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 |