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Patent Owner

Sydnexis, Inc.

Petitioner

Eyenovia, Inc.

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Eyenovia, Inc. v. Sydnexis, Inc.

IPR2022-00415 | Patent Trial and Appeal Board

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Filed Jan. 7, 2022

Terminated July 13, 2023

Judges Jamie Wisz, John New, Susan Mitchell, and Erica Franklin

Case Type Inter Partes Review

Status Final Written Decision - Appealed

Challenged Patent 16/785,413

Patent No. 10,888,557 assignments

Tech Center 1600

Art Unit 1627

Inventors Gregory I. OSTROW, Kenneth J. WIDDER, David S. BAKER, Harun TAKRURI

Last Updated: 5 months ago

Filing Date	#	Filing and Exhibits
Entries matching. Show All.
9/14/2023	09-14-2023-Patent_Owner	Event: Notice of Appeal Patent Owner Notice: notice of appeal 38: Patent Owner's Notice of Appeal
7/13/2023	07-13-2023-Board	Event: Final Written Decision (All Claims Cancelled) Board Final Written Decision: original 37: Final Written Decision: original
7/12/2023	07-12-2023-Board	Board Other: Hearing transcript 36: Other: Hearing transcript
5/8/2023	05-08-2023-Board	Board Order: Other 35: Order: Panel Change Order
4/12/2023	04-12-2023-Petitioner	Petitioner Notice: Exhibit list 33: Petitioner's Updated Exhibit List Petitioner Exhibit 1096: Petitioner's Demonstratives for Oral Argument
4/12/2023	04-12-2023-Patent_Owner	Patent Owner Other: other 34: Patent Owner's Demonstratives
4/7/2023	04-07-2023-Patent_Owner	Patent Owner Reply to Opposition 32: Patent Owner's Reply ISO Motion to Exclude Evidence
4/5/2023	04-05-2023-Petitioner	Petitioner Notice: Exhibit list 31: Petitioner's Updated Exhibit List
3/31/2023	03-31-2023-Petitioner	Petitioner Opposition 30: Petitioner’s Opposition to Patent Owner’s Motion to Exclude Evidence Petitioner Exhibit 1089: Excerpts of Sambrook & Russell, Molecular Cloning: A Laboratory Manual, (3d ed., 2001) Petitioner Exhibit 1090: Excerpts of “4.1.3 BUFFER SOLUTIONS” from European Pharmacopoeia, (5th ed., 2004) Petitioner Exhibit 1091: “Calbiochem® Buffers: A guide for the preparation and use of buffers in biological systems,” University of North Carolina School of Medicine Department of Pharmacology Petitioner Exhibit 1092: MilliporeSigma web page titled “Buffer Reference Center” Petitioner Exhibit 1093: NIH National Library of Medicine PubChem web page titled “Monosodium phosphate” Petitioner Exhibit 1094: NIH National Library of Medicine PubChem web page titled “Disodium hydrogen phosphate” Petitioner Exhibit 1095: Declaration of Rebecca L. Baker
3/24/2023	03-24-2023-Patent_Owner	Patent Owner Motion: Other 29: Patent Owner's Motion to Exclude Evidence
3/8/2023	03-08-2023-Board	Board Order: on Motion 28: ORDER Setting Oral Argument 37 C.F.R. sec 42.70
3/3/2023	03-03-2023-Patent_Owner	Patent Owner Notice: Other 26: Patent Owner's Request for Oral Argument Patent Owner Notice: Updated Mandatory Notice 27: Patent Owner's Updated Mandatory Notices
3/3/2023	03-03-2023-Petitioner	Petitioner Other: other 25: Petitioner's Request for Oral Argument
2/24/2023	02-24-2023-Patent_Owner	Patent Owner Notice: Other 24: Patent Owner's Sur-Reply
2/6/2023	02-06-2023-Petitioner	Petitioner Notice: Other 23: Petitioner's Notice of Supplemental Evidence
1/23/2023	01-23-2023-Patent_Owner	Patent Owner Other: other 22: Patent Owner's Objections to Evidence
