`FOR THE DISTRICT OF DELAWARE
`IN RE: OZEMPIC
`(SEMAGLUTIDE)
`PATENT LITIGATION
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`MDL NO. 22-MD-3038 (CFC)
`ANDA CASE
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`C.A. No. 22-294 (CFC)
`CONSOLIDATED
`ANDA CASE
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`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS
`INC., et al.,
`
`Defendants.
`
`DR. REDDY’S LABORATORIES, LTD.’S AND DR. REDDY’S
`LABORATORIES, INC.’S STIPULATION CONCERNING INVALIDITY
`GROUNDS
`Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`
`(collectively, “DRL”) submit this stipulation concerning its invalidity grounds.
`
`On October 20, 2023, DRL filed petition number IPR2024-00009 with the
`
`Patent Trial and Appeal Board (“PTAB”) requesting inter partes 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:
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1099, p. 1 of 3
`
`
`
`Ground
`1
`2
`3
`4
`5
`
`Basis for Unpatentability
`Claims
`Anticipated by WO421
`1-3
`Anticipated by Lovshin
`1-3
`1-10 Obvious over WO421 considering the ’424 publication
`1-10 Obvious over WO537 considering Lovshin
`1-10 Obvious over NCT657 and NT773 considering the ’424
`publication
`
`On _____, 2024, the PTAB instituted IPR2024-00009 and joined DRL as a
`
`party (“Institution Decision”) to the Mylan IPR. Accordingly, DRL stipulates1 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. For the avoidance of doubt, DRL
`
`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 DRL’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).
`
`1 Pursuant to Director Vidal’s Interim Procedure for Discretionary Denials in AIA Post-Grant
`Proceedings with Parallel District Court Litigation, Petitioner DRL offered a stipulation before
`the PTAB consistent with the stipulation set forth in Sotera Wireless, Inc. v. Masimo Corp.,
`IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) ( precedential as to§ II.A).
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1099, p. 1 of 3
`
`
`
`HEYMAN ENERIO GATTUSO &
`HIRZEL LLP
`
`Dominick T. Gattuso (#3630)
`300 Delaware Avenue, Suite 200
`Wilmington, DE 19801
`(302) 472-7300
`dgattuso@hegh.law
`
`Attorneys for Defendants Dr.
`Reddy’s Laboratories, Ltd. and Dr.
`Reddy’s Laboratories, Inc.
`
`Dated: March __, 2024
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1099, p. 1 of 3
`
`