Fed. Cir. Order Dismissing Appeal | Mar 7, 2025 | PAPER | BOARD |
Notice of Appeal | Apr 12, 2023 | PAPER | PETITIONER |
Final Written Decision: original | Feb 9, 2023 | PAPER | BOARD |
Other: Hearing transcript | Jan 17, 2023 | PAPER | BOARD |
Updated List of Petitioner's Exhibits | Nov 14, 2022 | PAPER | PETITIONER |
Petitioner's Demonstratives for Oral Argument | Nov 14, 2022 | EXHIBIT | PETITIONER |
Patent Owner's Hearing Demonstratives | Nov 14, 2022 | EXHIBIT | PATENT OWNER |
Petitioner's Reply in Support of Motion to Exclude | Nov 9, 2022 | PAPER | PETITIONER |
Patent Owner's Opposition to Petitioner's Motion to Exclude | Nov 2, 2022 | PAPER | PATENT OWNER |
Order: ORDER Setting Oral Argument 37 C.F.R. § 42.70 | Oct 26, 2022 | PAPER | BOARD |
Petitioner's Motion to Exclude | Oct 26, 2022 | PAPER | PETITIONER |
Updated List of Petitioner's Exhibits | Oct 26, 2022 | PAPER | PETITIONER |
Exhibit 1086 | Oct 26, 2022 | EXHIBIT | PETITIONER |
Exhibit 1087 | Oct 26, 2022 | EXHIBIT | PETITIONER |
Patent Owner's Sur-Reply | Oct 11, 2022 | PAPER | PATENT OWNER |
Deposition Transcript of Craig Dyar, Ph.D., R.Ph. | Oct 11, 2022 | EXHIBIT | PATENT OWNER |
Patent Owner's Request for Oral Argument | Oct 5, 2022 | PAPER | PATENT OWNER |
Petitioner's Request for Oral Argument | Oct 5, 2022 | PAPER | PETITIONER |
Notice of Joint Stipulation to Modify Due Date 3 | Sep 14, 2022 | PAPER | PETITIONER |
Patent Owner's Amended Notice of Deposition of Hugh D. C. Smyth, Ph.D | Sep 13, 2022 | PAPER | PATENT OWNER |
Patent Owner's Amended Notice of Deposition of Craig Dyar, Ph.D., R.Ph. | Sep 13, 2022 | PAPER | PATENT OWNER |
Patent Owner's Notice of Deposition of Hugh D. C. Smyth, Ph.D. | Sep 7, 2022 | PAPER | PATENT OWNER |
Patent Owner's Notice of Deposition of Craig Dyar, Ph.D., R.Ph. | Sep 7, 2022 | PAPER | PATENT OWNER |
Patent Owner's Objections to Evidence | Aug 31, 2022 | PAPER | PATENT OWNER |
Petitioner's Reply to Patent Owner's Response | Aug 24, 2022 | PAPER | PETITIONER |
Updated List of Petitioner's Exhibits | Aug 24, 2022 | PAPER | PETITIONER |
PubChem Epinephrine | Aug 24, 2022 | EXHIBIT | PETITIONER |
PubChem Sumatriptan | Aug 24, 2022 | EXHIBIT | PETITIONER |
ARS Pharma | Aug 24, 2022 | EXHIBIT | PETITIONER |
Deposition of Michael A. Kaliner, M.D. | Aug 24, 2022 | EXHIBIT | PETITIONER |
Deposition of Joseph W. Wyse, Ph.D. | Aug 24, 2022 | EXHIBIT | PETITIONER |
Reply Expert Declaration of S. Craig Dyar, Ph.D., R.Ph | Aug 24, 2022 | EXHIBIT | PETITIONER |
Expert Declaration of Hugh D.C. Smyth, Ph.D. | Aug 24, 2022 | EXHIBIT | PETITIONER |
Wagner | Aug 24, 2022 | EXHIBIT | PETITIONER |
Oualha | Aug 24, 2022 | EXHIBIT | PETITIONER |
Petitioner's Notice of Deposition of Joseph W. Wyse, Ph.D. | Jul 22, 2022 | PAPER | PETITIONER |
Petitioner's Notice of Deposition of Michael A. Kaliner, M.D. | Jul 22, 2022 | PAPER | PETITIONER |
Notice of Joint Stipulation to Modify Due Dates 2 and 3 | Jun 27, 2022 | PAPER | PETITIONER |
Petitioner's Notice of Objections Under 37 CFR 42.64 to Evidence Submitted in Support of Patent Owner's Response | May 25, 2022 | PAPER | PETITIONER |
