`
`
`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 FOURTH UPDATED EXHIBIT LIST
`
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Eye Therapies, LLC hereby
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`
`
`submits a current listing of Patent Owner Exhibits. Exhibit 2216 is being filed today.
`
`EXHIBIT
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`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)
`
`2008
`
`U.S. Patent No. 6,982,079 B2, Compositions For Treating Hyperemia
`
`2009
`
`Ji Hoon Lee, et al., “Efficacy of brimonidine tartrate 0.2% ophthalmic
`solution in reducing halos after laser in situ keratomileusis,” J. of
`Cataract & Refractive Surgery, 34:963-967 (2008)
`
`1
`
`
`
`
`
`EXHIBIT
`
`2010
`
`2011
`
`2012
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`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
`
`2019
`
`2020
`
`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/daf/index.cfm?event=o
`verview.process&ApplNo=020490
`
`Drugs@ FDA Approved Drug Information, Alphagan 0.15%,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=o
`verview.process&ApplNo=021262
`
`Press Release, “Allergan to focus on Alphagan-P, discontinue
`Alphagan
`(July
`8,
`2002),
`https://www.healio.com/news/ophthalmology/20120331/allergan-to-
`focus-on-alphagan-p-discontinue-alphagan
`
`Alphagan P (brimonidine tartrate ophthalmic solution) 0.1%,
`Approval Letter (Aug. 19, 2005)
`CONFIDENTIAL Declaration of Robert J. Noecker, MD, MBA
`(Under Seal and Public versions)
`
`2
`
`
`
`
`
`EXHIBIT
`2021
`
`2022
`2023
`
`2024
`
`2025
`
`2026
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`2032
`2033
`
`2034
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`CONFIDENTIAL Declaration of Robert O. Williams, III, Ph.D.
`(Under Seal and Public versions)
`Declaration of Stephen G. Davies, D.Phil.
`CONFIDENTIAL Declaration of John Ferris (Under Seal and
`Public versions)
`CONFIDENTIAL Declaration 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 Linda Felton,
`(Pharmaceutical Press 2012), Pp. 9 - 28.
`CONFIDENTIAL 3.2.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 N021770, (Brimonidine
`Tartrate (Alphagan P) Solution/Drops 0.1%),
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Pro
`duct_No=001&Appl_No=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%),
`
`3
`
`
`
`
`
`EXHIBIT
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Pro
`duct_No=001&Appl_No=021262&Appl_type=N
`“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., “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_docs/nda/2001/21-
`262_Alphagan%20P%20Ophthalmic_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
`000_ChemR.pdf
`de Mendoza et al., “Molecular recognition of oxoanions based on
`guanidinium receptors,” 36 CHEM. SOC. REV. 198, 198 (2007) (de
`Mendoza 2007)
`Bagwell, Kyle, “The Economic Analysis of Advertising,” Columbia
`University Department of Economics Discussion Paper Series,
`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
`
`4
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`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 of the 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 KSR v. Teleflex,”
`New York University Law Review, December 2011, Vol. 86, No. 6,
`2070-2112.
`Thomas, Randall and Ron Melton, “2016 Clinical Guide to
`Ophthalmic Drugs,” Review of Optometry, May 15, 2016, 1-51.
