`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`V.
`
`JANSSEN ONCOLOGY, INC,
`Patent Owner
`
`
`
`Inter Parfes Review No. IPR2016-01332
`
`U.S. Patent No. 8,822,438
`
`DECLARATION OF MARC B. GARNICK, M.D.
`
`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 1
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`
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`facts set forth in this Declaration and am competent to testify to the same.
`
`2.
`
`I have been retained by counsel
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`for Mylan Pharmaceuticals Inc.
`
`(“Mylan” or “Petitioner”) in connection with the above-captioned inter panes
`
`review (“IPR”).
`
`3.
`
`I am educated and experienced in medicine,
`
`including prostate
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`oncology, as detailed in my previous Declaration that was filed with the Petition as
`
`Exhibit MYL 1002, and my Curriculum Vitae filed as Exhibit A to MYL 1002.
`
`I
`
`understand that my declaration will be included in Petitioner’s Exhibit List as
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`MYL Ex. 1083.
`
`I have examined Exhibits 1019, 1025, 1028, 1040, and 1041. All
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`of the exhibits are publicly available, or derived from documents that are publicly
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`available.
`
`4.
`
`MYL 1025 is a true and correct copy of two chapters of Kasper, D.L.
`
`er al. (Eds.), Harrison is Principles of Internal Medicine (16th ed. 2005). MYL
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`1025 comprises the cover page, date of publication, authorship, table of contents,
`
`Chapter 81, entitled “Hyperplastic and Malignant Diseases of the Prostate” and
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`Chapter 321, entitled “Disorders. of the Adrenal Cortex,” the two chapters cited in
`
`my declaration. MYL 1025 comprises excerpts from a publicly available
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`document.
`
`The chapters making up MYL 1025, as initially provided, were
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`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 2
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`
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`complete. The Patent Owner’s Objections to Evidence Pursuant to 37 C.F.R.
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`§ 42.64(b)( 1) do not point to any reason that the chapters making up MYL 1025
`
`were not complete.
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`5.
`
`MYL 1040 is a true and correct copy of a document entitled
`
`Treatment ofMetastatic Castration Resistant Prostate Cancer accessed and printed
`
`on June 28, 2016, by me or under my direction from the webpage of the American
`
`Society of Clinical Oncology (“ASCO”) at www.cancer.net at
`
`the URL or
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`webpage address of: http:/fwww.cancer.net/research-and-advocacy/asco-care-and~
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`treatment-recommendations-patients/treatment-metastatic-castration—resistant-
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`the ASCO website (www.cancer.net) on June 28, 2016, at the URL or webpage
`
`address at http://www.caneer.net/research-and-advocacy/asco—care-and-treatment-
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`recommendations—patients/treatment—metastatic-castration-resistant-prostate—cancer
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`and clicked on the “print” button on the browser. The resulting document is MYL
`
`1040 and therefore is complete. MYL 1040 is publicly available including from
`
`the ASCO website at http://www.cancer.net/research-and-advocacy/asco—care-and
`
`treatment-recommendations-patients/treatment-metastatic—castration-resistant-
`
`prostate-cancer.
`
`6.
`
`MYL 1041 is a true and correct copy of a webpage from the American
`
`Cancer Society’s website at www.cancer.org, which was accessed and printed on
`
`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 3
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`
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`June 28, 2016, by me or under my direction from the webpage of the American
`
`Cancer
`
`Society
`
`(“ACS”)
`
`at
`
`the URL
`
`or webpage
`
`address
`
`of:
`
`http://www.cancer.org/caneer/prostatecancer/detaiIedguide/prostate—cancer-key-
`
`statistics. To print this document, I or someone under my direction accessed the
`
`ACS website (www.cancer.org) on June 28, 2016, at the URL or webpage address
`
`at http://www.cancer.org/cancer/prostatecancer/detai1edguide/prostate—cancer—key-
`
`statistics and clicked on the “print” button on the browser. The resulting document
`
`is MYL 1041 and therefore is complete. MYL 1041 is publicly available including
`
`from
`
`the
`
`ACS
`
`website
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`at
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`http :/fwww.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer—key-
`
`statistics.
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`February8’2017
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`Respectfully submitted,
`
`
`
`I I.”/:'5fi¢£€p/ /B
`
`Marc B. Gamick, M.D.
`
`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 4
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`
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