UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`DECLARATION OF MICHAEL E. TATE REGARDING
`EXHIBITS 2170, 2171, 2172, and 2179
`
`
`
`Aventis Exhibit 2235
`Mylan v. Aventis, IPR2016-00712
`
`
`
`
`
`
`
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`DECLARATION OF MICHAEL E. TATE REGARDING
`EXHIBITS 2170, 2171, 2172, and 2179
`
`
`
`Aventis Exhibit 2235
`Mylan v. Aventis, IPR2016-00712
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`Introduction
`1. My name is Michael E. Tate. I am the same Michael E. Tate
`
`that submitted an expert declaration concerning secondary considerations relating
`
`to the obviousness of subject matter claimed in U.S. Patent No. 8,927,592 on
`
`December 23, 2016, Exhibit 2149. I respectfully submit this declaration based on
`
`my personal knowledge in support of Patent Owner’s Exhibits 2170, 2171, 2172,
`
`and 2179 that were cited in my December 23, 2016 declaration.
`
`II. Exhibit 2172
`2.
`The Red Book provides drug pricing and product information
`
`published by Truven Health Analytics.1 It is reported to be one of the oldest
`
`sources of drug information in the United States.2 It is routinely used and relied on
`
`in the pharmaceutical industry, and I and others at Charles River Associates have
`
`relied on the Red Book in providing consultation regarding intellectual property in
`
`the context of strategy, licensing, valuation, and/or litigation consulting.
`
`
`1 RED BOOK: A Comprehensive, Consistent Drug Pricing Resource, Truven
`Health Analytics, available at http://micromedex.com/products/product-
`suites/clinical-knowledge/redbook (Exh. 2236).
`2 RED BOOK From Thomson Reuters Continues Providing Average Wholesale
`Prices for Drugs as Others Stop Supplying This Important Data, PR Newswire
`(April 8, 2010), http://www.prnewswire.com/news-releases/red-book-from-
`thomson-reuters-continues-providing-average-wholesale-prices-for-drugs-as-
`others-stop-supplying-this-important-data-90250542.html (Exh. 2237).
`
`
`
`2
`
`
`
`
`
`3.
`
`The Red Book is an online-only electronic database available at
`
`the following URL: http://micromedex.com/products/product-suites/clinical-
`
`knowledge/redbook (Exh. 2236). The website states that the information is
`
`regularly updated to reflect current pricing.3 A user must purchase a license to
`
`access the database. After signing in, the user can search for particular drugs or
`
`products. Search results display the product name, active ingredient, manufacturer,
`
`and pricing, among other information. Search results can be exported to an
`
`electronic spreadsheet file.
`
`4.
`
`Exhibit 2172 contains true and accurate information exported
`
`from the Red Book Online database on December 14, 2016. On that date, the Red
`
`Book online database was searched for the drugs Xtandi®, Zytiga®, Xofigo®, and
`
`Jevtana®. The search results were each exported as electronic spreadsheets. The
`
`spreadsheets were combined and converted into a PDF file, and stamped for this
`
`proceeding as Exh. 2172.
`
`5.
`
`Exhibit 2238 is a true and accurate screenshot of the search
`
`result on the Red Book Online website for Xtandi® conducted on January 9,
`
`
`3 RED BOOK: A Comprehensive, Consistent Drug Pricing Resource, Truven
`Health Analytics, available at http://micromedex.com/products/product-
`suites/clinical-knowledge/redbook (Exh. 2236).
`
`
`
`3
`
`
`
`
`
`2017.4 This is an example of what the Red Book Online displays prior to exporting
`
`the search result as a spreadsheet.
`
`6.
`
`Exhibit 2239 is a true and accurate screenshot of the search
`
`result on the Red Book Online website for Zytiga® conducted on January 9, 2017.5
`
`This is an example of what the Red Book Online displays prior to exporting the
`
`search result as a spreadsheet.
`
`7.
`
`Exhibit 2240 is a true and accurate screenshot of the search
`
`result on the Red Book Online website for Xofigo® conducted on January 9,
`
`2017.6 This is an example of what the Red Book Online displays prior to exporting
`
`the search result as a spreadsheet.
`
`8.
`
`Exhibit 2241 is a true and accurate screenshot of the search
`
`result on the Red Book Online website for Jevtana® conducted on January 9,
`
`2017.7 This is an example of what the Red Book Online displays prior to exporting
`
`the search result as a spreadsheet.
`
`9.
`
`Exhibit 2242 is a true and accurate copy of “Understanding
`
`RED BOOK Online Search Results,” a guide by Truven Health Analytics on
`
`
`4 The price for Xtandi® has increased $552.83/month since December 14, 2016,
`but this does not change my conclusions in the expert report.
`5 The price for Zytiga® has not changed since December 14, 2016.
`6 The price for Xofigo® has not changed since December 14, 2016.
`7 The price for Jevtana® has not changed since December 14, 2016.
`
`
`
`4
`
`
`
`
`
`searching the Red Book, available at
`
`http://www.micromedexsolutions.com/micromedex2/4.36.0/WebHelp/RED_BOO
`
`K/Search_Results/RED_BOOK_Search_Results.htm.
`
`III. Exhibits 2170, 2171, and 2179
`10.
`I understand that Exhibits 2170, 2171, and 2179 are Sanofi
`
`marketing documents that describe the market share of Jevtana®.8 This
`
`understanding has been further confirmed by the Declaration of Art Lathers
`
`(Exhibit 2231). I understand that Sanofi relies on these market share reports in the
`
`course of its business.9
`
`11. Slide 32 of Exhibit 2171 is titled “Methodology,” and sets forth
`
`how data is collected for market share. Slides 28-31 describe the panel of
`
`physicians. Slides 36-37 provide further information about data collection and
`
`reporting. Slides 38-46 display the “Prostate Cancer Treatment Survey.” Upon
`
`review of Exhibits 2170 and 2171, I have no reason to believe that the market
`
`share data reported was collected in a different way than reported in Exhibit 2171
`
`at slide 32.
`
`
`8 Exhibit 2231 ¶¶3-4.
`9 Exhibit 2231 at ¶¶2-3.
`
`
`
`5
`
`
`
`
`
`12.
`
`I also understand that Exhibit 2179 is the underlying data
`
`displayed in Exhibit 2170.10 I have personal knowledge that Exhibit 2179 is the
`
`“raw” data displayed in Exhibit 2170 because the native version of Exhibit 2170
`
`produces an excel sheet with the data in Exhibit 2179.
`
` declare that under penalty of perjury under the laws of the United
`
` I
`
`States of America that the foregoing is true and correct, and all statements made of
`
`my own knowledge are true and that all statements made on information and belief
`
`are believed to be true. I understand that willful false statements and the like are
`
`punishable by fine or imprisonment or both (18 U.S.C. § 1001).
`
`
`
`
`
`_______________________________
`Michael E. Tate
`Vice President
`Charles River Associates
`January 17, 2017
`
`
`
`10 Exhibit 2231 ¶¶6.
`
`
`
`6
`
`
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