`BAU-LUM00063901
`CONFIDENTIAL LUM.0205.USA.21 (Under Seal and Public
`versions)
`Reserved
`Reserved
`LUM.1827.USA.21
`Lumify_v9 - PRC APRVD
`CONFIDENTIAL IRI Panel Data (Under Seal and Public
`versions)
`CONFIDENTIAL IRI Point-of-Sale Data (Under Seal and Public
`versions)
`Visine Supplemental Approval, October 17, 2018
`
`
`
`EXHIBIT
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`2052
`
`2053
`2054
`2055
`2056
`2057
`
`2058
`
`2059
`
`5
`
`
`
`
`
`EXHIBIT
`2060
`2061
`2062
`2063
`2064
`2065
`2066
`2067
`
`2068
`2069
`2070
`2071
`2072
`2073
`2074
`
`2075
`2076
`
`2077
`
`2078
`
`2079
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`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, November 29, 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 December 31, 2021
`Bausch Health Companies Inc. Q4 and FY 2021 Financial Results
`Johnson & Johnson SEC Form 10-K for the fiscal year ended
`December 31, 2006
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=o
`verview.process&ApplNo=020065 (viewed August 16, 2022)
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm
`?Appl_Type=N&Appl_No=020226#41039 (viewed August 16,
`2022)
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Pro
`duct_No=001&Appl_No=208144&Appl_type=N (viewed August
`22, 2022)
`
`6
`
`
`
`
`
`EXHIBIT
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`2089
`
`2090
`
`2091
`
`2092
`
`2093
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=o
`verview.process&ApplNo=020485 (viewed July 11, 2022)
`https://www.amazon.com/Lumify-Redness-Reliever-Drops-7-
`5mL/dp/B07BVYZL88/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)
`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)
`
`7
`
`
`
`
`
`EXHIBIT
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`2100
`
`2101
`
`2102
`
`2103
`
`2104
`
`2105
`
`2106
`
`2107
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`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=69166de
`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-rights-for-the-private-label-version-
`of-lumify-in-the-us?c4src=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)
`https://ir.bauschhealth.com/news-releases/2017/12-22-2017-
`200318686 (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)
`
`8
`
`
`
`
`
`EXHIBIT
`2108
`2109
`2110
`
`2111
`
`2112
`
`2113
`
`2114
`
`2115
`
`2116
`
`2117
`
`2118
`2119
`
`2120
`
`2121
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`https://www.lumifydrops.com/faqs (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-resource_topics_rightrail=1
`(viewed August 16, 2022)
`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)
`
`9
`
`
`
`
`
`EXHIBIT
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`2128
`
`2129
`
`2130
`
`2131
`
`2132
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`https://pitchbook.com/profiles/company/492664-60#overview
`(viewed August 18, 2022)
`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-
`generic-equivalent-of-firazyr-301123357.html (viewed July 8, 2022)
`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)
`
`10
`
`
`
`
`
`EXHIBIT
`2133
`
`2134
`
`2135
`
`2136
`
`2137
`
`2138
`
`2139
`
`2140
`2141
`2142
`2143
`
`2144
`
`2145
`2146
`
`2147
`2148
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`https://rohtoeyedrops.com/collections/redness-
`reliever/products/rohto_all_in_one_multi-symptom_eye_drops
`(viewed August 18, 2022)
`https://rohtoeyedrops.com/collections/redness-
`reliever/products/cool_relief_eye_drops (viewed August 18, 2022)
`https://rohtoeyedrops.com/collections/redness-
`reliever/products/rohto_max_strength_redness_relief_cooling_eye_
`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
`August 8, 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)
`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)
`Reserved
`https://www.walgreens.com/store/c/productlist/walgreens-redness-
`relief/N=361377-118 (viewed August 8, 2022)
`
`11
`
`
`
`
`
`EXHIBIT
`2149
`
`2150
`
`2151
`
`2152
`
`2153
`
`2154
`
`2155
`
`2156
`
`2157
`2158
`
`2159
`2160
`
`2161
`
`2162
`2163
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`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=L1600
`(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/2020/208144
`Orig1s006lbl.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
`(March 8, 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)
