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`Case IPR2022-00142
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`United States Patent No. 8,293,742
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`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 THIRD UPDATED EXHIBIT LIST
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`Case IPR2022-00142
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`United States Patent No. 8,293,742
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`Petitioner hereby submits a current listing of Petitioner’s Exhibits.
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`UPDATED EXHIBIT LIST
`
`Description
`
`Exhi
`bit
`1001 U.S. Patent No. 8,293,742 (filed July 27, 2009) (issued Oct. 23, 2012) (’742
`Patent)
`1002 Expert Declaration of Neal A. Sher, M.D. (Sher)
`1003 Expert Declaration of Paul A. Laskar, Ph.D. (Laskar)
`1004 U.S. Patent No. 6,294,553 (filed Feb. 14, 2001) (issued Sep. 25, 2001) (’553
`patent)
`1005 Walters, Thomas R., et al. “A Pilot Study of Life Efficacy and Safety of
`AGN 190342-Lf 0.02% And 0.08% In Patients with Elevated Intraocular
`Pressure.” Association for Research in Vision and Ophthalmology, vol. 32,
`no. 4, 15 Mar. 1991, p. 988 (Walters 1991)
`1006 Norden, Richard A. “Effect of Prophylactic Brimonidine or Bleeding
`Complications and Flap Adherence after Laser in Situ Keratomileusis.”
`Journal of Refractive Surgery, vol. 18, no. 4, 2002, pp. 468–471 (Norden
`2002)
`1007 U.S. Patent 6,242,442 (filed Dec. 7, 1999) (issued June 5, 2001) (’442
`patent)
`1008 “ALPHAGAN® (brimonidine tartrate ophthalmic solution) 0.2%.”
`Physicians’ Desk Reference, 52th ed., Medical Economics Company, Inc.,
`1998, p. 487 (Alphagan® Label 1998)
`1009 53 Fed. Reg. 7076-7093 (Mar. 4, 1988) (Federal Register 1988)
`1010 U.S. Application 12/460,941 filed July 27, 2009, downloaded from PAIR
`(’941 Application)
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`1011 U.S. Provisional Application 61/207,481 filed February 12, 2009,
`downloaded from PAIR (’481 Provisional)
`1012 U.S. Provisional Application 61/203,120 filed December 18, 2008,
`downloaded from PAIR (’120 Provisional)
`1013 U.S. Provisional Application 61/192,777 filed September 22, 2008,
`downloaded from PAIR (’777 Provisional)
`1014 U.S. Provisional Application 61/137,714 filed August 1, 2008, downloaded
`from PAIR (’714 Provisional)
`1015 Timmermans, et al., “Structure-Activity Relationships in Clonidine-Like
`Imidazolines and Related Compounds,” Progress in Pharmacology, edited
`by H. Grobecker et al., vol. 3, No. 1, Gustav Fischer Verlag, New York,
`NY, 1980 (Timmermans 1980)
`1016 Griffith, Robert K. “Adrenergics and Adrenergic- Blocking Agents.”
`Burger's Medicinal Chemistry and Drug Discovery, edited by Donald J.
`Abraham, 6th ed., vol. 6, John Wiley & Sons, Inc., New York, NY, 2003,
`pp. 2–37 (Griffith 2003)
`1017 Wickberg-Matsson, Anna, and Ulf Simonsen. “Potent α2A-Adrenoceptor–
`Mediated Vasoconstriction by Brimonidine in Porcine Ciliary Arteries.”
`Investigative Ophthalmology & Visual Science, vol. 42, no. 9, Aug. 2001,
`pp. 2049–2055 (Wikberg 2001)
`1018 Robin, Alan L., and Yochanan Burnstein. “Selectivity of Site of Action and
`Systemic Effects of Topical Alpha Agonists.” Current Opinion in
`Ophthalmology, vol. 9, no. 2, 1998, pp. 30–33 (Robin 1998)
`1019 Lachkar, Yves, and Surinda Dhanjill. “Effect of Brimonidine Tartrate on
`Ocular Hemodynamic Measurements.” Archives of Ophthalmology, vol.
