APOTEX INC. et al. vs. Soleno Therapeutics, Inc. et al.

Explore the PTAB proceeding PGR2026-00034 filed by APOTEX INC. et al. on 2026-04-21. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

PGR2026-00034

Filing Date

2026-04-21

Accorded Filing Date

2026-04-21

Institution Decision Date

2026-10-08

Last Modified Date

2026-10-21

Proceeding Type

PGR

Termination Date

—

Trial Status

Trial Instituted

Parties & Counsel

Petitioner

APOTEX INC. et al.

Represented By

Malik, Jitendraet al

Patent Owner / Respondent

Soleno Therapeutics, Inc. et al.

Represented By

Osman, Ingeet 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 19224580

Respondent Patent Number 12419895

External Links

Espacenet

Google Patents

Respondent Inventor Neil M. COWEN

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

25 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name FISH & RICHARDSON P.C. (Neurocrine Biosciences)

Customer Number 155654

Address P.O. BOX 1022, MINNEAPOLIS, MN, 55440-1022, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
37640	John Hayden	202-783-5070
39117	David Bradfute	858-342-8148
43162	Richard Sterba	202-783-5070
46731	Christine Goddard	617-542-5070
47443	John Brennan	212-765-5070
48097	Scott Reid	858-500-9986
50006	Jill Martin	858-922-1414
53631	Lyle Spruce	858-617-7235
55900	Michael Ruse Jr	619-695-4609
59578	Min Lin	858-416-7614
65676	Nathaniel Chongsiriwatana	858-723-2904
65838	Gregory Bradford	858-617-7057
68097	Hanbiao Yang	858-354-2847
70838	Annie King	617-368-2121
71928	Craig Boyle	212-641-2265
72172	Colin Hughes	858-354-7752
73238	Sejin Ahn	858-378-3495
74627	Evan Davey	302-778-8457
75097	Natalie Bilci	858-239-6841
77256	Justin Sears	212-641-2296
77914	Ashley Biernesser	617-521-7033
78815	Timothy Mcfadden	617-542-5070
79844	Armbien Sabillo	858-378-0833
82074	Edith Cheng	858-617-7600
82314	Katie Bitting	617-368-2106

Proceeding Documents

145

PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(1) MOTION

2026-10-21 FILING PARTY: PETITIONER

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Institution Decision: Grant DECISION

2026-10-08 FILING PARTY: BOARD

Download

Director Discretionary Decision: Refer RESPONSE

2026-08-19 FILING PARTY: BOARD

Download

2069

Ex. 2069 - Talebizadeh 2005 Exhibit

2026-07-22 FILING PARTY: PATENT OWNER

Download

1020

Ex. 1020 Andrew J. Shoffstall et al., The High Direct Medical Costs of Prader-Willi Syndrome Exhibit

2026-07-22 FILING PARTY: PETITIONER

Download

APOTEX INC. et al. vs. Soleno Therapeutics, Inc. et al.

Proceeding Overview

Parties & Counsel

Petitioner

APOTEX INC. et al. Follow

Represented By

Patent Owner / Respondent

Soleno Therapeutics, Inc. et al. Follow

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(1) MOTION

Institution Decision: Grant DECISION

Director Discretionary Decision: Refer RESPONSE

Ex. 2069 - Talebizadeh 2005 Exhibit

Ex. 1020 Andrew J. Shoffstall et al., The High Direct Medical Costs of Prader-Willi Syndrome Exhibit

Ex. 2083 - Exploring Drug Discovery & Development (5.5.2025) Exhibit

Ex. 2068 - Sinnema 2013 Exhibit

Ex. 2074 - Soleno Press Release (Apr. 29, 2024) Exhibit

Ex. 2049 - Dimitropoulos 2000 Exhibit

Ex 1033 Ass’n for Accessible Meds., By the Numbers: IPR Speeds Patient Access to Lower-Cost Medicine Exhibit

Ex. 2085 - Inside Precision Medicine (Mar. 28, 2025) Exhibit

Ex. 2082 - BioSpace (Feb. 26, 2026) Exhibit

Ex. 2079 - FDA, Search Orphan Drug Designations and Approvals Exhibit

Ex. 2093 - USPTO Statutory Disclaimer as filed Exhibit

Ex. 2041 - Benarroch 2007 Exhibit

Ex. 2055 - Haqq 2012 Exhibit

Ex. 2056 - Hoybye 2003 Paper Exhibit

Ex. 2059 - Itariu 2014 Exhibit

Ex. 2038 - Phentermine prescribing information Exhibit

Ex 1029 U.S. Food & Drug Admin., Generic Competition and Drug Prices: New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices Exhibit

