APOTEX INC. et al. v. Soleno Therapeutics, Inc. et al. - PGR2026-00034

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

Case Details

Proceeding Number
PGR2026-00034
Filing Date
Apr 21, 2026
Petitioner
APOTEX INC. et al.
Respondent
Soleno Therapeutics, Inc. et al.
Status
Pending
Respondent Application Number
19224580
Respondent Tech Center
1600
Respondent Patent Number
12419895

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Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.

Document NameFiling DateCategoryFiling Party

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Ex. 2001 - USP 9,757,384 B2 (Cowen)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 1

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 2

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 3

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 4

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 5

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 6

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 7

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 8

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 9

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 10

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 11

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2002 - USP 9,757,384 B2 FH - Part 12

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2003 - USP 12,419,895 B1 Family Tree

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2004 - USP Appl Publ No. US 2016-0136178 A1 (Cowen)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2006 - Soleno Therapeutics, Inc. SEC Form 10-K (YE 2017)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2007 - Soleno News Release - 4Q & Full-Year 2018 Financial Results (Globenewswire 3.18.2019)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2008 - Soleno News Release - 4Q & Full-Year 2019 Financial Results (Globenewswire 3.4.2020)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2009 - Soleno News Release - 4Q & Full-Year 2020 Financial Results (Globenewswire 3.3.2021)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2010 - Soleno News Release - 4Q & Full-Year 2021 Financial Results (Globenewswire 3.31.2022)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2011 - Soleno News Release - 4Q & Full-Year 2022 Financial Results (Globenewswire 3.21.2023)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2012 - Soleno News Release - 4Q & Full-Year 2023 Financial Results (Globenewswire 3.6.2024)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2013 - Soleno News Release - 4Q & Full-Year 2024 Financial Results (Globenewswire 2.27.2025)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2014 - BioSpace Press Release - VYKAT XR Launch Update & Soleno 1Q 2025 Financial Results (5.8.2025)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2015 - Apotex, Generics - A Force for Accessible Medicine

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2016 - Aptoex, What We’ve Created

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2017 - FDA, Orange Book-Approved Drug Products with Therapeutic Equivalence Evaluations

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2018 - FDA, Search Orphan Drug Designations and Approvals - VykatXR

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2019 - NIH, ClinicalTrials.gov, Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities (9.8.2022)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2020 - NIH, ClinicalTrials.gov, Study of Diazoxide Choline in Patients With PWS (9.21.2023)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2021 - NIH, ClinicalTrials.gov, Open-Label Extension Study of DCCR in PWS (4.19.2024)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2022 - NIH, ClinicalTrials.gov, PWS Outcomes Assessment Study (11.4.2024)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2023 - NIH, ClinicalTrials.gov, Open-Label Extension Study of DCCR in Patients With PWS (4.2.2025)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2024 - NIH, ClinicalTrials.gov, Observational Study of VYKAT XR in Patients With PWS (5.19.2026)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2025 - PWSA Blog, Breaking News! FDA Approves 1st-EverTreatment for Hyperphagia in PWS (3.26.2025)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2026 - PWSA Blog, With New Treatment Comes Renewed Hope (3.27.2025)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2027 - KKF Health News, Revolutionary Drug for Extreme Hunger... (6.16.2025)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2028 - Neurocrine, Neurocrine to Acquire Soleno... (4.6.2026)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2029 - USPTO, FAQs for Interim Processes for PTAB Workload Management

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2030 - USPTO, Dir. Mem., Add'l Discretionary Inst. Considerations (3.11.2026)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2031 - Aptoex Petition & Expert Declaration Comparison

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2032 - Jabri-Shumaker emails Re Vykat XR Orange Book Patent - Petition for Post Grant Review (5.15.2026)

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2033 - Apotex CREATES Act Request 01.06.2026

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2034 - Apotex CREATES Act Request 02.13.26

Jun 22, 2026EXHIBITPATENT OWNER

Ex. 2005 - Declaration of Ramesh Tharuvai

Jun 22, 2026EXHIBITPATENT OWNER

Patent Owner's Brief on Discretionary Denial

Jun 22, 2026PAPERPATENT OWNER

Patent Owner's Mandatory Notices

May 11, 2026PAPERPATENT OWNER

Patent Owner's Power of Attorney

May 11, 2026PAPERPATENT OWNER

Notice filing date accorded

Apr 22, 2026PAPERBOARD

Petition: as filed

Apr 21, 2026PAPERPETITIONER

EX1001 U.S. Patent No. 12,419,895 to Cowen

Apr 21, 2026EXHIBITPETITIONER

EX1002 Orange Book Vykat

Apr 21, 2026EXHIBITPETITIONER

EX1003 Organic Chemistry

Apr 21, 2026EXHIBITPETITIONER

EX1004 Vykat Package Insert

Apr 21, 2026EXHIBITPETITIONER

EX1005 Declaration of Dr. Hollander

Apr 21, 2026EXHIBITPETITIONER

EX1006 Curriculum Vitae of Dr. Hollander

Apr 21, 2026EXHIBITPETITIONER

EX1007 Cassidy

Apr 21, 2026EXHIBITPETITIONER

EX1008 International Patent Pub. No. WO 2014/197753 to Cotter

Apr 21, 2026EXHIBITPETITIONER

EX1010 Ashcroft

Apr 21, 2026EXHIBITPETITIONER

EX1011 Hyperstat Diazoxide

Apr 21, 2026EXHIBITPETITIONER

EX1012 Proglycem Diazoxide

Apr 21, 2026EXHIBITPETITIONER

EX1013 Remington

Apr 21, 2026EXHIBITPETITIONER

EX 1014 FDA Guidance

Apr 21, 2026EXHIBITPETITIONER

EX1015 U.S. Patent No. 12,419,895 File History

Apr 21, 2026EXHIBITPETITIONER

EX1016 U.S. Patent Pub. No. 2014/0364367 to Cotter

Apr 21, 2026EXHIBITPETITIONER

EX1017 Miller

Apr 21, 2026EXHIBITPETITIONER

EX1018 PDR 2008

Apr 21, 2026EXHIBITPETITIONER

EX1009 WO2009006483 - Cowen Part 1

Apr 21, 2026EXHIBITPETITIONER

EX1009 WO2009006483 - Cowen Part 2

Apr 21, 2026EXHIBITPETITIONER

Notice: Power of Attorney

Apr 21, 2026PAPERPETITIONER