`116, no. 12, Dec. 1998, pp. 1591–1594 (Lachkar 1998)
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`1020 Carlsson, Anthony M, et al. “The Effect of Brimonidine Tartrate on Retinal
`Blood Flow in Patients with Ocular Hypertension.” American Journal of
`Ophthalmology, vol. 129, no. 3, Mar. 2000, pp. 297–301 (Carlsson 2000)
`1021 David, R. “Brimonidine (Alphagan®): A Clinical Profile Four Years after
`Launch.” European Journal of Ophthalmology, vol. 11, no. 2_suppl, 2001,
`pp. S72–S77 (David 2001)
`1022 Schuman, Joel S., et al. “A 1-Year Study of Brimonidine Twice Daily In
`Glaucoma and Ocular Hypertension.” Archives of Ophthalmology, vol. 115,
`no. 7, July 1997, pp. 847-852 (Schuman 1997)
`1023 Scruggs, Jennifer T., et al. “The Teardrop Sign: A Rare Dermatological
`Reaction to Brimonidine.” British Journal of Ophthalmology, vol. 84, no. 6,
`2000, pp. 671–672 (Scruggs 2000)
`1024 File Wrapper, U.S. Application 12/460,941 filed July 27, 2009, downloaded
`from PAIR
`1025 Pasquali, Theodore A., et al. “Dilute Brimonidine to Improve Patient
`Comfort and Subconjunctival Hemorrhage After Lasik.” Journal of
`Refractive Surgery, vol. 29, no. 7, 2013, pp. 469–475 (Pasquali 2013)
`1026 Murphy, P. J., et al. “How Red Is a White Eye? Clinical Grading of Normal
`Conjunctival Hyperaemia.” Eye, vol. 21, no. 5, 2006, pp. 633–638 (Murphy
`2007)
`1027 Derick, Robert J., et al. “Brimonidine Tartrate.” Ophthalmology, vol. 104,
`no. 1, Jan. 1997, pp. 131–136 (Derick 1997)
`1028 Burke, James, et al. “Adrenergic and Imidazoline Receptor-Mediated
`Responses to UK-14,304-18 (Brimonidine) in Rabbits and, Monkeys.” The
`Imidazoline Receptor: Pharmacology, Functions, Ligands and Relevance to
`Biology and Medicine, edited by Donald J. Reis, et al., Vol. 763, The New
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`York Academy of Sciences, New York, NY, 1995, pp. 78–95. (Burke 1995)
`1029 David, Robert, et al. “Brimonidine in the Prevention of Intraocular Pressure
`Elevation Following Argon Laser Trabeculoplasty,” Archives of
`Ophthalmology, vol. 111, No. 10, Oct. 1993, pp. 1387–1390 (David 1993)
`1030 U.S. Patent Application Publication No. 2005/0244463 (filed Apr. 30,
`2004) (published Nov. 3, 2005) (US 2005/0244463)
`1031 United States, Center for Drug Evaluation and Research, and Joanne
`Holmes. NDA 20-613 AlphaganTM (Brimonidine Ophthalmic Solution)
`0.2% Sterile, vol. 1, U.S. Food and Drug Administration, 1985, pp. 1–286.
`(CDER Records 20613)
`1032 Rahman, Mamum Q., et al. “Brimonidine for Glaucoma.” Expert Opinion
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`1033 U.S. Patent No. 6,562,873 (filed July 10, 2001) (issued May 13, 2003) (’873
`patent)
`1034 Chien, Du-Shieng, et al. “Corneal and Conjunctival/Scleral Penetration of
`P-Aminoclonidine, AGN 190342, and Clonidine in Rabbit Eyes.” Current
`Eye Research, vol. 9, no. 11, 1990, pp. 1051–1059 (Chien 1990)
`1035 Burke, James, and Michal Schwartz. “Preclinical Evaluation of
`Brimonidine.” Survey of Ophthalmology, vol. 41, no. 1, Nov. 1996, pp. S9–
`S18 (Burke 1996)
`1036 Petitioner’s Limitation By Limitation Listing for U.S. Patent No. 8,293,742
`1037
`Not used
`-
`1042
`1043
`
`
`Slayback Defendants’ Stipulation to Limit Invalidity Contentions [D.I. 18]
`in Bausch & Lomb, Inc. et al. v. Slayback Pharma LLC et al., Civil Action
`No. 21-16766 (D.N.J.) (Stipulation)
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`1044 Declaration of Robert Frederickson III in Support of Motion for Pro Hac
`Vice Admission
`1045 Bausch Health Companies, 2018 Q3 Earnings Call Transcript, dated
`November 6, 2018
`1046 Side-by-Side Comparison of Figures 2 and 6 of U.S. Patent No. 9,259,425
`(filed October 3, 2013) (issued February 16, 2016) (Noecker)
`1047 Declaration of Ivan T. Hofmann in Support of Petitioner’s Reply (Hofmann
`Reply)
