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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Case IPR2017-01053
`Patent 8,268,299
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`ALCON RESEARCH, LTD.,
`Patent Owner
`
`
`Case IPR2017-01053
`Patent 8,268,299
`
`
`
`
`
`
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`
`
`ALCON RESEARCH, LTD.’S FOURTH UPDATED EXHIBIT LIST
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`Case IPR2017-01053
`Patent 8,268,299
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`2004
`
`Description
`
`Alcon
`Exhibit
`No.
`2001 Declaration of Adam L. Perlman in Support of Motion for Pro Hac Vice
`Admission Pursuant to 37 C.F.R. § 42.10(c)
`2002 Declaration of Alexander S. Zolan in Support of Motion for Pro Hac
`Vice Admission Pursuant to 37 C.F.R. § 42.10(c)
`2003 Declaration of Christopher J. Mandernach in Support of Motion for Pro
`Hac Vice Admission Pursuant to 37 C.F.R. § 42.10(c)
`Center for Drug Evaluation and Research, Medical Review, NDA No.
`21-994. Available at:
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/
`021994s000TOC.cfm
`2005 United States Patent Application Publication No. 2007/0212420 A1
`2006 Declaration of Bhagwati P. Kabra, Ph.D.
`2007 Declaration of Stephen Shannon, MBA, Ph.D.
`2008 Alcon Laboratory Notebook No. 11118, pp. 77–82
`2009 Alcon Laboratory Notebook No. 11781, pp.19–21
`2010 Alcon Laboratory Notebook No. 10545, p. 51
`2011 Alcon Laboratory Notebook No. 10750, p. 81
`2012 Alcon Laboratory Notebook No. 11068, pp. 17–24
`2013 Alcon Laboratory Notebook No. 9988, p. 87
`2014 Alcon Laboratory Notebook No. 13160, p. 66
`2015 Alcon Laboratory Notebook No. 13292, pp. 38–39
`2016 Alcon Laboratory Notebook No. 11781, pp. 81–83
`2017 Adjunctive Pages to Alcon Laboratory Notebook No. 11781, pp. 81–83
`2018 Alcon Laboratory Notebook No. 10750, p. 19
`2019 Alcon Laboratory Notebook No. 10545, p. 41
`2020 Alcon Laboratory Notebook No. 10750, p. 21
`2021 Alcon Laboratory Notebook No. 12586, p. 63
`2022 Alcon Laboratory Notebook No. 12034, p. 91
`2023 Declaration of Soumyajit Majumdar, Ph.D.
`2024 Curriculum Vitae of Soumyajit Majumdar, Ph.D
`2025 Declaration of George Zhanel, Ph.D
`2026 Curriculum Vitae of George Zhanel, Ph.D
`2027 Declaration of Richard K. Parrish, II, M.D.
`2028 Curriculum Vitae of Richard K. Parrish, II, M.D.
`2029 Declaration of Henry Grabowski, Ph.D.
`2030 Curriculum Vitae of Henry Grabowski, Ph.D.
`1
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`Case IPR2017-01053
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`Patent 8,268,299
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`The Merck Index, An Encyclopedia of Chemicals, Drugs, and
`2031
`Biologicals (13th ed. 2001), Merck Research Laboratories, 1810
`53 Fed. Reg. 7076 (Mar. 4, 1988)
`2032
`2033 U.S. Pharmacopeia 23 (1995)
`2034 Remington: The Science and Practice of Pharmacy (20th ed. 2000)
`Final Report on the Safety Assessment of Polyquaternium-10,
`2035
`7 J. of the Am. College of Toxicology 347 (1988)
`2036 United States Patent No. 5,336,508
`2037 United States Patent No. 5,393,491
`2038 United States Patent No. 5,741,817
`2039 United States Patent No. 6,872,705
`2040
`TRAVATAN Z® and Other Prostaglandin Analog Drugs
`2041
`TRAVATAN Z® Wholesale Dollar Sales
`TRAVATAN Z® and Other Prostaglandin Analog Drugs, Share of
`2042
`Wholesale Dollar Sales
`2043 Number of Prescriptions for TRAVATAN Z®
`TRAVATAN Z® and Other Prostaglandin Analog Drugs, Share of
`2044
`Prescriptions
`2045 Number of New Prescriptions for TRAVATAN Z®
`TRAVATAN Z® and Other Prostaglandin Analog Drugs, Share of New
`2046
`Prescriptions
`2047
`TRAVATAN Z® Unit Sales
`TRAVATAN Z® and Other Prostaglandin Analog Drugs, Share of Unit
`2048
`Sales
`TRAVATAN Z®, TRAVATAN®, and LUMIGAN®, Cumulative
`2049
`Wholesale Dollar Sales
`2050 Number of Prescriptions for TRAVATAN®
`TRAVATAN Z® and Other Prostaglandin Analog Drugs, Share of Voice
`2051
`Excluding Retail Value of Samples
`TRAVATAN Z® and Other Prostaglandin Analog Drugs, Share of Voice
`Including Retail Value of Samples
`TRAVATAN Z®, TRAVATAN®, and LUMIGAN®, Marketing-to-Sales
`Ratio Excluding Retail Value of Samples
`TRAVATAN Z®, TRAVATAN®, and LUMIGAN®, Promotional
`Spending Excluding Retail Value of Samples
