`
`_____________________
`
`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 THIRD MOTION TO SEAL
`
`
`
`
`
`
`
`
`
`I.
`
`INTROUDCTION
`
`Pursuant to the protective order and 37 C.F.R. § 42.14, Petitioner Apotex
`
`Inc. (“Apotex”) hereby moves to seal (1) Patent Owner’s (“Novo’s”) Patent Owner
`
`Preliminary Response (the “POPR”), Paper No. 15, (2) Apotex’s Reply to the
`
`POPR (the “Reply”), and (3) Ex. 2010.1 Good cause exists for sealing those
`
`documents. That is because those documents contain Apotex’s confidential
`
`business information, which, if disclosed, would likely cause competitive harm to
`
`Apotex.
`
`Apotex requested entry of the Board’s default protective order in its First
`
`Motion. Novo has consented to the default protective order. Ex. 3001.
`
`II. GOOD CAUSE EXISTS TO SEAL THE OPPOSITION AND REPLY
`
`Pursuant to the protective order and 37 C.F.R. § 42.14, Apotex moves to seal
`
`the POPR, the Reply, and Ex. 2010. As the Board has found in similar cases,
`
`“good cause” exists to seal those documents because they contain Apotex’s
`
`business information that has not been made public. Celltrion, Inc., v. Genentech,
`
`Inc., IPR2016-01667, Paper No. 20 at 4 (PTAB Aug. 18, 2017) (granting motion to
`
`
`1 Apotex previously filed a motion to seal (“First Motion”), Paper No. 3, (1) its
`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 (the “Joinder Motion”) and
`(2) the Declaration of Robert Shapiro (the “Shapiro Declaration”), Ex. 1507.
`Novo did not oppose the First Motion.
`
`
`
`-1-
`
`
`
`seal non-public business information, including information about drug
`
`development and regulatory strategies), Paper No. 31 at 4 (PTAB July 23, 2018)
`
`(granting motion to expunge that information from the record); Unified Patents
`
`Inc. v. Dragon Intellectual Prop., LLC, IPR2014-00216, Paper No. 40, 6-7 (PTAB
`
`Feb. 27, 2015) (granting motion to seal non-public business information, including
`
`information relating to business strategies); see also 37 C.F.R. § 42.54.
`
`Specifically, certain portions of the POPR, the Reply, and Ex. 2010 contain
`
`confidential information that describes Apotex’s confidential drug development
`
`and regulatory approval strategies. Those portions of the documents are those that
`
`reference or incorporate confidential information from the Shapiro Declaration, the
`
`Joinder Motion, the POPR, or Ex. 2010. See First Motion (describing confidential
`
`information in the Shapiro Declaration and the Joinder Motion). If the confidential
`
`information in POPR, the Reply, and Ex. 2010 were publicly disclosed, it would
`
`likely cause competitive business harm to Apotex.
`
`The versions of the POPR and Ex. 2010 that Novo filed are unredacted and
`
`nonpublic. Because the entirety of Ex. 2010 contains confidential information,
`
`Apotex has not filed a redacted version. Concurrently with this motion, Apotex
`
`has filed a public version of the POPR redacting the limited portions of the motion
`
`
`
`-2-
`
`
`
`that reference or incorporate confidential information from the Shapiro
`
`Declaration, the Joinder Motion, or Ex. 2010.
`
`Apotex has filed a unredacted, nonpublic version of the Reply concurrently
`
`with this motion. Apotex has also concurrently filed a redacted, public version of
`
`its Reply redacting the limited portions of the motion that reference or incorporate
`
`confidential information from the Shapiro Declaration, the Joinder Motion, the
`
`POPR, or Ex. 2010.
`
`III. CONCLUSION
`
`For the foregoing reasons, Apotex respectfully requests that the Board grant
`
`this motion to seal.
`
`
`
`Dated: July 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
`
`
`
`-3-
`
`
`
`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
`
`THIRD MOTION TO SEAL was made on Patent Owner to the following email
`
`addresses:
`
`J. Steven Baughman
`Megan Raymond
`Michael F. Milea
`Joshua Reich
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`steve.baughman@groombridgewu.com
`megan.raymond@groombridgewu.com
`mike.milea@groombridgewu.com
`joshua.reich@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
`
`Dated: July 1, 2024
`
`
`
`
`
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