Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 1 of 9 PageID #: 4832
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE OZEMPIC (SEMAGLUTIDE) PATENT
`LITIGATION
`
`MDL No. 22-md-3038-CFC-EGT
`ANDA CASE
`
`NOVO NORDISK INC. AND NOVO
`NORDISK A/S,
`
`
`
`
`
`
`Plaintiffs/Counterclaim Defendants,
`
`v.
`
`
`RIO BIOPHARMACEUTICALS INC., et al.,
`
`
`
`
`
`Defendants/Counterclaim Plaintiffs.
`
`NOVO NORDISK INC. AND NOVO
`NORDISK A/S,
`Plaintiffs/Counterclaim Defendants,
`v.
`
`
`MYLAN PHARMACEUTICALS INC.,
`Defendant/Counterclaim Plaintiff.
`
`
`
`C.A. No. 22-294-CFC-EGT
`CONSOLIDATED
`ANDA CASE
`
`C.A. No. 22-1040-CFC-EGT
`
`ANDA CASE
`
`DEFENDANTS’ STIPULATION REGARDING INVALIDITY
`GROUNDS FOR U.S. PATENT NO. 10,335,462
`
`
`
`
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`MPI EXHIBIT 1326 PAGE 1
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`
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE OZEMPIC (SEMAGLUTIDE) PATENT
`LITIGATION
`
`MDL No. 22-md-3038-CFC-EGT
`ANDA CASE
`
`NOVO NORDISK INC. AND NOVO
`NORDISK A/S,
`
`
`
`
`
`
`Plaintiffs/Counterclaim Defendants,
`
`v.
`
`
`RIO BIOPHARMACEUTICALS INC., et al.,
`
`
`
`
`
`Defendants/Counterclaim Plaintiffs.
`
`NOVO NORDISK INC. AND NOVO
`NORDISK A/S,
`Plaintiffs/Counterclaim Defendants,
`v.
`
`
`MYLAN PHARMACEUTICALS INC.,
`Defendant/Counterclaim Plaintiff.
`
`
`
`C.A. No. 22-294-CFC-EGT
`CONSOLIDATED
`ANDA CASE
`
`C.A. No. 22-1040-CFC-EGT
`
`ANDA CASE
`
`DEFENDANTS’ STIPULATION REGARDING INVALIDITY
`GROUNDS FOR U.S. PATENT NO. 10,335,462
`
`
`
`
`
`
`
`
`
`MPI EXHIBIT 1326 PAGE 1
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`
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`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 2 of 9 PageID #: 4833
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`
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`Defendants Mylan Pharmaceuticals Inc. (“Mylan”), Rio Biopharmaceuticals
`
`Inc. and EMS S/A (collectively “Rio”), and Zydus Worldwide DMCC, Zydus
`
`Pharmaceuticals (USA) Inc., and Zydus Lifesciences Limited, (collectively
`
`“Zydus”) (collectively, “Defendants”) submit the following stipulation to remove
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`certain invalidity grounds related to U.S. Patent Number 10,335,462 (“the ’462
`
`patent”) from this action.
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`
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`WHEREAS, in 2022, Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S
`
`(collectively, “Plaintiffs”) asserted the ’462 patent against each Defendant in this
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`case, including Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
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`(collectively, “DRL”) and Sun Pharmaceutical Industries Ltd. and Sun
`
`Pharmaceutical Industries, Inc. (collectively, “Sun”), in connection with their
`
`respective Abbreviated New Drug Applications for semaglutide injection products.
`
`See
`
`C.A.
`
`No.
`
`22-294,
`
`D.I.
`
`1;
`
`C.A.
`
`No.
`
`22-296,
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`D.I. 1; C.A. No. 22-297, D.I. 1; C.A. No. 22-298, D.I. 1; C.A. No. 22-1040, D.I. 1.
