Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLC et al. - IPR2021-01324

Fed. Cir. Order Dismissing Appeal

Notice of Appeal

Final Written Decision: original

Other: Hearing transcript

Updated List of Petitioner's Exhibits

Petitioner's Demonstratives for Oral Argument

Patent Owner's Hearing Demonstratives

Petitioner's Reply in Support of Motion to Exclude

Patent Owner's Opposition to Petitioner's Motion to Exclude

Order: ORDER Setting Oral Argument 37 C.F.R. § 42.70

Petitioner's Motion to Exclude

Updated List of Petitioner's Exhibits

Exhibit 1086

Exhibit 1087

Patent Owner's Sur-Reply

Deposition Transcript of Craig Dyar, Ph.D., R.Ph.

Patent Owner's Request for Oral Argument

Petitioner's Request for Oral Argument

Notice of Joint Stipulation to Modify Due Date 3

Patent Owner's Amended Notice of Deposition of Hugh D. C. Smyth, Ph.D

Patent Owner's Amended Notice of Deposition of Craig Dyar, Ph.D., R.Ph.

Patent Owner's Notice of Deposition of Hugh D. C. Smyth, Ph.D.

Patent Owner's Notice of Deposition of Craig Dyar, Ph.D., R.Ph.

Patent Owner's Objections to Evidence

Petitioner's Reply to Patent Owner's Response

Updated List of Petitioner's Exhibits

PubChem Epinephrine

PubChem Sumatriptan

ARS Pharma

Deposition of Michael A. Kaliner, M.D.

Deposition of Joseph W. Wyse, Ph.D.

Reply Expert Declaration of S. Craig Dyar, Ph.D., R.Ph

Expert Declaration of Hugh D.C. Smyth, Ph.D.

Wagner

Oualha

Petitioner's Notice of Deposition of Joseph W. Wyse, Ph.D.

Petitioner's Notice of Deposition of Michael A. Kaliner, M.D.

Notice of Joint Stipulation to Modify Due Dates 2 and 3

Petitioner's Notice of Objections Under 37 CFR 42.64 to Evidence Submitted in Support of Patent Owner's Response

Patent Owner's Response

Declaration of Michael A. Kaliner, M.D.

Declaration of Joseph W. Wyse, Ph.D.

WO 2021/225976A1 (¿¿¿Zhang ¿¿¿976¿¿¿)

Second Declaration of Hugh David Charles Smyth, Ph.D., ARGENTUM PHARMS. v. CIPLA LIMITED, IPR2017-00807, Nov. 20, 2017

May 3, 2022 Deposition Transcript of Steven F. Weinstein

April 14, 2022 Deposition Transcript of Hugh D. C. Smyth

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)

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)

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)

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)

U.S. Patent Application Pub. No. US2010/0209357A1 (Levitt)

P. Martins, et al., Physicochemical properties of mucus and their impact on transmucosal drug, INTERNATIONAL JOURNAL OF PHARMACEUTICS 532 (2017) (¿¿¿Smyth 2017¿¿¿)

J. Leal, et al., Strategies to facilitate or block nose-to-brain drug delivery, INTERNATIONAL JOURNAL OF PHARMACEUTICS 570 (2019) (¿¿¿Smyth 2019¿¿¿)

D. Vllasaliu, et al., Epithelial Toxicity of Alkylglycoside Surfactants, JOURNAL OF PHARMACEUTICAL SCIENCES, Vol. 102, No. 1 (January 2013)

B. Bleske, et al., Effect of Vehicle on the Nasal Absorption of Epinephrine During Cardiopulmonary Resuscitation, PHARMACOTHERAPY, Vol. 16, No. 6, (1996)

K. Gradauer, et al., Dodecylmaltoside Modulates Bicellular Tight Junction Contacts To Promote Enhanced Permeability, MOLECULAR PHARMACEUTICS (2017)

WO 2017/223566A1 (¿¿¿Crystal ¿¿¿566¿¿¿)

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)

WO 2021/225974A1 (¿¿¿Zhang ¿¿¿974¿¿¿)

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)

WO 2018/093666A1 (¿¿¿Crystal ¿¿¿666¿¿¿)

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)

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)

Food and Drug Administration, U.S. Dept. of Health and Human Services, Guidance for Industry - Q8 Pharmaceutical Development (May 2006)

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)

A. Fortuna, et al., Intranasal delivery of systemic-acting drugs: Small-molecules and biomacromolecules, EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 88 (Mar. 2014)

L. Illum, Nasal drug delivery ¿¿¿ Recent developments and future prospects, JOURNAL OF CONTROLLED RELEASE, 161(Jan. 2012)

Food and Drug Administration, U.S. Dept. of Health and Human Services, Guidance for Industry ¿¿¿ Drug Product ¿¿¿ Chemistry, Manufacturing, and Controls Information (Jan. 2003)

Patent Owner's Notice of Deposition of Steven F. Weinstein, M.D.

