UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner
`
`____________
`
`Case IPR2021-008811
`Patent 9,254,338 B2
`____________
`
`DECLARATION OF DORIS WEBER
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`Exhibit 2286
`Page 01 of 07
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner
`
`____________
`
`Case IPR2021-008811
`Patent 9,254,338 B2
`____________
`
`DECLARATION OF DORIS WEBER
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`Exhibit 2286
`Page 01 of 07
`
`
`
`I, Doris Weber, declare as follows:
`
`1.
`
`I am a Senior Litigation Support Specialist with Patent Owner
`
`Regeneron Pharmaceuticals, Inc. I have personal knowledge of the facts in this
`
`declaration.
`
`2.
`
`Exhibit 2059 is a true and correct copy of the Regeneron Sample
`
`Analysis Report: PK06005-9-SA-01V1, which was signed by Study Director Ellen
`
`M. Koehler-Stec on July 28, 2010.
`
`3.
`
`Exhibit 2060 is a true and correct copy of Table 14.2.3/2a (“Summary
`
`of Proportion of Vision Loss from Baseline to Week 96, Last Observation Carried
`
`Forward”) of the VIEW1 Clinical Study Report (Protocol VGFT-OD-0605).
`
`4.
`
`Exhibit 2073 is a true and correct copy of the “Zaltrap
`
`non-comparability issue: Regeneron Sanofi Analytical Investigation Workshop”
`
`presentation of March 14, 2014.
`
`5.
`
`Exhibit 2128 is a true and correct copy of a compilation of
`
`Regeneron’s VGFT-OD-0605 (VIEW 1 Trial) Protocol Signature Pages,
`
`accompanying protocols dated June 3, 2009, January 16, 2008, October 19, 2007,
`
`June 16, 2007, and May 24, 2007, all of which were executed by Matthew Benz.
`
`6.
`
`Exhibit 2133 is a true and correct copy of Regeneron’s Earnings Call
`
`Transcript of February 13, 2012, as obtained from Bloomberg Transcript.
`
`2
`
`Exhibit 2286
`Page 02 of 07
`
`
`
`7.
`
`Exhibit 2134 is a true and correct copy of Regeneron’s Earnings Call
`
`Transcript of April 26, 2012, as obtained from Bloomberg Transcript.
`
`8.
`
`Exhibit 2135 is a true and correct copy of Regeneron’s Earnings Call
`
`Transcript of July 25, 2012, as obtained from Bloomberg Transcript.
`
`9.
`
`Exhibit 2136 is a true and correct copy of Regeneron’s Eylea
`
`Marketing Material dated February 2013.
`
`10.
`
`Exhibit 2137, uploaded in two parts, is a true and correct copy of
`
`Regeneron’s Eylea Marketing Material dated November 2013.
`
`11.
`
`Exhibit 2138 is a true and correct copy of Regeneron’s “Physician
`
`ATU: Wave 2” presentation of February 2013.
`
`12.
`
`Exhibit 2139 is a true and correct copy of Regeneron’s “For the
`
`Treatment of Wet Age-Related Macular Degeneration” presentation from 2012,
`
`including presenter’s notes.
`
`13.
`
`Exhibit 2140 is a true and correct copy of Regeneron’s “Physician
`
`ATU: Wave 5” presentation of November 2013.
`
`14.
`
`Exhibit 2163 is a true and correct copy of Regeneron’s “Physician
`
`ATU: Wave 4” presentation of August 6, 2013.
`
`15.
`
`Exhibit 2169, uploaded in six parts, is a true and correct copy of
`
`Regeneron’s “Eylea Sample Disbursement 2013 to 2021,” where pages 1 through
`
`3
`
`Exhibit 2286
`Page 03 of 07
`
`
`
`16891 present data from October 2013 to November 2020, and pages 16892
`
`through 25515 present data from October 27, 2020 to December 17, 2021.
`
`16.
`
`Exhibit 2170 is a true and correct copy of Regeneron’s “US Eylea
`
`P&L LTD” as of December 2021, which is a profit and loss statement for US
`
`Eylea sales from 2011 to 2021.
`
`17.
`
`Exhibit 2176 is a true and correct copy of Regeneron’s “Q4 2020
`
`Performance Update Wet AMD, DME, MEfRVO & DR w/out DME” presentation
`
`of January 29, 2021.
`
`18.
`
`Exhibit 2197 is a true and correct copy of Regeneron’s “Physician
`
`ATU – Benchmark Wave” presentation of September 15, 2011.
`
`19.
`
`Exhibit 2200 is a true and correct copy of Regeneron’s “U.S. Eylea
`
`Historical Brand P&L” presentation of May 2021.
`
`20.
