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UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`APOTEX INC.,
`Petitioner
`
`v.
`
`NOVO NORDISK A/S,
`PATENT OWNER
`_____________________
`
`CASE IPR2024-00631
`U.S. PATENT NO. 10,335,462
`ISSUED: JULY 2, 2019
`
`TITLE:
`USE OF LONG-ACTING GLP-1 PEPTIDES
`
`
`APOTEX’S MOTION FOR JOINDER UNDER
`35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`TO INTER PARTES REVIEW OF IPR2023-00724
`
`PROTECTIVE ORDER MATERIAL
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`PROTECTIVE ORDER MATERIAL
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`TABLE OF CONTENTS
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`Page
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`TABLE OF CONTENTS ........................................................................................ i
`I.
`STATEMENT OF PRECISE RELIEF REQUESTED ............................. 1
`II.
`STATEMENT OF FACTS ........................................................................... 2
`A.
`Procedural History of Pending IPR Proceedings .................................. 2
`B.
`Apotex’s Development of a Generic Ozempic® Product and
`Decision to File an IPR Petition ............................................................ 3
`III. LEGAL STANDARDS FOR JOINDER ..................................................... 5
`IV. STATEMENT OF REASONS FOR RELIEF REQUESTED .................. 6
`A.
`Each of the Kyocera Factors Weighs in Favor of Joinder .................... 6
`1.
`Joinder Is Appropriate ................................................................. 6
`2.
`Apotex’s Petition Presents No New Unpatentability Grounds ... 7
`3.
`Joinder Will Not Impact the Lead Case’s Schedule ................... 8
`4.
`Briefing and Discovery May Be Simplified ............................... 9
`The Board Should Waive the Joinder Timing Requirement ............... 10
`B.
`V. ALTERNATIVELY, THE BOARD SHOULD CONSOLIDATE
`THIS IPR PROCEEDING WITH MYLAN’S IPR
`PROCEEDING ............................................................................................ 11
`VI. CONCLUSION ............................................................................................ 12
`
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`PROTECTIVE ORDER MATERIAL
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`I.
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`STATEMENT OF PRECISE RELIEF REQUESTED
`Petitioner Apotex Inc. (“Apotex”) respectfully requests joinder to Mylan
`
`Phams., Inc. v. Novo Nordisk, A/S, IPR2023-00724 (the “Mylan IPR proceeding”),
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`or alternatively, consolidation of this proceeding with that proceeding. Apotex
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`files this motion concurrently with its petition for inter partes review (“IPR”) of
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`U.S. Patent No. 10,335,462 (the “’462 patent”). That petition challenges the same
`
`claims of the same patent on the same unpatentability grounds supported by the
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`same prior art, arguments, and evidence as Mylan’s petition.
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`Joinder is appropriate here pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. §
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`42.122(b), because it will reduce duplicative filings and discovery, promoting
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`quick and inexpensive resolution of the case. Apotex has filed a substantially
`
`identical petition to Mylan, Apotex’s experts have adopted the opinions set forth in
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`Mylan’s declarations in their entirety, and Apotex is willing to be a silent
`
`understudy to Mylan. Notably, Novo Nordisk A/S (“Patent Owner”) does not
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`oppose joinder of two other petitioners, Doctor Reddy’s Laboratories (“DRL”) and
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`Sun Pharmaceuticals Industries, Ltd. (“Sun”).
`
`Apotex files its joinder motion less than four months after the regulatory
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`deadline for seeking joinder, see 37 C.F.R. § 42.122(b), in view of business
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`considerations concerning Apotex’s products, not due to lack of diligence nor for
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`an improper purpose. In view of the efficiencies gained by joinder, Apotex’s
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`explanation for the timing of its filing, and the fact that the Board has not yet
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`issued a joinder decision in the DRL and Sun IPR proceedings, the Board should
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`waive the timing requirement for joinder and thus grant Apotex’s motion for
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`joinder.
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`Alternatively, if the Board does not waive the timing requirement for
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`joinder, Apotex respectfully requests that the Board consolidate this IPR with
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`Mylan’s IPR pursuant to 35 U.S.C. § 315(d) and 37 C.F.R. § 42.122(a). Unlike
`
`joinder, there is no timing requirement for consolidation, and consolidation is
`
`appropriate for all the same reasons as joinder.
`
`II.
`
`STATEMENT OF FACTS
`Procedural History of Pending IPR Proceedings
`A.
`On March 16, 2023, Mylan filed the first IPR petition challenging the ’462
`
`patent. Mylan, Paper No. 1, IPR2023-00724. On October 4, 2023, the Board
`
`issued its decision to institute inter partes review. Mylan, Paper No. 10, IPR2023-
`
`00724. DRL and Sun subsequently filed IPR petitions challenging the ’462 patent.
