`U.S. Patent 10,335,462
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00724
`Patent 10,335,462
`______________________
`
`DECLARATION OF DEVRAJ CHAKRAVARTY
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`Novo Nordisk Exhibit 2049
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
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`IPR2023-00724
`U.S. Patent 10,335,462
`I, Devraj Chakravarty, hereby declare under penalty of perjury:
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`1.
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`I am an Associate Director, Regulatory Affairs at Novo Nordisk Inc.1
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`Except as otherwise indicated, I have personal knowledge of the facts set forth in
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`this Declaration. All statements herein made of my own knowledge are true and all
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`statements made on information and belief are believed to be true. If called upon to
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`do so, I would testify competently thereto.
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`2.
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`EX2048 is a true and correct copy of a document titled Drug Product
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`Semaglutide B, 1.34 mg/ml, Description and Composition of the Drug Product,
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`dated June 6, 2014. This document accurately reflects the formulation (which we
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`refer to as “Semaglutide B”) that was used in the clinical trials for SUSTAIN 6 and
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`FLOW trials for the 1.0 mg dosage. This is the same formulation used for Novo
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`Nordisk’s commercial product Ozempic®. This document was stored in Novo
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`Nordisk’s regulatory files. This document was made and kept in the regular and
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`ordinary course of Novo Nordisk’s business, at or near the date appearing on the
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` Novo Nordisk Inc. is a privately held corporation wholly owned by Novo Nordisk
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` 1
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`Commercial Holdings, Inc. Novo Nordisk Commercial Holdings, Inc. is wholly
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`owned by Novo Nordisk US Holdings Inc. Novo Nordisk US Holdings Inc. is a
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`privately held corporation wholly owned by Novo Nordisk A/S.
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`2
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`Novo Nordisk Exhibit 2049
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
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`IPR2023-00724
`U.S. Patent 10,335,462
`document (June 6, 2014), and was made by persons with knowledge of the facts and
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`opinions stated therein.
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`I have been warned that willful false statements and the like are punishable by fine
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`or imprisonment, or both (18 U.S.C. 1001) and may jeopardize the validity of the
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`patent at issue in this proceeding. I declare under penalty of perjury that the forego-
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`ing is true and correct.
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`Executed on January 17, 2024 at Plainsboro, New Jersey.
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`/Devraj Chakravarty/
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`Devraj Chakravarty
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`3
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`Novo Nordisk Exhibit 2049
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
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`
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