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`
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`WHEREAS, on March 16, 2023, Mylan filed petition number IPR2023-00724
`
`(“Mylan’s petition”) with the Patent Trial and Appeal Board (“PTAB”), requesting
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`inter partes review (“IPR”) of the ’462 patent. Mylan’s petition included the
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`following grounds (“the IPR Grounds”):
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`- 2 -
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`MPI EXHIBIT 1326 PAGE 2
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`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 3 of 9 PageID #: 4834
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`
`
`Claim(s)
`Challenged
`1-3
`1-3
`1-10
`1-10
`
`Statutory Basis1
`Anticipation under § 102(a), (e)
`Anticipation under § 102(b)
`Obviousness under § 103(a)
`Obviousness under § 103(a)
`
`1-10
`
`Obviousness under § 103(a)
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`Reference(s)/Combinations
`WO4212
`Lovshin3
`WO5374, Lovshin
`W0421 considering the ’424
`publication5
`NCT6576 and NCT7737
`considering the ’424 publication
`
`
`On October 4, 2023, the PTAB instituted Mylan’s petition on the IPR Grounds. The
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`PTAB scheduled oral argument for Mylan’s petition to be held on August 27, 2024.
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`
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`WHEREAS, on October 20, 2023, DRL filed petition number IPR2024-00009
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`(“DRL’s petition”) with the PTAB, requesting inter partes review of the ’462 patent.
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`DRL’s petition relied on the same grounds as those in Mylan’s petition. On April
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`25, 2024, the PTAB instituted DRL’s petition and joined DRL as a party to Mylan’s
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`petition.
`
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`1 The pre-Leahy-Smith America Invents Act (“pre-AIA”) provisions apply to the
`’462 patent.
`2 International patent application publication number WO 2011/138421.
`3 Lovshin, Incretin-Based Therapies for Type 2 Diabetes Mellitus, 5 NATURE REV.
`ENDOCRINOLOGY 262 (2009).
`4 International patent application publication number WO 2006/097537.
`5 U.S. Patent Application Publication No. 2007/0010424.
`6 Clinical Trial No. NCT00696657.
`7 Clinical Trial No. NCT00851773.
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`- 3 -
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`MPI EXHIBIT 1326 PAGE 3
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`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 4 of 9 PageID #: 4835
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`WHEREAS, on November 2, 2023, Sun filed petition number IPR2024-
`
`00107 (“Sun’s petition”) with the PTAB, requesting inter partes review of the ’462
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`patent. Sun’s petition relied on the same grounds as those in Mylan’s petition. On
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`May 28, 2024, the PTAB instituted Sun’s petition and joined Sun as a party to
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`Mylan’s petition.
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`
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`WHEREAS, DRL and Sun previously stipulated to be bound by the estoppel
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`provisions in 35 U.S.C. § 315(e)(2). C.A. No. 22-md-3038, D.I. Nos. 333, 334.
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`
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`WHEREAS, Rio and Zydus did not file IPR petitions related to the ’462
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`patent.
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`
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`WHEREAS, a ten day trial is scheduled to begin in this action on December
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`9, 2024, which is likely after the PTAB will issue its decision regarding the
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`unpatentability of the ’462 patent.
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`- 4 -
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`MPI EXHIBIT 1326 PAGE 4
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`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 5 of 9 PageID #: 4836
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`NOW THEREFORE, Defendants8 hereby stipulate and agree as follows:9
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`1.
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`Because the PTAB will determine whether the ’462 patent is
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`unpatentable as anticipated or obvious with respect to the IPR Grounds, Defendants
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`will not raise those same invalidity grounds at trial in this action;10
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`2.
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`To the extent any of Defendants’ experts in this action have opined that
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`the ’462 patent is invalid as anticipated or obvious on the basis of the IPR Grounds,
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`Defendants agree those experts will not testify on those invalidity grounds at trial in
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`this action;
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`3.
`
`Nothing in this stipulation affects Defendants’ right to appeal an
`
`adverse decision from the PTAB with respect to the ’462 patent to the United States
`
`Court of Appeals for the Federal Circuit;
`
`
`8 As noted above, this stipulation has been filed on behalf of Mylan, Rio, and Zydus.
