Case number IPR2020-01318
Regeneron Pharmaceuticals, Inc. et al. v. Novartis Pharma AG et al. > Documents
| Date Field | Doc. No. | Party | Description |
|---|---|---|---|
| Jul 16, 2020 | 1 | petitioner | Power of Attorney Download |
| Jul 16, 2020 | 1001 | petitioner | U.S. Patent No. 9,220,631 Download |
| Jul 16, 2020 | 1002 | petitioner | Prosecution File History of U.S. Patent No. 9,220,631 - 3/4 Download |
| Jul 16, 2020 | 1002 | petitioner | Prosecution File History of U.S. Patent No. 9,220,631 - 2/4 Download |
| Jul 16, 2020 | 1002 | petitioner | Prosecution File History of U.S. Patent No. 9,220,631 - 1/4 Download |
| Jul 16, 2020 | 1002 | petitioner | Prosecution File History of U.S. Patent No. 9,220,631 - 4/4 Download |
| Jul 16, 2020 | 1003 | petitioner | Declaration of Horst Koller under 37 C.F.R. 1.68 Download |
| Jul 16, 2020 | 1004 | petitioner | Curriculum Vitae of Horst Koller Download |
| Jul 16, 2020 | 1005 | petitioner | Declaration of James Agalloco under 37 C.F.R. 1.68 Download |
| Jul 16, 2020 | 1006 | petitioner | Curriculum Vitae of James Agalloco Download |
| Jul 16, 2020 | 1007 | petitioner | PCT Patent Publication No. WO 2011/006877 to Sigg Download |
| Jul 16, 2020 | 1008 | petitioner | PCT Patent Publication No. WO 2009/030976 to Boulange Download |
| Jul 16, 2020 | 1009 | petitioner | Internet Archive WayBack Machine, March 7, 2011 Record of Drugs.com, Macugen Prescribing Information Download |
| Jul 16, 2020 | 1010 | petitioner | Certified English Translation of Bruno Reuter and Claudia Petersen. Die Silikonisierung von Spritzen: Trends, Methoden, Analyseverfahren, TechnoPharm 2, Nr. 4 (2012): 238-244. (Reuter) Download |
| Jul 16, 2020 | 1011 | petitioner | Bhavnesh D. Shah & Bhupendra G. Prajapati, Pre-Filled Syringes: A New Concept, PHARMA BIO WORLD 51 (2009) Download |
| Jul 16, 2020 | 1012 | petitioner | Arno Fries, Drug Delivery of Sensitive Biopharmaceuticals With Prefilled Syringes, 9(5) DRUG DELIVERY TECH. 22 (2009) Download |
| Jul 16, 2020 | 1013 | petitioner | Thomas Schoenknecht, Prefilled Syringes: Why New Developments Are Important In Injectable Delivery Today, in PREFILLED SYRINGES INNOVATIONS THAT MEET THE GROWING DEMAND (OnDrugDelivery 2005) Download |
| Jul 16, 2020 | 1014 | petitioner | U.S. Patent Publication No. 2012/0091026 to Chacornac Download |
| Jul 16, 2020 | 1015 | petitioner | Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010) (Nema Vol. 1) - 3/4 Download |
| Jul 16, 2020 | 1015 | petitioner | Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010) (Nema Vol. 1) - 2/4 Download |
| Jul 16, 2020 | 1015 | petitioner | Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010) (Nema Vol. 1) - 1/4 Download |
| Jul 16, 2020 | 1015 | petitioner | Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010) (Nema Vol. 1) - 4/4 Download |
| Jul 16, 2020 | 1016 | petitioner | Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and Processing (3rd ed. 2010) (Nema Vol. 2) - 3/4 Download |
| Jul 16, 2020 | 1016 | petitioner | Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and Processing (3rd ed. 2010) (Nema Vol. 2) - 1/4 Download |
| Jul 16, 2020 | 1016 | petitioner | Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and Processing (3rd ed. 2010) (Nema Vol. 2) - 2/4 Download |
| Jul 16, 2020 | 1016 | petitioner | Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and Processing (3rd ed. 2010) (Nema Vol. 2) - 4/4 Download |
| Jul 16, 2020 | 1017 | petitioner | PCT Patent Publication No. WO 2007/035621 to Scypinski Download |
| Jul 16, 2020 | 1018 | petitioner | U.S. Patent Publication No. 2003/0003014 to Metzner Download |
| Jul 16, 2020 | 1019 | petitioner | U.S. Pharmacopeia, USP 789, Particulate Matter in Ophthalmic Solutions, USP 34 NF 29 (2011) Download |
