The weekly litigation news digest is live. Subscribe now

Alvotech USA Inc. et al. v. Regeneron Pharmaceuticals, Inc. - PGR2025-00085

Explore the PTAB proceeding PGR2025-00085 filed by Alvotech USA Inc. et al. against Regeneron Pharmaceuticals, Inc. on Sep 17, 2025. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
PGR2025-00085
Filing Date
Sep 17, 2025
Petitioner
Alvotech USA Inc. et al.
Respondent
Regeneron Pharmaceuticals, Inc.
Status
Pending
Respondent Application Number
17384070
Respondent Tech Center
1600
Respondent Patent Number
12168036

Decision Documents New

Decision pending - set alert to receive updates

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.

Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

PET Opposition to Discretionary Denial Brief

Dec 26, 2025PAPERPETITIONER

USP11103552

Dec 26, 2025EXHIBITPETITIONER

EO

Dec 26, 2025EXHIBITPETITIONER

WH Fact Sheet

Dec 26, 2025EXHIBITPETITIONER

Alvotech Press Release

Dec 26, 2025EXHIBITPETITIONER

FDA Press Release

Dec 26, 2025EXHIBITPETITIONER

Teva/Alvotech Press Release

Dec 26, 2025EXHIBITPETITIONER

Regeneron's Preliminary Patent Owner Response (PGR2025-00085)

Dec 26, 2025PAPERPATENT OWNER

Public Trial Transcript Excerpts, Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 22-cv-61 (N.D.W. Va.)

Dec 26, 2025EXHIBITPATENT OWNER

Wang, Protein Aggregation and Its Inhibition in Biopharmaceutics, 289 Int. J. Pharm. 1 (2005) (“Wang 2005”)

Dec 26, 2025EXHIBITPATENT OWNER

Wang, Instability, Stabilization, and Formulation of Liquid Protein Pharmaceuticals, 1856 Int. J. Pharm. 129 (1999) (“Wang 1999”)

Dec 26, 2025EXHIBITPATENT OWNER

Philip J. Rosenfeld et al., Maximum Tolerated Dose of a Humanized Anti-Vascular Endothelial Growth Factor Antibody Fragment for Treating Neovascular Age-Related Macular Degeneration, 112 Ophthalmology 1048 (2005) (“Rosenfeld 2005”)

Dec 26, 2025EXHIBITPATENT OWNER

U.S. Patent Application Publication No. 2004/0197324 (“Liu 2004”)

Dec 26, 2025EXHIBITPATENT OWNER

U.S. Patent No. 7,087,411 (“Daly”)

Dec 26, 2025EXHIBITPATENT OWNER

WO 2006/138181 (”Gokarn”)

Dec 26, 2025EXHIBITPATENT OWNER

Rahul N. Khurana et al., Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular AgeRelated Macular Degeneration, 128 Ophthalmology 1027 (2021) (“Khurana 2021”)

Dec 26, 2025EXHIBITPATENT OWNER

James A. Dixon et al., VEGF Trap-Eye for the Treatment of Neovascular Age-Related Macular Degeneration, 18 Expert Opinion Investigational Drugs 1573 (2009) (“Dixon 2009”)

Dec 26, 2025EXHIBITPATENT OWNER

Pravin U. Dugel et al., HAWK and HARRIER: Ninety-Six-Week Outcomes from the Phase 3 Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration, 128 Ophthalmology 89 (2021) (“Dugel”)

Dec 26, 2025EXHIBITPATENT OWNER

John S.Y. Park & David R. Chow, Clinical Primer on Eylea HD: Review of the Current Data, Retina Specialist (Apr. 13, 2024), https://www.retina-specialist.com/article/clinical-primer-oneylea-hd-review-of-the-current-data (“Park”)

Dec 26, 2025EXHIBITPATENT OWNER

Vabysmo Label 2024 (“Vabysmo Label”)

Dec 26, 2025EXHIBITPATENT OWNER

Jonas L. Fast et al., Physical Instability of a Therapeutic Fc Fusion Protein: Domain Contributions to Conformational and Colloidal Stability, 48 Biochemistry 11724 (2009) (“Fast”)

Dec 26, 2025EXHIBITPATENT OWNER

Zaltrap Label 2023 (“Zaltrap Label”)

Dec 26, 2025EXHIBITPATENT OWNER

Michael Thomas, Comparative Effectiveness of Aflibercept for the Treatment of Patients with Neovascular Age-related Macular Degeneration, 7 Clinical Ophthalmology 495 (2013) (“Thomas”)

Dec 26, 2025EXHIBITPATENT OWNER

Alvotech, Report of Foreign Private Issuer (Form 6-K) (June 23, 2025) (“Alvotech Press Release”)

Dec 26, 2025EXHIBITPATENT OWNER

Molecular Partners, Molecular Partners to Regain Global Rights to Abicipar, Molecular Partners News Release Details (Aug. 8, 2021) https://investors.molecularpartners.com/news-releases/news-release-details/molecular-partners-regain-globalrights-abicipar (“Molecular Partners Press Release”)

