`
`David L. Cavanaugh
`Reg. No. 36,476
`Owen K. Allen
`Reg. No. 71,118
`Robert J. Gunther, Jr.
`Pro Hac Vice to be filed
`Wilmer Cutler Pickering
`Hale and Dorr LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`Adam R. Brausa
`Reg. No. 60,287
`Daralyn J. Durie
`Pro Hac Vice to be filed
`Durie Tangri LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`MYLAN PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`
`Case IPR2016-01693
`Patent 6,407,213
`____________________________________________
`
`DECLARATION OF IRENE LOEFFLER
`
`Mylan v. Genentech
`IPR2016-01693
`Genentech Exhibit 2016
`
`
`
`IPR2016-01693
`Declaration of Irene Loeffler
`
`I, Irene Loeffler, declare as follows:
`
`1.
`
`I am the Associate Director of Records and Image Management in
`
`Genentech’s Corporate Records Management Program Group. I have personal
`
`knowledge of the facts set forth herein.
`
`2.
`
`I have worked at Genentech since 1987 holding various records
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`positions, including: Central Records Administrator; Manager, Biomedical
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`Records; Manager, Records and Image Management; Senior Manager, Records
`
`and Image Management; and my current role as Associate Director, Records and
`
`Image Management.
`
`3.
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`In connection with my duties and responsibilities at Genentech, I
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`oversee the ordering, assigning, tracking, recalling, scanning (previously
`
`microfilming), indexing, storing, and retrieving of laboratory notebooks.
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`4.
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`The exhibits listed below are true and authentic copies of several
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`Genentech laboratory notebooks. Each laboratory notebook receives a unique
`
`numerical identifier when it is issued, which allows Genentech to accurately track
`
`those records. The notebook numbers and scientists to whom they were issued are
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`as follows:
`
`a. Exhibit 2001: Notebook No. 10098 (Leonard Presta)
`
`b. Exhibit 2002: Notebook No. 10823 (Leonard Presta)
`
`c. Exhibit 2003: Notebook No. 11268 (Paul Carter)
`
`1
`
`
`
`IPR2016-01693
`Declaration of Irene Loeffler
`
`d. Exhibit 2004: Notebook No. 11643 (Paul Carter)
`
`e. Exhibit 2005: Notebook No. 10840 (John Brady)1
`
`f. Exhibit 2006: Notebook No. 11162 (John Brady)
`
`g. Exhibit 2007: Notebook No. 11008 (Ann Rowland)
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`h. Exhibit 2008: Notebook No. 11297 (Tim Hotaling)
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`i. Exhibit 2009: Notebook No. 11568 (Monique Carver).
`
`5.
`
`At the time that these notebooks were issued, Genentech scientists
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`were instructed to record all work in their assigned notebooks and to sign and date
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`each entry on a daily basis; no data was to be held back for later entry. Any
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`attachments, such as computer data, were to be permanently affixed to the
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`notebooks without covering any other entries. These instructions are included
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`behind the front cover of Genentech’s laboratory notebooks to remind Genentech’s
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`scientists of their responsibility to maintain timely and accurate records of their
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`research.
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`6.
`
`I am familiar with Genentech’s practices regarding the creation,
`
`modification, and keeping of its laboratory notebooks through my employment
`
`with Genentech. Each of the laboratory notebooks listed above was created by
`
`1 At the time that Notebooks 10840 and 11162 were issued, Mr. Brady’s name was
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`John Ridgway. He subsequently changed his name to John Ridgway Brady.
`
`2
`
`
`
`IPR2016-01693
`Declaration of Irene Loeffler
`
`Genentech personnel during the regular course of business. It was the regular
`
`practice of Genentech’s personnel to create such records at or near the time the
`
`recorded act, event, condition, or opinion occurred. It was the general practice of
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`Genentech’s personnel to date such documents as of the date the record was
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`created or modified. Such records would only be made by someone with
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`knowledge or from information transmitted by someone with knowledge.
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`7.
`
`It was Genentech’s general practice to recall for imaging laboratory
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`notebooks one year after they were issued or as soon as they were completed.
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`Genentech microfilmed the notebooks until November 2007 at which time
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`Genentech began scanning the notebooks. Exhibits 2001-2009 were initially
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`microfilmed approximately one year after they were issued and then scanned in
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`high-resolution color in or around November 2016.
`
`3
`
`
`
`IPR2016-01693
`Declaration of Irene Loeffler
`
`I declare under penalty of perjury of the laws of the United States of
`
`America that the foregoing is true and correct.
`
`Executed on: December 9, 2016
`
`4