IPR2023-00724
` U.S. Patent No. 10,335,462
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00724
`Patent 10,335,462
`______________________
`
`
`
` NOVO NORDISK A/S’S MOTION TO SEAL AND FOR ENTRY OF A
`PROTECTIVE ORDER PURSUANT TO 37 C.F.R. § 42.54
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` U.S. Patent No. 10,335,462
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00724
`Patent 10,335,462
`______________________
`
`
`
` NOVO NORDISK A/S’S MOTION TO SEAL AND FOR ENTRY OF A
`PROTECTIVE ORDER PURSUANT TO 37 C.F.R. § 42.54
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`IPR2023-00724
` U.S. Patent No. 10,335,462
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`Introduction
`Pursuant to 37 C.F.R. Sections 42.14, 42.54, and 42.55, Patent Owner Novo
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`I.
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`Nordisk A/S (“Novo”) hereby moves for entry of the Protective Order (EX2079)
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`and further moves to seal its Patent Owner Response and certain exhibits submitted
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`with its Patent Owner Response as described herein. Petitioner Mylan
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`Pharmaceuticals Inc. (“Mylan”) has advised Novo that Mylan does not oppose this
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`motion for entry of the Protective Order submitted as Exhibit 2079 and to seal
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`certain documents.
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`II. Good Cause Exists for Entry of a Protective Order
`Following institution of this proceeding, Novo and Mylan conferred upon
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`entry of a protective order in this case. The parties agreed to the Board’s default
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`protective order. See Patent Trial and Appeal Board Consolidated Trial Practice
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`Guide 117–22 (Nov. 2019). Novo moves for entry of the Protective Order
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`submitted below as Exhibit 2079 and agrees to abide by the terms of the Protective
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`Order.
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`III. Good Cause Exists to Seal the Patent Owner Response and Supporting
`Exhibits
`Pursuant to the stipulated protective order and 37 C.F.R. Sections 42.54 and
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`42.55, Novo moves to seal (i) its Patent Owner Response submitted concurrently
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`with this motion; and (ii) the following exhibits submitted in support of its Patent
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`Owner Response:
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`1
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`IPR2023-00724
`IPR2023-00724
` U.S. Patent No. 10,335,462
`US. Patent No. 10,335,462
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`
`• EX2021
`EX2021
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`• EX2022
`EX2022
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`• EX2023
`EX2023
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`• EX2024
`EX2024
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`• EX2025
`EX2025
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`• EX2026
`EX2026
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`• EX2027
`EX2027
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`• EX2028
`EX2028
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`• EX2029
`EX2029
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`• EX2030
`EX2030
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`• EX2031
`EX2031
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`• EX2032
`EX2032
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`• EX2033
`EX2033
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`• EX2034
`EX2034
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`• EX2035
`EX2035
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`• EX2036
`EX2036
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`• EX2038
`EX2038
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`• EX2039
`EX2039
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`• EX2040
`EX2040
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`2
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`IPR2023-00724
`IPR2023-00724
` U.S. Patent No. 10,335,462
`US. Patent No. 10,335,462
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`• EX2041
`EX2041
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`• EX2046
`EX2046
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`• EX2047
`EX2047
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`• EX2048
`EX2048
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`• EX2050
`EX2050
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`• EX2051
`EX2051
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`• EX2056
`EX2056
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`• EX2300
`EX2300
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`• EX2301
`EX2301
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`• EX2302
`EX2302
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`• EX2303
`EX2303
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`• EX2304
`EX2304
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`• EX2305
`EX2305
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`• EX2306
`EX2306
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`• EX2307
`EX2307
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`• EX2308
`EX2308
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`• EX2309
`EX2309
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`• EX2310
`EX2310
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`• EX2311
`EX2311
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`3
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`IPR2023-00724
`IPR2023-00724
` U.S. Patent No. 10,335,462
`US. Patent No. 10,335,462
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`• EX2312
`EX2312
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`• EX2313
`EX2313
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`• EX2314
`EX2314
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`• EX2315
`EX2315
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`• EX2316
`EX2316
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`• EX2317
`EX2317
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`• EX2318
`EX2318
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`• EX2320
`EX2320
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`• EX2321
`EX2321
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`• EX2322
`EX2322
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`• EX2323
`EX2323
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`• EX2324
`EX2324
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`• EX2325
`EX2325
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`• EX2326
`EX2326
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`• EX2327
`EX2327
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`• EX2328
`EX2328
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`• EX2329
`EX2329
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`• EX2330
`EX2330
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`• EX2331
`EX2331
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`4
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`IPR2023-00724
` U.S. Patent No. 10,335,462
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`• EX2332
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`• EX2333
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`• EX2334
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`Novo has also concurrently filed redacted versions of its Patent Owner
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`Responses and Exhibits 2050, 2051, 2056, and 2300. Exhibits 2021-2036, 2038-
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`2041, 2046-2048, 2301-2318, and 2320-2334 are redacted in their entirety and are
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`submitted to the Board with this motion for filing under seal. Novo has served
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`Mylan with both confidential and redacted versions of the Patent Owner Response
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`and supporting exhibits.
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`As the Board found in similar cases, “good cause” exists to seal Novo’s
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`Patent Owner Response and the supporting exhibits because they include Novo’s
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`non-public business information. Celltrion, Inc. v. Genentech, Inc., IPR2016-
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`01667, Pap.31, 4 (July 23, 2018); Greene’s Energy Grp., LLC v. Oil States Energy
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`Servs., LLC, IPR2014-00216, Pap.27, 5 (Sept. 23, 2014); 37 C.F.R. § 42.54.