1/13/2023	01-13-2023-Petitioner	Petitioner Pet Reply to PO Resp 21: Petitioner's Reply to Patent Owner's Response Petitioner Exhibit 1071: Freedom of Information Act (FOIA) Request No. 58532 filed with National Library of Medicine on August 7, 2022 and automated response. Petitioner Exhibit 1072: National Library of Medicine Freedom of Information Act (FOIA) Request No. 58532 and August 8, 2022 response. Petitioner Exhibit 1078: December 9, 2022, Deposition Transcript of Paul A. Laskar, Ph.D. Petitioner Exhibit 1079: 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). Petitioner Exhibit 1080: United States Patent Publication No. 2011/0184017 Al to Kanzawa et al. Petitioner Exhibit 1081: Chapter 4: Reagents, in Directorate for the Quality of Medicine & Health Care of the Council of Europe (EDQM), European Pharmacopoeia (5th ed. 2004) Petitioner Exhibit 1082: 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). Petitioner Exhibit 1083: 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). Petitioner Exhibit 1084: Monosodium phosphate, PubChem, available at https://pubchem.ncbi.nlm.nih.gov/compound/Monosodium-phosphate#section=pH (last visited Dec. 5, 2022). Petitioner Exhibit 1085: Disodium hydrogen phosphate, PubChem, available at https://pubchem.ncbi.nlm.nih.gov/compound/24203#section=Refractive-Index (last visited Dec. 5, 2022). Petitioner Exhibit 1086: Declaration of Dr. Paul A. Laskar Ph.D (Ex. 1014) in IPR2018-01020, executed on May 14, 2018. Petitioner Exhibit 1087: U.S. Patent No. 8,791,154 to Gamache et al., (Ex. 1001 in IPR2018-01020). Petitioner Exhibit 1088: U.S. Patent No. 6,995,186 B2 to Castillo et al., (Ex. 1005 in IPR2018-01020).
11/21/2022	11-21-2022-Petitioner	Petitioner Notice: Notice of deposition 20: Petitioner's Notice of Deposition of Paul A. Lasker, Ph.D.
10/21/2022	10-21-2022-Patent_Owner	Patent Owner PO Response to Pet 19: Patent Owner's Response Patent Owner Exhibit 2003: October 21, 2022, Declaration of Paul A. Laskar, Ph.D. Patent Owner Exhibit 2009: September 30, 2022, Deposition Transcript of Dr. Stephen R. Byrn Patent Owner Exhibit 2010: 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) Patent Owner Exhibit 2011: 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)
10/14/2022	10-14-2022-Board	Board Order: on Motion 18: ORDER Granting Petitioners Unopposed Motions for Admission Pro Hac Vice of Thomas H. Wintner 37 C.F.R. sec 42.10
9/8/2022	09-08-2022-Patent_Owner	Patent Owner Notice of Deposition 17: Updated Byrn Deposition Notice
9/1/2022	09-01-2022-Patent_Owner	Patent Owner Notice of Deposition 16: Notice of Deposition of Stephen R. Byrn, Ph.D.
8/31/2022	08-31-2022-Patent_Owner	Patent Owner Notice 15: Joint Stipulation to Modify the Scheduling Order
8/12/2022	08-12-2022-Petitioner	Petitioner Notice 14: Petitioner's Notice of Supplemental Evidence
8/2/2022	08-02-2022-Petitioner	Petitioner Motion 13: UNOPPOSED MOTION FOR PRO HAC VICE ADMISSION OF THOMAS H. WINTNER Petitioner Exhibit 1059: DECLARATION OF THOMAS H. WINTNER
7/29/2022	07-29-2022-Patent_Owner	Patent Owner Objection 12: Patent Owner's Objections to Evidence
7/19/2022	07-19-2022-Petitioner	Petitioner Notice 11: Petitioner's Updated Mandatory Notices
7/15/2022	07-15-2022-Board	Event: Petition Institution (Granted) Board Institution Decision: Grant 9: DECISION Granting Institution of Inter Partes Review 35 U.S.C. 314 Board Other: other 10: SCHEDULING ORDER
