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`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
`Patent 8,927,592
`_____________________________
`
`
`EVIDENTIARY DECLARATION OF MR. ROBERT MCSORLEY
`
`
`
`MYLAN - EXHIBIT 1094
`Mylan Laboratories Limited v. Aventis Pharma S.A.
`IPR2016-00712
`
`
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`I, Robert McSorley, declare as follows:
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`1.
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`I am the same Robert McSorley who previously submitted a declaration
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`(EX1044; “Original Declaration”) in this Inter Partes Review (“IPR”) proceeding,
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`filed with the Petitioner’s Reply and Opposition to Contingent Motion to Amend on
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`March 14, 2017. My Original Declaration set forth my credentials, qualifications, and
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`publications. My curriculum vitae was included with the Original Declaration as
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`Attachment 1. That information all remains the same.
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`2.
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`I make this Declaration based on my personal knowledge and inspection
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`of Exhibits 1044, 1057, 1060-1079, and 1089-1090.
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`3.
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`I note that my Original Declaration contained six consecutive paragraphs
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`numbered as follows: 69, 70, 71, 70, 71, 72. For purposes of clarity, these paragraphs
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`may be referred to, respectively, as follows: 69, 70, 71, 70.A, 71.A, 72. I have
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`attached hereto a copy of Confidential Exhibit 1044 in which I have caused to be
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`interlineated the designation “A” to demarcate paragraphs 70.A and 71.A, as
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`discussed above.
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`4.
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`I have reviewed and am familiar with Exhibit 1057, which is a true and
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`correct copy of the online article of the Encyclopaedia Britannica (last accessed on
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`March 14, 2017) describing the former German chemical concern Hoechst
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`Aktiengesellschaft that eventually underwent a merger to form Aventis. The article is
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`available on the Encyclopaedia Britannica web site. It is accepted practice among
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`-1-
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`economic and financial experts to rely upon such encyclopedia articles as a reliable
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`source of information.
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`5.
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`I have reviewed and am familiar with Exhibit 1060, which is a true and
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`correct copy of the Taxotere Label (Package Insert) that is available for download
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`from the “Drugs@FDA” database, which is a database of drug information hosted by
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`the U.S. Food and Drug Administration. The Drugs@FDA database identifies Exhibit
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`1060 as the Taxotere Label, SUPPL-63, with a date of April 13, 2012. It is accepted
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`practice among economic and financial experts to rely upon FDA records from the
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`FDA website as authentic copies of those public records.
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`6.
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`I have reviewed and am familiar with Exhibit 1061, which is a true and
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`correct copy of a September 11, 2014 Medscape article relating to the FDA approval
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`of the drug Xtandi. Medscape is a website (www.medscape.com) that provides news
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`and information related to the healthcare field. The article was downloaded from the
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`Medscape website on March 13, 2017. I have relied on such articles from Medscape
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`and similar websites in my own research and practice outside the context of litigation.
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`7.
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`I have reviewed and am familiar with Exhibit 1062, which is a true and
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`correct copy of a drug information page from chemocare.com relating to the drug
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`mitoxantrone. The article was downloaded from the Chemocare website on March 14,
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`2017. I have relied on such articles from Chemocare and similar websites in my own
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`-2-
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`research and practice outside the context of litigation.
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`8.
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`I have reviewed and am familiar with Exhibit 1063, which is a true and
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`correct copy of a drug information page from chemocare.com (“Chemocare”) relating
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`to the drug estramustine. Chemocare is a website that provides information relating to
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`chemotherapy and other anticancer drugs sold in the healthcare market. The article
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`was downloaded from the Chemocare website on March 14, 2017. I have relied on
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`such articles from Chemocare and similar websites in my own research and practice
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`outside the context of litigation.
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`9.
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`I have reviewed and am familiar with Exhibit 1064, which is a true and
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`correct copy of a 2000 article from Drugs & Therapy Perspectives reproduced on
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`Medscape. The article relates to the drug Ketoconazole. The article was downloaded
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`from the Medscape website on March 14, 2017. I have relied on such articles from
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`Medscape and similar websites in my own research and practice outside the context of
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`litigation.
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`10.