`TRAVATAN Z® and Other Prostaglandin Analog Drugs,
`Formulary Placement for Commercial Plans 2017–2018
`TRAVATAN Z® and Other Prostaglandin Analog Drugs,
`Formulary Placement for Commercial Plans 2017–2018
`
`2056
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`2
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`2052
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`2053
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`2054
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`2055
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`2057
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`2058
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`2064
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`2065
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`2066
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`2067
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`Case IPR2017-01053
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`Patent 8,268,299
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`TRAVATAN Z® and Other Prostaglandin Analog Drugs,
`Formulary Placement for Medicare Plans 2017–2018
`TRAVATAN Z® and Other Prostaglandin Analog Drugs,
`Formulary Placement for Medicare Plans 2017–2018
`“Bibliography of Published Papers and Presentations Using
`2059
`QuintilesIMS Information,” QuintilesIMS Institute, May 2017
`2060 U.S. Food and Drug Administration, TRAVATAN Z® NDA Approval
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`2061 Alcon, Inc., Form 20-F 2006
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`2075
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`Case IPR2017-01053
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`Patent 8,268,299
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`Berndt, E. R., 2001, “The U.S. Pharmaceutical Industry: Why Major
`Growth in Times of Cost Containment?” Health Affairs, Vol. 20, No. 2,
`pp. 100–114
`Berndt, E. R., 2002, “Pharmaceuticals in U.S. Health Care:
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`Vol. 16, No. 4, pp. 45–66
`Coscelli, A. and M. Shum, 2004, “An Empirical Model of Learning and
`Patient Spillovers in New Drug Entry,” Journal of Econometrics, Vol.
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`Lakdawalla, D. and T. Philipson, 2012, “Does Intellectual Property
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`Law and Economics, Vol. 55, No. 1, pp. 151–187
`Ross, J. S. and A. S. Kesselheim, 2013, “Prescription-Drug Coupons—
`No Such Thing as a Free Lunch,” The New England Journal of
`Medicine, Vol. 369, No. 13, pp. 1188–1189
`“Prescription Drug Discount Coupons: Implications for Public and
`Commercial Health Care Plans,” Congressional Research Service,
`November 5, 2015, available at
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`1b5df95d1210de9d33ca46c9b64d.pdf
`“Prescription Drug Discount Coupons and Patient Assistance Programs
`(PAPs),” Congressional Research Service, June 15, 2017, available at
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`Starner, C., et al., 2014, “Specialty Drug Coupons Lower Out-of-Pocket
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`No. 10, pp. 633–640, W-212–213
`Tenaglia, M., 2012, “Copay Cards and Coupons: Letting the Facts Get
`in the Way,” PharmExec.com, available at
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`Case IPR2017-01053
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`Patent 8,268,299
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`“Medicines Use and Spending Shifts: A Review of the Use of Medicines
`in the U.S. in 2014,” IMS Institute for Healthcare Informatics, April
`2015, available at
`https://www.redaccionmedica.com/contenido/images/IIHI_Use_of_Med
`icines_Report_2015.pdf
`“Click Here for valuable information and a special $20 Rebate,” July 30,
`2003, available at
`https://web.archive.org/web/20030730072726/http://www.lumigan.com:
`80/
`“$20 Rebate Offer,” July 25, 2004, available at
`https://web.archive.org/web/20040725093240/http://www.lumigan.com:
`80/tools/rebateform.aspx
`“Save on LUMIGAN®, Save $20 on your next prescription,” October 1,
`2005, available at
`https://web.archive.org/web/20051001071622/http://lumigan.com:80/
`“If you’re taking LUMIGAN®, and would like a rebate coupon for up to