| Jul 16, 2020 | 1020 | petitioner | U.S. Patent Publication No. 2011/276005 to Hioki Download |
| Jul 16, 2020 | 1021 | petitioner | PCT Patent Publication No. WO 2007/149334 to Furfine Download |
| Jul 16, 2020 | 1022 | petitioner | Michael W. Stewart et al., Fresh From the Pipeline Aflibercept, 11 NAT. REV. DRUG DISCOV. 269 (2012) Download |
| Jul 16, 2020 | 1023 | petitioner | U.S. Patent No. 7,060,269 to Baca Download |
| Jul 16, 2020 | 1024 | petitioner | Prosecution File History of U.S. Patent No. 7,060,269, 3/3 Download |
| Jul 16, 2020 | 1024 | petitioner | Prosecution File History of U.S. Patent No. 7,060,269, 2/3 Download |
| Jul 16, 2020 | 1024 | petitioner | Prosecution File History of U.S. Patent No. 7,060,269, 1/3 Download |
| Jul 16, 2020 | 1025 | petitioner | Lu Liu et al., Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab: Effects of Long-term Storage and Product Mishandling, 52(2) INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE 1023 (2011) Download |
| Jul 16, 2020 | 1026 | petitioner | U.S. Patent No. 7,404,278 to Wittland Download |
| Jul 16, 2020 | 1027 | petitioner | U.S. Food and Drug Administration, Lucentis Highlights of the Prescribing Information, (June 2010) Download |
| Jul 16, 2020 | 1028 | petitioner | International Organization for Standardization, ISO 11040-4 Prefilled Syringes Part 4: Glass Barrels for Injectables (2nd ed. 2007) (ISO 11040-4) Download |
| Jul 16, 2020 | 1029 | petitioner | PCT Patent Publication No. WO 2008/077155 to Lam Download |
| Jul 16, 2020 | 1030 | petitioner | James A. Dixon, et al. "VEGF Trap-Eye for the treatment of neovascular age-related macular degeneration." Expert opinion on investigational drugs 18.10 (2009): 1573-1580 Download |
| Jul 16, 2020 | 1031 | petitioner | Declaration of Dr. Szilard Kiss under 37 C.F.R. 1.68 Download |
| Jul 16, 2020 | 1032 | petitioner | Curriculum Vitae of Dr. Szilard Kiss Download |
| Jul 16, 2020 | 1033 | petitioner | Declaration of James L. Mullins, Ph.D. Download |
| Jul 16, 2020 | 1034 | petitioner | Dow Corning 365 35% Dimethicone NF Emulsion Frequently Asked Questions (2002) Download |
| Jul 16, 2020 | 1035 | petitioner | European Patent Application No. 12174860 to Novartis AG Download |
| Jul 16, 2020 | 1036 | petitioner | U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice (September 2004) Download |
| Jul 16, 2020 | 1037 | petitioner | Affidavit of Internet Archive Office Manager Download |
| Jul 16, 2020 | 1038 | petitioner | Internet Archive WayBack Machine, March 8, 2011 Record of Drugs.com, Welcome to Drugs.com Download |
| Jul 16, 2020 | 1039 | petitioner | Internet Archive WayBack Machine, February 25, 2011 Record of Drugs.com, FDA Professional Drug Information Download |
| Jul 16, 2020 | 1040 | petitioner | U.S. Food and Drug Administration, Eylea Highlights of the Prescribing Information, (November 2011) Download |
| Jul 16, 2020 | 1041 | petitioner | U.S. Food and Drug Administration, Guidance for Industry: Container Closure Systems for Packaging Human and Biologics Chemistry, Manufacturing, and Controls Documentation (May 1999) Download |
| Jul 16, 2020 | 1042 | petitioner | International Standard ISO-7864, Sterile hypodermic needles for single use, ISO 7864:1993(E) Download |
| Jul 16, 2020 | 1043 | petitioner | International Standard ISO-9626, Stainless steel needle tubing for the manufacture of medical devices Amendment 1, ISO 9626:1991/Amd.1:2001(E) Download |
| Jul 16, 2020 | 1044 | petitioner | Advait Badkar, et al. Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches, American Association of Pharmaceutical Sciences, June 2011, 12(2): 564-572 Download |
| Jul 16, 2020 | 1045 | petitioner | William Leventon, Medical Device Sterilization: What Manufacturers Need to Know (MDDI online, Sept. 1, 2002) Download |