`
`Dr. Reddy’s Lab’ys v. Novo Nordisk A/S, IPR2024-00009, Paper No. 2 (PTAB Oct.
`
`20, 2023); Sun Pharm. Indus. Ltd. v. Novo Nordisk A/S, IPR2024-00107, Paper No.
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`3 (PTAB Nov. 2, 2023). DRL and Sun concurrently filed motions seeking joinder
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`to Mylan’s IPR proceeding, expressing their willingness to be silent understudies
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`to Mylan and explaining that their petitions were substantially identical to Mylan’s
`
`petition. See DRL, IPR2024-00009, Paper No. 3 (PTAB Oct. 20, 2023); Sun,
`
`IPR2024-00107, Paper No. 2 (PTAB Nov. 2, 2023). Patent Owner agreed not to
`
`oppose those motions.1 DRL, IPR2024-00009, Paper No. 12 (PTAB Nov. 20,
`
`2023); Sun, IPR2024-00107, Paper No. 8 (PTAB Nov. 28, 2023). The Board has
`
`not yet issued institution decisions as to DRL’s and Sun’s IPR petitions.
`
`B. Apotex’s Development of a Generic Ozempic® Product and
`Decision to File an IPR Petition
`The ’462 patent is directed to semaglutide. Ex.1001. Semaglutide is sold as
`
`Ozempic® in the form of an injectable pre-filled syringe. Ex. 1507 ¶ 1.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Patent Owner only opposes institution of DRL’s and Sun’s IPRs for reasons
`arising from those parties’ participation in co-pending district court litigation
`involving the ’462 patent. DRL, IPR2024-00009, Paper No. 13 (PTAB Jan. 26,
`2024). Apotex, however, is not a party to that litigation.
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`PROTECTIVE ORDER MATERIAL
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`As part of that process, Apotex identified and retained its own experts to
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`support its petition. Each of Apotex’s experts adopted in toto the opinions set forth
`
`in the respective declarations submitted by Mylan’s experts. Ex. 1501 ¶ 1; Ex.
`
`1503 ¶ 1; Ex. 1505 ¶ 1. As such, Apotex’s IPR petition and three underlying
`
`expert declarations are substantially identical to Mylan’s petition and expert
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`declarations, respectively.
`
`III. LEGAL STANDARDS FOR JOINDER
`The Board’s decision to permit joinder to a previously instituted IPR
`
`proceeding is a discretionary one. 35 U.S.C. § 315(c). In rendering that decision,
`
`the Board considers: (1) the reasons why joinder is appropriate, (2) whether the
`
`new petition presents new unpatentability grounds, (3) any impact on the trial
`
`schedule for the existing IPR, and (4) how briefing or discovery may be simplified
`
`(collectively, the “Kyocera factors”). Kyocera Corp. v. Softview LLC, IPR2013-
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`PROTECTIVE ORDER MATERIAL
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`00004, Paper No. 15 at 4 (PTAB Apr. 24, 2013); see also, e.g., Hyundai Motor Co.
`
`v. Am. Vehicular Sci. LLC, IPR2014-01543, Paper No. 11 at 3 (PTAB Oct. 24,
`
`2014); Macronix Int’l Co. v. Spansion LLC, IPR2014-00898, Paper No. 15 at 4
`
`(PTAB Aug. 13, 2014).
`
`Under 37 C.F.R. § 42.122(b), a petitioner may request joinder to a
`
`previously instituted IPR proceeding “no later than one month after the institution
`
`date” of that proceeding. Nonetheless, the Board may waive or suspend this rule,
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`37 C.F.R. § 42.5(b), and has done so on at least two occasions, GlobalFoundries
`
`U.S. Inc. v. Godo Kaisha IP Bridge 1, IPR2017-00925, Paper No. 13 at 8 (PTAB
`
`June 9, 2017); Sony Corp. of Am. v. Network-1 Security Sols., IPR2013-00495,
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`Paper No. 13 at 9 (PTAB Sept. 16, 2013).
`
`IV. STATEMENT OF REASONS FOR RELIEF REQUESTED
`A. Each of the Kyocera Factors Weighs in Favor of Joinder
`Joinder Is Appropriate
`1.
`Joinder of Apotex to Mylan’s IPR proceeding is appropriate here. Joinder
`
`will reduce duplicative filings and discovery, promoting quick and inexpensive
`
`resolution of the case for the benefit of Board, Patent Owner, and Apotex. That is
`
`because Apotex (1) has filed a substantially identical petition to Mylan, such that
`
`the unpatentability grounds raised in its petition are the same as those in Mylan’s
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`PROTECTIVE ORDER MATERIAL
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`petition, (2) has filed substantially identical supporting declarations to Mylan, with
`
`its experts adopting the opinions set forth in Mylan’s declarations in their entirety,
`
`and (3) is willing to be a silent understudy to Mylan. See §§ IV.A.2-4, infra.
