`
`
`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
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