`1048 Declaration of Paul Laskar, Ph.D In Support of Petitioner’s Reply
`1049 Declaration of Neal A. Sher, M.D. in Support of Petitioner’s Reply (Sher
`Reply)
`1050 Deposition Transcript of Stephen G. Davies, DPhil, dated October 28, 2022
`1051 Deposition Transcript of John Ferris, dated November 2, 2022
`1052 Deposition Transcript of John Jarosz, dated November 11, 2022
`1053 Deposition Transcript of Robert Noecker, M.D., dated November 13, 2022
`1054 Deposition Transcript of Robert O. Williams, III, Ph.D., dated November
`15, 2022
`1055 U.S. Pharmacopeia 28-National Formulary 23, 2005
`1056 Conrad, J.M., Reay, W.A., Polcyn, R.E., and Robinson, J.R., Influence of
`Tonicity and pH on Lacrimation and Ocular Drug Availability, Journal of
`the Parenteral Drug Association, vol. 32, no. 4, pp. 149-161, July-August
`1978 (Conrad 1978)
`1057 Gonnering, R., Edelhauser, H.F., Van Horn, D.L., and Durant, W., The pH
`Tolerance of Rabbit and Human Corneal Endothelium, Investigative
`Ophthalmology & Visual Science, vol. 18, no. 4, pp. 373-390, April 1979
`(Gonnering 1979)
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`1058 Naphcon A, Alcon Laboratories, Inc.
`1059 Srinivasan, S. and Venkiteshwar, M., A Decade of Effective Dry Eye
`Disease Management with Systane Ultra (Polyethylene Glycol/Propylene
`Glycol with Hydroxypropyl Guar) Lubricant Eye Drops, Clinical
`Ophthalmology, vol. 15, pp. 2421-2435, June 9, 2021 (Srinivasan 2021)
`1060 Brimonidine Tartrate, Drugs@FDA: FDA-Approved Drugs,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.
`process&ApplNo=020613 (last accessed December 8, 2022)
`1061 Aieta, E.M. & Roberts, P.V. (1985) The chemistry of oxo-chlorine
`compounds relevant to chlorine dioxide generation. In: Jolley, R.L., Bull,
`R.J., Davis, W.P., Katz, S., Roberts, M.H., Jr & Jacobs, V.A., eds, Water
`Chlorination: Chemistry, Environmental Impact and Health Effects, Vol. 5,
`Ann Arbor, MI, Lewis Publishers, pp. 783–794 (Aieta 1985)
`1062 Not Used
`1063 Center For Drug Evaluation and Research, Application Number: 21-770
`Medical Review
`1064 Remington: The Science and Practice of Pharmacy, pp. 1380-1416, 1563-
`1576; 1995 (Remington 1995)
`1065 Not Used
`1066 Not Used
`1067 Patent Assignment Search,
`https://assignment.uspto.gov/patent/index.html#/patent/search/resultFilter?s
`earchInput=8293742 (last accessed Dec. 2, 2022)
`1068 Ivan T. Hofmann CV and Testimony
`1069 Bausch SEC Form 10-Q, for the period ended June 30, 2022, available at
`https://otp.tools.investis.com/clients/us/bausch_health_companies/SEC/sec-
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`show.aspx?FilingId=16064281&Cik=0000885590&Type=PDF&hasPdf=1
`(last accessed Nov. 17, 2022)
`1070 Bausch Fourth Quarter 2018 Earnings Call Transcript, dated February 20,
`2019, available at https://seekingalpha.com/article/4242568-bausch-health-
`companies-inc-bhc-ceo-joseph-papa-on-q4-2018-results-earnings-call-
`transcript (last accessed Nov. 17, 2022)
`1071 Bausch Second Quarter 2019 Earnings Call Transcript, dated August 6,
`2019, available at https://seekingalpha.com/article/4282236-bausch-health-
`companies-inc-bhc-ceo-joseph-papa-on-q2-2019-results-earnings-call-
`transcript (last accessed Nov. 17, 2022)
`1072 Bausch Fourth Quarter 2020 Earnings Call Transcript, dated February 24,
`2021, available at https://seekingalpha.com/article/4408646-bausch-health-
`companies-inc-bhc-ceo-joe-papa-on-q4-2020-results-earnings-call-
`transcript (last accessed Nov. 17, 2022)
`1073 Bausch Fourth Quarter 2021 Earnings Call Transcript, dated February 23,
`2022, available at https://seekingalpha.com/article/4489552-bausch-health-
`companies-inc-bhc-ceo-joseph-papa-on-q4-2021-results-earnings-call-
`transcript (last accessed Nov. 17, 2022)
`1074 MUSE Creative Awards, dated Apr. 11, 2019,
`https://www.hg.agency/news/muse-awards (last accessed Nov. 17, 2022).
