`U.S. Patent No. 8,293,742
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SLAYBACK PHARMA LLC
`
`Petitioner
`
`v.
`
`EYE THERAPIES LLC
`
`Patent Owner
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`PETITIONER’S OBJECTIONS TO
`PATENT OWNER’S EVIDENCE SUBMITTED WITH
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Slayback Pharma LLC
`
`(“Petitioner”) objects to the admissibility of the following evidence filed by Patent
`
`Owner Eye Therapies LLC (“Patent Owner”) on August 29, 2022, with its Patent
`
`Owner’s Response.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because they
`
`are being filed and served within five business days of the filing of Patent Owner’s
`
`Response. Petitioner’s objections provide notice to Patent Owner that Petitioner
`
`may move to exclude these exhibits under 37 C.F.R. § 42.64(c).
`
`In this Paper, objection “R” is for lack of relevance or causing undue
`
`prejudice, pursuant to Federal Rules of Evidence (“FRE”) 401, 402, and/or 403.
`
`In this Paper, Petitioner’s objections to Patent Owner’s exhibits for hearsay
`
`(“H”), pursuant to FRE 802, apply to the extent Patent Owner seeks to rely on such
`
`exhibits for the truth of any matters stated in such exhibits and do not fall into any
`
`hearsay exception.
`
`In this Paper, objection “A” is for lack of authenticity, pursuant to FRE 901.
`
`In this Paper, objection “F” is for lack of foundation, pursuant to FRE 602.
`
`In this Paper, objection “I” is for improper expert testimony, pursuant to FRE
`
`701, 702, and/or 703.
`
`In this Paper, objection “L” is for calling for a legal conclusion.
`
`In this Paper, objection “NP” reflects that the exhibit was not published or
`
`
`
`
`
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`publicly available prior to the earliest filing date of the challenged patent, and
`
`therefore cannot be considered prior art. Petitioner objects to these exhibits to the
`
`extent Patent Owner relies on them for the knowledge of a POSA.
`
`Exhibit descriptions provided in the below table are taken from Patent
`
`Owner’s Updated Exhibit List and are used for identification purposes only.
`
`Petitioner’s use of Patent Owner’s exhibit descriptions does not indicate that
`
`Petitioner agrees with Patent Owner’s descriptions or any other characterizations of
`
`such exhibits.
`
`
`
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`OBJECTIONS
`
`Objections
`
`Description
`Bausch & Lomb, Inc., et al. v. Slayback
`Pharma LLC, et al. , C.A. 21-16766 (D.N.J.),
`Joint Discovery Plan submitted Feb. 3, 2022
`Bausch & Lomb, Inc., et al. v. Slayback
`Pharma LLC, et al. , C.A. 21-16766 (D.N.J.),
`Defendants’ First Set of Requests for
`Production to Plaintiffs Nos. 1-2 served on
`Dec. 29, 2021
`Bausch & Lomb, Inc., et al. v. Slayback
`Pharma LLC, et al. , C.A. 21-16766 (D.N.J.),
`ECF No. 15, Scheduling Order signed by the
`Honorable Douglas E. Arpert, U.S.M.J. on
`Feb. 15, 2022
`Bausch & Lomb, Inc., et al. v. Slayback
`Pharma LLC, et al. , C.A. 21-16766 (D.N.J.),
`ECF No. 11, Order Setting the Initial
`Scheduling Conference dated Dec. 15, 2021
`Notice of Paragraph IV Certification Re:
`Slayback Pharma LLC’s Brimondine Tartrate
`Ophthalmic Solution, 0.025%, U.S. Patent
`Nos. 8,293,742 and 9,259,425 dated Aug. 13,
`2021
`Bausch & Lomb, Inc., et al. v. Slayback
`Pharma LLC, et al. , C.A. 21-16766 (D.N.J.),
`ECF No. 1, Complaint for Patent
`Infringement filed Sept. 10, 2021
`Louis B. Cantor, “Brimondine in the
`treatment of glaucoma and ocular
`hypertension,” Therapeutics & Clinical Risk
`Mgmt., 2(4):337-346 (2006)
`U.S. Patent No. 6,982,079 B2, Compositions
`For Treating Hyperemia
`Ji Hoon Lee, et al., “Efficacy of brimonidine
`tartrate 0.2% ophthalmic solution in reducing
`halos after laser in situ keratomileusis,” J. of
`
`R
`
`R
`
`R
`
`R
`
`R
`
`R, H
`
`
`
`
`
`
`
`Exhibit
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`
`
`
`
`
`
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`
`Cataract & Refractive Surgery, 34:963-967
`(2008)
`U.S. Patent No. 5,021,416, Method for Using
`(2-Imidazolin-2-Ylamino) Quinoxalines to
`Reduce or Maintain Intraocular Pressure
`Press Release, "New Survey From Bausch +
`Lomb and Glaucoma Research Foundation
`Reveals Emotional and Social Impact of
`Hyperemia on Glaucoma Patients" (Jan. 4,
`2022), https://www.bausch.com/our-
`company/recentnews/artmid/11336/articleid/6
`83
`Alphagan® (brimonidine tartrate ophthalmic
`solution) 0.5% and 0.2%, Alphagan® P
`(brimonidine tartrate ophthalmic solution)
`0.15%, Highlights of Prescribing Information
`(Dec. 20, 2001)
`Visine-A Label (June 14, 2002)
`Alphagan® P (brimonidine tartrate
`ophthalmic solution) 0.1 % and 0 .15%,
`Highlights of Prescribing Information (Aug.
