`
`_____________________
`
`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 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”) Opposition to
`
`Petitioner’s Motion for Joinder (the “Opposition”), Paper No. 9 and (2) Apotex’s
`
`Reply to the Patent Owner’s Opposition to Petitioner’s Motion for Joinder (the
`
`“Reply”).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 previously 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 Opposition and the Reply. 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 seal
`
`
`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-
`
`
`
`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 Opposition and the Reply 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, and/or the Opposition. See First Motion (describing confidential
`
`information in the Shapiro Declaration and the Joinder Motion). If the confidential
`
`information in the Opposition and the Reply were publicly disclosed, it would
`
`likely cause competitive business harm to Apotex.
`
`The version of the Opposition that Novo filed is unredacted and nonpublic.
`
`Concurrently with this motion, Apotex has filed a public version of the Opposition
`
`redacting the limited portions of the motion that reference or incorporate
`
`confidential information from the Shapiro Declaration or the Joinder Motion.
`
`
`
`-2-
`
`
`
`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, or the
`
`Opposition.
`
`III. CONCLUSION
`For the foregoing reasons, Apotex respectfully requests that the Board grant
`
`this motion to seal.
`
`
`
`Dated: April 15, 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
`
`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: April 15, 2024
`
`
`
`
`
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