`1075 MUSE Creative Awards, https://museaward.com/ (last accessed Nov. 17,
`2022)
`1076 Helen & Gertrude, https://www.hg.agency/ (last accessed Nov. 17, 2022)
`1077 2019 Silver Winner, Lumify® Redness Reliever Drops,
`https://museaward.com/winner-info.php?id=2187 (last accessed Nov. 17,
`2022)
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`1078 2019 Rose Gold Winner, Lumify® Redness Reliever Drops,
`https://museaward.com/winner-info.php?id=2186 (last accessed Nov. 17,
`2022)
`1079 Wavemaker US wins two Gold Effie Awards, dated June 3, 2019,
`https://wavemakerglobal.com/usa/news-wavemaker-us-wins-two-gold-
`effie-awards (last accessed Nov. 17, 2022)
`1080 Our Work, Wavemaker, https://wavemakerglobal.com/our-work (last
`accessed Nov. 17, 2022)
`1081 Ben Adams, Bausch + Lomb kicks off TikTok challenge for Lumify, asking
`consumers to ‘dance with their eyes,’ FiercePharma (July 29, 2022),
`https://www.fiercepharma.com/marketing/bausch-lomb-kickstarts-tiktok-
`campaign-lumify-it-asks-consumers-dance-their-eyes (last accessed Nov.
`17, 2022)
`1082 Bausch + Lomb Launches the #LUMIFYEyeDance Challenge on TikTok,
`PRNewsWire (July 28, 2022), https://www.prnewswire.com/news-
`releases/bausch--lomb-launches-the-lumifyeyedance-challenge-on-tiktok-
`301594922.html (last accessed Nov. 17, 2022)
`1083 #lumifyeyedance, TikTok,
`https://www.tiktok.com/tag/lumifyeyedance?lang=en (last accessed Nov.
`17, 2022)
`1084 Disclosures 101 for Social Media Influencers, Federal Trade Commission
`(Nov. 2019), https://www.ftc.gov/system/files/documents/plain-
`language/1001a-influencer-guide-508_1.pdf (last accessed Nov. 17, 2022)
`1085 @Allenface, Tik Tok,
`https://www.tiktok.com/@allanface/video/7129967072628657454?is_copy
`_url=1&is_from_webapp=v1&lang=en (last accessed Nov. 17, 2022)
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`1086 @orionsisters, TikTok,
`https://www.tiktok.com/@orionsisters/video/7124396970558459179?is_co
`py_url=1&is_from_webapp=v1&lang=en (last accessed Nov. 17, 2022)
`1087 Bausch + Lomb #LUMIFYEyeDance Challenge Wins 2022 Public
`Relations and Marketing Excellence Award for External Campaign of the
`Year from Business Intelligence Group, PRNewsWire (Nov. 1, 2022),
`https://www.prnewswire.com/news-releases/bausch--lomb-lumifyeyedance-
`challenge-wins-2022-public-relations-and-marketing-excellence-award-for-
`external-campaign-of-the-year-from-business-intelligence-group-
`301664009.html (last accessed Nov. 17, 2022)
`1088 Wilson, et al., The Corneal Wound Healing Response: Cytokine-mediated
`Interaction of the Epithelium, Stroma, and Inflammatory Cells, Progress in
`Retinal and Eye Research, Volume 20, Issue 5, 2001, Pages 625-637,9462
`https://doi.org/10.1016/S1350-9462(01)00008-8. (Wilson 2001)
`1089 Solomon, et al., Pro- and anti-inflammatory forms of interleukin-1 in the
`tear fluid and conjunctiva of patients with dry-eye disease. Invest
`Ophthalmol Vis Sci. 2001 Sep;42(10):2283-92. PMID: 11527941 (Solomon
`2001)
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`Vessels: Physiology and Pharmacology, Journal of Cardiovascular
`Pharmacology, vol. 6, supplement 4, pp. S547-558, 1984 (Langer 1984)
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`postsynaptic α-adrenergic receptors (α-ARs) of both the α1 and α2 type.
