`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`SLAYBACK PHARMA LLC,
`
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Eye Therapies, LLC hereby
`
`submits a currentlisting of Patent Owner Exhibits. Exhibits 2020-2052, 2055-2146,
`
`2148-2187, 2190-2200, and 2211, including both underseal and public versions of
`
`Exhibits 2020-2021, 2023-2024, 2028, 2052, 2057-2058, 2156, 2166-2168, and
`
`2195-2196,are being filed today.
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`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 Infringementfiled
`Sept. 10, 2021
`
`Louis B. Cantor, “Brimondine in the treatment of glaucoma and
`ocular hypertension,” Therapeutics & Clinical Risk Mgmt., 2(4):
`337-346 (2006)
`
`2008
`
`US. Patent No. 6,982,079 B2, Compositions For Treating Hyperemia
`
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`
`DESCRIPTION
`
`2009
`
`2010
`
`2011
`
`2012
`
`Ji Hoon Lee,et al., “Efficacy ofbrimonidinetartrate 0.2% ophthalmic
`solution in reducing halos after laser in situ keratomileusis,” J. of
`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/recent-
`news/artmid/11336/articleid/683
`
`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)
`
`2013
`
`Visine-A Label (June 14, 2002)
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`Alphagan® P (brimonidinetartrate ophthalmic solution) 0.1% and
`0.15%, Highlights of Prescribing Information (Aug. 19, 2005)
`
`Alphagan™ (brimonidinetartrate 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/daf/index.cfm?event=o
`verview.process&AppINo=020490
`
`Drugs@ FDA Approved Drug Information, Alphagan 0.15%,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=o
`verview.process&AppINo=021262
`
`Press Release, “Allergan to focus on Alphagan-P, discontinue
`Alphagan
`(July
`8,
`2002),
`https://www.healio.com/news/ophthalmology/2012033 1/allergan-to-
`focus-on-alphagan-p-discontinue-alphagan
`
`
`
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`
`DESCRIPTION
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`Alphagan P (brimonidine tartrate ophthalmic solution) 0.1%,
`ApprovalLetter (Aug. 19, 2005)
`
`CONFIDENTIALDeclaration of Robert J. Noecker, MD, MBA
`(Under Seal and Public versions)
`
`CONFIDENTIALDeclaration of Robert O. Williams, III, Ph.D.
`(Under Seal and Public versions)
`
`Declaration of Stephen G. Davies, D.Phil.
`
`CONFIDENTIALDeclaration of John Ferris (Under Seal and
`Public versions)
`
`CONFIDENTIALDeclaration of John C. Jarosz (Under Seal and
`Public versions)
`
`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 LindaFelton,
`(Pharmaceutical Press 2012), Pp. 9 - 28.
`
`CONFIDENTIAL3.2.P.5.6 Justification of Specifications (BAU-
`LUM00057392-57399) (Under Seal and Public versions)
`
`“Legal Recognition - Standards Categories”, The United States
`Pharmacopeia Convention, https://www.usp.org/about/legal-
`recognition/standard-categories
`
`Agarwal, Priyanka,et al. “Review: Formulation Considerations for
`the Management of Dry Eye Disease.” Pharmaceutics, vol. 13, no.
`2, Feb. 2021, pp. 1-19 (Agarwal 2021)
`
`21 CFR § 330.10 (2002) (21 CFR § 330.10)
`
`67 Fed. Reg. 3,060 (January 23, 2002)
`
`
`
`
`
`
`
`
`
`Orange Approved Drug Products with Therapeutic Equivalence
`Evaluations, Patent and Exclusivity for NO21262, (Brimonidine
`Tartrate (Alphagan P) Solution/Drops 0.15%),
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Pro
`ductNo=001&ApplNo=021262&Appl_type=N
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`“Drug Application Process for Nonprescription Drugs”,
`https://www.fda.gov/drugs/types-applications/drug-application-
`process-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., “Developmentof 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_docs/nda/2001/21-
`262Alphagan%20P%200phthalmic_chemr.pdf
`
`Alphagan P (Brimonidine Tartrate) Ophthalmic Solution 0.1%,
`Center for Drug Evaluation and Research, Application No. 21-770,
`Chemistry Review(s),
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021770s
`000ChemR.pdf
`
`de Mendozaet al., “Molecular recognition of oxoanions based on
`guanidinium receptors,” 36 CHEM. Soc. REV. 198, 198 (2007) (de
`Mendoza 2007)
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`
`2033
`
`DESCRIPTION
`
`Orange Approved DrugProducts with Therapeutic Equivalence
`Evaluations, Patent and Exclusivity for NO21770, (Brimonidine
`Tartrate (Alphagan P) Solution/Drops 0.1%),
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Pro
`ductNo=001&Appl_No=021770&Appl_type=N
`
`2034
`
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`DESCRIPTION
`
`Bagwell, Kyle, “The Economic Analysis of Advertising,” Columbia
`University Department of Economics Discussion PaperSeries,
`Discussion Paper No.: 0506-01, August 2005.