`
`Exhibit 2205 is a true and correct copy of Regeneron’s “DME Market
`
`Assessment” presentation of August 2014.
`
`21.
`
`Exhibit 2208 is a true and correct copy of Regeneron’s “Eylea MD
`
`ATU – Wave 2 Final Questionnaire” dated December 19, 2012.
`
`22.
`
`Exhibit 2218 is a true and correct copy of Regeneron’s “Eylea
`
`(aflibercept) Injection: Components of Reimbursement” presentation of September
`
`2015, including presenter’s notes.
`
`4
`
`Exhibit 2286
`Page 04 of 07
`
`
`
`23.
`
`Exhibit 2229 is a true and correct copy of Regeneron’s WAC Pricing
`
`File, which was exported on May 19, 2021.
`
`24.
`
`Exhibit 2272 is a true and correct copy of Regeneron’s “Eylea Q2
`
`2021 Performance” presentation of August 2, 2021.
`
`25.
`
`Exhibit 2273 is a true and correct copy of the “Anti-VEGF Category
`
`Sales Shares” report dated February 2022, which was received from Vestrum
`
`Health, LLC.
`
`26.
`
`Exhibit 2274 is a true and correct copy of Regeneron’s “Eylea Wet
`
`AMD Line of Therapy Insights” presentation of April 6, 2020.
`
`27.
`
`Exhibit 2275 is a true and correct copy of Regeneron’s “Vestrum
`
`Anti-VEGF Market Share Adjustment Overview” presentation of May 10, 2019.
`
`28.
`
`Exhibit 2276 is a true and correct copy of Regeneron’s “Eylea Q2
`
`2020 Performance (Vestrum Projection Data)” presentation of August 4, 2020.
`
`29.
`
`Exhibit 2277 is a true and correct copy of Regeneron’s “Marketing
`
`Planning Process” presentation of September 2011.
`
`30.
`
`Exhibit 2278 is a true and correct copy of Regeneron’s “Wave 1 2021
`
`Performance Update Wet AMD, DME, MEfRVO, and DR w/out DME”
`
`presentation of September 2021.
`
`31.
`
`Exhibit 2279 is a true and correct copy of Regeneron’s “ATU Sales
`
`Share Data: All Indications,” copyrighted 2021.
`
`5
`
`Exhibit 2286
`Page 05 of 07
`
`
`
`32.
`
`Exhibit 2280 is a true and correct copy of Regeneron’s “ATU Sales
`
`Share Data: Wet AMD,” copyrighted 2021.
`
`33.
`
`Exhibit 2281 is a true and correct copy of Regeneron’s “ATU Sales
`
`Share Data: DME,” copyrighted 2021.
`
`34.
`
`Exhibit 2282 is a true and correct copy of Regeneron’s “ATU Sales
`
`Share Data: CRVO,” copyrighted 2021.
`
`35.
`
`Exhibit 2283 is a true and correct copy of Regeneron’s “ATU Sales
`
`Share Data: BRVO,” copyrighted 2021.
`
`36.
`
`Exhibit 2284 is a true and correct copy of Regeneron’s “ATU Sales
`
`Share Data: DR w/o DME,” copyrighted 2021.
`
`37.
`
`Exhibit 2285 is a true and correct copy of Regeneron’s “Eylea Gross
`
`& Net Sales P&L YTD,” copyrighted 2021.
`
`38.
`
`Exhibit 2243 is a true and correct copy of “Preferences and Trends
`
`(PAT) Survey 2016” obtained from the American Society of Retina Specialists.
`
`39.
`
`Exhibit 2244 is a true and correct copy of “Preferences and Trends
`
`(PAT) Survey 2015” obtained from the American Society of Retina Specialists.
`
`40.
`
`Exhibit 2250, uploaded in two parts, is a true and correct copy of
`
`“Preferences and Trends (PAT) Survey 2014” obtained from the American Society
`
`of Retina Specialists.
`
`6
`
`Exhibit 2286
`Page 06 of 07
`
`
`
`41.
`
`Exhibit 2259is a true and correct copy of “Preferences and Trends
`
`Membership Survey 2009”obtained from the American Society of Retina
`
`Specialists.
`
`I hereby declare that all statements made herein of my own knowledge are
`
`true andthat all statements made on information and belief are believed to be true;
`
`and further that these statements are made with the knowledge that willful false
`
`statements andthelike are punishable by fine, imprisonment, or both, under Section
`
`1001 of Title 18 of the United States Code.
`
`Dated: March 7, 2022
`
`L/,
`
`Doris Weber
`
`White Plains, New York
`
`7
`
`Exhibit 2286
`
`Page 07 of 07
`
`Exhibit 2286
`Page 07 of 07
`
`
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