| Jul 16, 2020 | 1046 | petitioner | Pamela Carter, et al. The lowdown on low temperature sterilization for packaged devices, Healthcare Purchasing News, July 2008, 42-45. Download |
| Jul 16, 2020 | 1047 | petitioner | U.S. Patent Publication No. 2005/0182370 to Hato Download |
| Jul 16, 2020 | 1048 | petitioner | Download |
| Jul 16, 2020 | 1049 | petitioner | Bryon Lambert, et al. Radiation and Ethylene Oxide Terminal Sterilization Experiences with Drug Eluting Stent Products, American Association of Pharmaceutical Sciences, December 2011, 12(4):1116-1126 Download |
| Jul 16, 2020 | 1050 | petitioner | K. Kereluk, et al. Microbiological Aspects of Ethylene Oxide Sterilization: I. Experimental Apparatus & Methods, Applied Microbiology 1970, 19(1):146-151. Download |
| Jul 16, 2020 | 1051 | petitioner | Carl Hultman, et al. The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide, Pharmaceutical Engineering, January/February 2007, 27(1):1-6 Download |
| Jul 16, 2020 | 1052 | petitioner | John R. Gillis & Gregg Mosley, Validation of Pharmaceutical Processes, Chapter 16 Validation of Ethylene Oxide Sterilization Processes (2011), pp.241-262 Download |
| Jul 16, 2020 | 1053 | petitioner | FDA Pesticide Analytical Manual Vol. 1, Chapter 6 - HPLC Download |
| Jul 16, 2020 | 1054 | petitioner | Kim, Leo & D Amore, Patricia, ASIP Centennial Commentary A Brief History of Anti-VEGF for the Treatment of Ocular Angiogenesis, The American Journal of Pathology, August 2012 182(2):376-379 Download |
| Jul 16, 2020 | 1055 | petitioner | J.S. Penn, et al. Vascular Endothelial Growth Factor in Eye Disease, Prog. Retin Eye Res., July 2008, 27(4):331-371 Download |
| Jul 16, 2020 | 1056 | petitioner | U.S. Food and Drug Administration, Trivaris Highlights of the Prescribing Information, (May 2008) Download |
| Jul 16, 2020 | 1057 | petitioner | Internet Archive WayBack Machine, May 17, 2011 Record of U.S. Pharmacopeia, Understanding USP NF Download |
| Jul 16, 2020 | 1058 | petitioner | Christine I. Falkner-Radler, et al. Needle Size in Intravitreal Injections-Preliminary Results of a Randomized Clinical Trial, AVRO Annual Meeting Abstract, March 2012, 54(884) Download |
| Jul 16, 2020 | 1059 | petitioner | Carsten H. Meyer et al., Steps for a Safe Intravitreal Injection Technique A look at how European and American approaches compare, Retinal Physician (July 1, 2009) Download |
| Jul 16, 2020 | 1060 | petitioner | Curriculum Vitae of James L. Mullins, Ph.D. Download |
| Jul 16, 2020 | 1061 | petitioner | DUPONT TYVEK COMPLIANCE TO ISO 11607-1:2006 (2011) Download |
| Jul 16, 2020 | 1062 | petitioner | Center for Drug Evaluation and Research, Application Number: 21-756, Approved Labeling, Macugen (pegaptanib sodium injection) (December 17, 2004) Download |
| Jul 16, 2020 | 1063 | petitioner | Evangelos S. Gragoudas et al., Pegaptanib for Neovascular Age-Related Macular Degeneration, New England Journal of Medicine 2004; 351:2805-16, with Supplementary Appendix Download |
| Jul 16, 2020 | 1064 | petitioner | Bruno Reuter and Claudia Petersen. Die Silikonisierung von Spritzen: Trends, Methoden, Analyseverfahren, TechnoPharm 2, Nr. 4 (2012): 238-244. (Untranslated German version) Download |
| Jul 16, 2020 | 2 | petitioner | Petitioner's Notice of Ranking Petitions Download |
| Jul 16, 2020 | 3 | petitioner | Petition for Inter Partes Review Download |
| Jul 22, 2020 | 4 | board | Notice of Accord Filing Date Download |
| Jul 28, 2020 | 5 | petitioner | Petitioner's Updated Mandatory Notices Pursuant to 37 C.F.R. 42.8 Download |
| Aug 6, 2020 | 6 | patent_own | Patent Owners' Submission of Mandatory Notice Information Under 37 C.F.R. s. 42.8(a)(2) Download |
