Azurity Pharmaceuticals, Inc. vs EXELIXIS, INC.

Director Discretionary Decision: Deny

Petitioner's Sur-Reply to Patent Owner's Reply to Petitioner's Opposition to Patent Owner's Discretionary Denial Brief

Defendants’ Trial Exhibit DTX-328, Exelixis, Inc. v. MSN Labs

FAQs for Interim Processes for PTAB Workload Management

Defendants’ Trial Exhibit DTX-91, Exelixis, Inc. v. MSN Labs.

Patent Owner's Reply to Petitioner's Opposition to Patent Owner's Discretionary Denial Brief

Email Correspondence

Patent Owner's Prelimnary Response

Petitioner's Response to Patent Owner's Discretionary Denial Brief

D.I. 1, Exelixis v MSN, 1:25-cv-00346

Petitioner's Sotera Stipulation

CAFC-2025-1241, Exelixis Notice of Docketing

Patent Owner's Discretionary Denial Brief

Trial Tr. Vol. 1, Oct. 23, 2023

Trial Tr. Vol. 2, Oct. 24, 2023

Trial Tr. Vol. 3, Oct. 25, 2023

Trial Tr. Vol. 4, Oct. 26, 2023,

File History (Partial) for U.S. Patent Application No. 15/348,716

File History (Partial) for U.S. Patent Application No. 17/170,275

File History (Partial) for U.S. Patent Application No. 18/436,836

Defendants’ Opening Post-Trial Brief on Invalidity, Dec. 12, 2023, Exelixis, Inc. v. MSN Labs. Private Ltd., et al., No. 22-228-RGA (D. Del.)

Complaint, Exelixis, Inc. v. Azurity Pharms., Inc. et al., No. 25-cv- 00478 (D. Del. Apr. 18, 2025), D.I. 1

First Amended Complaint, Exelixis, Inc. v. Azurity Pharms., Inc. et al., No. 25-cv-00478 (D. Del. Apr. 24, 2025), D.I. 7

Letter from Azurity Pharms., Inc. to Exelixis, Inc. Re: Notice of Paragraph IV Certification (Mar. 5, 2025), Letter and Enclosure Annexure C

Patent Owner's Update to Mandatory Notices

Patent Owner's Update to Mandatory Notices

Notice: Notice filing date accorded

Notice: Power of Attorney

Notice: Mandatory Notice

U.S. Patent 12,128,039 ("the '039 patent")

WO 2010/083414 ("Brown")

Remington - The Science and Practice of Pharmacy (2005)

CABOMETYX Product Insert

COMETRIQ Product Insert

U.S. Patent 7,579,473 ("the '473 patent")

Gibson - Pharmaceutical Preformulation and Formulation (2009)

D.I. 168 Exelixis v. MSN, 22-cv-00228-RGA

D.I. 176 Exelixis v. MSN, 22-cv-00228-RGA

D.I. 175 Exelixis v. MSN, 22-cv-00228-RGA

D.I. 163 Exelixis v. MSN, 22-cv-00228-RGA

D.I. 162 Exelixis v. MSN, 22-cv-00228-RGA

Rowe et al. "Handbook of Pharmaceutical Excipients"

D.I. 186 Exelixis v. MSN, 22-cv-00228-RGA

U.S. Patent 7,169,789 ("Kubo")

Hoffmann "Elements of Synthesis Planning"

Newhouse et al. "The economies of synthesis"

Burns et al. "Redox Economy in Organic Synthesis"

Pross et al.

Furuta et al.

Aulton "Dosage Form Design and Manufacture"

Felpin et al.

U.S. EPA - Toxicological Review of Quinoline (2001)

FDA - Guidance for Industry, Genotoxic and Carciniogenic Impurities (2008)

EMEA - Guideline on the Limits of Genotoxic Impurities (2006)

Robinson - Control of Genotoxic Impurities in API

U.S. Patent 8,067,436 ("the '436 patent")

FDA Q3A - Guidance for Industry

U.S. Application Serial No. 18/436,836 (Prosecution History Excerpt)

U.S. Patent 11,298,349 ("the '349 patent")

U.S. Patent 8,877,776 ("the '776 patent")

U.S. Patent 11,098,015 ("the '015 patent")

Maddula et al.

U.S. Patent Publication No. 2009/0105299 ("the '299 publication")

FDA Q3B - Guidance for Industry

Bristol-Myers Squibb and Exelixis Collaboration

U.S. Application Serial No. 11/753,514 (Prosecution History Excerpt)

Huynh "Molecularly targeted therapy in hepatocellular carcinoma"

Guiochon "Preparative liquid chromatography"

Ratain et al.

Gotink et al.

Sherman - Advances in Chemotherapy

Salgia et al.

Van Cutsem et al.

Eder et al.

Joly - Poster Abstract

Hutson et al.

Brandt - Practical Aspects of Preparative HPLC

Dreicer Declaration

Buckton Declaration

Notice: Power of Attorney

Dichtel Declaration

Petition: as filed