`
`Further, Patent Owner’s agreement not to oppose joinder of DRL and Sun to
`
`Mylan’s IPR proceeding shows that joinder is appropriate in circumstances such as
`
`DRL’s and Sun’s. DRL, IPR2024-00009, Paper No. 12; Sun, IPR2024-00107,
`
`Paper No. 8. And, apart from filing its motion outside the 1-month window,
`
`Apotex is almost identically situated to DRL and Sun given its substantively
`
`identical petition and expert declarations and willingness to serve as a silent
`
`understudy. See DRL, IPR2024-00009, Paper No. 3; Sun, IPR2024-00107, Paper
`
`No. 2.
`
`For the foregoing reasons, this factor weighs in favor of joinder.
`
`2.
`
`Apotex’s Petition Presents No New Unpatentability
`Grounds
`Apotex’s petition presents identical grounds, prior art, challenged claims,
`
`evidence, and unpatentability arguments as Mylan’s petition.
`
`Further, Apotex’s expert testimony is substantially identical to Mylan’s
`
`expert testimony. If Mylan allows, Apotex will rely on Mylan’s declarants and
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`withdraw its own declarants. Even if Mylan does not allow that, if Mylan’s
`
`experts’ declarations and deposition transcripts become publicly available, Apotex
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`PROTECTIVE ORDER MATERIAL
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`will rely on the publicly available declarations and transcripts and withdraw its
`
`own declarations. And even if Apotex were compelled to rely on its own
`
`declarants, Apotex’s expert declarations are substantially identical to Mylan’s
`
`expert declarations. So there would be little impact on the case if Apotex must rely
`
`on its own experts’ declarations. See, e.g., Sawai USA, Inc. v. Biogen MA Inc.,
`
`IPR2019-00789, Paper No. 17 at 19-21 (PTAB Sept. 12, 2019) (granting joinder,
`
`reasoning that the petitions had “no substantial difference” and new petitioner had
`
`its own expert declarations but agreed to withdraw them); SAP Am. Inc. v.
`
`Clouding IP, LLC, IPR2014-00306, Paper No. 13, at 4 (PTAB May 19, 2014)
`
`(granting joinder where petitioner agreed to same condition).
`
`For the foregoing reasons, this factor weighs in favor of joinder.
`
`Joinder Will Not Impact the Lead Case’s Schedule
`3.
`Joinder will not affect the lead case’s schedule. Apotex’s petition has no
`
`new unpatentability grounds, so no additional briefing or discovery is necessary.
`
`Further, Apotex will adhere to the deadlines set in the Mylan IPR proceeding.
`
`Moreover, Apotex is willing to be a silent understudy to Mylan, as discussed
`
`below. For the foregoing reasons, this factor weighs in favor of joinder.
`
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`PROTECTIVE ORDER MATERIAL
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`Briefing and Discovery May Be Simplified
`4.
`To simplify briefing and discovery, Apotex is willing to be a silent
`
`understudy to Mylan, meaning that the following conditions will apply if joinder is
`
`granted and Mylan remains an active party:
`
`(1) Apotex’s filings will be consolidated with Mylan’s filings, unless a filing
`
`solely concerns issues that do not involve Mylan;
`
`(2) Apotex will not raise any new grounds or arguments not already raised
`
`by Mylan; and
`
`(3) Apotex will abide by 37 C.F.R. § 42.53 or any agreement between Patent
`
`Owner and Mylan concerning taking of testimony. See Mylan Pharms. Inc. v.
`
`Novartis AG, IPR2015-00268, Paper No. 17 at 5-6 (PTAB Apr. 10, 2015) (granting
`
`joinder, holding that same proposed conditions “are consistent with the
`
`‘understudy’ role that Petitioner agrees to assume, as well as Petitioner’s assertion
`
`that its presence would not require introducing any additional arguments, briefing,
`
`or discovery.”); Sony Corp. v. Memory Integrity, LLC, IPR2015-01353, Paper No.
`
`11 at 6-7 (PTAB Oct. 15, 2015) (granting joinder where petitioner agreed to same
`
`conditions). Accordingly, this factor also weighs in favor of joinder.
`
`For the foregoing reasons, each of the Kyocera factors weigh in favor of
`
`joinder and therefore the Board should join Apotex to Mylan’s IPR proceeding.
`
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`PROTECTIVE ORDER MATERIAL
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`The Board Should Waive the Joinder Timing Requirement
`B.
