharma Licensing, Inc. et al., No. 14-cv-00667 (D.N.J.),
`served January 11, 2016
`Inc., Equipment
`Confidential BioScience Laboratories,
`Tracking Form for Study No. 151142-203, test date November
`23, 2015
`Inoculum
`Inc.,
`Confidential BioScience Laboratories,
`Preparation Tracking Form for Study No. 151142-203, test
`dates November 2015 – January 2016
`Inc., Media/Diluent
`Confidential BioScience Laboratories,
`Tracking Form for Study No. 151142-203, test dates November
`2015 – December 2015
`Confidential BioScience Laboratories, Inc., Media Production
`and Growth Testing Data Sheet for Study No. 151142-203,
`dated October 2015 – January 2016
`Inc., Neutralization
`Confidential BioScience Laboratories,
`Verification for Preservative Effectiveness Testing for Study
`No. 151142-203, dated November 2015 – January 2016
`Confidential BioScience Laboratories,
`Inc., TSA/SDA
`Equivalency Evaluation for Study No. 151142-203, dated
`February 14, 2016
`
`On February 12, 2016, Patent Owner served Exhibits 2247 – 2257 and filed
`
`an Updated Exhibit List. See IPR2015-00902, Paper 49. On February 16, 2016,
`
`Patent Owner served Exhibits 2258 – 2263 and filed an additional Updated Exhibit
`
`2
`
`
`
`List. See IPR2015-00902, Paper 50. Petitioner objects to Patent Owner’s use of
`
`and/or reliance on the above-identified exhibits as untimely and without justification
`
`for delay.
`
`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, Case 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.”).1 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 . . . .” 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
`
`1 While Petitioner recognizes that Patent Owner did not file the exhibits identified
`
`herein and only served such exhibits, while filing Updated Exhibit Lists, Petitioner
`
`objects to the extent such course of action was intended to evade the mandates of 37
`
`C.F.R. § 42.123.
`
`3
`
`
`
`Owner provided an explanation for why such supplemental information could not
`
`have been obtained and disclosed earlier, as required under § 42.123(b).
`
`In particular, each of the above-identified exhibits pertain to testing of Patent
`
`Owner’s own product, which product has been available to Patent Owner for testing
`
`long before the institution of trial in this proceeding. As a result, Petitioner
`
`respectfully requests that the Patent Trial and Appeal Board deny the admission and
`
`consideration of any of the above-identified exhibits, and additionally notes that any
`
`expert testimony on the subject matter offered by Patent Owner, to the extent
`
`admitted, should be afforded little or no weight under 37 C.F.R. § 42.65(a) as a result
`
`of Patent Owner’s failure to disclose the information earlier.
`
`Respectfully submitted,
`
`Date: February 17, 2016
`
`/Jitendra Malik /
`
`Jitendra Malik
`Reg. No. 55823
`Lead Counsel for Petitioner
`4721 Emperor Blvd., Suite 400
`Durham, North Carolina 27703
`
`4
`
`
`
`Telephone: 919-862-2200
`Fax: 919-862-2260
`Jitty.Malik@alston.com
`
`Lead Counsel for Petitioners
`InnoPharma Licensing Inc.,
`InnoPharma Licensing LLC,
`InnoPharma Inc., InnoPharma LLC,
`Mylan Pharmaceuticals Inc., and
`Mylan Inc.
`
`5
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`
`The undersigned hereby certifies that the foregoing document entitled
`
`PETITIONER’S OBJECTION TO EVIDENCE UNDER 37 C.F.R. §
`
`42.64(b)(1) was served electronically via e-mail on February 17, 2016 to
`
`Patent Owner’s counsel of record upon the following:
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`M. Andrew Holtman
`andy.holtman@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`joshua.goldberg@finnegan.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /s/ 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
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`H. James Abe
`Reg. No. 61182
`333 South Hope Street
`16th Floor
`Los Angeles, California 90071
`james.abe@alston.com
`
`Joseph Michael Janusz
`Registration No. 70,396
`Alston & Bird LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, North Carolina 28280
`(704) 444-1000
`joe.janusz@alston.com
`
`Petitioners
`for
`Attorneys
`InnoPharma Licensing,
`Inc.,
`InnoPharma Licensing LLC,
`InnoPharma Inc., InnoPharma
`LLC, Mylan Pharmaceuticals
`Inc., and Mylan Inc.
`
`2
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