`
`Congressional Budget Office, “Promotional Spending for
`Prescription Drugs,” December 2, 2009.
`
`Ching, Andrew T. and Masakazu Ishihara, “Measuring the
`Information and Persuasive Roles of Detailing on Prescribing
`Decisions,” Management Science, July 2012, Vol. 58, No. 7, 1374-
`1387
`
`Gonzalez, Agustin L., et al., “A survey of optometrists’ ophthalmic
`medication prescribing,” Clinical Optometry, March 5, 2014, Vol. 6,
`11-15.
`
`IRI, “New Product Pacesetters: Innovation Before the 'New
`Normal,’” May 2020.
`
`Carlton, Dennis W.and Jeffery M. Perloff, Modern Industrial
`Organization, 4th Ed., Pearson Education Limited 2015.
`
`Samuelson, Paul A. and William D. Nordhaus, Economics, 19th Ed.,
`McGraw-Hill 2010.
`
`Spiegel, A.J. and C. F. Gerber, “The compatibility of
`tetrahydrozoline hydrochloride solutions,” Journal ofthe American
`Pharmaceutical Association, July 1959, Vol. 20, No. 7, 404-405.
`
`Thomas, Natalie A. “Secondary Considerations in Nonobviousness
`Analysis: The Use of Objective Indicia Following KSRv.Teleflex,”
`New York University Law Review, December 2011, Vol. 86, No. 6,
`2070-2112.
`
`2050
`
`Thomas, Randall and Ron Melton, “2016 Clinical Guide to
`Ophthalmic Drugs,” Review ofOptometry, May 15, 2016, 1-51.
`
`2051
`
`BAU-LUM00063901
`
`2052
`
`CONFIDENTIAL LUM.0205.USA.21 (Under Seal and Public
`versions)
`
`2053
`
`Reserved
`
`2054
`
`Reserved
`
`
`
`
`
`
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`2055
`
`LUM.1827.USA.21
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`2071
`
`2072
`
`2073
`
`2074
`
`2075
`
`2076
`
`Lumifyv9 - PRC APRVD
`
`CONFIDENTIALIRI Panel Data (Under Seal and Public
`versions)
`
`CONFIDENTIALIRI Point-of-Sale Data (Under Seal and Public
`versions)
`
`Visine Supplemental Approval, October 17, 2018
`
`Lumify Supplemental Approval, April 30, 2019
`
`Lumify Supplemental Approval, February 21, 2019
`
`Lumify Supplemental Approval, March 5, 2020
`
`Lumify Supplemental Approval, November 29, 2021
`
`Lumify Supplemental Approval, September 23, 2020
`
`Lumify NDA Approval, December 22, 2017
`
`Lumify NDA Summary Overview, November29, 2017
`
`Bausch + Lomb Corporation SEC Form 10-Q for the quarterly
`period ended March 31, 2022
`
`Bausch + Lomb Corporation Q1 2022 Financial Results
`
`Bausch + Lomb Corporation SEC Form S-1, January 13, 2022
`
`Bausch + Lomb Corporation SEC Form S-1A, April 28, 2022
`
`Valeant Pharmaceuticals International, Inc. 2017 Annual Report
`
`Bausch Health Companies Inc. 2018 Annual Report
`
`Bausch Health Companies Inc. Q1 2019 Financial Results
`
`Bausch Health Companies Inc. SEC Form 10-K for the fiscal year
`ended December31, 2021
`
`Bausch Health Companies Inc. Q4 and FY 2021 Financial Results
`
`Johnson & Johnson SEC Form 10-K for the fiscal year ended
`December31, 2006
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`2077
`
`2078
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=o
`verview.process&AppINo=020065 (viewed August 16, 2022)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm
`?ApplType=-N&ApplNo=020226#41039 (viewed August 16,
`2022)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Pro
`2079
`ductNo=001&ApplNo=208144&Appl_type=N (viewed August
`22, 2022)
`
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`2089
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=o
`verview.process&AppINo=020485 (viewed July 11, 2022)
`
`https://www.amazon.com/Lumify-Redness-Reliever-Drops-7-
`S5mL/dp/BO7BVYZL88/ref-sr_1_4?keywords=lumify+drops&qid=
`1656719062&sr=8-4 (viewed July 1, 2022)
`
`https://www.bausch.com/about-bausch-lomb/locations/ (viewed July
`8, 2022)
`
`https://www.bausch.com/news/messages-from-ceo/article/1/
`(viewed July 8, 2022)
`
`https://www.bausch.com/products/otc-eye-care-
`supplements/redness-relief/ (viewed August 15, 2022)
`
`https://www.businesswire.com/news/home/20220729005454/en/Dr.
