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`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
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`Plaintiffs,
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MDL No. 22-MD-3038 (CFC)
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`ANDA CASE
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` C.A. No. 22-294-CFC
`CONSOLIDATED
`ANDA CASE
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`)
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`v.
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`RIO BIOPHARMACEUTICALS INC.,
`et al.,
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`Defendants.
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
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`
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`Plaintiffs,
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`v.
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`MYLAN PHARMACEUTICALS INC.,
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`Defendant.
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`SUN PHARMACEUTICAL INDUSTRIES LTD.’S AND SUN
`PHARMACEUTICAL INDUSTRIES INC.’S STIPULATION OF
`INVALIDITY CONTENTIONS
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`Defendants Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical
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`Industries, Inc. (collectively, “Sun”) submit this stipulation of invalidity contentions.
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`RLF1 30924573v.1
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`Novo Nordisk Exhibit 2542
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
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`
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`Case 1:22-md-03038-CFC Document 333 Filed 05/01/24 Page 2 of 3 PageID #: 5698
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`On November 2, 2023, Sun filed petition number IPR2024-00107 with the
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`Patent Trial and Appeal Board requesting inter parties review of U.S. Patent No.
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`10,335,462 (the “’462 Patent”) (the “Petition”) and joinder to IPR2023-00724 (“the
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`Mylan IPR”). The Petition asserted the same grounds of invalidity as the Mylan IPR:
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`Ground
`1
`2
`3
`4
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`5
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`Claims
`1–3
`1–3
`1–10
`1–10
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`1–10
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`Basis for Unpatentability
`Anticipated by WO421
`Anticipated by Lovshin
`Obvious over WO421 considering the ’424 publication
`Obvious over WO537 considering Lovshin
`Obvious over NCT657 and NCT773 considering the
`’424 publication
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`Sun hereby stipulates that if the Patent Trial and Appeal Board (PTAB)
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`institutes IPR2024-00107, then Sun will agree to be bound by the estoppel
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`provisions set forth in 35 U.S.C. § 315(e)(2) in this civil action as of the date of
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`institution of the Petition. For the avoidance of doubt, Sun also stipulates that it is
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`bound by the estoppel provisions set forth in 35 U.S.C. § 315(e)(2) in this civil action
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`as of the date of the Institution Decision as such provisions would apply to Petitioner
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`Mylan Pharmaceutical, Inc. in the Mylan IPR. This stipulation is not intended, and
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`should not be construed, to limit Sun’s ability to assert invalidity of the ’462 Patent
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`in this civil action on any other ground beyond the scope of the estoppel provisions
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`set forth in 35 U.S.C. § 315(e)(2). This stipulation shall not apply if the PTAB does
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`not institute IPR2024-00107.
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`RLF1 30924573v.1
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`2
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`Novo Nordisk Exhibit 2542
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
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`Case 1:22-md-03038-CFC Document 333 Filed 05/01/24 Page 3 of 3 PageID #: 5699
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`DATED: May 1, 2024
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`/s/ Sara M. Metzler
`Kelly E. Farnan (#4395)
`Sara M. Metzler (#6509)
`Richards, Layton & Finger, P.A.
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`302-651-7700
`farnan@rlf.com
`metzler@rlf.com
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`Attorneys for Defendants Sun
`Pharmaceutical Industries Ltd. and
`Sun Pharmaceutical Industries Inc.
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`
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`RLF1 30924573v.1
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`3
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`Novo Nordisk Exhibit 2542
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
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