`“Healthcare”, Ispos, https://www.ipsos.com/en-hk/healthcare
`“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)
`U.S. 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)
`
`12
`
`
`
`
`
`EXHIBIT
`2164
`
`2165
`
`2166
`
`2167
`
`2168
`
`2169
`
`2170
`
`2171
`
`2172
`
`2173
`
`2174
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`“Lumify Lovers of the Month - Meet Dillon Pena”,
`https://www.lumifydrops.com/lovers/march-2021-dillon-pena
`(Lumify Lovers)
`“Bausch + Lomb Receives FDA Approval of LumifyTM - The only
`Over-the-Counter Eye Drop with Low-Dose Brimonidine for the
`Treatment of Eye Redness”, (December 22, 2017),
`https://ir.bauschhealth.com/news-releases/2017/12-22-2017-
`200318686
`CONFIDENTIAL 10-100-0008 Clinical Study Report (Excerpted)
`(Under Seal and Public versions)
`CONFIDENTIAL 11-100-0015 Clinical Study Report (Excerpted)
`(Under Seal and Public versions)
`CONFIDENTIAL 13-100-0005 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)
`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: Symptoms and 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)
`
`13
`
`
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`2175
`
`2176
`
`2177
`
`2178
`
`2179
`
`DESCRIPTION
`G. Munoz et al., “Increased risk for flap dislocation with
`perioperative brimonidine use in femtosecond laser in 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 cornea is transparent and free of blood
`vessels, allowing vision”, Schepens Eye Research Institute (July 17,
`2006), https://www.eurekalert.org/news-releases/652982
`Sclera: Definition, Anatomy & Function, Cleveland Clinic,
`https://my.clevelandclinic.org/health/body/22088-sclera
`“Is 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
`N. Sher, “Red eye: What's dangerous? What's not?”, Patient Care,
`18(19):87-114, (November 15, 1984)
`Highlights of Prescribing Information for SIMBRINZA™
`(brinzolamide/brimonidine tartrate ophthalmic suspension)
`1%/0.2%
`C. N. Soparkar et 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)
`2184 M. Stafford-Smith, MD. et al., “Alpha-adrenergic mRNA subtype
`expression in the human nasal turbinate,” Can. J. Anesth.,
`54(7):549-555 (2007) (Stafford-Smith)
`2185 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)
`
`2180
`
`2181
`
`2182
`
`2183
`
`14
`
`
`
`
`
`EXHIBIT
`2186
`
`2187
`
`2188
`2189
`2190
`
`2191
`2192
`2193
`2194
`
`2195
`
`2196
`
`2197
`
`2198
`
`2199
`
`2200
`
`2201
`2202
`2203
`2204
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`DESCRIPTION
`O. Uretmen, et al., Letters to the Editor: Prophylactic Brimonidine
`Before LASIK (2003) (Uretmen)
`R. R. Ruffolo, Jr., “α-Adrenoceptors”, Monogr. Neural. Sci.,10:224-
`253 (Karger, Basel 1984).
`Reserved
`Reserved
`U.S. 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 NDA 208144, Section 2.3.P.1.1 Finished Product
`Composition (Excerpted) (Under Seal and Public versions)
`K. S. Bower, Overview of Refractive Surgery, Am. Fm. Physician.
`2001;64(7):1183-1191.
`Deposition Transcript of Paul A. Laskar, Ph.D., dated August 4,
`2022
`Enhancing the Management of Red Eye,
`https://www.lumifydrops.com/siteassets/ecp/pdfs/Lumify-news.pdf
`P. Watts & N. Hawksworth, Delayed hypersensitivity to
`brimonidine tartrate 0.2% associated with high intraocular pressure,
`Eye (2002) 16, 132-135
`Reserved
`Reserved
`Reserved
`Reserved
`
`15
`
`
`
`Case No. IPR2022-00142
`U.S. Patent No. 8,293,742
`
`EXHIBIT
`2205
`2206
`2207
`2208
`2209
`2210
`2211
`
`2212
`
`2213
`
`2214
`
`2215
`
`2216
`
`DESCRIPTION
`
`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)
`Deposition Transcript of Paul A. Laskar, Ph.D., dated January 18,
`2023
`Deposition Transcript of Dr. Neal A. Sher, M.D., dated January 27,
`2023
`Redacted Version of Petitioner’s Exhibit 1051 Deposition
`Transcript of John Ferris, dated November 2, 2022
`Declaration of Robert Gorman Jr. in Response to Slayback’s
`Objections to Patent Owner’s Exhibit Nos. 2028, 2057-2058, 2156,
`2166-2168, and 2195-2196 (served but not filed on Sept. 20, 2022)
`Patent Owner Eye Therapies, LLC’s Demonstratives
`
`
`
`
`
`Dated: February 22, 2023
`
`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
`
`Fourth Updated Exhibit List and Exhibit 2216 were served electronically via
`
`email on February 22, 2023 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: February 22, 2023
`
`
`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
