Notice of Refund | Feb 9, 2021 | PAPER | BOARD |
Petitioner's Request for Refund of Post-Institution Fees | Feb 2, 2021 | PAPER | PETITIONER |
Termination Decision Document | Dec 7, 2020 | PAPER | BOARD |
Petitioner's Unopposed Motion to Terminate the Proceeding | Dec 2, 2020 | PAPER | PETITIONER |
Nov. 20, 2020, E-mail from E. Holland to B. Ferguson | Dec 2, 2020 | EXHIBIT | PETITIONER |
Petitioner's Reply Regarding 35 U.S.C. ¿¿¿¿ 314(a), 325(d) | Nov 25, 2020 | PAPER | PETITIONER |
ORDER
Conduct of the Proceeding
37 C.F.R. ¿¿¿¿ 42.5, 42.20 | Nov 17, 2020 | PAPER | BOARD |
Ex. 3001 | Nov 17, 2020 | EXHIBIT | BOARD |
Hearing by Teleconference, October 29, 2020 | Nov 3, 2020 | EXHIBIT | PETITIONER |
Patent Owners' Response to Petitioner's Notice Ranking Petitions | Oct 22, 2020 | PAPER | PATENT OWNER |
Novartis Pharma AG, Novartis Technology LLC, and Novartis Pharmaceuticals Corporation's Patent Owner Preliminary Response | Oct 22, 2020 | PAPER | PATENT OWNER |
Patent Owners' Motion to Seal | Oct 22, 2020 | PAPER | PATENT OWNER |
Exhibit 2030 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Sealed Exhibit 2031 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Sealed Exhibit 2032 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Sealed Exhibit 2033 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Sealed Exhibit 2034 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Sealed Exhibit 2035 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Sealed Exhibit 2036 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Sealed Exhibit 2037 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Patent Owners' Unopposed Motion for a Modified Protective Order | Oct 22, 2020 | PAPER | PATENT OWNER |
Sealed Exhibit 2038 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Sealed Exhibit 2039 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2013 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2017 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2021 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2022 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2025 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2026 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2028 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2001 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2002 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2003 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2004 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2005 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2006 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2007 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2008 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2009 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2010 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2011 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2012 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2014 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2015 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2016 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2018 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2019 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2020 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2023 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2024 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2027 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2029 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2040 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2041 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2042 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2043 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2044 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2047 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Redacted Exhibit 2030 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2045 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2046 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2048 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Patent Owner Novartis Pharma AG's Power of Attorney | Aug 6, 2020 | PAPER | PATENT OWNER |
Patent Owner Novartis Technology LLC's Power of Attorney | Aug 6, 2020 | PAPER | PATENT OWNER |
Patent Owners' Submission of Mandatory Notice Information Under 37 C.F.R. s. 42.8(a)(2) | Aug 6, 2020 | PAPER | PATENT OWNER |
Patent Owner Novartis Pharmaceuticals Corporation's Power of Attorney | Aug 6, 2020 | PAPER | PATENT OWNER |
Petitioner's Updated Mandatory Notices Pursuant to 37 C.F.R. 42.8 | Jul 28, 2020 | PAPER | PETITIONER |
Notice of Accord Filing Date | Jul 22, 2020 | PAPER | BOARD |
Power of Attorney | Jul 16, 2020 | PAPER | PETITIONER |
Curriculum Vitae of James Agalloco | Jul 16, 2020 | EXHIBIT | PETITIONER |
Curriculum Vitae of Horst Koller | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent No. 9,220,631 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Declaration of Horst Koller under 37 C.F.R. 1.68 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Declaration of James Agalloco under 37 C.F.R. 1.68 | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2011/006877 to Sigg | Jul 16, 2020 | EXHIBIT | 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) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Arno Fries, Drug Delivery of Sensitive Biopharmaceuticals With Prefilled Syringes, 9(5) DRUG DELIVERY TECH. 22 (2009) | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent Publication No. 2012/0091026 to Chacornac | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2009/030976 to Boulange | Jul 16, 2020 | EXHIBIT | PETITIONER |
Internet Archive WayBack Machine, March 7, 2011 Record of Drugs.com, Macugen Prescribing Information | Jul 16, 2020 | EXHIBIT | PETITIONER |
