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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`WOCKHARDT BIO AG
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.
`Patent Owner
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`_____________________
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`_____________________
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`SUPPLEMENTAL DECLARATION OF
`PAUL A. GODLEY, M.D., Ph.D., MPP
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`WCK1129
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
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`I, Paul A. Godley, hereby declare as follows.
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`1.
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`I am over the age of eighteen and otherwise competent to make this
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`declaration.
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`2.
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`I am the same Paul A. Godley who submitted a declaration on August
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`10, 2016 in the inter partes review proceeding IPR2016-01582. My initial
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`declaration was marked as Wockhardt Exhibit 1002.
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`3.
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`I understand from counsel that Patent Owner Janssen Oncology, Inc.
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`filed a paper on February 2, 2017, which, in part, objected to Exhibit 1034 cited in
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`my initial declaration. I understand that Janssen asserted that the Petition and my
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`Declaration did not establish the origin of Exhibit 1034 or that Exhibit 1034 is a
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`true and correct copy of what it purports to be. I disagree with Janssen’s assertions
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`and submit this supplemental declaration in response.
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`4.
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`Exhibit 1034 is a copy of a document comprising the approved
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`prescribing information for Taxotere®. Experts in medical oncology routinely rely
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`on materials such as Exhibit 1034 when analyzing a drug product’s method of
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`action, such as in the opinion set forth in my initial declaration. Exhibit 1034 is a
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`true and correct copy of the Taxotere® prescribing information as published on the
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`FDA’s website, www.accessdata.fda.gov, accessed on August 8, 2016.
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`5.
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`I hereby declare that all statements made herein of my own
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`knowledge are true and that all statements made on information and belief are
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`2
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`WCK1129
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
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`believed to be true, and further that these statements were made with the
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`knowledge that willful false statements and the like so made are punishable by fine
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`or imprisonment, or both, under Section 1001 of Title 18 of the United States
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`Respectfully submitted,
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`Paul A. Godley, M.D., Ph.D., MPP
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`Code.
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`
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`Date:
`5071871
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`3
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`WCK1129
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
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