`19, 2005)
`Alphagan™ (brimonidine tartrate ophthalmic
`solution) 0.2% Sterile, Approval Letter (Sept.
`6, 1996)
`Drugs@FDA Approved Drug Information,
`Alphagan 0.5%,
`https://www.accessdata.fda.gov/scripts/cder/d
`af/index.cfm?event=overview.process&App1
`No=020490
`Drugs@FDA Approved Drug Information,
`Alphagan 0.15%,
`https://www.accessdata.fda.gov/scripts/cder/d
`af/index.cfm?event=overview.process&Appl
`No=021262
`Press Release, “Allergan to focus on
`Alphagan-P, discontinue Alphagan (July 8,
`2002),
`
`
`
`R, H, A, NP
`
`
`
`H, A
`
`
`
`
`
`R, H, A
`
`R, H, A
`
`R, H, A
`
`
`
`
`
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`
`https://www.healio.com/news/ophthalmology/
`20120331/allergan-tofocus-on-alphagan-p-
`discontinue-alphagan
`Alphagan P (brimonidine tartrate ophthalmic
`solution) 0.1%, Approval Letter (Aug. 19,
`2005)
`
`2019
`
`2020
`
`CONFIDENTIAL Declaration of Robert J.
`Noecker, MD, MBA (Under Seal and Public
`versions)
`
`2021
`
`CONFIDENTIAL Declaration of Robert O.
`Williams, III, Ph.D. (Under Seal and Public
`versions)
`
`2022
`
`Declaration of Stephen G. Davies, D.Phil.
`
`2023
`
`CONFIDENTIAL Declaration of John Ferris
`(Under Seal and Public versions)
`
`R, H
`
`To the extent this
`declaration cites to an
`objected-to exhibit,
`Petitioner objects to the
`paragraph(s) in which
`said citation appears for
`the same reason that
`Petitioner objects to the
`cited exhibit.
`To the extent this
`declaration cites to an
`objected-to exhibit,
`Petitioner objects to the
`paragraph(s) in which
`said citation appears for
`the same reason that
`Petitioner objects to the
`cited exhibit.
`To the extent this
`declaration cites to an
`objected-to exhibit,
`Petitioner objects to the
`paragraph(s) in which
`said citation appears for
`the same reason that
`Petitioner objects to the
`cited exhibit.
`I (¶¶ 5, 7-8, 9, 14-18,
`20, 21-26)
`
`To the extent this
`declaration cites to an
`objected-to exhibit,
`
`
`
`
`
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`Petitioner objects to the
`paragraph(s) in which
`said citation appears for
`the same reason that
`Petitioner objects to the
`cited exhibit .
`
`I (¶¶ 107-112)
`
`To the extent this
`declaration cites to an
`objected-to exhibit,
`Petitioner objects to the
`paragraph(s) in which
`said citation appears for
`the same reason that
`Petitioner objects to the
`cited exhibit.
`
`2024
`
`CONFIDENTIAL Declaration of John C.
`Jarosz (Under Seal and Public versions)
`
`
`
`
`
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`USP 32, General Notices and Requirements,
`“Applying to Standards, Tests, Assays, and
`Other Specifications of the United States
`Pharmacopeia”, Pp. 1 - 12
`65 Fed. Reg. 83,041 (December 29, 2000)
`Skwietczynski, “Chapter 2 - Analysis of
`Medicinals”, Remington Essentials of
`Pharmaceuticals, edited by Linda Felton,
`(Pharmaceutical Press 2012), Pp. 9 - 28
`CONFIDENTIAL 3.2.P.5.6 Justification of
`Specifications (BAULUM00057392-
`57399) (Under Seal and Public versions)
`“Legal Recognition - Standards Categories”,
`The United States Pharmacopeia Convention,
`https://www.usp.org/about/legalrecognition/st
`andard-categories
`Agarwal, Priyanka, et al. "Review:
`Formulation Considerations for the
`Management of Dry Eye Disease."
`Pharmaceutics, vol. 13, no. 2, Feb. 2021 , pp.
