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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________
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`EISAI INC.
`Petitioner
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`v.
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`CRYSTAL PHARMACEUTICAL (SUZHOU) CO., LTD.
`Patent Owner
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`____________________
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`Patent No. 10,759,779
`____________________
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`DECLARATION OF DONNA M. MEUTH IN SUPPORT OF PETITION
`FOR POST-GRANT REVIEW OF U.S. PATENT NO. 10,759,779
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`Page 1 of 5
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`EISAI EXHIBIT 1039
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`I, Donna M. Meuth, based on my personal knowledge and information,
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`hereby declare as follows:
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`1.
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`I have been an employee of Eisai, Inc. (“Eisai”) since 2009. Between
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`April 2013 and the present, I have held the position of Associate General Counsel
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`for Intellectual Property. Before then, I held the positions of Senior Patent Counsel
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`and Associate Senior Patent Counsel.
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`2.
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`As part of my regular job duties, I support outside counsel in various
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`forms of patent prosecution and intellectual property litigation, including post-
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`grant proceedings before the U.S. Patent and Trademark Office. My
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`responsibilities also include regularly conversing with current and former Eisai
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`employees and reviewing and understanding documents that Eisai generated during
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`the ordinary course of its business. My regular job duties further include
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`supervising the collection of documents from electronic databases storing
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`documents that Eisai has submitted to governmental agencies, such as the U.S.
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`Food and Drug Administration, as part of its regular business activities.
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`3.
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`In performing my regular job duties, I have become familiar with the
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`general record keeping practices relating to both hard-copy and electronic
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`documents that Eisai employees generate as part of their regular business activities
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`to support the development of new drug products, such as technical reports,
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`records of experimental results, laboratory notebooks, and project status reports, as
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`well as the storage and maintenance of such documents in the regular course of
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`business.
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`4.
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`For purposes of preparing Eisai’s petition for Post-Grant Review of
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`U.S. Patent No. 10,759,779 (“Petition”), I supervised the collection of the
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`following documents, which I understand are exhibits cited in the Petition:
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`Exhibit 1011: This document is a true and correct copy of a report
`titled “Manufacture of GMP 8th and 9th lots of E2006 (ER-562007-
`00) for formal stability study” signed on February 22, 2017, which
`provides the method that Eisai used to manufacture Lot 169R2601.
`As part of their regular business activities, I understand Eisai
`scientists routinely generate reports memorializing methods that were
`used to prepare lots of a given drug substance, such as lemborexant. I
`also understand a true and correct copy of this document was
`collected from Eisai’s study report management system, which is
`where such documents are electronically kept in the course of
`regularly conducted business activity.
`Exhibit 1012: This document is a true and correct copy of an X-ray
`powder diffraction (“XRPD”) pattern for lemborexant from Lot
`169R2601, which was used for formal stability studies, that is dated
`December 1, 2016. I understand Eisai scientists routinely generate
`XRPD patterns for samples of drug substance used for formal stability
`studies. I also understand a true and correct copy of this document
`was collected from Eisai’s shipping inspection records in Kashima,
`Japan, which is where the originals of such documents are kept in the
`course of regularly conducted business activity.
`Exhibit 1015: This document is a true and correct copy of an entry
`from the laboratory notebook of Dr. George Moniz that was created
`on December 3, 2010. As part of his regular job duties, I understand
`that Dr. Moniz was involved in the synthesis of lemborexant and
`memorialized such experiments in his laboratory notebook. I also
`understand that a true and correct copy of this document was collected
`from Eisai’s electronic notebook system, which is where notebooks of
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`Eisai scientists are electronically kept in the course of regularly
`conducted business activity.
`Exhibit 1016: This document is a true and correct copy of a monthly
`report from the Eisai Andover PST – Analytical Chemistry group for
`December 2010 concerning the “HAND” project. As part of their
`regular business activity, I understand that members of the Eisai
`Andover PST – Analytical Chemistry group prepared monthly reports
`in 2010 detailing their activity in the development of lemborexant as a
`drug substance, which included obtaining XRPD patterns of
`lemborexant that scientists in the group prepared. I understand that a
`true and correct copy of this document was collected from the hard
`drive folder of Jianxun (Joe) Zhou, who is a former Senior Scientist,
`Analytical Chemistry, in the Eisai Andover PST group. I understand
`the document was obtained from Dr. Zhou’s folder named “Monthly
`Report” on Eisai’s internal “eris03” server, which is where such
`documents are electronically kept in the course of regularly conducted
`business activity.
`Exhibit 1017: This document is a true and correct copy of an entry
`from the laboratory notebook of Dr. Annie Wearing that was created
`on December 5, 2010. As part of her regular job duties, I understand
`Dr. Wearing was involved in the synthesis of lemborexant and
`memorialized such experiments in her laboratory notebook. I
`understand that a true and correct copy of this document was collected
`from Eisai’s electronic notebook system, which is where notebooks of
`Eisai scientists are electronically kept in the course of regularly
`conducted business activity.
`Exhibit 1018: This document is a true and correct copy of the
`“Manufacturing Process Development” section (Section 3.2.S.2.6)
`from Eisai’s New Drug Application (“NDA”) for lemborexant. As
`part of its regular business activity, Eisai submits NDAs for new drug
`products, which includes, inter alia, discussion of manufacturing
`processes and data and results from experiments that Eisai scientists
`conducted. I understand that a true and correct copy of this document
`was collected from Eisai’s U.S. Regulatory database, which is where
`such documents are electronically kept in the course of regularly
`conducted business activity.
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`I hereby declare that all statements made herein are of my own knowledge
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`and are true and that all statements made on information and belief are believed to
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`be true; and further that these statements were made with the knowledge that
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`willful false statements and the like so made are punishable by fine or
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`imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
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`Date: February 3, 2021
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`By: ____/Donna M. Meuth/____________
`Donna M. Meuth, Esq.
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