`$20 off, please click here,” June 16, 2006, available at
`https://web.archive.org/web/20060616100836/http://www.allergan.com:
`80/site/products/consumers/home.asp?id=lumigan
`“Save on LUMIGAN®, Save $20 on your next prescription,” June 13,
`2007, available at
`https://web.archive.org/web/20070613153631/http://www.lumigan.com:
`80/
`“Save on LUMIGAN®, Save $20 on your next prescription,” August 14,
`2008, available at
`https://web.archive.org/web/20080814171216/http://www.lumigan.com:
`80/
`“Save on LUMIGAN®, Save $20 on your next prescription,” June 27,
`2009, available at
`https://web.archive.org/web/20090627083643/http://www.lumigan.com:
`80/
`“Sign Up for Savings and Helpful E-mail Updates,” June 23, 2010,
`available at
`https://web.archive.org/web/20100623235100/http://www.lumigan.com:
`80/Offers/Default.aspx
`“Sign Up for Savings and Helpful E-mail Updates,” September 15,
`2011, available at
`https://web.archive.org/web/20110915021341/http://www.lumigan.com:
`80/Offers/Default.aspx
`
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`2095
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`2096
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`2097
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`2098
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`2099
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`2100
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`2101
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`2102
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`2103
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`2104
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`Case IPR2017-01053
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`Patent 8,268,299
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`“Sign Up for Savings and Helpful E-mail Updates,” August 30, 2011,
`available at
`https://web.archive.org/web/20110830041856/http://www.lumigan.com:
`80/Offers/Offer01.aspx
`“Allergan, the maker of LUMIGAN® 0.01% ophthalmic solution, is
`offering a valuable rebate,” August 5, 2012, available at
`https://web.archive.org/web/20120805082203/http://www.lumigan.com:
`80/Offers/Default.aspx
`“Allergan, the maker of LUMIGAN® 0.01% ophthalmic solution, is
`offering a valuable rebate,” June 6, 2013, available at
`https://web.archive.org/web/20130606060651/http://www.lumigan.com:
`80/offers/default.aspx
`“Allergan, the maker of LUMIGAN® 0.01% ophthalmic solution, is
`offering a valuable rebate,” June 27, 2014, available at
`https://web.archive.org/web/20140627221626/http://www.lumigan.com:
`80/Offers/Default.aspx
`“Save up to $25 instantly on your next LUMIGAN® 0.01%
`prescription,” April 17, 2015, available at
`https://web.archive.org/web/20150417201847/http://www.lumigan.com:
`80/Save-Prescription/Coupon
`“Save up to $25 instantly on your next LUMIGAN® 0.01%
`prescription,” August 15, 2016, available at
`https://web.archive.org/web/20160815103712/http://www.lumigan.com:
`80/Save-Prescription/Coupon
`“Save up to $25 instantly on your next LUMIGAN® 0.01%
`prescription,” May 14, 2017, available at
`https://web.archive.org/web/20170514083605/http://www.lumigan.com:
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`“Join Vision Matters™,” January 11, 2010, available at
`https://web.archive.org/web/20100111030643/http://www.xalatan.com:8
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`“Save on Xalatan,” August 9, 2011, available at
`https://web.archive.org/web/20110809113336/http://www.xalatan.com:8
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`“Now that you know about the cost savings available for brand-name
`XALATAN, learn how XALATAN can help reduce high eye pressure,”
`May 25, 2013, available at
`https://web.archive.org/web/20130525073522/http://www.xalatan.com:8
`0/content/index.aspx
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`“You May Save Up to $75 Per Month With the XALATAN Savings
`Card!” February 14, 2015, available at
`https://web.archive.org/web/20150214082124/http://xalatan.com//
`“Request or Activate Your XALATAN Savings Card Today,”
`December 13, 2017, available at https://www.xalatan.com/xalatan-
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`“Drug Safety Alerts: Allergan Announces Discontinuation of Lumigan®
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`Case IPR2017-01053