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`Exhibits 2021-2036, 2038-2041, 2046-2048, 2302-2318, and 2319-2334 all have
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`been produced in the co-pending litigation as confidential under the terms of the
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`Protective Order entered in that case. This confidential information contains non-
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`public research and development information in the form of proprietary clinical
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`and scientific data concerning semaglutide, confidential information about drug
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`development and regulatory approval strategies, and confidential business
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`5
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`information, including relating to financial information and proprietary marketing
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`IPR2023-00724
` U.S. Patent No. 10,335,462
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`strategies. EX2052, ¶ 3 (Jiang Decl.). If this confidential information were
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`publicly disclosed, it would likely cause competitive business harm to Novo.
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`EX2052, ¶ 4 (Jiang Decl.). Further, EX2301 contains confidential information in
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`the form of third-party proprietary business and financial information provided to
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`Novo Nordisk contingent upon and subject to confidentiality restrictions and the
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`sealing of this information under the terms of the PTAB’s default protective order.
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`EX2052, ¶¶ 3-4 (Jiang Decl.).
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`IV. Conclusion
`For the foregoing reasons, Novo respectfully requests that the Board grant
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`this motion to seal and for entry of a protective order.
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`Dated: January 17, 2024
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`
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`
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`Respectfully submitted by:
`
`/Megan Raymond/
`J. Steven Baughman (Reg. No. 47,414)
`Megan Raymond (Reg. No. 72,997)
`Michael Milea (Reg. No. 71, 863)
`
`Attorneys For Patent Owner
`Novo Nordisk A/S
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`6
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`IPR2023-00724
` U.S. Patent No. 10,335,462
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`CERTIFICATE OF PAGE COUNT
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`The undersigned certifies that the foregoing NOVO NORDISK A/S’S
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`MOTION TO SEAL AND FOR ENTRY OF A PROTECTIVE ORDER
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`PURSUANT TO 37 C.F.R. § 42.54 complies with the 15-page limitation in 37
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`C.F.R. §42.24(a)(1)(v).
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`Dated: January 17, 2024
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`Respectfully Submitted,
`
`/Megan Raymond/
`By:
`Megan Raymond (Reg. No. 72,997)
`GROOMBRIDGE, WU, BAUGHMAN &
`STONE LLP
`801 17th Street, NW, Suite 1050
`Washington, DC, 20006
`P: (202)-505-5878
`megan.raymond@groombridgewu.com
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`1
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`IPR2023-00724
` U.S. Patent No. 10,335,462
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of NOVO NORDISK A/S’S
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`MOTION TO SEAL AND FOR ENTRY OF A PROTECTIVE ORDER
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`PURSUANT TO 37 C.F.R. § 42.54 has been served in its entirety by causing the
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`aforementioned document to be electronically mailed to the following attorneys of
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`
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`record for the Petitioner listed below:
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`Petitioner’s Counsel of Record:
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`Lead Counsel:
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`Brandon M. White
`Reg. No. 52,354
`White-ptab@perkinscoie.com
`Perkins Coie LLP
`700 13th Street, NW
`Washington, DC 20005
`Telephone: (202) 654-6200
`
`By Electronic Mail
`Backup Counsel: Emily J. Greb
`Reg. No. 68,244
`Greb-ptab@perkinscoie.com
`Perkins Coie LLP
`33 East Main Street
`Madison, WI 53703
`Telephone: (608) 663-7460
`
`Courtney Prochnow, PhD
`Reg. No. 67,639
`Prochnow-ptab@perkinscoie.com
`Perkins Coie LLP
`633 W. 5th St., Ste 5850
`Los Angeles, CA 90071
`Telephone: (310) 788-9900
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`2
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`IPR2023-00724
` U.S. Patent No. 10,335,462
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`Christopher D. Jones
`Reg. No. 76,472
`Jones-ptab@perkinscoie.com
`Perkins Coie LLP
`700 13th Street, NW
`Washington, DC 20005
`Telephone: (202) 654-6200
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`Jonathan I. Tietz, PhD
`Reg. No. 76,753
`Tietz-ptab@perkinscoie.com
`Perkins Coie LLP
`700 13th Street, NW
`Washington, DC 20005
`Telephone: (202) 654-6200
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`Matthew A. Lembo
`Reg. No. 75,633
`Lembo-ptab@perkinscoie.com
`Perkins Coie LLP
`1155 Avenue of the Americas
`Floor 22
`New York, NY 10036
`Telephone: (212) 262-6900
`
`Shannon M. Bloodworth
`SBloodworth@perkinscoie.com
`Perkins Coie LLP
`700 13th Street, NW
`Washington, DC 20005
`Telephone: (202) 654-6200
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`David L. Anstaett
`DAnstaett@perkinscoie.com
`Perkins Coie LLP
`33 East Main Street
`Madison, WI 53703
`Telephone: (608) 663-7460
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`3
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`IPR2023-00724
` U.S. Patent No. 10,335,462
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`Bryan D. Beel
`BBeel@perkinscoie.com
`Perkins Coie LLP
`1120 NW Couch St.
`Portland, OR 97209
`Telephone: (503) 727-2000
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`Nathan Kelley
`Kelley_nathan-ptab@perkinscoie.com
`Perkins Coie LLP
`700 13th Street, NW
`Washington, DC 20005
`Telephone: (202) 654-6200
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`Semaglutide-Ozempic@perkinscoie.com
`By Electronic Mail
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`
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`Dated: January 17, 2024
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` Respectfully submitted,
`By: /Sayem Osman
`Sayem Osman
`
`4
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