5/24/2022	05-24-2022-Patent_Owner	Patent Owner Reply 8: Patent Owner's Sur-Reply
5/23/2022	05-23-2022-Board	Board Exhibit 3001: Exhibit 3001
5/17/2022	05-17-2022-Petitioner	Petitioner Reply 7: Petitioner's Reply to Patent Owner's Preliminary Response Petitioner Exhibit 1056: 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) Petitioner Exhibit 1057: 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) Petitioner Exhibit 1058: August 4, 2017 FDA Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review for NDA 206289 (Akorn Inc., Atropine Sulfate Ophthalmic Solution, USP 1%)
4/18/2022	04-18-2022-Patent_Owner	Event: Preliminary Response Patent Owner Preliminary Response 6: Patent Owner's Preliminary Response Patent Owner Exhibit 2001: EX2001 - Laskar Declaration Patent Owner Exhibit 2002: EX2002 - Laskar CV Patent Owner Exhibit 2004: EX2004 - PAIR - PAIRPrintServlet Patent Owner Exhibit 2005: EX2005 - Internet Archives Affidavit Patent Owner Exhibit 2006: EX2006 - Amneal Pharms FDA Page Patent Owner Exhibit 2007: EX2007 - Apotex FDA Page 215624 Patent Owner Exhibit 2008: EX2008 - Intl Medication Sys FDA Page
1/18/2022	01-18-2022-Board	Board Notice: Notice filing date accorded 3: Notice: Notice filing date accorded
1/18/2022	01-18-2022-Patent_Owner	Patent Owner Mandatory Notice 4: Patent Owner's Mandatory Notices Patent Owner Power of Attorney 5: Patent Owner's Power of Attorney
1/7/2022	01-07-2022-Petitioner	Event: Petition Petitioner Petition 1: Petition for Inter Partes Review of U.S. Patent No. 10,888,557 Petitioner Power of Attorney 2: Petitioner's Power of Attorney Petitioner Exhibit 1001: U.S. Patent No. 10,888,557 to Ostrow et al. Petitioner Exhibit 1002: Declaration of Dr. Stephen Byrn, Ph.D. Petitioner Exhibit 1003: Chia et al., Atropine for the Treatment of Childhood Myopia: Safety and Efficacy of 0.5%, 0.1%, and 0.01% Doses (Atropine for the Treatment of Myopia 2), OPHTHALMOLOGY 119(2): 347��354 (2012) Petitioner Exhibit 1004: Akorn Atropine CareTM (atropine sulfate ophthalmic solution), NDA 206289 Product Label (Revised July 2014) Petitioner Exhibit 1005: Albert A. Kondritzer & Peter Zvirblis, Stability of Atropine in Aqueous Solution, J. AM. PHARM. ASSOC. 46(9):531��535 (1957) Petitioner Exhibit 1006: International Publication No. WO 2014/182620 to Wu et al. Petitioner Exhibit 1007: Lund et al., The Kinetics of Atropine and Apoatropine in Aqueous Solutions, ACTA CHEM. SCAND. 22:3085-3097 (1968) Petitioner Exhibit 1008: McBrien et al., Point-Counterpoint. How does atropine exert its anti-myopia effects?, OPHTHALMIC & PHYSIOL. OPT. 33:373��378 (2013) Petitioner Exhibit 1009: U.S. Patent Publication No. 2007/0254914 to Wu et al. Petitioner Exhibit 1010: Chua et al., Atropine for the Treatment of Childhood Myopia, OPHTHALMOLOGY 113(12):2285��2291 (2006) Petitioner Exhibit 1011: Shih et al., An intervention trial on efficacy of atropine and multi-focal glasses in controlling myopic progression, ACTA OPHTHALMOL. SCAND. 