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`Patent 8,268,299
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`2140
`Proposed Standing Protective Order
`Adjunctive Data to Alcon Laboratory Notebook No. 11068 (Vol. 1 of 4)
`2141 –
`Served
`but not
`filed
`2142 –
`Served
`but not
`filed
`2143 –
`Served
`but not
`filed
`2144 –
`Served
`but not
`filed
`2145 –
`Served
`but not
`
`Adjunctive Data to Alcon Laboratory Notebook No. 11068 (Vol. 2 of 4)
`
`Adjunctive Data to Alcon Laboratory Notebook No. 11068 (Vol. 3 of 4)
`
`Adjunctive Data to Alcon Laboratory Notebook No. 11068 (Vol. 4 of 4)
`
`Adjunctive Data to Alcon Laboratory Notebook No. 11118
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`2135
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`2137
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`2138
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`filed
`2146 –
`Served
`but not
`filed
`2147 –
`Served
`but not
`filed
`2148 –
`Served
`but not
`filed
`2149 –
`Served
`but not
`filed
`2150 –
`Served
`but not
`filed
`2151 –
`Served
`but not
`filed
`2152 –
`Served
`but not
`filed
`2153 –
`Served
`but not
`filed
`2154 –
`Served
`but not
`filed
`2155 –
`Served
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`Case IPR2017-01053
`Patent 8,268,299
`
`Adjunctive Data to Alcon Laboratory Notebook No. 11781
`
`Adjunctive Data to Alcon Laboratory Notebook No. 13160
`
`Adjunctive Data to Alcon Laboratory Notebook No. 13292
`
`Adjunctive Data to Alcon Laboratory Notebook No. 9988
`
`Alcon Laboratory Notebook No. 10545 with Adjunctive Data (Vol. 1 of
`2)
`
`Alcon Laboratory Notebook No. 10545 with Adjunctive Data (Vol. 2 of
`2)
`
`Alcon Laboratory Notebook No. 10750 with Adjunctive Data (Vol. 1 of
`2)
`
`Alcon Laboratory Notebook No. 10750 with Adjunctive Data (Vol. 2 of
`2)
`
`Alcon Laboratory Notebook No. 11068
`
`Alcon Laboratory Notebook No. 11118
`
`10
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`

`

`
`
`
`Case IPR2017-01053
`Patent 8,268,299
`
`Alcon Laboratory Notebook No. 11781
`
`Alcon Laboratory Notebook No. 12034 with Adjunctive Data (Vol. 1 of
`3)
`
`Alcon Laboratory Notebook No. 12034 with Adjunctive Data (Vol. 2 of
`3)
`
`Alcon Laboratory Notebook No. 12034 with Adjunctive Data (Vol. 3 of
`3)
`
`Alcon Laboratory Notebook No. 12586 with Adjunctive Data
`
`but not
`filed
`2156 –
`Served
`but not
`filed
`2157 –
`Served
`but not
`filed
`2158 –
`Served
`but not
`filed
`2159 –
`Served
`but not
`filed
`2160 –
`Served
`but not
`filed
`2161 –
`Served
`but not
`filed
`2162 –
`Served
`but not
`filed
`2163 –
`Served
`but not
`filed
`2164 –
`Served
`but not
`filed
`2165 Declaration of Alexander S. Zolan
`
`Alcon Laboratory Notebook No. 9988
`
`Alcon Laboratory Notebook No. 13160
`
`Alcon Laboratory Notebook No. 13292
`
`Winslow & Haywood, The Specific Potency of Certain Cations with
`Reference to Their Effect on Bacterial Viability, J. Bacteriol, Jul 1931;
`22(1): 49–69
`
`11
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`

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`
`
`Case IPR2017-01053
`Patent 8,268,299
`
`Dated: January 17, 2018
`
`Respectfully submitted,
`
`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Lead Counsel for
`Patent Owner
`
`Williams & Connolly LLP
`725 Twelfth Street NW
`Washington, D.C. 20005
`202-434-5338 (Telephone)
`202-434-5029 (Facsimile)
`dkrinsky@wc.com
`
`
`
` 
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`12
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`Case IPR2017-01053
`
`Patent 8,268,299
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the foregoing “ALCON RESEARCH,
`
`LTD.’S FOURTH UPDATED EXHIBIT LIST” was served on January 17, 2018,
`
`via electronic mail upon the following attorneys of record for the Petitioner:
`
`Michael R. Houston
`Joseph P. Meara
`James P. McParland
`FOLEY & LARDNER LLP
`mhouston@foley.com
`jmeara-pgp@foley.com
`jmcparland@foley.com
`ARG-travatanZ@foley.com
`
`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS LLC
`tliu@agpharm.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Lead Counsel for Patent Owner
`
`
`
`
`
`Dated: January 17, 2018
`
`
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`13
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