IPR2024-00009
`U.S. Patent 10,335,462
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`DR. REDDY’S LABORATORIES, INC.
`and
`DR. REDDY’S LABORATORIES, LTD.,
`
`Petitioners
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2024-00009
`Patent 10,335,462
`______________________
`
`DECLARATION OF SAYEM OSMAN
`
`
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00001
`
`
`U.S. Patent 10,335,462
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`DR. REDDY’S LABORATORIES, INC.
`and
`DR. REDDY’S LABORATORIES, LTD.,
`
`Petitioners
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2024-00009
`Patent 10,335,462
`______________________
`
`DECLARATION OF SAYEM OSMAN
`
`
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00001
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`I, Sayem Osman, make the following Declaration pursuant to 28 U.S.C. § 1746:
`
`1.
`
`I am a paralegal at the law firm of Groombridge, Wu, Baughman & Stone
`
`LLP.
`
`2.
`
`I provide this Declaration in connection with the above-identified Patent
`
`Owner’s Preliminary Response to the Inter Partes Review proceeding that is being
`
`requested at the U.S. Patent and Trademark Office by Petitioners under 35 U.S.C.
`
`§§ 311-319, 37 C.F.R. § 42. Unless otherwise stated, the facts stated in this
`
`Declaration are based on my personal knowledge.
`
`3.
`
`EX2001 hereto is a true and correct copy of an excerpt of Defendants’ Initial
`
`Invalidity Contentions Regarding to Defendants’ Initial Invalidity Contentions
`
`Regarding U.S. Patent Nos. 8,129,343; 8,536,122; 8,114,833; 8,920,383;
`
`9,775,953; 9,457,154; and 10,335,462, In re: Ozempic (Semaglutide) Patent
`
`Litigation, No. 1:22-cv-01040-CFC, (D. Del. Oct. 20, 2022) which I retrieved on
`
`June 29, 2023, as an attachment to an email from Novo Nordisk A/S’s counsel at
`
`Fenwick & West LLP. Other than excerpting the pages, striking through the
`
`confidentiality designation, and adding an exhibit label and page numbers to the
`
`bottom of all pages of EX2001, no other alterations have been made.
`
`4.
`
`EX2002 hereto is a true and correct copy of Petition for Inter Partes Review
`
`of U.S. Patent No. 10,335,462, which I retrieved on January 24, 2024, from the
`
`United States Patent & Trademark Office’s P-Tacts website
`
`1
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00002
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`(https://ptacts.uspto.gov/ptacts/public-informations/petitions/1553774/download-
`
`documents?artifactId=b_q1LlcUgnhslVIMU0tD9zkdxWsQEEBi-V1wQDdI_1YE-
`
`eov0D-4ToU). An exhibit label and page numbers have been added to the bottom
`
`of all pages of EX2002 but no other alterations have been made.
`
`5.
`
`EX2004 hereto is a true and correct copy of the Stipulation and Order
`
`Regarding Trial of the MPI Ozempic Litigation, In re: Ozempic (Semaglutide)
`
`Patent Litigation, MDL No. 22-MD-03038, Dkt. 245 (D. Del. Oct. 31, 2023) which
`
`I retrieved on January 24, 2024, from
`
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-md-
`
`03038/In_Re--_Ozempic_%28Semaglutide%29_Patent_Litigation/245/. Other than
`
`excerpting the pages and adding an exhibit label and page numbers to the bottom of
`
`all pages of EX2004, no other alterations have been made.
`
`6.
`
`EX2005 hereto is a true and correct copy of an email from E. Goldschlager to
`
`Counsel dated Nov. 29, 2023 re: IPR2023-00724 Request for Conference Call. I
`
`received this email on Nov. 29, 2023 as a member of an email distribution group.
`
`An exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2005 but no other alterations have been made.
`
`7.
`
`EX2006 hereto is a true and correct copy of the Scheduling & Consolidation
`
`Order, Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc., No. 1:22-cv-00294, Dkt.
`
`22 (D. Del. June 30, 2023) which I retrieved on January 24, 2024, from
`
`2
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00003
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-cv-
`
`00294/Novo_Nordisk_Inc._et_al_v._Rio_Biopharmaceuticals_Inc._et_al/22/. An
`
`exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2006 but no other alterations have been made.
`
`8.
`
`EX2007 hereto is a true and correct copy of an excerpt of a Hearing
`
`Transcript of Dec. 13, 2023 Claim Construction Hearing, Novo Nordisk Inc. v.
`
`Mylan Pharmaceuticals Inc., No. 23-101-CFC (D. Del. Dec. 13, 2023), which I
`
`understand was received by Novo Nordisk’s counsel Groombridge, Wu, Baughman
`
`& Stone. An exhibit label and page numbers have been added to the bottom of all
`
`pages of EX2007 but no other alterations have been made.
