Azurity Pharmaceuticals, Inc. vs. EXELIXIS, INC.

Explore the PTAB proceeding IPR2025-00427 filed by Azurity Pharmaceuticals, Inc. on 2025-01-09. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2025-00427

Filing Date

2025-01-09

Accorded Filing Date

2025-01-09

Institution Decision Date

2025-07-02

Last Modified Date

2025-10-06

Proceeding Type

IPR

Termination Date

2025-07-02

Trial Status

Discretionary Denial

Parties & Counsel

Petitioner

Azurity Pharmaceuticals, Inc.

Represented By

Morrell, Andrewet al

Patent Owner / Respondent

EXELIXIS, INC.

Represented By

Whelan, Emilyet al

Tribunal & Venue

Tribunal

Patent Trial and Appeal Board (USPTO)

Technology Center

TC 1600 - Biotechnology & Organic Chemistry

Patent Information

1 Patent Involved

Respondent Application Number 18436836

Respondent Patent Number 12128039

External Links

Espacenet

Google Patents

Respondent Inventor Jo Ann Wilson et al

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

21 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name JONATHAN P. O''BRIEN, PH.D./Exelixis - HONIGMAN LLP

Customer Number 91684

Address 650 Trade Centre Way, Suite 200, Kalamazoo, MI, 49002-0402, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
31060	Pamela Simonton	650-344-9441
34251	Douglas Siegel	616-649-1920
34440	Eric Sosenko	734-418-4252
35004	Thomas Wootton	269-337-7706
40259	Lucy Yang	269-337-7746
48951	Heidi Berven	269-337-7710
49048	Timothy Bogel	248-566-8526
50852	Jonathan O'Brien	269-337-7704
52377	Zhe Wu	650-837-7000
53665	Matthew Szalach	248-566-8662
54243	Brett Krueger	616-649-1970
55888	Andrew Weber	269-337-7700
59348	Thomas Appledorn	248-566-8522
60258	Kathryn Doyle	269-337-7836
60403	Kelly Murphy	269-337-7834
62418	Christopher Forbes	269-337-7852
62688	Fernando Alberdi	734-418-4264
69267	Brenda Hefti	650-837-7000
69738	Andrew Chipouras	269-337-7756
71343	Li Gao	517-484-8282
72777	Grant Griffith	248-566-8502

Proceeding Documents

Notice: refund approved NOTICE

2025-10-06 FILING PARTY: BOARD

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Request for Refund OTHER

2025-10-03 FILING PARTY: PETITIONER

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Director Discretionary Decision: Deny RESPONSE

2025-07-02 FILING PARTY: BOARD

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

2025-06-19 FILING PARTY: PETITIONER

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

2025-06-16 FILING PARTY: PATENT OWNER

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Azurity Pharmaceuticals, Inc. vs. EXELIXIS, INC.

Proceeding Overview

Parties & Counsel

Petitioner

Azurity Pharmaceuticals, Inc.

Represented By

Patent Owner / Respondent

EXELIXIS, INC.

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

Notice: refund approved NOTICE

Request for Refund OTHER

Director Discretionary Decision: Deny RESPONSE

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

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

FAQs for Interim Processes for PTAB Workload Management Exhibit

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

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

Email Correspondence Exhibit

Patent Owner's Prelimnary Response POPR

Petitioner's Sotera Stipulation Exhibit

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

CAFC-2025-1241, Exelixis Notice of Docketing Exhibit

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

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

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.) Exhibit

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

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

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

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

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

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

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

Patent Owner's Discretionary Denial Brief RESPONSE

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

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

Patent Owner's Update to Mandatory Notices NOTICE

Patent Owner's Update to Mandatory Notices NOTICE

Notice: Notice filing date accorded NOTICE

Notice: Mandatory Notice NOTICE

Notice: Power of Attorney NOTICE

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

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

Gotink et al. Exhibit

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

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

Robinson - Control of Genotoxic Impurities in API Exhibit

FDA Q3B - Guidance for Industry Exhibit

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

Salgia et al. Exhibit

Gibson - Pharmaceutical Preformulation and Formulation (2009) Exhibit

Rowe et al. "Handbook of Pharmaceutical Excipients" Exhibit

Sherman - Advances in Chemotherapy Exhibit

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

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

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

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

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

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

Huynh "Molecularly targeted therapy in hepatocellular carcinoma" Exhibit

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

Van Cutsem et al. Exhibit

Furuta et al. Exhibit

Maddula et al. Exhibit

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

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

Hoffmann "Elements of Synthesis Planning" Exhibit

COMETRIQ Product Insert Exhibit

Ratain et al. Exhibit

Aulton "Dosage Form Design and Manufacture" Exhibit

Remington - The Science and Practice of Pharmacy (2005) Exhibit

Brandt - Practical Aspects of Preparative HPLC Exhibit

Guiochon "Preparative liquid chromatography" Exhibit

Burns et al. "Redox Economy in Organic Synthesis" Exhibit

Joly - Poster Abstract Exhibit