Bhavnesh D. Shah & Bhupendra G. Prajapati, Pre-Filled Syringes: A New Concept, PHARMA BIO WORLD 51 (2009) | Jul 16, 2020 | EXHIBIT | 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) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 9,220,631 - 1/4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 9,220,631 - 2/4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent Publication No. 2003/0003014 to Metzner | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 9,220,631 - 3/4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 9,220,631 - 4/4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2007/035621 to Scypinski | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Pharmacopeia, USP 789, Particulate Matter in Ophthalmic Solutions, USP 34 NF 29 (2011) | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2007/149334 to Furfine | Jul 16, 2020 | EXHIBIT | PETITIONER |
Michael W. Stewart et al., Fresh From the Pipeline Aflibercept, 11 NAT. REV. DRUG DISCOV. 269 (2012) | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent Publication No. 2011/276005 to Hioki | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent No. 7,060,269 to Baca | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010) (Nema Vol. 1) - 2/4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010) (Nema Vol. 1) - 3/4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 7,060,269, 2/3 | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | 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) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010) (Nema Vol. 1) - 1/4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010) (Nema Vol. 1) - 4/4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 7,060,269, 1/3 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 7,060,269, 3/3 | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent No. 7,404,278 to Wittland | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Food and Drug Administration, Lucentis Highlights of the Prescribing Information, (June 2010) | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2008/077155 to Lam | Jul 16, 2020 | EXHIBIT | PETITIONER |
Curriculum Vitae of Dr. Szilard Kiss | Jul 16, 2020 | EXHIBIT | PETITIONER |
International Organization for Standardization, ISO 11040-4 Prefilled Syringes Part 4: Glass Barrels for Injectables (2nd ed. 2007) (ISO 11040-4) | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Declaration of Dr. Szilard Kiss under 37 C.F.R. 1.68 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Declaration of James L. Mullins, Ph.D. | Jul 16, 2020 | EXHIBIT | PETITIONER |
Affidavit of Internet Archive Office Manager | Jul 16, 2020 | EXHIBIT | PETITIONER |
Internet Archive WayBack Machine, March 8, 2011 Record of Drugs.com, Welcome to Drugs.com | Jul 16, 2020 | EXHIBIT | PETITIONER |
Internet Archive WayBack Machine, February 25, 2011 Record of Drugs.com, FDA Professional Drug Information | Jul 16, 2020 | EXHIBIT | PETITIONER |
Dow Corning 365 35% Dimethicone NF Emulsion Frequently Asked Questions (2002) | Jul 16, 2020 | EXHIBIT | PETITIONER |
European Patent Application No. 12174860 to Novartis AG | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice (September 2004) | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Food and Drug Administration, Eylea Highlights of the Prescribing Information, (November 2011) | Jul 16, 2020 | EXHIBIT | 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) | Jul 16, 2020 | EXHIBIT | PETITIONER |
International Standard ISO-9626, Stainless steel needle tubing for the manufacture of medical devices Amendment 1, ISO 9626:1991/Amd.1:2001(E) | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent Publication No. 2005/0182370 to Hato | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Department of Labor, Occupational Safety & Health Administration, Ethylene Oxide (EtO): Understanding OSHA¿¿¿s Exposure monitoring Requirements, 2007 OSHA3325-01N (2007) | Jul 16, 2020 | EXHIBIT | PETITIONER |
International Standard ISO-7864, Sterile hypodermic needles for single use, ISO 7864:1993(E) | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
William Leventon, Medical Device Sterilization: What Manufacturers Need to Know (MDDI online, Sept. 1, 2002) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Pamela Carter, et al. The lowdown on low temperature sterilization for packaged devices, Healthcare Purchasing News, July 2008, 42-45. | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
K. Kereluk, et al. Microbiological Aspects of Ethylene Oxide Sterilization: I. Experimental Apparatus & Methods, Applied Microbiology 1970, 19(1):146-151. | Jul 16, 2020 | EXHIBIT | PETITIONER |
John R. Gillis & Gregg Mosley, Validation of Pharmaceutical Processes, Chapter 16 Validation of Ethylene Oxide Sterilization Processes (2011), pp.241-262 | Jul 16, 2020 | EXHIBIT | PETITIONER |
FDA Pesticide Analytical Manual Vol. 1, Chapter 6 - HPLC | Jul 16, 2020 | EXHIBIT | PETITIONER |
Carl Hultman, et al. The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide, Pharmaceutical Engineering, January/February 2007, 27(1):1-6 | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
J.S. Penn, et al. Vascular Endothelial Growth Factor in Eye Disease, Prog. Retin Eye Res., July 2008, 27(4):331-371 | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Food and Drug Administration, Trivaris Highlights of the Prescribing Information, (May 2008) | Jul 16, 2020 | EXHIBIT | 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) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Curriculum Vitae of James L. Mullins, Ph.D. | Jul 16, 2020 | EXHIBIT | PETITIONER |
DUPONT TYVEK COMPLIANCE TO ISO 11607-1:2006 (2011) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Center for Drug Evaluation and Research, Application Number: 21-756, Approved Labeling, Macugen (pegaptanib sodium injection) (December 17, 2004) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Internet Archive WayBack Machine, May 17, 2011 Record of U.S. Pharmacopeia, Understanding USP NF | Jul 16, 2020 | EXHIBIT | 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) | Jul 16, 2020 | EXHIBIT | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Bruno Reuter and Claudia Petersen. Die Silikonisierung von Spritzen: Trends, Methoden, Analyseverfahren, TechnoPharm 2, Nr. 4 (2012): 238-244. (Untranslated German version) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Petitioner's Notice of Ranking Petitions | Jul 16, 2020 | PAPER | PETITIONER |
Petition for Inter Partes Review | Jul 16, 2020 | PAPER | PETITIONER |