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Case 1:22-md-03038-CFC Document 333 Filed 05/01/24 Page 1 of 3 PageID #: 5697
`
`
`
`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
`
`
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`
`
`
`Plaintiffs,
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`MDL No. 22-MD-3038 (CFC)
`
`ANDA CASE
`
`
`
`
` C.A. No. 22-294-CFC
`CONSOLIDATED
`ANDA CASE
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`
`RIO BIOPHARMACEUTICALS INC.,
`et al.,
`
`Defendants.
`
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`Defendant.
`
`
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.’S AND SUN
`PHARMACEUTICAL INDUSTRIES INC.’S STIPULATION OF
`INVALIDITY CONTENTIONS
`
`Defendants Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical
`
`Industries, Inc. (collectively, “Sun”) submit this stipulation of invalidity contentions.
`
`
`
`
`
`RLF1 30924573v.1
`
`Novo Nordisk Exhibit 2542
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Case 1:22-md-03038-CFC Document 333 Filed 05/01/24 Page 2 of 3 PageID #: 5698
`
`
`On November 2, 2023, Sun filed petition number IPR2024-00107 with the
`
`Patent Trial and Appeal Board requesting inter parties review of U.S. Patent No.
`
`10,335,462 (the “’462 Patent”) (the “Petition”) and joinder to IPR2023-00724 (“the
`
`Mylan IPR”). The Petition asserted the same grounds of invalidity as the Mylan IPR:
`
`
`
`Ground
`1
`2
`3
`4
`
`5
`
`
`
`Claims
`1–3
`1–3
`1–10
`1–10
`
`1–10
`
`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
`
`Sun hereby stipulates that if the Patent Trial and Appeal Board (PTAB)
`
`institutes IPR2024-00107, then Sun will agree to be bound by the estoppel
`
`provisions set forth in 35 U.S.C. § 315(e)(2) in this civil action as of the date of
`
`institution of the Petition. For the avoidance of doubt, Sun also stipulates that it is
`
`bound by the estoppel provisions set forth in 35 U.S.C. § 315(e)(2) in this civil action
`
`as of the date of the Institution Decision as such provisions would apply to Petitioner
`
`Mylan Pharmaceutical, Inc. in the Mylan IPR. This stipulation is not intended, and
`
`should not be construed, to limit Sun’s ability to assert invalidity of the ’462 Patent
`
`in this civil action on any other ground beyond the scope of the estoppel provisions
`
`set forth in 35 U.S.C. § 315(e)(2). This stipulation shall not apply if the PTAB does
`
`not institute IPR2024-00107.
`
`
`RLF1 30924573v.1
`
`2
`
`Novo Nordisk Exhibit 2542
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Case 1:22-md-03038-CFC Document 333 Filed 05/01/24 Page 3 of 3 PageID #: 5699
`
`
`
`
`
`
`
`
`
`
`
`
`
`DATED: May 1, 2024
`
`
`
`
`
`
`
`/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
`
`Attorneys for Defendants Sun
`Pharmaceutical Industries Ltd. and
`Sun Pharmaceutical Industries Inc.
`
`
`
`RLF1 30924573v.1
`
`3
`
`Novo Nordisk Exhibit 2542
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

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