Ex. 1019 Sneha S K, US FDA Approves First Treatment for Rare Genetic Disorder Prader-Willi Syndrome Exhibit

Ex. 2071 - Waele 2008 Exhibit

Ex. 2086 - MedPath (Jan. 5, 2026) Exhibit

Ex 1024 U.S. Patent No. 10,456,408 File History Excerpts Exhibit

Ex. 2046 - Cassidy 2012 Exhibit

Ex. 2052 - Goldstone 2001 Exhibit

Ex. 2084 - FirstWord PHARMA (Sept. 24, 2025) Exhibit

Ex. 2064 - Miller 2014 Exhibit

Ex. 2044 - Butler 1998 Exhibit

Ex. 2067 - Shapira 2004 Exhibit

Ex. 2061 - McTaggart 2010 Exhibit

Ex. 2045 - Butler 2006 (EXCERPTS) Exhibit

Ex. 2054 - Goldstone 2008 Exhibit

Ex. 2075 - Soleno Press Release (Mar. 26, 2025) Exhibit

Ex 1028 U.S. Food & Drug Admin., Generic Drugs Exhibit

Ex 1031 Alexandra Hutzler et al., Trump Unveils TrumpRx Website He Says Will Help Americans Buy Lower-Priced Prescription Drugs Exhibit

Ex. 2043 - Brambilla 2011 Exhibit

Ex. 2047 - Deal 2013 Exhibit

Ex. 2087 - Miller 2024 Exhibit

Ex. 2062 - Miller 2007 Exhibit

Ex. 2040 - Bekx 2003 Exhibit

Ex. 2089 - Patient Worthy (Nov. 17, 2025) Exhibit

Ex 1022 U.S. Patent No. 9,757,384 File History Excerpts Exhibit

Ex. 2078 - FDA, Designating an Orphan Product (8.12.2024) Exhibit

Ex. 2076 - FDA, Breakthrough Therapy (1.4.2018) Exhibit

Ex 1032 Soleno Therapeutics, Inc., Annual Report Exhibit

Ex. 2088 - Miller 2026 Exhibit

Ex. 2091 - Butler 2000 Exhibit

Ex 1030 Hayden Dublois, From Most Expensive to Most Favored: How the Trump Administration Is Bringing Down Prescription Drug Prices Exhibit

Ex 1027 Nomination of John A. Squires to be Under Sec’y of Com. for Intell. Prop. & Dir. of the U.S. Patent & Trademark Office Exhibit

Ex. 2057 - Hoybye 2003 Thesis Exhibit

Ex 1023 U.S. Patent No. 10,058,557 File History Excerpts Exhibit

Ex. 2081 - BioSpace (Apr. 6, 2020) Exhibit

Ex. 2048 - DiMario 1996 Exhibit

Ex. 2070 - Theodoro 2006. Exhibit

Ex. 2094 - USPTO, Acting Dir. Mem., Enforcement & Non-Waiver of 37 CFR 42.104 (7.31.2025) Exhibit

Ex. 2072 - Waters 2012 (EXCERPT) Exhibit

Ex. 2037 - Gunay-Aygun 2001 Exhibit

Ex 1026 Nomination of John A. Squires to be Under Sec’y of Com. for Intell. Prop. & Dir. of the U.S. Patent & Trademark Office Exhibit

Ex. 2080 - Acadia Press Release (Sept. 24, 2025) Exhibit

Ex. 2060 - Marzullo 2005 Exhibit

PETITIONER’S OPPOSITION TO PATENT OWNER’S BRIEF ON DISCRETIONARY DENIAL RESPONSE

Ex. 1021 Merlin G. Butler et al., Age Distribution, Comorbidities and Risk Factors for Thrombosis in Prader–Willi Syndrome Exhibit

Ex. 2092 - Black 1968 Exhibit

Ex 1025 U.S. Patent No. 10,874,676 File History Excerpts Exhibit

APOTEX INC. et al.

Soleno Therapeutics, Inc. et al.