`
`———————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`———————
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`ETON PHARMACEUTICALS, INC.,
`
`Petitioner
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`v.
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`EXELA PHARMA SCIENCES, LLC,
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`Patent Owner
`
`———————
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`U.S. PATENT NO. 10,583,155
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`
`DECLARATION OF JUDY K. HE
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`
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`Eton Ex. 1105
`1 of 4
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`1. My name is Judy He. I am over 21 years of age. I am an attorney at
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`Haynes and Boone, LLP, representing Eton Pharmaceuticals, Inc. (hereinafter
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`“Eton”) in connection with the above-captioned matter. I submit this declaration
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`upon my personal knowledge in support of Eton’s Petition for Post Grant Review of
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`U.S. Patent No. 10,583,155.
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`2.
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`On May 28, 2020, I accessed https://beta.regulations.gov and searched
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`for “fda-2018-p-1808”. I received five results under the “Documents” tab (also
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`available at https://beta.regulations.gov/search?filter=fda-2018-p-1808), and I
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`downloaded each of them, including:
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`a. Citizen Petition from Lachman Consultant Services, Inc;
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`b. Attachment 1 Orange Book re Citizen Petition from Lachman
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`Consultant Services, Inc;
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`c. Attachment 2 Proposed Labeling re Citizen Petition from Lachman
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`Consultant Services, Inc;
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`d. Attachment 3 Approved Labeling for Reference Listed Drug re
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`Citizen Petition from Lachman Consultant Services, Inc; and
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`e. Acknowledgment Letter from FDA DDM to Lachman Consultant
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`Services, Inc
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`3.
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`Pages 1 to 3 of Exhibit 1092 is a true and correct copy of the above-
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`referenced “Citizen Petition from Lachman Consultant Services, Inc,” that I
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`2
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`Eton Ex. 1105
`2 of 4
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`
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`downloaded on May 28, 2020 from https://beta.regulations.gov/document/FDA-
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`2018-P-1808-0001.
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`4.
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`Page 4 of Exhibit 1092 is a true and correct copy of the above-
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`referenced “Attachment 1 Orange Book re Citizen Petition from Lachman
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`Consultant Services, Inc,”
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`that I downloaded on May 28, 2020 from
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`https://beta.regulations.gov/document/FDA-2018-P-1808-0003.
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`5.
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`Pages 5 to 6 of Exhibit 1092 is a true and correct copy of the above-
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`referenced “Attachment 2 Proposed Labeling re Citizen Petition from Lachman
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`Consultant Services, Inc,”
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`that I downloaded on May 28, 2020 from
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`https://beta.regulations.gov/document/FDA-2018-P-1808-0004.
`
`6.
`
`Pages 7 to 11 of Exhibit 1092 is a true and correct copy of the above-
`
`referenced “Attachment 3 Approved Labeling for Reference Listed Drug re Citizen
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`Petition from Lachman Consultant Services, Inc,” that I downloaded on May 28,
`
`2020 from https://beta.regulations.gov/document/FDA-2018-P-1808-0005.
`
`7.
`
`Page 12 of Exhibit 1092 is a true and correct copy of the above-
`
`referenced “Acknowledgment Letter from FDA DDM to Lachman Consultant
`
`Services,
`
`Inc,”
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`that
`
`I
`
`downloaded
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`on May
`
`28,
`
`2020
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`from
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`https://beta.regulations.gov/document/FDA-2018-P-1808-0002.
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`8.
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`I hereby declare under penalty of perjury under the laws of the United
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`States of America that the foregoing is true and correct, and that all statements made
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`3
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`Eton Ex. 1105
`3 of 4
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`
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`of my own knowledge are true and that all statements made on information and belief
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`are believed to be true. I understand that willful false statements are punishable by
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`fine or imprisonment or both. See 18 U.S.C. § 1001.
`
`Date:
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`7 20
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`Respectfully submitted,
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`Judy K. He
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`Eton Ex. 1105
`4 of 4
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`Eton Ex. 1105
`4 of 4
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`
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