`The Board should waive the joinder timing requirement. As an initial
`
`matter, the reasons discussed above as to why joinder is appropriate weigh heavily
`
`in favor of waiving the requirement. See § IV.A.1, supra; GlobalFoundries,
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`IPR2017-00925, Paper No. 13 at 7-8 (waiving requirement, reasoning in part that
`
`new petition raised no new unpatentability grounds, trial schedule would not need
`
`to be adjusted, and petitioner agreed to serve as a silent understudy); Sony,
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`IPR2013-00495, Paper No. 13 at 9 (same).
`
`Moreover, the timing of Apotex’s filing was not due to lack of diligence or
`
`some improper purpose. Rather Apotex filed now due to business considerations
`
`relating to its development of a generic Ozempic® product and, upon achieving
`
`heightened confidence that it would develop a product, acted diligently in
`
`preparing its petition, declarations, and the present motion. See § II, supra.
`
`It should also be noted that Apotex’s decision to file now, rather than earlier,
`
`has not impacted the proceedings thus far, as the Board has not yet addressed
`
`DRL’s or Sun’s joinder motions. Nor would joinder impact the proceedings going
`
`forward, given that Apotex would serve as a silent understudy to Mylan.
`
`For these reasons, the joinder timing requirement should be waived.
`
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`PROTECTIVE ORDER MATERIAL
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`-10-
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`

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`V. ALTERNATIVELY, THE BOARD SHOULD CONSOLIDATE THIS
`IPR PROCEEDING WITH MYLAN’S IPR PROCEEDING
`If the Board does not waive the timing requirement for joinder to Mylan’s
`
`IPR proceeding, it should instead consolidate this IPR proceeding with Mylan’s
`
`IPR proceeding. The Board may consolidate one IPR proceeding with another
`
`proceeding before it, 35 U.S.C. § 315(d); 37 C.F.R. § 42.122(a), and the Board’s
`
`rules do not limit the timing of a consolidation motion, 37 C.F.R. § 42.122(a)
`
`(setting no timing requirement for a consolidation motion).
`
`Consolidation is appropriate for the same reasons as joinder, namely that
`
`consolidation will reduce duplicative filings and discovery, promoting quick and
`
`inexpensive resolution of these issues for the benefit of Board, Patent Owner, and
`
`Apotex. See § IV.A.1. That is because Apotex has filed a substantially identical
`
`petition to Mylan with the same unpatentability grounds, its experts have adopted
`
`the opinions set forth in Mylan’s declarations in their entirety, and it is willing to
`
`be a silent understudy to Mylan. Sony Elecs. Inc. v. Jawbone Innovations, LLC,
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`IPR2023-01110, Paper No. 12 at 2-3 (PTAB Feb. 9, 2024) (granting consolidation
`
`where petitions were “substantially identical” and one petitioner agreed to be an
`
`understudy, reasoning that consolidation would “secure a just, speedy, and
`
`inexpensive resolution to the proceedings” and promote efficiency); ZTE (USA)
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`PROTECTIVE ORDER MATERIAL
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`Inc. v. Evolved Wireless LLC, IPR2016-01277, Paper No. 8 (PTAB Dec. 21, 2016)
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`(granting consolidation where petitions were “identical in substance”).
`
`VI. CONCLUSION
`For the foregoing reasons, Apotex respectfully requests that the Board join
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`Apotex to Mylan’s proceeding, or alternatively, consolidate the two proceedings.
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`PROTECTIVE ORDER MATERIAL
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`-12-
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`

`

`Dated: March 1, 2024
`STEPTOE LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Telephone: 212-506-3900
`Fax: 212-506-3950
`Email: Semaglutide@Steptoe.com
`
`Respectfully submitted,
`
`
`
`/John J. Molenda/
`John J. Molenda
`Reg. No. 47,804
`Lead Counsel for Apotex
`
`
`PROTECTIVE ORDER MATERIAL
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`-13-
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`

`

`CERTIFICATE OF SERVICE
`
`The undersigned certifies that, in accordance with 37 C.F.R. § 42.6(e) and 37
`
`C.F.R. § 42.105, and with Patent Owner’s consent, electronic service of APOTEX’S
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`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22
`
`AND 42.122(b) TO INTER PARTES REVIEW OF IPR2023-00724 was made on
`
`Patent Owner to the following email addresses:
`
`Dated: March 1, 2024
`
`
`J. Steven Baughman
`Megan Raymond
`Michael F. Milea
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`steve.baughman@groombridgewu.com
`megan.raymond@groombridgewu.com
`mike.milea@groombridgewu.com
`Novo-Semaglutide-IPR@groombridgewu.com
`
`
`
`/s/ John J. Molenda
`John J. Molenda (Reg. No. 47,804)
`Lawrence Kass (Reg. No. 40,671)
`Tyler Doh (Reg. No. 80,274)
`Michael I. Green (Reg. No. 80,436)
`STEPTOE LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Tel: (212) 506-3900
`
`Counsel for Apotex
`
`
`
`

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