`-Reddys-Laboratories-enters-into-a-licensing-agreement-with-
`Slayback-Pharma-to-%E2%80%A61/3 (viewed August 22, 2022)
`
`https://www.cleareyes.com/eye-drops/redness-relief (viewed July
`11, 2022)
`
`https://www.cleareyes.com/eye-drops/sensitive-eyes-relief/clear-
`eyes-complete-sensitive-eyes#ingredients (viewed August 15, 2022)
`
`https://www.cleareyes.com/eye-drops/redness-relief/clear-eyes-
`cooling-comfort-itchy-eye-relief#ingredients (viewed August 15,
`2022)
`
`https://www.cleareyes.com/eye-drops/redness-relief/clear-eyes-
`maximum-redness-relief-eye-drops#ingredients (viewed August 15,
`2022)
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`
`DESCRIPTION
`
`2090
`
`2091
`
`2092
`
`2093
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`2100
`
`2101
`
`2102
`
`2103
`
`https://www.cleareyes.com/eye-drops/redness-relief/clear-eyes-
`redness-relief-eye-drops#directions (viewed August 16, 2022)
`
`https://www.cleareyes.com/eye-drops/redness-relief/clear-eyes-
`redness-relief-eye-drops#ingredients (viewed August 15, 2022)
`
`https://www.cleareyes.com/eye-drops/for-travelers/travelers-eye-
`relief#ingredients (viewed August 15, 2022)
`
`https://www.cvs.com/shop/personal-care/eye-care/drops-
`lubricants/q/CVS_Health/Eye_Drops/brpt (viewed August 8, 2022)
`
`https://www.cvs.com/shop/lumify-redness-reliever-eye-drops-
`prodid-1910106 (viewed July 1, 2022)
`
`https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=69 1 66de
`c-fb86-4c 76-9efe-88c3bb 12a8f0 (viewed August 15, 2022)
`
`https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3c41a5
`8-fc93-4e6c-99be-0529edfb54a4 (viewed August 16, 2022)
`
`https://eyewire.news/news/dr-reddys-laboratories-enters-into-a-
`licensing-agreement-to-obtain-nghts-for-the-private-label-version-
`of-lumify-in-the-us?c4sre=article:infinite-scroll (viewed August 16,
`2022)
`
`https://fda.report/Company/Bausch-Lomb-Inc (viewed August 15,
`2022)
`
`https://fda.report/Company/Prestige-Brands-Holdings-Inc (viewed
`August 15, 2022)
`
`https://www.glamour.com/gallery/best-beauty-innovators-of-2022
`(viewed July 23, 2022)
`
`https://intothegloss.com/2021/12/top-25-2021-cheap-thrills-beauty-
`under-35-dollars/ (viewed August 22, 2022)
`
`https://introwellness.com/eyes/drops/lumify-eye-drops-review/
`(viewed August 16, 2022)
`
`https://ir.bauschhealth.com/news-releases/2018/05-07-2018-
`130249958 (viewed July 1, 2022)
`
`
`
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`
`DESCRIPTION
`
`2104
`
`2105
`
`2106
`
`2107
`
`2108
`
`2109
`
`2110
`
`2111
`
`2112
`
`2113
`
`2114
`
`2115
`
`2116
`
`2117
`
`https://ir.bauschhealth.com/news-releases/2017/12-22-2017-
`2003 18686 (viewed August 16, 2022)
`
`https://ir.bauschhealth.com/news-releases/2018/07-13-2018 (viewed
`August 15, 2022)
`
`https://ir.bauschhealth.com/news-releases/2013/27-05-2013 (viewed
`August 16, 2022)
`
`https://ir.nielsen.com/news-events/press-releases/news-
`details/2020/Capitalizing-on-Innovation-Trends-Today-Will-Drive-
`Business-Growth-in-the-New-Normal/default.aspx (viewed August
`16, 2022)
`
`https://www.lumifydrops.com/fags (viewed July 22, 2022)
`
`https://www.lumifydrops.com (viewed August 23, 2022)
`
`https://www.lumifydrops.com/professional/clinical-information
`(viewed July 12, 2022)
`