| Aug 6, 2020 | 7 | patent_own | Patent Owner Novartis Pharma AG's Power of Attorney Download |
| Aug 6, 2020 | 8 | patent_own | Patent Owner Novartis Pharmaceuticals Corporation's Power of Attorney Download |
| Aug 6, 2020 | 9 | patent_own | Patent Owner Novartis Technology LLC's Power of Attorney Download |
| Oct 22, 2020 | 10 | patent_own | Novartis Pharma AG, Novartis Technology LLC, and Novartis Pharmaceuticals Corporation's Patent Owner Preliminary Response Download |
| Oct 22, 2020 | 11 | patent_own | Patent Owners' Response to Petitioner's Notice Ranking Petitions Download |
| Oct 22, 2020 | 12 | patent_own | Patent Owners' Motion to Seal Download |
| Oct 22, 2020 | 13 | patent_own | Patent Owners' Unopposed Motion for a Modified Protective Order Download |
| Oct 22, 2020 | 2001 | patent_own | Exhibit 2001 Download |
| Oct 22, 2020 | 2002 | patent_own | Exhibit 2002 Download |
| Oct 22, 2020 | 2003 | patent_own | Exhibit 2003 Download |
| Oct 22, 2020 | 2004 | patent_own | Exhibit 2004 Download |
| Oct 22, 2020 | 2005 | patent_own | Exhibit 2005 Download |
| Oct 22, 2020 | 2006 | patent_own | Exhibit 2006 Download |
| Oct 22, 2020 | 2007 | patent_own | Exhibit 2007 Download |
| Oct 22, 2020 | 2008 | patent_own | Exhibit 2008 Download |
| Oct 22, 2020 | 2009 | patent_own | Exhibit 2009 Download |
| Oct 22, 2020 | 2010 | patent_own | Exhibit 2010 Download |
| Oct 22, 2020 | 2011 | patent_own | Exhibit 2011 Download |
| Oct 22, 2020 | 2012 | patent_own | Exhibit 2012 Download |
| Oct 22, 2020 | 2013 | patent_own | Exhibit 2013 Download |
| Oct 22, 2020 | 2014 | patent_own | Exhibit 2014 Download |
| Oct 22, 2020 | 2015 | patent_own | Exhibit 2015 Download |
| Oct 22, 2020 | 2016 | patent_own | Exhibit 2016 Download |
| Oct 22, 2020 | 2017 | patent_own | Exhibit 2017 Download |
| Oct 22, 2020 | 2018 | patent_own | Exhibit 2018 Download |
| Oct 22, 2020 | 2019 | patent_own | Exhibit 2019 Download |
| Oct 22, 2020 | 2020 | patent_own | Exhibit 2020 Download |
| Oct 22, 2020 | 2021 | patent_own | Exhibit 2021 Download |
| Oct 22, 2020 | 2022 | patent_own | Exhibit 2022 Download |
| Oct 22, 2020 | 2023 | patent_own | Exhibit 2023 Download |
| Oct 22, 2020 | 2024 | patent_own | Exhibit 2024 Download |
| Oct 22, 2020 | 2025 | patent_own | Exhibit 2025 Download |
| Oct 22, 2020 | 2026 | patent_own | Exhibit 2026 Download |
| Oct 22, 2020 | 2027 | patent_own | Exhibit 2027 Download |
| Oct 22, 2020 | 2028 | patent_own | Exhibit 2028 Download |
| Oct 22, 2020 | 2029 | patent_own | Exhibit 2029 Download |
| Oct 22, 2020 | 2030 | patent_own | Redacted Exhibit 2030 Download |
| Oct 22, 2020 | 2040 | patent_own | Exhibit 2040 Download |
| Oct 22, 2020 | 2041 | patent_own | Exhibit 2041 Download |
| Oct 22, 2020 | 2042 | patent_own | Exhibit 2042 Download |
| Oct 22, 2020 | 2043 | patent_own | Exhibit 2043 Download |
| Oct 22, 2020 | 2044 | patent_own | Exhibit 2044 Download |
| Oct 22, 2020 | 2045 | patent_own | Exhibit 2045 Download |
| Oct 22, 2020 | 2046 | patent_own | Exhibit 2046 Download |
| Oct 22, 2020 | 2047 | patent_own | Exhibit 2047 Download |
| Oct 22, 2020 | 2048 | patent_own | Exhibit 2048 Download |
| Nov 3, 2020 | 1065 | petitioner | Hearing by Teleconference, October 29, 2020 Download |
| Nov 17, 2020 | 14 | board | Download |
| Nov 17, 2020 | 3001 | board | Ex. 3001 Download |
| Nov 25, 2020 | 15 | petitioner | Download |
| Dec 2, 2020 | 1066 | petitioner | Nov. 20, 2020, E-mail from E. Holland to B. Ferguson Download |
| Dec 2, 2020 | 16 | petitioner | Petitioner's Unopposed Motion to Terminate the Proceeding Download |
| Dec 7, 2020 | 17 | board | Termination Decision Document Download |
| Feb 2, 2021 | 18 | petitioner | Petitioner's Request for Refund of Post-Institution Fees Download |
| Feb 9, 2021 | 19 | board | Notice of Refund Download |