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`I have reviewed and am familiar with Exhibits 1065, 1068-1072, 1074,
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`and 1079, each of which bear markings from Sanofi or Aventis and each of which
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`bears numbering with the prefix “SA_JEV.” I understand that each of these
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`documents was produced in this proceeding (IPR2016-00712) from the records of the
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`Patent Owner and that the Patent Owner has not challenged the authenticity of these
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`
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`-3-
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`documents. As Mr. Tate has relied upon a subset of similar documents (e.g., Exhibits
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`2170-2171) in support of his opinions, it is appropriate for an expert in my field to
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`evaluate Mr. Tate’s opinions in the context of the remainder of the available
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`documents, including Exhibits 1065, 1068-1072, 1074, and 1079.
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`11.
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`I have reviewed and am familiar with Exhibit 1066, which is a true and
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`correct copy of an article on off-label drug use published on the American Cancer
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`Society’s website, www.cancer.org. The article was downloaded from
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`www.cancer.org on March 14, 2017. I have relied on information from the American
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`Cancer Society’s website in my own research and practice outside the context of
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`litigation as a reliable source of information on cancer.
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`12.
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`I have reviewed and am familiar with Exhibit 1067, which is a true and
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`correct copy of the National Drug Monograph for cabazitaxel, provided online by the
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`Pharmacy Benefits Management Services of the U.S. Department of Veterans Affairs
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`(www.pbm.va.gov). The monograph is available for download at
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`http://www.pbm.va.gov/clinicalguidance/drugmonographs/CabazitaxelDrugMonograp
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`h.doc (last accessed March 14, 2017) and bears a date of March 2011. It is accepted
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`practice among economic and financial experts to rely upon government records from
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`the U.S. Department of Veterans Affairs as authentic copies of those public records.
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`13.
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`I have reviewed and am familiar with Exhibit 1073, which is a true and
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`-4-
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`correct copy of a November 18, 2014 article from the Tufts Center for the Study of
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`Drug Development. The article was downloaded from the Tufts University website on
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`March 14, 2017. I have relied on online articles from research centers such as the
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`Tufts Center for the Study of Drug Development in my own research and practice
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`outside the context of litigation.
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`14.
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`I have reviewed and am familiar with Exhibit 1076, which is a true and
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`correct copy of a December 2, 2009 publication by the Congressional Budget Office
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`discussing promotional spending for prescription drugs. The publication is available
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`for download from the CBO website at http://www.cbo.gov/sites/default/files/111th-
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`congress-2009-2010/reports/12-02-drugpromo_brief.pdf. It is accepted practice
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`among economic and financial experts to rely upon government records from the
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`Congressional Budget Office as authentic copies of those public records.
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`15.
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`I have reviewed and am familiar with Exhibits 1075, 1077-1078. I have
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`relied on each of these references in my own research and practice outside the context
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`of litigation.
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`16.
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`I have reviewed and am familiar with Exhibit 1089, which is a true and
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`correct copy of sales data compiled by and downloaded from IMS Health. IMS Health
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`is a company that specializes in providing financial information regarding the
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`healthcare industry. I view IMS Health as a reliable source of accurate information
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`-5-
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`and have relied on data from IMS Health in my own research and practice. In my
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`opinion, others in the scientific, business, and regulatory communities similarly rely
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`upon and believe IMS Health to be a reliable source of accurate information.
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`17.
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`I have reviewed and am familiar with Exhibit 1090, which is a true and
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`correct copy of prescription data for prostate cancer drugs compiled by and
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`downloaded from IMS Health. I view IMS Health as a reliable source of accurate
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`information and have relied on data from IMS Health in my own research and
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`practice. In my opinion, others in the scientific, business, and regulatory communities
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`similarly rely upon and believe IMS Health to be a reliable source of accurate
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`information.
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`18.
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`I declare that all statements made herein of my knowledge are true, and
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`that all statements made on information and belief are believed to be true, and that
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`these statements were made with the knowledge that willful false statements and the
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`like so made are punishable by fine or imprisonment, or both, under Section 1001 of
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`Title 18 of the United States Code.
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`
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`Dated: April 3, 2017
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`
`By:
`
`
`Robert McSorley
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`
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`
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`-6-
`
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`MYLAN LABORATORIES LIMITED,
`
`Petitioner,
`
`v.
`
`AVENTIS PHARMA, S.A.,
`
`Patent Owner.
`
`_____________________________
`
`Patent No. 8,927,592
`
`_____________________________
`
`
`
`DECLARATION OF MR. ROBERT MCSORLEY
`
`
`
`MYLAN - EXHIBIT 1044
`Mylan Laboratories Limited v. Aventis Pharma S.A.
`IPR2016-00712
`0001
`
`REMAINDER OF ATTACHMENT REDACTED FOR PROTECTIVE ORDER MATERIAL
`
`
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