`https://www.lumifydrops.com/professional (viewed August 15,
`2022)
`
`https://www.lumifydrops.com/lumify-science (viewed July 12,
`2022)
`
`https://www.mckinsey.com/industries/life-sciences/our-insights/the-
`secret-of-successful-drug-launches (viewed August 16, 2022)
`
`https://www.newyou.com/beauty-awards/new-beauty-awards-2018/
`(viewed July 23, 2022)
`
`https://www.ophthalmologyweb.com/1315-News/346489-FDA-
`Approves-LUMIFY-a-Brimonidine-OTC-for-Ocular-Redness/
`(viewed August 16, 2022)
`
`https://www.optometricmanagement.com/issues/2006/november-
`2006/how-to-maximize-prescription-authority (viewed August 22,
`2022)
`
`https://www.optometrytimes.com/view/b-l-licenses-new-
`technology-treating-ocular-redness?qt-resourcetopicsrightrail=1
`(viewed August 16, 2022)
`
`
`
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`
`https://patents.bausch.com (viewed August 17, 2022)
`
`Advanced Eye Relief Drug Facts, available at
`https://pi.bausch.com/globalassets/pdf/downloads/consumer/vision-
`care/safety/advanced-eye-relief-redness-drug-facts.pdf
`
`Advanced Eye Relief Max Drug Facts, available at
`https://pi.bausch.com/globalassets/pdf/downloads/consumer/vision-
`care/safety/advanced-eye-relief-maximum-redness-drug-facts.pdf
`
`https://pink.pharmaintelligence.informa.com/RS148905/Lumify-
`Ad-Launches-As-Bausch-Spends-More-Behind-OTC-Eye-Care-
`Brands (viewed August 16, 2022)
`
`https://pitchbook.com/profiles/company/492664-60#overview
`(viewed August 18, 2022)
`
`
`
` generic-equivalent-of-firazyr-30 1123357.html (viewed July 8, 2022)
`
`EXHIBIT
`
`2118
`
`2119
`
`2120
`
`2121
`
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`2128
`
`https://www.prestigebrands.com/products/eye-ear-nose-throat/clear-
`eyes (viewed July 11, 2022)
`
`https://www.prnewswire.com/news-releases/bausch--lomb-licenses-
`new-technology-with-potential-to-treat-millions-affected-by-ocular-
`redness-185856742 html (viewed August 16, 2022)
`
`https://www.prnewswire.com/news-releases/nielsens-bases-names-
`lumify-eye-drops-to-2020-us-bases-top-25-breakthrough-
`innovations-list-301143761.html (viewed July 17, 2022)
`
`https://www.prnewswire.com/news-releases/slayback-pharma-
`announces-fda-approval-of-hydroxyprogesterone-caproate-
`injection-usp-1-250-mg-5-ml-in-a-multi-dose-vial-the-first-generic-
`equivalent-of-makena-injection- 1-250-mg-5-ml-multi-dose-vial-
`300771547.html (viewed August 19, 2022)
`
`https://www.prnewswire.com/news-releases/slayback-pharma-
`announces-the-final-approval-and-launch-of-generic-zovirax-
`acyclovir-ointment-5-300383519.html (viewed August 16, 2022)
`
`https://www.prnewswire.com/news-releases/slayback-pharma-
`announces-approval-of-icatibant-injection-30-mg3-ml-10-mg-ml-
`
`10
`
`
`
`
`
`EXHIBIT
`
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`
`2134
`
`2135
`
`2136
`
`2137
`
`2138
`
`2139
`
`2140
`
`2141
`
`2142
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`
`https://www.prnewswire.com/news-releases/slayback-pharma-
`announces-launch-of-merzee-norethindrone-acetate-and-ethinyl-
`estradiol-capsules-and-ferrous-fumarate-capsules-1-mg20-mcg-
`generic-equivalent-of-taytulla-301222104.html (viewed July 8,
`2022)
`
`https://www.reviewofoptometry.com/article/when-to-prescribe-an-
`otc-allergy-drop (viewed August 22, 2022)
`