`
`9.
`
`EX2008 hereto is a true and correct copy of the Claim Construction Order, In
`
`re: Ozempic (Semaglutide) Patent Litigation, MDL No. 22-MD-03038, Dkt. 148
`
`(D. Del. July 25, 2023) which I retrieved on January 24, 2024, from
`
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-md-
`
`03038/In_Re--_Ozempic_%28Semaglutide%29_Patent_Litigation/148/. Other than
`
`excerpting the pages and adding an exhibit label and page numbers to the bottom of
`
`all pages of EX2008, no other alterations have been made.
`
`10. EX2009 hereto is a true and correct copy of the Joint Stipulation and Order
`
`Amending Scheduling Order, In re: Ozempic (Semaglutide) Patent Litigation, MDL
`
`No. 22-MD-03038-CFC, Dkt. 268 (D. Del. Dec. 1, 2023), which I retrieved on
`
`3
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00004
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`
`January 24, 2024, from
`
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-md-
`
`03038/In_Re--_Ozempic_%28Semaglutide%29_Patent_Litigation/268/. An exhibit
`
`label and page numbers have been added to the bottom of all pages of EX2009 but
`
`no other alterations have been made.
`
`11. EX2010 hereto is a true and correct copy of an excerpt of a Non-Confidential
`
`Excerpt of Novo Nordisk’s Second Amended Disclosures to Dr. Reddy’s
`
`Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc.,, In re: Ozempic (Semaglutide)
`
`Patent Litigation, No. 22-MD-03038-CFC (D. Del. July 28, 2023), which I
`
`received on January 26, 2024, as an attachment to an email from Novo Nordisk
`
`A/S’s counsel at Fenwick & West LLP. Other than excerpting the pages, striking
`
`through the confidentiality designation, and adding an exhibit label and page
`
`numbers to the bottom of all pages of EX2010, no other alterations have been
`
`made.
`
`12. EX2011 hereto is a true and correct copy of United States Patent No.
`
`8,114,833 which I retrieved on January 24, 2024, from the United States Patent &
`
`Trademark Office’s Patent Public Search Basic (PPUBS Basic) website
`
`(https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/8114833). An
`
`exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2011 but no other alterations have been made.
`
`4
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00005
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`13. EX2012 hereto is a true and correct copy of the Waiver of Service of
`
`Summons for Dr. Reddy’s Laboratories, Inc., Novo Nordisk Inc. v. Dr. Reddy’s
`
`Lab’ys Ltd., No. 1:22-cv-00298-CFC, Dkt. 6 (D. Del., Mar. 4, 2022), which I
`
`retrieved on January 26, 2024 from
`
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-cv-
`
`00298/Novo_Nordisk_Inc._et_al_v._Dr._Reddy%27s_Laboratories_Ltd._et_al/6/.
`
`An exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2012 but no other alterations have been made.
`
`14. EX2013 hereto is a true and correct copy of the Waiver of Service of
`
`Summons for Dr. Reddy’s Laboratories Ltd., Novo Nordisk Inc. v. Dr. Reddy’s
`
`Lab’ys Ltd., No. 1:22-cv-00298-CFC, Dkt. 7 (D. Del. Mar. 4, 2022), which I
`
`retrieved on January 26, 2024 from
`
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-cv-
`
`00298/Novo_Nordisk_Inc._et_al_v._Dr._Reddy%27s_Laboratories_Ltd._et_al/7/.
`
`An exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2013 but no other alterations have been made.
`
`15. EX2014 hereto is a true and correct copy of an excerpt of the Redacted Patent
`
`Owner’s Response, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724,
`
`Pap.30 (Jan. 17, 2023), which I retrieved on January 25, 2024 from
`
`https://ptacts.uspto.gov/ptacts/public-informations/petitions/1553774/download-
`
`5
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00006
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`documents?artifactId=YsEnVu4ftxcTMQcC5gGzzywFkHUzJXnYgM-
`
`hMM3wNUu6AQSIpaedcJ4. An exhibit label and page numbers have been added
`
`to the bottom of all pages of EX2014 but no other alterations have been made.
`
`16. EX2015 hereto is a true and correct copy of an excerpt of Novo Nordisk’s
`
`Initial Responses to Defendants’ Initial Invalidity Contentions Regarding U.S.
`
`Patent Nos. 8,129,343; 8,536,122; 8,114,833; 8,920,383; 9,775,953; 9,457,154; and
`
`10,335,462, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-01040-
`
`CFC, (D. Del. Dec. 21, 2022), which I understand was received by counsel at
`
`Groombridge, Wu, Baughman & Stone from counsel at Fenwick & West on
`
`January 24, 2023, and which I received from counsel at Groombridge, Wu,
`
`Baughman & Stone on June 29, 2023. Other than excerpting the pages, striking
`
`through the confidentiality designation, and adding an exhibit label and page
`
`numbers to the bottom of all pages of EX2015, no other alterations have been
`
`made.
