Eyenovia, Inc. vs Sydnexis, Inc.

Patent Owner's Notice of Appeal

Final Written Decision: original

Other: Hearing transcript

Order: Panel Change Order

Petitioner's Demonstratives for Oral Argument

Petitioner's Updated Exhibit List

Patent Owner's Demonstratives

Patent Owner's Reply ISO Motion to Exclude Evidence

Petitioner's Updated Exhibit List

Petitioner’s Opposition to Patent Owner’s Motion to Exclude Evidence

Excerpts of Sambrook & Russell, Molecular Cloning: A Laboratory Manual, (3d ed., 2001)

Excerpts of “4.1.3 BUFFER SOLUTIONS” from European Pharmacopoeia, (5th ed., 2004)

“Calbiochem® Buffers: A guide for the preparation and use of buffers in biological systems,” University of North Carolina School of Medicine Department of Pharmacology

MilliporeSigma web page titled “Buffer Reference Center”

NIH National Library of Medicine PubChem web page titled “Monosodium phosphate”

NIH National Library of Medicine PubChem web page titled “Disodium hydrogen phosphate”

Declaration of Rebecca L. Baker

Patent Owner's Motion to Exclude Evidence

ORDER Setting Oral Argument 37 C.F.R. sec 42.70

Petitioner's Request for Oral Argument

Patent Owner's Request for Oral Argument

Patent Owner's Updated Mandatory Notices

Patent Owner's Sur-Reply

Petitioner's Notice of Supplemental Evidence

Patent Owner's Objections to Evidence

Petitioner's Reply to Patent Owner's Response

Freedom of Information Act (FOIA) Request No. 58532 filed with National Library of Medicine on August 7, 2022 and automated response.

National Library of Medicine Freedom of Information Act (FOIA) Request No. 58532 and August 8, 2022 response.

December 9, 2022, Deposition Transcript of Paul A. Laskar, Ph.D.

Appendix 1: 1 Preparation of Reagents and Buffers Used in Molecular Cloning, in Sambrook, J. F., & Russell, D. W., Molecular cloning: A laboratory manual (3d ed. 2001).

United States Patent Publication No. 2011/0184017 Al to Kanzawa et al.

Chapter 4: Reagents, in Directorate for the Quality of Medicine & Health Care of the Council of Europe (EDQM), European Pharmacopoeia (5th ed. 2004)

Buffers: A guide for the preparation and use of buffers in biological systems, Calbiochem (2006), available at https://www.med.unc.edu/pharm/sondeklab/wp-content/uploads/sites/868/2018/10/buffers_calbiochem.pdf (last visited Dec. 5, 2022).

Buffer Reference Center, MilliporeSigma, available at https://www.sigmaaldrich.com/US/en/technical-documents/protocol/protein-biology/protein-concentration-and-buffer-exchange/buffer-reference-center (last visited Dec. 5, 2022).

Monosodium phosphate, PubChem, available at https://pubchem.ncbi.nlm.nih.gov/compound/Monosodium-phosphate#section=pH (last visited Dec. 5, 2022).

Disodium hydrogen phosphate, PubChem, available at https://pubchem.ncbi.nlm.nih.gov/compound/24203#section=Refractive-Index (last visited Dec. 5, 2022).

Declaration of Dr. Paul A. Laskar Ph.D (Ex. 1014) in IPR2018-01020, executed on May 14, 2018.

U.S. Patent No. 8,791,154 to Gamache et al., (Ex. 1001 in IPR2018-01020).

U.S. Patent No. 6,995,186 B2 to Castillo et al., (Ex. 1005 in IPR2018-01020).

Petitioner's Notice of Deposition of Paul A. Lasker, Ph.D.

Patent Owner's Response

October 21, 2022, Declaration of Paul A. Laskar, Ph.D.

September 30, 2022, Deposition Transcript of Dr. Stephen R. Byrn

Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., Case Nos. 18-1962-LPS, 19-1067-LPS, April 27, 2021Trial Decision, D.I. 294, D.I. 307 (D. Del. Aug. 2, 2021)

Reckitt Benckiser Inc. v. Tris Pharma, Inc., Case No. 09-3125-FLW, Decision on Summary Judgment, D.I. 220 (D.N.J. Dec. 2, 2011)

ORDER Granting Petitioners Unopposed Motions for Admission Pro Hac Vice of Thomas H. Wintner 37 C.F.R. sec 42.10

Updated Byrn Deposition Notice

Notice of Deposition of Stephen R. Byrn, Ph.D.

Joint Stipulation to Modify the Scheduling Order

Petitioner's Notice of Supplemental Evidence

UNOPPOSED MOTION FOR PRO HAC VICE ADMISSION OF THOMAS H. WINTNER

DECLARATION OF THOMAS H. WINTNER

Patent Owner's Objections to Evidence

Petitioner's Updated Mandatory Notices

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

SCHEDULING ORDER

Patent Owner's Sur-Reply

Exhibit 3001

Petitioner's Reply to Patent Owner's Preliminary Response

FDA Approval Package for Akorn Inc., Atropine Sulfate Ophthalmic Solution, USP, 1%, available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000Approv.pdf (last visited 5/12/2022)

DailyMed database webpages for ATROPINE (atropine sulfate) solution/ drops, Akorn Inc., available at https://dailymed.nlm.nih.gov/dailymed/ (sites last visited 5/12/2022)

August 4, 2017 FDA Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review for NDA 206289 (Akorn Inc., Atropine Sulfate Ophthalmic Solution, USP 1%)

Patent Owner's Preliminary Response

EX2001 - Laskar Declaration

EX2002 - Laskar CV

EX2004 - PAIR - PAIRPrintServlet

EX2005 - Internet Archives Affidavit

EX2006 - Amneal Pharms FDA Page

EX2007 - Apotex FDA Page 215624

EX2008 - Intl Medication Sys FDA Page

Notice: Notice filing date accorded

Patent Owner's Mandatory Notices

Patent Owner's Power of Attorney

Petition for Inter Partes Review of U.S. Patent No. 10,888,557

Petitioner's Power of Attorney

U.S. Patent No. 10,888,557 to Ostrow et al.

Declaration of Dr. Stephen Byrn, Ph.D.

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Drugs@FDA: FDA-Approved Drugs: AKORN NDA 206289, U.S. FDA, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206289

Application Number: 206289Orig1s000 Summary Review, U.S. FDA CTR. FOR DRUG EVALUATION & RES. (July 18, 2014)

Akorn Atropine CareTM (atropine sulfate ophthalmic solution), Advertisement Rev. 08/11

Akorn Atropine CareTM (Atropine Sulfate Ophthalmic Solution, 1%), Product Label Rev. 06/08

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U.S. Patent No. 10,842,787 File History - Part 2

U.S. Patent No. 10,842,787 File History - Part 3

U.S. Patent No. 10,842,787 File History - Part 4

U.S. Patent No. 10,842,787 File History - Part 5

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U.S. Patent No. 10,888,557 File History - Part 1

U.S. Patent No. 10,888,557 File History - Part 2

U.S. Patent No. 10,888,557 File History - Part 3

U.S. Patent No. 10,888,557 File History - Part 4

U.S. Patent No. 10,888,557 File History - Part 5