Notice of Refund | Jun 1, 2021 | PAPER | BOARD |
Petitioner's Request for Refund of Post-Institution Fees | May 18, 2021 | PAPER | PETITIONER |
ORDER
Conduct of the Proceeding
37 C.F.R. ���� 42.5, 42.20 | May 3, 2021 | PAPER | BOARD |
Petitioner���s Unopposed Motion to Withdraw Its Request for Rehearing of The Board���s Decision Denying Inter Partes Review | Apr 27, 2021 | PAPER | PETITIONER |
Notification of Receipt of Withdrawal of POP Request | Apr 22, 2021 | PAPER | BOARD |
Ex. 3004 | Apr 22, 2021 | EXHIBIT | BOARD |
Notification of Receipt of POP Request | Mar 24, 2021 | PAPER | BOARD |
Ex. 3003 | Mar 24, 2021 | EXHIBIT | BOARD |
Petitioner's Request for Rehearing | Feb 12, 2021 | PAPER | PETITIONER |
Trial Instituted Document | Jan 15, 2021 | PAPER | BOARD |
Exhibit 3002 | Jan 15, 2021 | EXHIBIT | BOARD |
Exhibit 2047 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2050 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2052 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2057 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Novartis Pharma AG, Novartis Technology LLC, and Novartis Pharmaceuticals Corporation's Patent Owner Sur-Reply | Dec 11, 2020 | PAPER | PATENT OWNER |
Exhibit 2048 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2049 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2051 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2053 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2054 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2055 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2056 | Dec 11, 2020 | EXHIBIT | PATENT OWNER |
Petitioner's Reply Regarding 35 U.S.C. ¿¿¿¿ 314(a), 325(d) | Nov 25, 2020 | PAPER | PETITIONER |
November 24, 2020 Email re Motion to Terminate Proceedings in IPR2020-01318 | Nov 25, 2020 | EXHIBIT | PETITIONER |
Letter to E. Holland re Pending IPR Petitions, November 20, 2020 | Nov 25, 2020 | EXHIBIT | PETITIONER |
U.S. Application 13/382,380 Prosecution History | Nov 25, 2020 | EXHIBIT | PETITIONER |
Novartis¿¿¿s Opening Markman Brief, November 10, 2020 | Nov 25, 2020 | EXHIBIT | PETITIONER |
Sigg Declaration From 13/382,380 Prosecution History | Nov 25, 2020 | EXHIBIT | PETITIONER |
Joint Disclosure of Proposed Claim Construction Chart | Nov 25, 2020 | EXHIBIT | 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 |
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 2005 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2007 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2008 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2017 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2004 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2006 | 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 2013 | 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 2021 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2022 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2023 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2024 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2026 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2027 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2028 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2029 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2041 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2042 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2044 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2045 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2025 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2040 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2043 | Oct 22, 2020 | EXHIBIT | PATENT OWNER |
Exhibit 2046 | Oct 22, 2020 | EXHIBIT | 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 Pharma AG's Power of Attorney | Aug 6, 2020 | PAPER | PATENT OWNER |
Patent Owner Novartis Pharmaceuticals Corporation'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 |
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 |
U.S. Patent No. 9,220,631 (¿¿¿the ¿¿¿631 Patent¿¿¿) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Declaration of James Agalloco under 37 C.F.R. ¿¿ 1.68. | Jul 16, 2020 | EXHIBIT | PETITIONER |
Declaration of Horst Koller under 37 C.F.R. ¿¿ 1.68. | Jul 16, 2020 | EXHIBIT | PETITIONER |
Curriculum Vitae of Horst Koller | Jul 16, 2020 | EXHIBIT | PETITIONER |
Curriculum Vitae of James Agalloco | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2011/006877 to Sigg et al. (¿¿¿Sigg¿¿¿) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Internet Archive WayBack Machine, March 7, 2011 Record of Drugs.com, Macugen Prescribing Information | Jul 16, 2020 | EXHIBIT | PETITIONER |
Certified English Translation of Bruno Reuter and Claudia Petersen | Jul 16, 2020 | EXHIBIT | PETITIONER |
Thomas Schoenknecht, Prefilled Syringes: Why New Developments Are Important In Injectable Delivery Today | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent Publication No. 2012/0091026 to Chacornac et al. | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent Publication No. 2003/0003014 to Metzner et al. | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent Publication No. 2011/276005 to Hioki et al. | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2007/149334 to Furfine et al. | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2009/030976 to Boulange et al. (¿¿¿Boulange¿¿¿) | Jul 16, 2020 | EXHIBIT | PETITIONER |