Notice of Joint Stipulation to Modify Due Dates 1 and 2

Petitioner's Updated Power of Attorney

Petitioner's Updated Mandatory Notices

Patent Owner's Notice of Deposition of Hugh D. C. Smyth, Ph.D.

Petitioner's Notice of Objections Under 37 CFR 42.64 to Evidence Submitted in Support of Patent Owner's Preliminary Response

DECISION Granting Institution of Inter Partes Review 35 U.S.C. 314

SCHEDULING ORDER

Patent Owner's Sur-Reply

Petitioner's Authorized Reply to Patent Owner's Preliminary Response

ORDER Conduct of Proceedings

Exhibit 3001

ORDER Granting Patent Owners Unopposed Motion for Pro Hac Vice Admission of Thomas H. Wintner 37 C.F.R. sec 42.10

UNOPPOSED MOTION OF AEGIS THERAPEUTICS, LLC FOR PRO HAC VICE ADMISSION OF THOMAS H. WINTNER

DECLARATION OF THOMAS H. WINTNER Aegis

Patent Owner's Preliminary Response

U.S. Patent No. 10,682,414 Prosecution History Excerpt 06-04-2019 TrackOne Request Granted

U.S. Patent No. 10,682,414 Prosecution History Excerpt 2019-09-09 List of References Cited by Applicant and Considered by Examiner

U.S. Patent No. 10,682,414 Prosecution History Excerpt 2019-06-21 Non-Final Rejection

U.S. Patent No. 10,039,710 (¿¿¿Potta ¿¿¿710 patent¿¿¿)

US 2017/0079907 (¿¿¿Potta ¿¿¿907 application¿¿¿)

US 2017/0216199 (¿¿¿Potta ¿¿¿199 application¿¿¿)

US 2018/0289639 (¿¿¿Potta ¿¿¿639 application¿¿¿)

US 2018/0318215 (¿¿¿Potta ¿¿¿215 application¿¿¿)

U.S. Patent Application Ser. No. 15/890,131 Prosecution History Excerpts

U.S. Patent Application Ser. No. 15/482,283 Prosecution History Excerpts

Sumatriptan ¿¿¿ PubChem

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notices

Notice of Accord Filing Date

414 Patent

Smyth

Weinstein

Potta

Maggio '145

Srisawat

414 patent Prosecution History excerpts

16007999 Application - Potta

Fleming

Reber 2017

Riedl 2003

Arthur 2015

Simons 2011

Maggio 2013

Maggio 2014

Maggio 2006

Davis 2003

Munjal

Kee

Hill

Munjal 2017

Cunningham 2018

Macdonald 838

Auvi-Q Product Label

130 patent

564 patent

156 patent

444 patent

791 patent

913 patent

Opiant Pharma 2017 Press Release

Srisawat Bio

Maggio 2010

Frew 2011

Simons 2000

Simons 2006

Aegis 2017 Press Release

Ring 2018

Cayman Chem prod sheet

Steed 2014

Kulkarni

Handbook 2009

Breuer 2013

Rawas Qalaji 2006

Kemp 2008

Zhao 2012

Simons 2001

Simons 1998

Liew 2017

Pumphrey 2000

Campbell 2015

Jayamali 2017

Budhwani 2004

Arfi 2005

Shaver 2006

Khoueiry 2013

Pires 2009

Sinnott 2003

Junior 2009

Kanwar 2010

2004 UAB News

October 2013 Aegis Press Release

Internet Archive

Maggio 2013A

Whitney Decl

Headache journal online

Headache MARC Record

ASU library record

Asian Pac J MARC Record

Petition for Inter Partes Review of US Patent No. 10,682,414

Petitioners Power of Attorney