Notice: refund approved | Jan 5, 2026 | PAPER | BOARD |
Petitioner’s Request for Refund of Post-institution Fees | Dec 23, 2025 | PAPER | PETITIONER |
Order Denying Director Review of Institution Decision | Dec 15, 2025 | PAPER | BOARD |
Authorized Response to Director Review Request | Oct 27, 2025 | PAPER | PATENT OWNER |
Email, Subject_IPR2025-00893 Director Review Request | Oct 21, 2025 | EXHIBIT | BOARD |
Request for Director Review - Institution Decision | Oct 20, 2025 | PAPER | PETITIONER |
Director Discretionary Decision: Deny | Sep 19, 2025 | PAPER | BOARD |
Petitioner’s Updated Mandatory Notices | Sep 4, 2025 | PAPER | PETITIONER |
Ex 3001 | Aug 25, 2025 | EXHIBIT | BOARD |
Ex 3002 | Aug 25, 2025 | EXHIBIT | BOARD |
Petitioner Motion for PHV Admission of S. Lockner | Aug 25, 2025 | PAPER | PETITIONER |
Petitioner’s Response to Patent Owner’s Request for Discretionary Denial | Aug 25, 2025 | PAPER | PETITIONER |
Exhibit 1053 Memorandum Order, ECF 71 | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1054 Text Order | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1055 Orphan Drug Designation and Approvals – Sun, FDA | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1056 Orphan Drug Designation and Approvals – Nivagen, FDA | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1057 Defendant Sun’s Motion to Stay Deadlines and Motion for Protective Order Pending Transfer | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1058 Press Release - Sun Pharma Launches SEZABY™ in the U.S. for Treatment of Neonatal Seizures | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1059 Nivagen’s Supplemental Responses to Sun’s Second Set of Interrogatories | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1060 Han et al. (2022) | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1061 Letter from FDA to Sun Pharmaceutical Industries, Inc. | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1062 Amended Rule 16 Scheduling Order, ECF 119 | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1063 Pretrial Scheduling Order, ECF 209 | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1064 Scheduling and Trial Order for Jury Trial, ECF 34 | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1065 Amended Scheduling Order, ECF 76 | Aug 25, 2025 | EXHIBIT | PETITIONER |
Exhibit 1066 Declaration of Justin T. Oakland | Aug 25, 2025 | EXHIBIT | PETITIONER |
20250825 Patent Owner Nivagen Updated Mandatory Notice'076 pat IPR 00893 | Aug 25, 2025 | PAPER | PATENT OWNER |
20250825 Patent Owner Nivagen Updated Power of Atty '076 IPR00893 (executed) | Aug 25, 2025 | PAPER | PATENT OWNER |
ORDER Granting Patent Owner’s Motion for Admission Pro Hac Vice of Yixin H. Tang Conditionally Granting Patent Owner’s Motion for Admission Pro Hac Vice of Christopher M. Bruno 37 C.F.R. §¿42.10 | Aug 21, 2025 | PAPER | BOARD |
Petitioner's Motion for Pro Hac Vice Admission of S. Lockner | Aug 20, 2025 | PAPER | PETITIONER |
Certification of Peter M. Kohlhepp | Aug 20, 2025 | EXHIBIT | PETITIONER |
Petitioner's Notice of Intent to Designate a Provisionally Recognized PTAB Attorney as Back-up Counsel | Aug 20, 2025 | PAPER | PETITIONER |
Declaration in Support of Motion for PHV Admission | Aug 20, 2025 | EXHIBIT | PETITIONER |
20250818 Ex2029-KlibanovDeclaration | Aug 18, 2025 | EXHIBIT | PATENT OWNER |
20250818 Ex2030-KlibanovCV | Aug 18, 2025 | EXHIBIT | PATENT OWNER |
20250818 Nivagen Patent Owner Preliminary Resp Brief | Aug 18, 2025 | PAPER | PATENT OWNER |
20250818 Patent Owner Nivagen Motion for C. Bruno PHV '076 pat IPR 2025-00893 | Aug 18, 2025 | PAPER | PATENT OWNER |
Patent Owner Brief Support of Req Discr Denial IPR2025-00893 Pat No 11878076 | Jul 18, 2025 | PAPER | PATENT OWNER |