79:233��236 (2001) Petitioner Exhibit 1012: Lee et al., Prevention of Myopia Progression with 0.05% Atropine Solution, J. OCUL. PHARMACOL. & THER. 22(1):41��46 (2006) Petitioner Exhibit 1013: Fang et al., Prevention of Myopia Onset with 0.025% Atropine in Premyopic Children, J. OCUL. PHARMACOL. & THER. 26(4):341��345 (2010) Petitioner Exhibit 1014: Shih et al., Effects of Different Concentrations of Atropine on Controlling Myopia in Myopic Children, J. OCUL. PHARMACOL. & THER. 15(1):85��90 (1999) Petitioner Exhibit 1015: Wu et al., The Long-Term Results of Using Low-Concentration Atropine Eye Drops for Controlling Myopia Progression in Schoolchildren, J. OCUL. PHARMACOL. & THER. 27(5):461��466 (2011) Petitioner Exhibit 1016: Chia et al., Atropine for the Treatment of Childhood Myopia: Changes after Stopping Atropine 0.01%, 0.1% and 0.5%, AM. J. OPHTHALMOL. 157(2):451��457.e1 (2014) Petitioner Exhibit 1017: Zvirblis et al., The Kinetics of the Hydrolysis of Atropine, J. AM. PHARM. ASSOC. 45(7): 450��454 (1956) Petitioner Exhibit 1018: USP 24 Official Monographs / Atropine, THE UNITED STATES PHARMACOPEIA 177-180 (2000) Petitioner Exhibit 1019: John D. Mullins & Gerald Hecht, Pharmaceutical Necessities and Ophthalmic Preparations, in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY, VOLUME II 1380��1416, 1563��1576 (Alfonso R. Gennaro ed., 19th ed. 1995) Petitioner Exhibit 1020: 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 Petitioner Exhibit 1021: Application Number: 206289Orig1s000 Summary Review, U.S. FDA CTR. FOR DRUG EVALUATION & RES. (July 18, 2014) Petitioner Exhibit 1022: Akorn Atropine CareTM (atropine sulfate ophthalmic solution), Advertisement Rev. 08/11 Petitioner Exhibit 1023: Akorn Atropine CareTM (Atropine Sulfate Ophthalmic Solution, 1%), Product Label Rev. 06/08 Petitioner Exhibit 1024: Schier et al., Preparing for Chemical Terrorism: Stability of Injectable Atropine Sulfate, ACAD. EMERG. MED. 11(4):329��334 (2004) Petitioner Exhibit 1025: European Patent Publication No. 0332826 to Tashma Petitioner Exhibit 1026: Anschel et al., Parenteral Formulation VI: Hydrolytic Degradation of Esters in Parenteral Solutions, BULLETIN PARENTER. DRUG ASSOC. 26(6):271��289 (1972) Petitioner Exhibit 1027: Sumie Yoshioka & Valentino J. Stella, STABILITY OF DRUGS AND DOSAGE FORMS 228 (2007) Petitioner Exhibit 1028: Ann E. Mair & G. Smith, The Detection of Atropine and Its Degradation Products by Thin-Layer Chromatography, J. CLIN. PHARM. 2:101-104 (1977) Petitioner Exhibit 1029: Parmar et al., The solution, solid state stability and kinetic investigation in degradation studies of lercanidipine: study of excipients compatibility of lercanidipine, PHARM. DEV. TECHNOL. 17(6):730-740 (2011) Petitioner Exhibit 1030: Deliang Zhou et al., Chapter 5 �� Drug Stability and Degradation Studies, in DEVELOPING SOLID ORAL DOSAGE FORMS PHARMACEUTICAL THEORY AND PRACTICE 87-124 (Yihong Qiu et al. eds., 2009) Petitioner Exhibit 1031: R.B. Taylor & A.S. Shivji, A critical appraisal of drug stability testing methods, PHARM. RES. 4(3):177-80 (1987) Petitioner Exhibit 1032: U.S. Patent No. 5,716,952 to WoldeMussie et al. Petitioner Exhibit 1033: U.S. Patent Publication No. 2012/0015035 to Wildsoet et al. Petitioner Exhibit 1034: Garcia-Valldecabres et al., pH Stability of ophthalmic solutions, OPTOMETRY 75(3):161��168 (2004) Petitioner Exhibit 1035: Lallemand et al., Successfully Improving Ocular Drug Delivery Using the Cationic Nanoemulsion, Novasorb, J. DRUG DELIV. 2012:1��16 (2012) Petitioner Exhibit 1036: Erica L. Fletcher & Noel A. Brennan, The effect of solution tonicity on the eye, CLIN. & EXP. OPTOM. 