`Defendants DRL and Sun previously stipulated to be bound by the estoppel
`provisions in 35 U.S.C. § 315(e)(2). C.A. No. 22-md-3038, D.I. Nos. 333, 334.
`9 Defendants Rio and Zydus make this stipulation without prejudice to their right to
`pursue all available defenses in this action, including the IPR Grounds, should the
`PTAB terminate or otherwise conclude the pending IPRs without reaching a final
`written decision on the merits of the patentability of the challenged claims.
`10 Defendants reserve the right to introduce for consideration at trial or prior to any
`final disposition of the Court any Final Written Decision issued by the PTAB or any
`final decision issued by the United States Court of Appeals for the Federal Circuit
`relating to the IPR petitions.
`
`
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`- 5 -
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`MPI EXHIBIT 1326 PAGE 5
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`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 6 of 9 PageID #: 4837
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`4.
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`Nothing in this stipulation is intended, and should not be construed, to
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`limit Defendants’ right to assert any other grounds of invalidity or non-infringement
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`with respect to the ’462 patent at trial in this action; and
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`5.
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`Nothing in this stipulation affects Defendants’ right to challenge the
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`validity of U.S. Patent No. 8,129,343, which has also been asserted by Plaintiffs in
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`this action.
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`[Remainder of Page Intentionally Left Blank]
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`- 6 -
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`MPI EXHIBIT 1326 PAGE 6
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`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 7 of 9 PageID #: 4838
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`AGREED AND STIPULATED TO:
`August 8, 2024
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`RICHARDS, LAYTON & FINGER, P.A.
`
`
`/s/ Sara M. Metzler
`Kelly E. Farnan (#4395)
`Sara M. Metzler (#6509)
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`302-651-7705
`farnan@rlf.com
`metzler@rlf.com
`
`Attorneys for Defendants Sun
`Pharmaceutical Industries Ltd. and
`Sun Pharmaceutical Industries Inc.
`
`YOUNG CONAWAY STARGATT &
`TAYLOR, LLP
`
`/s/ Alexis N. Stombaugh
`Pilar G. Kraman (#5199)
`Alexis N. Stombaugh (#6702)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`pkraman@ycst.com
`astombaugh@ycst.com
`
`Attorneys for Defendants Zydus
`Worldwide DMCC, Zydus
`Pharmaceuticals (USA) Inc., and
`Zydus Lifesciences Limited
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`- 7 -
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`MPI EXHIBIT 1326 PAGE 7
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`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 8 of 9 PageID #: 4839
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`HEYMAN ENERIO GATTUSO &
`HIRZEL LLP
`
`/s/ Dominick T. Gattuso
`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.
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`STAMOULIS & WEINBLATT LLC
`
`
`/s/ Stamatios Stamoulis
`Stamatios Stamoulis (#4606)
`Richard C. Weinblatt (#5080)
`800 N. West Street, Third Floor
`Wilmington, DE 19801
`(302) 999-1540
`stamoulis@swdelaw.com
`weinblatt@swdelaw.com
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`Attorney for Defendant Mylan
`Pharmaceuticals, Inc.
`
`MORRIS JAMES LLP
`
`
`/s/ Kenneth L. Dorsney
`Kenneth L. Dorsney (#3726)
`Cortlan S. Hitch (#6720)
`500 Delaware Avenue, Suite 1500
`Wilmington, DE 19801
`(302) 888-6800
`kdorsney@morrisjames.com
`chitch@morrisjames.com
`Attorneys for Defendants Rio
`Pharmaceuticals, Inc. and EMS S/A
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`MPI EXHIBIT 1326 PAGE 8
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`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 9 of 9 PageID #: 4840
`Case 1:22-cv-01040-CFC-EGT Document 241 Filed 08/08/24 Page 9 of 9 PagelD #: 4840
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`MPI EXHIBIT 1326 PAGE 9
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`MPI EXHIBIT 1326 PAGE 9
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