`https://www.riteaid.com/shop/ra-rednss-relf-eye-drp-5z-0354534
`(viewed August 8, 2022)
`
`https://www.riteaid.com/shop/rite-aid-eye-care-sterile-eye-drops-0-
`5-fl-oz (viewed August 8, 2022)
`
`https://rohtoeyedrops.com/collections/redness-
`reliever/products/rohtoallinonemulti-symptomeyedrops
`(viewed August 18, 2022)
`
`https://rohtoeyedrops.com/collections/redness-
`reliever/products/coolrelief_eyedrops (viewed August 18, 2022)
`
`https://rohtoeyedrops.com/collections/redness-
`reliever/products/rohtomaxstrengthrednessreliefcoolingeye_
`drops (viewed August 18, 2022)
`
`https://rohtoeyedrops.com/collections/redness-
`reliever/products/rohto-eye-drops-optic-glow (viewed August 18,
`2022)
`
`https://rohtoeyedrops.com/collections/redness-
`reliever/products/rohto-digi-eye-digital-eye-strain-eye-drops
`(viewed August 18, 2022)
`
`https://rohtoeyedrops.com/collections/redness-reliever (viewed July
`11, 2022)
`
`https://www.similasanusa.com/redness-itchy-eye-relief™ (viewed
`August8, 2022)
`
`https://slayback-pharma.com/about-us/ (viewed August 15, 2022)
`
`https://slayback-pharma.com/products/ (viewed August 16, 2022)
`
`https://slayback-pharma.com (viewed August 22, 2022)
`
`11
`
`
`
`
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`2143
`
`2144
`
`2145
`
`2146
`
`https://www.target.com/p/lumify-eye-drops/-/A-54293362 (viewed
`July 1, 2022)
`
`https://www.thezoereport.com/beauty-awards (viewed July 23,
`2022)
`
`https://us.mentholatum.com/about-us/ (viewed July 11, 2022)
`
`https://www.verywellhealth.com/best-eye-drops-for-red-eyes-
`5184209 (viewed July 12, 2022)
`
`2147
`
`Reserved
`
`2148
`
`2149
`
`2150
`
`2151
`
`2152
`
`2153
`
`2154
`
`2155
`
`2156
`
`https://www.walgreens.com/store/c/productlist/walgreens-redness-
`relief/N=361377-118 (viewed August 8, 2022)
`
`https://www.walmart.com/ip/LUMIFY-Redness-Reliever-Eye-
`Drops-Brimonidine-Tartrate-Ophthalmic-Solution-0-025-from-
`Bausch-Lomb-0-08-Fl-Oz-2-5-mL/193381081?athbdg=L 1600
`(viewed July 1, 2022)
`
`https://walrus.com/questions/lumify-vs-visine-what-is-the-
`difference (viewed August 16, 2022)
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208 144
`Orig1sO006Ibl.pdf (viewed August 18, 2022)
`
`“LUMIFY™ Redness Reliever Eye Drops Honored By The
`National Association of Chain Drug Stores As Product Showcase
`Winner”, PRNewswire (September 10, 2018)
`
`Rory Evans and Maureen Choi, “The Best of beauty 2019”, Brides
`(April/May 2019)
`
`“NewBeauty 2019 Award Winners: Best Innovations”, NewBeauty
`(March8, 2019)
`
`“Beauty Awards, The Best Even More, Never Knew We Needed”,
`New Beauty (2022)
`
`CONFIDENTIAL “Lumify ECP A&U Report”, 27 March 2020
`(Under Seal and Public versions)
`
`2157
`
`“Healthcare”, Ispos, https://www.ipsos.com/en-hk/healthcare
`
`12
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`
`
`
`DESCRIPTION
`
`“LUMIFY™ Redness Reliever Eye Drops Honored By The
`National Association of Chain Drug Stores As Product Showcase
`Winner”, PRNewswire (September 10, 2018)
`
`Bausch Health Q2 2022 Earning Presentation
`
`“About Us”, IRI available at https://www.iriworldwide.com/en-
`us/company/about-us(last visited July 25, 2022)
`
`US. Patent No. 8,293,742 (filed July 27, 2009) (issued Oct. 23,
`2012) (742 Patent) (Color)
`
`Deposition Transcript of Dr. Neal A. Sher, M.D.