Patent Owner's Response | May 18, 2022 | PAPER | PATENT OWNER |
Declaration of Michael A. Kaliner, M.D. | May 18, 2022 | EXHIBIT | PATENT OWNER |
Declaration of Joseph W. Wyse, Ph.D. | May 18, 2022 | EXHIBIT | PATENT OWNER |
WO 2021/225976A1 (���Zhang ���976���) | May 18, 2022 | EXHIBIT | PATENT OWNER |
Second Declaration of Hugh David Charles Smyth, Ph.D., ARGENTUM PHARMS. v. CIPLA LIMITED, IPR2017-00807, Nov. 20, 2017 | May 18, 2022 | EXHIBIT | PATENT OWNER |
May 3, 2022 Deposition Transcript of Steven F. Weinstein | May 18, 2022 | EXHIBIT | PATENT OWNER |
April 14, 2022 Deposition Transcript of Hugh D. C. Smyth | May 18, 2022 | EXHIBIT | PATENT OWNER |
Bryn Pharma, LLC, Poster L34, Pharmacokinetic and Pharmacodynamic Effects of Intranasal Epinephrine Versus Intramuscular Epinephrine in Adults, Presented at the American Academy of Allergy, Asthma & Immunology National Conference (Mar. 16, 2020) | May 18, 2022 | EXHIBIT | PATENT OWNER |
Bryn Pharma, LLC, Poster L20, 5-Period, 5-Treatment Crossover Study to Compare the Pharmacokinetics of Intranasal and Intramuscular Epinephrine Administration in Healthy Adult Participants (Feb. 26 ��� Mar. 1, 2021) | May 18, 2022 | EXHIBIT | PATENT OWNER |
Aquestive Therapeutics, Inc.109 Investor Update Deck Final, Anaphylaxis and Epinephrine AQST-109: Topline Results from Phase 1 PK Studay (Study 210010) (Oct. 25, 2021) | May 18, 2022 | EXHIBIT | PATENT OWNER |
J. Chen. et al, Poster 112, An Open-Label, 5-Treatment, Crossover, Single-Dose Pharmacokinetic Study of Epinephrine Nasal Spray in Comparison to EpiPen�� Intramuscular Injection in Healthy Adults With Seasonal Allergies (Feb. 2019) | May 18, 2022 | EXHIBIT | PATENT OWNER |
U.S. Patent Application Pub. No. US2010/0209357A1 (Levitt) | May 18, 2022 | EXHIBIT | PATENT OWNER |
P. Martins, et al., Physicochemical properties of mucus and their impact on transmucosal drug, INTERNATIONAL JOURNAL OF PHARMACEUTICS 532 (2017) (���Smyth 2017���) | May 18, 2022 | EXHIBIT | PATENT OWNER |
J. Leal, et al., Strategies to facilitate or block nose-to-brain drug delivery, INTERNATIONAL JOURNAL OF PHARMACEUTICS 570 (2019) (���Smyth 2019���) | May 18, 2022 | EXHIBIT | PATENT OWNER |
D. Vllasaliu, et al., Epithelial Toxicity of Alkylglycoside Surfactants, JOURNAL OF PHARMACEUTICAL SCIENCES, Vol. 102, No. 1 (January 2013) | May 18, 2022 | EXHIBIT | PATENT OWNER |
B. Bleske, et al., Effect of Vehicle on the Nasal Absorption of Epinephrine During Cardiopulmonary Resuscitation, PHARMACOTHERAPY, Vol. 16, No. 6, (1996) | May 18, 2022 | EXHIBIT | PATENT OWNER |
K. Gradauer, et al., Dodecylmaltoside Modulates Bicellular Tight Junction Contacts To Promote Enhanced Permeability, MOLECULAR PHARMACEUTICS (2017) | May 18, 2022 | EXHIBIT | PATENT OWNER |
WO 2017/223566A1 (���Crystal ���566���) | May 18, 2022 | EXHIBIT | PATENT OWNER |
E. Danielsen and G. Hansen, Probing the Action of Permeation Enhancers Sodium Cholate and N-dodecyl-��-D-maltoside in a Porcine Jejunal Mucosal Explant System, Pharmaceutics (2018) | May 18, 2022 | EXHIBIT | PATENT OWNER |