Bhavnesh D. Shah & Bhupendra G. Prajapati, Pre-Filled Syringes: A New Concept | Jul 16, 2020 | EXHIBIT | PETITIONER |
Arno Fries, Drug Delivery of Sensitive Biopharmaceuticals With Prefilled Syringes | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2007/035621 to Scypinski et al. | 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 |
U.S. Patent No. 7,060,269 to Baca et al. (¿¿¿Baca¿¿¿) | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
James A. Dixon, et al. "VEGF Trap-Eye for the treatment of neovascular age-related macular degeneration." | Jul 16, 2020 | EXHIBIT | PETITIONER |
Curriculum Vitae of Dr. Szilard Kiss | Jul 16, 2020 | EXHIBIT | PETITIONER |
Michael W. Stewart et al., Fresh From the Pipeline Aflibercept | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Patent No. 7,404,278 to Wittland et al. | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Food and Drug Administration, Lucentis¿¿ Highlights of the Prescribing Information | Jul 16, 2020 | EXHIBIT | PETITIONER |
International Organization for Standardization, ISO 11040-4 Prefilled Syringes ¿¿¿ Part 4: Glass Barrels for Injectables | Jul 16, 2020 | EXHIBIT | PETITIONER |
PCT Patent Publication No. WO 2008/077155 to Lam et al. | Jul 16, 2020 | EXHIBIT | PETITIONER |
Declaration of Dr. Szilard Kiss under 37 C.F.R. ¿¿ 1.68. | Jul 16, 2020 | EXHIBIT | PETITIONER |
Dow Corning¿¿ 365 35% Dimethicone NF Emulsion ¿¿¿ Frequently Asked Questions | Jul 16, 2020 | EXHIBIT | PETITIONER |
European Patent Application No. 12174860 to Novartis AG | 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 |
U.S. Food and Drug Administration, Eylea¿¿ Highlights of the Prescribing Information | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
International Standard ISO-7864, Sterile hypodermic needles for single use | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Affidavit of Internet Archive Office Manager | Jul 16, 2020 | EXHIBIT | PETITIONER |
John R. Gillis & Gregg Mosley, Validation of Pharmaceutical Processes | Jul 16, 2020 | EXHIBIT | PETITIONER |
U.S. Food and Drug Administration, Trivaris ¿¿ Highlights of the Prescribing Information | 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 |
Carsten H. Meyer et al., Steps for a Safe Intravitreal Injection Technique ¿¿¿ A look at how European and American approaches compare | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Evangelos S. Gragoudas et al., Pegaptanib for Neovascular Age-Related Macular Degeneration | Jul 16, 2020 | EXHIBIT | PETITIONER |
Bruno Reuter and Claudia Petersen. ¿¿¿Die Silikonisierung von Spritzen: Trends, Methoden, Analyseverfahren¿¿¿ | Jul 16, 2020 | EXHIBIT | PETITIONER |
International Standard ISO-9626, Stainless steel needle tubing for the manufacture of medical devices ¿¿¿ Amendment 1 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Advait Badkar, et al. Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches | Jul 16, 2020 | EXHIBIT | PETITIONER |
William Leventon, ¿¿¿Medical Device Sterilization: What Manufacturers Need to Know¿¿¿ | Jul 16, 2020 | EXHIBIT | PETITIONER |
Pamela Carter, et al. The lowdown on low temperature sterilization for packaged devices | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Bryon Lambert, et al. Radiation and Ethylene Oxide Terminal Sterilization Experiences with Drug Eluting Stent Products | Jul 16, 2020 | EXHIBIT | PETITIONER |
K. Kereluk, et al. Microbiological Aspects of Ethylene Oxide Sterilization: I. Experimental Apparatus & Methods | Jul 16, 2020 | EXHIBIT | PETITIONER |
Carl Hultman, et al. The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide | Jul 16, 2020 | EXHIBIT | PETITIONER |
FDA Pesticide Analytical Manual Vol. 1, Chapter 6 - HPLC | 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 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Christine I. Falkner-Radler, et al. Needle Size in Intravitreal Injections-Preliminary Results of a Randomized Clinical Trial | Jul 16, 2020 | EXHIBIT | PETITIONER |
Petition for Inter Partes Review | Jul 16, 2020 | PAPER | PETITIONER |
Power of Attorney for Petitioner Regeneron Pharmaceuticals, Inc. | Jul 16, 2020 | PAPER | PETITIONER |
Petitioner's Notice Ranking Petitions | Jul 16, 2020 | PAPER | PETITIONER |
Declaration of James L. Mullins, Ph.D. | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 9,220,631, pt. 2 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 9,220,631, pt. 3 | Jul 16, 2020 | EXHIBIT | PETITIONER |
J.S. Penn, et al. Vascular Endothelial Growth Factor in Eye Disease | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 9,220,631, pt.1 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging, pt. 1 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging, pt. 2 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging, pt. 3 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 1: Formulation and Packaging, pt. 4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 9,220,631, pt. 4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and Processing, pt. 1 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and Processing, pt. 2 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and Processing, pt. 3 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and Processing, pt. 4 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 7,060,269, pt. 1 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 7,060,269, pt. 2 | Jul 16, 2020 | EXHIBIT | PETITIONER |
Prosecution File History of U.S. Patent No. 7,060,269, pt. 3 | Jul 16, 2020 | EXHIBIT | PETITIONER |