`
`R
`
`
`
`R, NP
`
`R, H, A, NP
`
`R, H, A
`
`R, NP
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`
`R, H, A, NP
`
`R, H, A, NP
`
`R, H, A, NP
`
`1-19 (Agarwal 2021)
`21 CFR § 330.10 (2002) (21 CFR § 330.10) R, NP
`67 Fed. Reg. 3,060 (January 23, 2002)
`R
`Orange Approved Drug Products with
`Therapeutic Equivalence Evaluations, Patent
`and Exclusivity for N021770, (Brimonidine
`Tartrate (Alphagan P) Solution/Drops 0.1%),
`https://www.accessdata.fda.gov/scripts/cder/o
`b/patent_info.cfm?Product_No=00l&ApplNo
`=021770&Appl_type=N
`Orange Approved Drug Products with
`Therapeutic Equivalence Evaluations, Patent
`and Exclusivity for N021262, (Brimonidine
`Tartrate (Alphagan P) Solution/Drops 0.15%),
`https://www.accessdata.fda.gov/scripts/cder/o
`b/patent_info.cfm?Product_No=001&Appl_N
`o=021262&Appl_type=N
`“Drug Application Process for
`Nonprescription Drugs”,
`https://www.fda.gov/drugs/types-
`applications/drug-applicationprocess-
`nonprescription-drugs
`Zhu and Chauhan, “Effect of Viscosity on
`Tear Drainage and Ocular Residence Time”,
`Optometry and Vision Science, 85(8):E715-
`E725 (August 2008)
`Coffey et al., “Development of a non-settling
`gel formulation of 0.5% loteprednol etabonate
`for anti-inflammatory use as an ophthalmic
`drop”, Clinical Ophthalmology, 7:299-312
`(2013)
`Alphagan P (Brimonidine Tartrate)
`Ophthalmic Solution 0.15%, Center for Drug
`Evaluation and Research, Application No. 21-
`764, Chemistry Review(s),
`https://www.accessdata.fda.gov/drugsatfda_d
`ocs/nda/2001/21-
`262_Alphagan%20P%20Ophthalmic_chemr.p
`
`R
`
`R, NP
`
`
`
`2031
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`
`
`
`
`
`
`
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`U.S. Patent No. 8,293,742
`
`
`df
`Alphagan P (Brimonidine Tartrate)
`Ophthalmic Solution 0.1 %, Center for Drug
`Evaluation and Research, Application No. 21-
`770, Chemistry Review(s),
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`(Under Seal and Public versions)
`Reserved
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`LUM.1827.USA.21 (Lumify Brochure)
`Lumify_v9 - PRC APRVD
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`Seal and Public versions)
`CONFIDENTIAL IRI Point-of-Sale Data
`(Under Seal and Public versions)
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`2018
`Lumify Supplemental Approval, April 30,
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
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`(viewed August 8, 2022)
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`Petitioner reserves all
`Deposition Transcript of Dr. Neal A. Sher,
`objections made at the
`M.D.
`time of the deposition.
`"The Science of Lumify",
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`
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`CONFIDENTIAL 11-100-0015 Clinical
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`Prescribing Information Label for Lumify®
`(Lumify®label)
`Prescribing Information Label for Naphcon-
`A® (Naphcon-A® label)
`Prescribing Information for Visine®L.R.
`(Visine®L.R. label)
`Prescribing Information for Visine®Original
`(Visine®Original label)
`CONFIDENTIAL NDA 208144, Section 2.2
`Introduction (Excerpted) (Under Seal and
`
`
`
`
`
`R
`
`
`
`
`
`R
`
`
`
`
`R
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`H, A, NP
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`H, A, NP
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`H, A, NP
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`H, A, NP
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`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`Public versions)
`CONFIDENTIAL NDA 208144, Section
`2.3.P.1.1 Finished Product Composition
`(Excerpted) (Under Seal and Public versions)
`K. S. Bower, Overview of Refractive Surgery,
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`Deposition Transcript of Paul A. Laskar,
`Ph.D., dated August 4, 2022
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`https://www.lumifydrops.com/siteassets/ecp/p
`dfs/Lumify-news.pdf
`P. Watts & N. Hawksworth, Delayed
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`(2002) 16, 132-135
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Declaration of David Fisher in Response to
`Slayback’s Objections to Patent Owner's
`Exhibit No. 2011 (served but not filed on June
`16, 2022)
`
`H, A, NP
`
`
`Petitioner reserves all
`objections made at the
`time of the deposition
`
`H, A, NP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I (¶¶ 7-8)
`
`2196
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`2199
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`2200
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`2201
`2202
`2203
`2204
`2205
`2206
`2207
`2208
`2209
`2210
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`2211
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`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`Respectfully submitted,
`
`/Linnea P. Cipriano/
`Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
`
`Counsel for Petitioner
`Slayback Pharma LLC
`
`September 6, 2022
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`CERTIFICATE OF SERVICE
`
`I, Linnea P. Cipriano, certify that I caused to be served a true and correct
`
`copy of
`
`the foregoing PETITIONER’S OBJECTIONS TO PATENT
`
`OWNER’S EVIDENCE SUBMITTED WITH PATENT OWNER’S
`
`RESPONSE by email, as follows:
`
`Bryan Diner
`
`bryan.diner@finnegan.com
`
`Justin Hasford
`
`Justin.hasford@finnegan.com
`
`Caitlin O’Connell caitlin.oconnell@finnegan.com
`
`Christina Yang
`
`christina.yang@finnegan.com
`
`September 6, 2022
`
`
`
`
`
`
`
`
`
`
`/Linnea P. Cipriano/
`Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8000
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
`
`Counsel for Petitioner
`Slayback Pharma LLC
`
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