WO 2021/225974A1 (���Zhang ���974���) | May 18, 2022 | EXHIBIT | PATENT OWNER |
O. Rachid, et al., In Vivo Evaluation of Taste-Masked Fast-Disintegrating Sublingual Tablets of Epinephrine Microcrystals, AAPS PHARMSCITECH, Vol. 19, No. 8 (Nov. 2018) | May 18, 2022 | EXHIBIT | PATENT OWNER |
WO 2018/093666A1 (���Crystal ���666���) | May 18, 2022 | EXHIBIT | PATENT OWNER |
M. Rawas-Qalaji, et al., Adrenaline (epinephrine) microcrystal sublingual tablet formulation: enhanced absorption in a preclinical model, Royal Pharmaceutical Society, JOURNAL OF PHARMACY AND PHARMACOLOGY, 67 (2014) | May 18, 2022 | EXHIBIT | PATENT OWNER |
M. Rawas-Qalaji, et al., Sublingual Diffusion of Epinephrine Microcrystals from Rapidly Disintegrating Tablets for the Potential First-Aid Treatment of Anaphylaxis: In Vitro and Ex Vivo Study, AAPS PHARMSCITECH, Vol. 16, No. 5 (Oct. 2015) | May 18, 2022 | EXHIBIT | PATENT OWNER |
Food and Drug Administration, U.S. Dept. of Health and Human Services, Guidance for Industry - Q8 Pharmaceutical Development (May 2006) | May 18, 2022 | EXHIBIT | PATENT OWNER |
Food and Drug Administration, U.S. Dept. of Health and Human Services, Guidance for Industry ��� M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, Revision 1 (Jan. 2010) | May 18, 2022 | EXHIBIT | PATENT OWNER |
A. Fortuna, et al., Intranasal delivery of systemic-acting drugs: Small-molecules and biomacromolecules, EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 88 (Mar. 2014) | May 18, 2022 | EXHIBIT | PATENT OWNER |
L. Illum, Nasal drug delivery ��� Recent developments and future prospects, JOURNAL OF CONTROLLED RELEASE, 161(Jan. 2012) | May 18, 2022 | EXHIBIT | PATENT OWNER |
Food and Drug Administration, U.S. Dept. of Health and Human Services, Guidance for Industry ��� Drug Product ��� Chemistry, Manufacturing, and Controls Information (Jan. 2003) | May 18, 2022 | EXHIBIT | PATENT OWNER |
Patent Owner's Notice of Deposition of Steven F. Weinstein, M.D. | Apr 21, 2022 | PAPER | PATENT OWNER |
Notice of Joint Stipulation to Modify Due Dates 1 and 2 | Apr 8, 2022 | PAPER | PETITIONER |
Petitioner's Updated Power of Attorney | Apr 7, 2022 | PAPER | PETITIONER |
Petitioner's Updated Mandatory Notices | Apr 7, 2022 | PAPER | PETITIONER |
Patent Owner's Notice of Deposition of Hugh D. C. Smyth, Ph.D. | Apr 6, 2022 | PAPER | PATENT OWNER |
Petitioner's Notice of Objections Under 37 CFR 42.64 to Evidence Submitted in Support of Patent Owner's Preliminary Response | Mar 1, 2022 | PAPER | PETITIONER |
DECISION Granting Institution of Inter Partes Review 35 U.S.C. 314 | Feb 14, 2022 | PAPER | BOARD |
SCHEDULING ORDER | Feb 14, 2022 | PAPER | BOARD |
Patent Owner's Sur-Reply | Dec 23, 2021 | PAPER | PATENT OWNER |
Petitioner's Authorized Reply to Patent Owner's Preliminary Response | Dec 16, 2021 | PAPER | PETITIONER |
ORDER Conduct of Proceedings | Dec 9, 2021 | PAPER | BOARD |
Exhibit 3001 | Dec 9, 2021 | EXHIBIT | BOARD |
ORDER Granting Patent Owners Unopposed Motion for Pro Hac Vice Admission of Thomas H. Wintner 37 C.F.R. sec 42.10 | Nov 30, 2021 | PAPER | BOARD |