Ex2001-Docket | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2002-DI37-Docket-Control-Order 24-cv-36 | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2003-20250508-Amended-Invalidity-Contentions | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2004-DI54-RULE 4-3 JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2005-20250429-4th-DEF-RFPs | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2006-20250709-7th-DEF-ROGs | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2007-20250709-6th-DEF-RFAs | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2008-20241018-Motion-Rogatory | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2009-Subpoena-BlankRome | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2010-Curia-subpoena | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2011-Deposition-Notices | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2012-Expert-Undertakings | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2014-LPR-41-disclosures | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2015-LPR-42-proposed-contr | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2016-Klibanov-Decl-Support of Claim Construction | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2017-DI58-redacted-opening-claim-constr-br | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2018-CorbelCap-subpoena | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2019-Sotera-emails | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2020-Communication chain re discovery | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2021-ExhibitB-1-608-Publ | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2022-ExhibitB-2-Nobelbar | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2023-ExhibitB-8-Hikma | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2024-Hikma Press Release | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2025 NDC 0641-0476 | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2026 NDC 0641-0477 | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2027-20241022-Invalidity-Contentions | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Ex2028-Batzer-Decl | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
EX2013-Communications chains regarding samples | Jul 18, 2025 | EXHIBIT | PATENT OWNER |
Notice: Mandatory Notice | May 23, 2025 | PAPER | PATENT OWNER |
Notice: Power of Attorney | May 23, 2025 | PAPER | PATENT OWNER |
Notice: Notice filing date accorded | May 23, 2025 | PAPER | BOARD |
Motion Pro Hac Vice - Yixin Tang | May 23, 2025 | PAPER | PATENT OWNER |
U.S. Patent No. 11,878,076 | Apr 22, 2025 | EXHIBIT | PETITIONER |
File History of U.S. Appl. No. 18/100,804 | Apr 22, 2025 | EXHIBIT | PETITIONER |
File History of Provisional U.S. Appl. No. 62/903,511 | Apr 22, 2025 | EXHIBIT | PETITIONER |
(Part 1 of 4) File History of Non-Provisional U.S. Appl. No. 17/025,881 | Apr 22, 2025 | EXHIBIT | PETITIONER |
(Part 2 of 4) File History of Non-Provisional U.S. Appl. No. 17/025,881 | Apr 22, 2025 | EXHIBIT | PETITIONER |
(Part 3 of 4) File History of Non-Provisional U.S. Appl. No. 17/025,881 | Apr 22, 2025 | EXHIBIT | PETITIONER |
(Part 4 of 4) File History of Non-Provisional U.S. Appl. No. 17/025,881 | Apr 22, 2025 | EXHIBIT | PETITIONER |
U.S. Publication No. 2021/0085608 A1 (the “’608 Publication”) | Apr 22, 2025 | EXHIBIT | PETITIONER |
U.S. Patent No. 11,406,598 | Apr 22, 2025 | EXHIBIT | PETITIONER |
File History of U.S. Appl. No. 17/854,914 | Apr 22, 2025 | EXHIBIT | PETITIONER |
Internet Archive - Pharmaceutical Interview Form, NOBELPHARMA CO. ("PIF") | Apr 22, 2025 | EXHIBIT | PETITIONER |
English Translation of Pharmaceutical Interview Form (Ex-1008) | Apr 22, 2025 | EXHIBIT | PETITIONER |
Decl. of R. Bernasch for Transl. of Pharmaceutical Interview Form (Ex-1008) | Apr 22, 2025 | EXHIBIT | PETITIONER |
Internet Archive Declaration of Pharmaceutical Interview Form (Ex-1008) | Apr 22, 2025 | EXHIBIT | PETITIONER |
U.S. Patent Application Publication No. US 2017/0143719 (“Parker”) | Apr 22, 2025 | EXHIBIT | PETITIONER |
Label: PHENOBARBITAL SODIUM - phenobarbital sodium injection ("West-Ward") | Apr 22, 2025 | EXHIBIT | PETITIONER |
Internet Archive Declaration of West-Ward (Ex-1013) | Apr 22, 2025 | EXHIBIT | PETITIONER |
Declaration of Raj Suryanarayanan, Ph.D. | Apr 22, 2025 | EXHIBIT | PETITIONER |