`
`“The Science of Lumify”, https://www.lumifydrops.com/lumify-
`science (The Science of Lumify)
`
`EXHIBIT
`
`2158
`
`2159
`
`2160
`
`2161
`
`2162
`
`2163
`
`2164
`
`2165
`
`(Under Seal and Public versions)
`
`“Lumify Lovers of the Month - Meet Dillon Pena”,
`https://www.lumifydrops.com/lovers/march-202 1 -dillon-pena
`(Lumify Lovers)
`“Bausch + Lomb Receives FDA Approval of Lumify™ - The only
`Over-the-Counter Eye Drop with Low-Dose Brimonidinefor the
`Treatment of Eye Redness”, (December 22, 2017),
`https://ir.bauschhealth.com/news-releases/2017/12-22-2017-
`200318686
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`2166
`
`CONFIDENTIAL10-100-0008 Clinical Study Report (Excerpted)
`
`2167
`
`2168
`
`2169
`
`2170
`
`CONFIDENTIAL11-100-0015 Clinical Study Report (Excerpted)
`(Under Seal and Public versions)
`
`CONFIDENTIAL13-100-0005 Clinical Study Report (Excerpted)
`(Under Seal and Public versions)
`
`Robert J. Derick, “Adrenergic Agonist Medications: Basic
`Mechanisms.” Journal of Glaucoma, 4(Supp. 1):S1-S7 (1995)
`(Derick 1995)
`
`Drug Application Process for Nonprescription Drugs, FDA,
`https://www.fda.gov/drugs/types-applications/drug-application-
`process-nonprescription-drugs (FDA Website)
`
`13
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`
`2171
`
`2172
`
`2173
`
`2174
`
`2175
`
`2176
`
`2177
`
`DESCRIPTION
`
`Definition of Ciliary Body - NCI Dictionary Cancer Terms,
`https://www.cancer.gov/publications/dictionaries/cancer-
`terms/def/ciliary-body
`
`Eyes: How They Work, Anatomy & Common Conditions,
`Cleveland Clinic, https://my.clevelandclinic.org/health/body/21823-
`eyes
`
`Glaucoma: Symptomsand causes, Mayo Clinic,
`https://www.mayoclinic.org/diseases-
`conditions/glaucoma/symptoms-causes/syc-20372839?p=1
`
`S. J. Morgan, “Chemical Burns of the Eye: Causes and
`Management,” British Journal of Ophthalmology, 71:854-857
`(1987) (Morgan 1987)
`
`G. Munozet al., “Increased risk for flap dislocation with
`perioperative brimonidine use in femtosecondlaserin situ
`keratomileusis,” J. Cataract Refract. Surg., 35:1338-1342 (2009)
`
`G. Raviola, “Conjunctival and Episcleral Blood Vessels are
`Permeable to Blood-borne Horseradish Peroxidase’, Invest.