UNOPPOSED MOTION OF AEGIS THERAPEUTICS, LLC FOR PRO HAC VICE ADMISSION OF THOMAS H. WINTNER | Nov 18, 2021 | PAPER | PATENT OWNER |
DECLARATION OF THOMAS H. WINTNER Aegis | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
Patent Owner's Preliminary Response | Nov 18, 2021 | PAPER | PATENT OWNER |
U.S. Patent No. 10,682,414 Prosecution History Excerpt 06-04-2019 TrackOne Request Granted | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
U.S. Patent No. 10,682,414 Prosecution History Excerpt 2019-09-09 List of References Cited by Applicant and Considered by Examiner | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
U.S. Patent No. 10,682,414 Prosecution History Excerpt 2019-06-21 Non-Final Rejection | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
U.S. Patent No. 10,039,710 (���Potta ���710 patent���) | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
US 2017/0079907 (���Potta ���907 application���) | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
US 2017/0216199 (���Potta ���199 application���) | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
US 2018/0289639 (���Potta ���639 application���) | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
US 2018/0318215 (���Potta ���215 application���) | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
U.S. Patent Application Ser. No. 15/890,131 Prosecution History Excerpts | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
U.S. Patent Application Ser. No. 15/482,283 Prosecution History Excerpts | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
Sumatriptan ��� PubChem | Nov 18, 2021 | EXHIBIT | PATENT OWNER |
Patent Owner's Power of Attorney | Sep 2, 2021 | PAPER | PATENT OWNER |
Patent Owner's Mandatory Notices | Sep 2, 2021 | PAPER | PATENT OWNER |
Notice of Accord Filing Date | Aug 18, 2021 | PAPER | BOARD |
414 Patent | Aug 12, 2021 | EXHIBIT | PETITIONER |
Smyth | Aug 12, 2021 | EXHIBIT | PETITIONER |
Weinstein | Aug 12, 2021 | EXHIBIT | PETITIONER |
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Maggio '145 | Aug 12, 2021 | EXHIBIT | PETITIONER |
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414 patent Prosecution History excerpts | Aug 12, 2021 | EXHIBIT | PETITIONER |
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Opiant Pharma 2017 Press Release | Aug 12, 2021 | EXHIBIT | PETITIONER |
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Aegis 2017 Press Release | Aug 12, 2021 | EXHIBIT | PETITIONER |
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Cayman Chem prod sheet | Aug 12, 2021 | EXHIBIT | PETITIONER |
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October 2013 Aegis Press Release | Aug 12, 2021 | EXHIBIT | PETITIONER |
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Headache journal online | Aug 12, 2021 | EXHIBIT | PETITIONER |
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Asian Pac J MARC Record | Aug 12, 2021 | EXHIBIT | PETITIONER |
Petition for Inter Partes Review of US Patent No. 10,682,414 | Aug 12, 2021 | PAPER | PETITIONER |
Petitioners Power of Attorney | Aug 12, 2021 | PAPER | PETITIONER |