`
`17. EX2016 hereto is a true and correct copy of the Transfer Order, In re:
`
`Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC, Dkt. 1 (D. Del.
`
`Aug. 5, 2022), which I retrieved on January 26, 2024 from
`
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-md-
`
`03038/In_Re--_Ozempic_%28Semaglutide%29_Patent_Litigation/1/. An exhibit
`
`6
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00007
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`label and page numbers have been added to the bottom of all pages of EX2016 but
`
`no other alterations have been made.
`
`18. EX2018 hereto is a true and correct copy of an excerpt of Defendants’
`
`Supplemental Invalidity Contentions, In re: Ozempic (Semaglutide) Patent
`
`Litigation, No. 22-MD-03038-CFC (D. Del. July 28, 2023), which I received on
`
`January 26, 2024, as an attachment to an email from Novo Nordisk A/S’s counsel at
`
`Fenwick & West LLP. Other than excerpting the pages, striking through the
`
`confidentiality designation, and adding an exhibit label and page numbers to the
`
`bottom of all pages of EX2018, no other alterations have been made.
`
`19. EX2019 hereto is a true and correct copy of Novo Nordisk Production Letter,
`
`In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del.
`
`Oct. 17, 2023), In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-01040-
`
`CFC, (D. Del. Dec. 21, 2022), which I received on January 26, 2024, as an
`
`attachment to an email from Novo Nordisk A/S’s counsel at Fenwick & West LLP.
`
`An exhibit label and page numbers have been added to the bottom of all pages of
`
`EX2019 but no other alterations have been made.
`
`20. EX2020 hereto is a true and correct copy of a Compilation of Defendants’
`
`Production Letters, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-
`
`03038-CFC (D. Del.), which I received on January 26, 2024, as an attachment to an
`
`email from Novo Nordisk A/S’s counsel at Fenwick & West LLP. Other than
`
`7
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00008
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`compiling the pages and adding an exhibit label and page numbers to the bottom of
`
`all pages of EX2020, no other alterations have been made.
`
`21. EX2021 hereto is a true and correct copy of a Compilation of Rule 30(b)(1)
`
`Deposition Notices, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-
`
`03038-CFC (D. Del.), which I received on January 26, 2024, as an attachment to an
`
`email from Novo Nordisk A/S’s counsel at Fenwick & West LLP. Other than
`
`compiling the pages and adding an exhibit label and page numbers to the bottom of
`
`all pages of EX2021, no other alterations have been made.
`
`22. EX2022 hereto is a true and correct copy of the Notice of Service for
`
`Defendants’ Initial Invalidity Contentions, In re: Ozempic (Semaglutide) Patent
`
`Litigation, No. 22-MD-03038-CFC, Dkt. 43 (D. Del. Oct. 20, 2022), which I
`
`retrieved on January 26, 2024 from
`
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-md-
`
`03038/In_Re--_Ozempic_%28Semaglutide%29_Patent_Litigation/43/. An exhibit
`
`label and page numbers have been added to the bottom of all pages of EX2022 but
`
`no other alterations have been made.
`
`23. EX2023 hereto is a true and correct copy of the Notice of Service for
`
`Defendants’ Supplemental Invalidity Contentions, In re: Ozempic (Semaglutide)
`
`Patent Litigation, No. 22-MD-03038-CFC, Dkt. 256 (D. Del. Nov. 6, 2023), which I
`
`retrieved on January 26, 2024 from
`
`8
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00009
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`https://www.docketalarm.com/cases/Delaware_District_Court/1--22-md-
`
`03038/In_Re--_Ozempic_%28Semaglutide%29_Patent_Litigation/256/. An exhibit
`
`label and page numbers have been added to the bottom of all pages of EX2023 but
`
`no other alterations have been made.
`
`24.
`
`I have been warned that willful false statements and the like are punishable
`
`by fine or imprisonment, or both. I make this declaration of my own personal
`
`knowledge, and all statements are true. If called to testify as to the truth of the
`
`matters stated herein, I could and would testify competently.
`
`25.
`
`I have been warned that willful false statements and the like are punishable
`
`by fine or imprisonment, or both (18 U.S.C. 1001) and may jeopardize the validity
`
`of the patent at issue in this proceeding, I declare under penalty of perjury under
`
`the laws of the United States of America that the foregoing is true and correct.
`
`Executed on this 26th day of January, 2026, at Addis Ababa, Ethiopia.
`
`
`
`
`
`
`
` /Sayem Osman/
`
` Sayem Osman
`
`9
`
`Novo Nordisk Exhibit 2001
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00010
`
`
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