Curriculum Vitae of Dr. Raj Suryanarayanan | Apr 22, 2025 | EXHIBIT | PETITIONER |
Excerpts of USP 40-NF 35: THE U.S. PHARMACOPEIA AND NATIONAL FORMULARY | Apr 22, 2025 | EXHIBIT | PETITIONER |
Impurities and Its Importance in Pharmacy, 3(2) INT. J. PHARM. SCI. REV. | Apr 22, 2025 | EXHIBIT | PETITIONER |
Jane D. Siegel et al., 2007 | Apr 22, 2025 | EXHIBIT | PETITIONER |
Selection of the Appropriate Package Type Terms and Recommendations... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Joanne Broadhead, Parenteral Dosage Forms, in PHARMACEUTICAL PREFORMULAT... | Apr 22, 2025 | EXHIBIT | PETITIONER |
NEAL G. ANDERSON, PRACTICAL PROCESS RESEARCH & DEVELOPMENT (1st ed. 2000) | Apr 22, 2025 | EXHIBIT | PETITIONER |
NEAL G. ANDERSON, PRACTICAL PROCESS RESEARCH & DEVELOPMENT (2d ed. 2012) | Apr 22, 2025 | EXHIBIT | PETITIONER |
Dejan S. Przic et al., Lyophilization-The Process and Industrial Use... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Duncan Q.M. Craig et al., The relevance of the amorphous state to pharma... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Michael J. Pikal, Freeze Drying, in ENCYCLOPEDIA OF PHARMACEUTICAL TECH... | Apr 22, 2025 | EXHIBIT | PETITIONER |
FREEZE-DRYING/LYOPHILIZATION OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Tomaž Einfalt et al., Methods of amorphization and investigation of the... | Apr 22, 2025 | EXHIBIT | PETITIONER |
(Part 1 of 2) POLYMORPHISM IN PHARMACEUTICAL SOLIDS (Harry G. Brittain... | Apr 22, 2025 | EXHIBIT | PETITIONER |
(Part 2 of 2) POLYMORPHISM IN PHARMACEUTICAL SOLIDS (Harry G. Brittain... | Apr 22, 2025 | EXHIBIT | PETITIONER |
JOEL BERNSTEIN, POLYMORPHISM IN MOLECULAR CRYSTALS (2002) | Apr 22, 2025 | EXHIBIT | PETITIONER |
Lian Yu, Amorphous pharmaceutical solids: preparation, characterization... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Pradip Hiwale et al., Variables Affecting Reconstitution Time of Dry Pow... | Apr 22, 2025 | EXHIBIT | PETITIONER |
John K. Haleblian, Characterization of Habits and Crystalline Modificat... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Annex 10: Stability testing of active pharmaceutical ingredients and fin... | Apr 22, 2025 | EXHIBIT | PETITIONER |
ICH Topic Q1A Stability Testing Guidelines: Stability Testing of New Dru... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Sun Hee Kim et al., Physicochemical Stability of Reconstituted Decitabin... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Takuya Iwamoto et al., Performance evaluation of the compounding robot,... | Apr 22, 2025 | EXHIBIT | PETITIONER |
U.S. Patent No. 9,138,456 | Apr 22, 2025 | EXHIBIT | PETITIONER |
Kou Kawada et al., A Clinical Trial Assessing the Efficacy and Safety of... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Jumpei Saito et al., Potentially Harmful Excipients in Neonatal Medicati... | Apr 22, 2025 | EXHIBIT | PETITIONER |
U.S. Patent Appl. No. 2010/0035904 A1 | Apr 22, 2025 | EXHIBIT | PETITIONER |
Internet Archive - Lynne Kelly, Phenobarbital sodium, CRITICAL CARE TRA... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Meg Snyder, Lyophilization: The basics, DRUG DISCOVERY & DEVELOPMENT... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Nancy J. Dietz et al., Phenobarbital Stability in Different Dosage Forms:.. | Apr 22, 2025 | EXHIBIT | PETITIONER |
U.S. Patent No. 6,077,545 | Apr 22, 2025 | EXHIBIT | PETITIONER |
Lyophilization of Parenteral (7/93): Guide to Inspections of Lyophilizat... | Apr 22, 2025 | EXHIBIT | PETITIONER |
Pets Mot. to Dismiss for Improper Venue or, in the Alternative, Tfer 24cv36 | Apr 22, 2025 | EXHIBIT | PETITIONER |
USPTO Patent Assignment Database Entry for U.S. Patent No. 11,878,076 | Apr 22, 2025 | EXHIBIT | PETITIONER |
U.S. Patent No. 11,878,076 - Highlighted | Apr 22, 2025 | EXHIBIT | PETITIONER |
Petition for Inter Partes Review of U.S. Patent No. 11,878,076 | Apr 22, 2025 | PAPER | PETITIONER |
Petitioner Sun Pharmaceutical Industries, Inc. Power of Attorney | Apr 22, 2025 | PAPER | PETITIONER |