`General Pharmacology: The Vascular System Volume 34, Issue 2, February
`2000, Pages 101-106 (Duka 2001)
`1092 Philipp M., Brede M., and Hein L., Physiological significance of α2-
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`adrenergic receptor subtype diversity: one receptor is not enough, American
`Journal of Physiology: Regulatory, Integrative and Comparative
`Physiology, vol. 2, pp. R287–295, 2002 (Philipp 2002)
`1093 Angus J.A., Cocks T.M., Wright C.E., Satoh K., and Campbell G.R. (1988)
`Endothelium-Dependent Responses in Large Arteries and in the
`Microcirculation, in Vanhoutte P.M., ed., Relaxing and Contracting
`Factors, Humana Press Inc, pp. 361–386 (Angus 1988)
`1094 Bockman C.S., Jeffries W.B., Abel P.W., Binding and Functional
`Characterization of Alpha-2 Adrenergic Receptor Subtypes on Pig Vascular
`Endothelium, Journal of Pharmacology and Experimental Therapeutics, vol.
`267, no. 3, pp. 1126–1133, 1993 (Bockman 1992)
`1095 Spector S.L. & Raizman M.B., Conjunctivitis Medicamentosa, Journal of
`Allergy and Clinical Immunology, vol. 94, no. 1, pp. 134–136, July 1994
`(Spector 1994)
`1096 Soparkar, C.N.S., et al., Acute and Chronic Conjunctivitis Due
`to Over-the-counter Ophthalmic Decongestants. Arch Ophthalmol 1997;
`115:34-38 (Soparkar 1997)
`1097 Stedman’s Medical Dictionary, 28th Ed, pp. 688-689
`1098 Morrow G.L. & Abbott R.L., Conjunctivitis, American Family Physician,
`vol. 57, no. 4, pp. 735–746, Feb. 15 1998 (Morrow 1998)
`1099 Pink Eye (Conjunctivitis), Mayo Clinic,
`https://www.mayoclinic.org/diseases-conditions/pink-eye/symptoms-
`causes/syc-
`20376355#:~:text=Pink%20eye%20(conjunctivitis)%20is%20an,to%20app
`ear%20reddish%20or%20pink (last accessed Dec. 14, 2022) (Mayo Clinic
`2022)
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`1100 Subconjunctival hemorrhage - American Academy of Ophthalmology,
`https://www.aao.org/image/subconjunctival-hemorrhage-7 (last accessed
`December 14, 2022)
`1101 Chapter 43: Ophthalmic Solutions of Remington: The Science and Practice
`of Pharmacy (2000)
`1102 Aslanides I.M., et al., Letter to the Editor. Ophthalmology Volume 112,
`Number 12, December 2005. 2238.e8-2238.e9 (Aslanides 2005)
`1103 Aslanides I.M., et al., The Effect of Topical Apraclonidine on
`Subconjunctival Hemmorhage and Flap Adherence in LASIK Patients.
`Journal of Refractive Surgery, Volume 22, June 2006. 585-588
`1104 Hong, S., et al., Effect of Prophylactic Brimonidine Instillation on Bleeding
`During Strabismus Surgery in Adults. American Journal of Opthamology.
`Volume 144, Issue 3, pp. 469-470, September 2007 (Hong 2007)
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`Dated: December 16, 2022
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`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
`Cell: (443) 235-1739
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
`
`Counsel for Petitioner Slayback Pharma LLC
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`CERTIFICATE OF SERVICE
`
`I, Linnea P. Cipriano, certify that I caused to be served a true and correct
`
`copy of the foregoing PETITIONER’S THIRD UPDATED EXHIBIT LIST by
`
`email, as follows:
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`Bryan Diner
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`bryan.diner@finnegan.com
`
`Justin Hasford
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`Justin.hasford@finnegan.com
`
`Caitlin O’Connell caitlin.oconnell@finnegan.com
`
`Christina Yang
`
`christina.yang@finnegan.com
`
`Dated: December 16, 2022
`
`
`
`/Linnea P. Cipriano/
`Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Cell: (443) 235-1739
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
`
`Counsel for Petitioner Slayback Pharma LLC
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