Sun Pharmaceutical Industries Ltd. et al. vs Novo Nordisk A/S

Termination Decision: Post-DI Settlement

Order: Order on Motions to Expunge

Order: On Protective Orders and Motions to Seal

Granting Institution of Inter Partes Review 35 U.S.C. § 314 Granting Motion for Joinder 35 U.S.C. § 315(c); 37 C.F.R. § 42.122

Exhibit 3001

PETITIONERS' REPLY TO PATENT OWNER'S FURTHER AUTHORIZED REPLY

Patent Owner's Further Authorized Reply

EX2031 - Email Exchange Between Counsel for Petitioner and Counsel for Patent Owner Regarding Request To File Stipulation

Updated Exhibit List May 1

EX1099 Sun Pharmaceutical Industries Ltd.’s and Sun Pharmaceutical Industries, Inc.’s Stipulation of Invalidity Contentions

Patent Owner's Sur-Reply

EX2028 - Excerpt of Opening Expert Report of Dr. John Bantle Regarding Invalidity of U.S. Patent No. 10,335,462, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del.)

EX2029 - Excerpt of Opening Expert Report of William J. Jusko, Ph.D. Regarding Invalidity of U.S. Patent No. 10,335,462, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del.)

EX2030 - Excerpt of Opening Expert Report of Dr. Paul Dalby Regarding Invalidity of U.S. Patent No. 10,335,462, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del.)

PETITIONERS REPLY TO PATENT OWNERS PRELIMINARY RESPONSE

Oral Order, Novo Nordisk Inc. v. Rio Biopharmaceuticals Inc., No. 22-294 (CFC) (D. Del. March 13, 2024)

EX2001 - Excerpt of 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. 22-MD-03038-CFC (D. Del. Oct. 20, 2022)

EX2002 - Petition for Inter Partes Review, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, Pap.1 (Mar. 16, 2023)

EX2003 - Declaration of Sayem Osman

EX2004 - Stipulation and Order Regarding Trial of the MPI Ozempic Litigation, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC, Dkt. 245 (D. Del. Oct. 31, 2023)

EX2005 - Nov. 29, 2023 Email from E. Goldschlager to Counsel, re: IPR2023-00724 – Request for Conference Call

EX2006 - Scheduling Order, Novo Nordisk Inc. v. Rio Biopharms., Inc., No. 1:22-cv-00294-CFC, Dkt. 22 (D. Del. June 30, 2022)

EX2007 - Excerpt of Transcript of Dec. 13, 2023 Claim Construction Hearing, Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc., No. 23-101-CFC (D. Del. Dec. 13, 2023)

EX2008 - Claim Construction Order, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC, Dkt. 148 (D. Del. July 25, 2023)

EX2009 - 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)

EX2010 - Excerpt of Novo Nordisk's Third Amended Disclosures to Defendants Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc., In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del. July 28, 2023)

EX2011 - U.S. Patent No. 8,114,833

EX2012 - Summons in a Civil Action, Sun Pharmaceutical Industries, Inc., Novo Nordisk Inc. v. Sun Pharmaceutical Indus. Ltd., No. 1:22-cv-00296-CFC, Dkt. 7 (D. Del. Mar. 7, 2022)

EX2013 - Summons in a Civil Action, Sun Pharmaceutical Industries Ltd., Novo Nordisk Inc. v. Sun Pharmaceutical Indus. Ltd., No. 1:22-cv-00296-CFC, Dkt. 8 (D. Del. Mar. 16, 2022)

EX2014 - Excerpt of Redacted Patent Owner's Response, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, Pap.30 (Jan. 17, 2023)

EX2015 - 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. 22-MD-03038-CFC (D. Del. InDec. 21, 2022) [REDACTED]

EX2016 - Transfer Order, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC, Dkt. 1 (D. Del. Aug. 5, 2022)

EX2018 - Excerpt of Defendants' Second Supplemental 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. 22-MD-03038-CFC (D. Del. Jan. 12, 2024) [REDACTED]

EX2019 - Novo Nordisk Production Letter, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del. Oct. 17, 2023) [REDACTED]

EX2020 - Compilation of Defendants' Production Letters, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del.) [REDACTED]

EX2021 - Compilation of Rule 30(b)(1) Deposition Notices, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del.)

EX2022 - Notice of Service for Defendants' Initial Invalidity Contentions, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del. Oct. 20, 2022)

EX2023 - Notice of Service for Defendants' Supplemental Invalidity Contentions, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D. Del. Nov. 6, 2023)

EX2024 - Stipulation for Extension of Time, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC, Dkt. 309 (D. Del. Feb. 9, 2024)

EX2025 - February 26, 2024 Email from C. Ferenc to M. Raymond, re: IPR2024-00107

EX2026 - Sun Pharmaceutical Industries Ltd.'s and Sun Pharmaceutical Industries Inc.'s Stipulation of Invalidity Contentions, Novo Nordisk Inc. v. Rio Biopharmaceuticals Inc., No. 22-cv-00294-CFC, Dkt. 275 (D. Del. Nov. 6, 2023)

EX2027 - Joint Stipulation and Order Extending Deadline for Certain Fact Discovery, In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-CFC, Dkt. 305 (D. Del. Feb. 6, 2024)

Preliminary Response

Notice: Notice filing date accorded

Joint Stipulation Regarding Petitioners' Motion for Joinder

EXPUNGED

Petitioner's Updated Mandatory Notice

Power of Attorney and Designation of Lead and Back-Up Counsel

Patent Owner's Mandatory Notices

U.S. Patent No. 10,335,462

Prosecution history excerpts for U.S. Patent No. 10,335,462

Declaration of John Bantle, MD

CV of John Bantle MD

Declaration of William J. Jusko, Ph.D.

CV of William J. Jusko, Ph.D.

Declaration of Paul Dalby, Ph.D.

CV of Paul Dalby, Ph.D.

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Drucker, The Incretin System: Glucagon-Like Peptide-1 Receptor Agonists and

Glaesner, Engineering and Characterization of the Long-Acting Glucagon-Like

HARRISON’S PRINCIPLES OF INTERNAL MED., Chapter 338 (Fauci et al. eds. 17th

Holst, Truncated Glucagon-like Peptide I, an Insulin-Releasing Hormone from

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FDA Guidance for Industry, Exposure-Response Relationships - Study Design,

International Conference on Harmonisation; Dose-Response Information to Sup

Garber, Efficacy of Metformin in Type II Diabetes: Results of a Double-Blin

Landersdorfer, Pharmacokinetic/Pharmacodynamic Modelling in Diabetes Mellit

Madsbad, An Overview of Once-Weekly Glucagon-Like Peptide-1 Receptor Agonis

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U.S. Patent No. 8,536,122

U.S. Patent No. 8,129,343

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Ozempic prescribing information (Oct. 2022)

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Prosecution history excerpts for U.S. Patent No. 9,764,003

Declaration of Melissa Weinberg, MD

CV of Melissa Weinberg, MD

Declaration of Craig Dyar, Ph.D.

CV of Craig Dyar, Ph.D.

Declaration of Alekha Dash, Ph.D.

CV of Alekha Dash, Ph.D.

Mylan Pharmaceuticals Inc., v. Novo Nordisk A/S, IPR2023-00724, Paper 10 (P

Notice : Power of Attorney- Petitioner

Motion : Joinder

Petition : as filed - Inter Partes Review of US Patent No. 10,335,462