76.1:17-21 (1993) Petitioner Exhibit 1037: U.S. Patent No. 10,842,787 File History - Part 1 Petitioner Exhibit 1037: U.S. Patent No. 10,842,787 File History - Part 2 Petitioner Exhibit 1037: U.S. Patent No. 10,842,787 File History - Part 3 Petitioner Exhibit 1037: U.S. Patent No. 10,842,787 File History - Part 4 Petitioner Exhibit 1037: U.S. Patent No. 10,842,787 File History - Part 5 Petitioner Exhibit 1038: Pfannkoch, The Preparation of Buffers and Other Solutions: A Chemist��s Perspective, MOLECULAR BIOLOGY PROBLEM SOLVER: A LABORATORY GUIDE Ch. 3:31��47 (Alan S. Gerstein ed., 2001) Petitioner Exhibit 1039: HANDBOOK OF PHARMACEUTICAL EXCIPIENTS 5��7, 193��196, 281��284, 351��352, 741��742, 984��989 (Raymond C. Rowe et al. eds., 7th ed. 2012) - Part 1 Petitioner Exhibit 1039: HANDBOOK OF PHARMACEUTICAL EXCIPIENTS 5��7, 193��196, 281��284, 351��352, 741��742, 984��989 (Raymond C. Rowe et al. eds., 7th ed. 2012) - Part 2 Petitioner Exhibit 1040: Waterman et al., Hydrolysis in Pharmaceutical Formulations, PHARM. DEV. & TECH. 7(2):113��146 (2002) Petitioner Exhibit 1041: Certified English Translation of Yuanda Wen, Preparation and Clinical Curative Effects of 0.05% Atropine Sulfate Eye Drops, CHINA PHARMACIST 11(2):194��196 (2008) Petitioner Exhibit 1042: M. R. W. Brown & D. A. Norton, The Preservation of Ophthalmic Preparations, J. SOC. COSMETIC CHEMISTS 16:369��393 (1965) Petitioner Exhibit 1043: Certified English Translation of CN 101049287A to Wu Peichang et al. Petitioner Exhibit 1044: Rajpal et al., Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence, PATIENT PREFER ADHERENCE 8:925��31 (2014) Petitioner Exhibit 1045: Chowhan et al., Ophthalmic Preparations, in REMINGTON: THE SCIENCE & PRACTICE OF PHARMACY 907-929 (22d ed. 2013) Petitioner Exhibit 1046: Kirchhoff et al., Analysis of atropine, its degradation products and related substances of natural origin by means of reversed-phase high-performance liquid chromatography, J. CHROMATOGRAPHY A 1046:115��120 (2004) Petitioner Exhibit 1047: PB Patel et al., Ophthalmic Drug Delivery System: Challenges and Approaches, SYSTEMATIC REVIEWS IN PHARMACY 1(2):113��120 (2010) Petitioner Exhibit 1048: International Publication No. WO 2012/161655 to Donald Tan and Wei Han Chua Petitioner Exhibit 1049: U.S. Patent Publication No. 2012/0203161 to Herekar Petitioner Exhibit 1050: English Translation of Jinshen Li, Preparation and Quality Control of 0.04% Atropine Sulfate Eye Drops, CHINA PHARMACY 17(2):111��113 (2006) Petitioner Exhibit 1051: John D. Mullins & Gerald Hecht, Tonicity, Osmoticity, Osmolality and Osmolarity and Stability of Pharmaceutical Products, in REMINGTON: THE SCIENCE & PRACTICE OF PHARMACY, Volume I 613��627, 639��647 (Alfonso R. Gennaro ed., 19th ed. 1995) Petitioner Exhibit 1054: MCGRAW-HILL DICTIONARY OF CHEMISTRY (2nd ed. 2003) Petitioner Exhibit 1055: U.S. Patent No. 10,888,557 File History - Part 1 Petitioner Exhibit 1055: U.S. Patent No. 10,888,557 File History - Part 2 Petitioner Exhibit 1055: U.S. Patent No. 10,888,557 File History - Part 3 Petitioner Exhibit 1055: U.S. Patent No. 10,888,557 File History - Part 4 Petitioner Exhibit 1055: U.S. Patent No. 10,888,557 File History - Part 5

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Eyenovia, Inc. v. Sydnexis, Inc.

IPR2022-00415 | Patent Trial and Appeal Board

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