`Ophthalmol. Vis. Sci., 24:725-736, (June 1983) (Raviola)
`
`“Scientists discover why corneais transparent and free of blood
`vessels, allowing vision”, Schepens Eye ResearchInstitute (July 17,
`2006), https://www.eurekalert.org/news-releases/652982
`
`2178
`
`Sclera: Definition, Anatomy & Function, Cleveland Clinic,
`
`https://my.clevelandclinic.org/health/body/22088-sclera
`
`“Ts the sclera avascular (without blood vessels)?”, American
`Academy of Ophthalmology (January 31, 2019),
`https://www.aao.org/eye-health/ask-ophthalmologist-q/is-sclera-
`avascular-without-blood-vessels
`
`2179
`
`2180
`
`2181
`
`N.Sher, “Red eye: What's dangerous? What's not?”, Patient Care,
`18(19):87-114, (November15, 1984)
`
`Highlights of Prescribing Information for SIMBRINZA™
`(brinzolamide/brimonidinetartrate ophthalmic suspension)
`1%/0.2%
`
`14
`
`
`
`
`
`
`
`EXHIBIT
`
`2182
`
`2183
`
`2184
`
`2185
`
`2186
`
`2187
`
`2188
`
`2189
`
`2190
`
`2191
`
`2192
`
`2193
`
`2194
`
`2195
`
`2196
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`
`C.N. Soparkaret al., “Acute and Chronic Conjunctivitis Due to
`Over-the-counter Ophthalmic Decongestants,” Arch. Ophthalmol.,
`115:34-38 (1997) (Soparkar)
`
`S. L. Spector, et al., “Conjunctivitis medicamentosa,” J. Allergy
`Clin. Immunol., 94:134-136 (1994) (Spector)
`
`M.Stafford-Smith, MD. et al., “Alpha-adrenergic mRNA subtype
`expression in the humannasalturbinate,” Can. J. Anesth.,
`54(7):549-555 (2007) (Stafford-Smith)
`
`M.Abelson,et al., “The Truth about Tachyphylaxis,” Review of
`Ophthalmology (March 16, 2006),
`https://www.reviewofophthalmology.com/article/the-truth-about-
`tachyphylaxis (Abelson 2006)
`
`O. Uretmen,et al., Letters to the Editor: Prophylactic Bimonidine
`Before LASIK (2003) (Uretmen)
`
`R. R. Ruffolo, Jr., “a-Adrenoceptors”, Monogr. Neural. Sci.,10:224-
`253 (Karger, Basel 1984).
`
`Reserved
`
`Reserved
`
`US. Patent 3,890,319 (filed Feb. 14, 1973) (issued June 17, 1975)
`(319 patent)
`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 Public versions)
`
`CONFIDENTIAL NDA208144,Section 2.3.P.1.1 Finished Product
`Composition (Excerpted) (Under Seal and Public versions)
`
`15
`
`
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`2197
`
`2198
`
`2199
`
`2200
`
`K. S. Bower, Overview of Refractive Surgery, Am. Fm. Physician.
`2001;64(7):1183-1191.
`
`Deposition Transcript of Paul A. Laskar, Ph.D., dated August4,
`2022
`
`Enhancing the Managementof Red Eye,
`https://www.lumifydrops.com/siteassets/ecp/pdfs/Lumify-news.pdf
`
`P. Watts & N. Hawksworth, Delayed hypersensitivity to
`brimonidinetartrate 0.2% associated with high intraocular pressure,
`Eye (2002) 16, 132-135
`
`2201
`
`Reserved
`
`2202
`
`2203
`
`Reserved
`
`Reserved
`
`2204
`
`Reserved
`
`2205
`
`Reserved
`
`2206
`
`Reserved
`
`2207
`
`2208
`
`Reserved
`
`Reserved
`
`2209
`
`Reserved
`
`2210
`
`Reserved
`
`2211
`
`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)
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`
`
`
`Dated: August 29, 2022
`
`Respectfully submitted,
`
`By:_/Bryan C. Diner/
`Bryan C. Diner
`Reg. No. 32,409
`
`Lead Counsel for Patent Owner
`Eye Therapies, LLC
`
`16
`
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Updated Exhibit List and Exhibits 2020-2052, 2055-2146, 2148-2187, 2190-2200,
`
`and 2211 to Patent Owner’s Response (including the Under Seal and Public
`
`versions of the Confidential Exhibits) were served electronically via email on
`
`August 29, 2022 to counsel of record for the Petitioner at the following:
`
`Linnea P. Cipriano
`Goodwin Proctor LLP
`620 Eight Avenue
`New York, NY 10018
`lcipriano@goodwinlaw.com
`
`Louis H. Weinstein
`Patrick G. Pollard
`Windels Marx Lane & Mittendorf, LLC
`1 Giralda Farms
`Madison, NJ 07940
`lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
`
`Robert Frederickson III
`Goodwin Proctor LLP
`100 Northern Avenue
`Boston, MA 02210
`rfrederickson@goodwinlaw.com
`
`The Petitioner has consented to service by electronic mail.
`
`Date: August 29, 2022
`
`
`By: /Geneva Eaddy/
`Geneva Eaddy, Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
`
`