Dec 26, 2025EXHIBITPATENT OWNER

Novartis, Novartis Reports One Year Results of Phase III MERLIN Study Evaluating Beovu® Every Four Week Dosing and Provides Update on Beovu Clinical Program, Novartis Media Releases (May 28, 2021) https://www.novartis.com/news/mediareleases/novartis-reports-one-year-results-phase-iii-merlin-studyevaluating-beovu-every-four-week-dosing-and-provides-updatebeovu-clinical-program (“Novartis Press Release”)

Dec 26, 2025EXHIBITPATENT OWNER

U.S. Patent Application Publication No. 2023/0416353

Dec 26, 2025EXHIBITPATENT OWNER

WO 2014/009465

Dec 26, 2025EXHIBITPATENT OWNER

U.S. Food & Drug Admin., Eylea HD Approval Letter (Aug. 18, 2018) (“Eylea HD FDA Approval Letter”)

Dec 26, 2025EXHIBITPATENT OWNER

Gerard A. Rodrigues, Functional Characterization of AbiciparPegol, an Anti-VEGF DARPin Therapeutic That Potently Inhibits Angiogenesis and Vascular Permeability, 59 Investigative Ophthalmology & Visual Science 5836 (2018) (“Rodrigues 2018”)

Dec 26, 2025EXHIBITPATENT OWNER

Patent Owner's Discretionary Denial Brief

Nov 26, 2025PAPERPATENT OWNER

Excerpts from the File History of U.S. Appl. No. 17/384,070

Nov 26, 2025EXHIBITPATENT OWNER

US 2018/0326126 (“Fiedler ’126”)

Nov 26, 2025EXHIBITPATENT OWNER

Australian Dep’t of Health & Human Aging, Australian Public Assessment Report for Aflibercept (July 2012) (“AusPAR”)

Nov 26, 2025EXHIBITPATENT OWNER

Ameya U. Borwankar et al., Viscosity Reduction of a Concentrated Monoclonal Antibody with Arginine.HCl and Arginine.Glutamate, 55 Ind. Eng. Chem. Rsch. 11225 (2016) (“Borwankar”)

Nov 26, 2025EXHIBITPATENT OWNER

Neal Whitaker et al., A Formulation Development Approach to Identify and Select Stable Ultra–High-Concentration Monoclonal Antibody Formulations with Reduced Viscosities, 106 J. Pharmaceutical Scis. 3230 (2017) (“Whitaker”)

Nov 26, 2025EXHIBITPATENT OWNER

Ameya U. Borwankar et al., Viscosity Reduction of a Concentrated Monoclonal Antibody with Arginine.HCl and Arginine.Glutamate: Supplementary Information, 55 Ind. Eng. Chem. Rsch. 11225 (2016) (“Borwankar SI”)

Nov 26, 2025EXHIBITPATENT OWNER

Eylea HD® Highlights of Prescribing Information (Oct. 2024)

Nov 26, 2025EXHIBITPATENT OWNER

AbbVie, Allergan, an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar Pegol, AbbVie News Center (June 26, 2020), https://news.abbvie.com/2020-06-26-Allerganan-AbbVie-Company-and-Molecular-Partners-ReceiveComplete-Response-Letter-from-FDA-on-Biologics-LicenseApplication-for-Abicipar-pegol (“AbbVie PR”)

Nov 26, 2025EXHIBITPATENT OWNER

Rod McNeil, Advances and Developments in Medical Retina, 25 Eye News 1 (2019) (“McNeil”)

Nov 26, 2025EXHIBITPATENT OWNER

Rehan M. Hussain & Thomas A. Ciulla, Emerging Vascular Endothelial Growth Factor Antagonists to Treat Neovascular Age-Related Macular Degeneration, 22 Expert Op. Emerging Drugs 235 (2017) (“Hussain”)

Nov 26, 2025EXHIBITPATENT OWNER

Angus Liu, Novartis Calls off 3 Beovu Trials Testing More Frequent Dosing on Concerns of Vision-Threatening Side Effect, FiercePharma (June 1, 2021) (“Liu”)

Nov 26, 2025EXHIBITPATENT OWNER

Beovu Label (2024)

Nov 26, 2025EXHIBITPATENT OWNER

Philip J. Rosenfeld & David J. Browning, Editorial: Is This a 737 Max Moment for Brolucizumab?, 216 Am. J. Ophthalmology A7 (2020) (“Rosenfeld”)

Nov 26, 2025EXHIBITPATENT OWNER

J. Gaudreault et al., Preclinical Pharmacokinetics of Ranibizumab (rhuFabV2) After a Single Intravitreal Administration, 46 Invest. Ophthalmol Vis. Sci. 726 (2005) (“Gaudreault”)

Nov 26, 2025EXHIBITPATENT OWNER

Notice: Power of Attorney

Oct 8, 2025PAPERPATENT OWNER

Notice: Mandatory Notice

Oct 8, 2025PAPERPATENT OWNER

Notice: NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

Sep 26, 2025PAPERBOARD

US Patent No. 12168036

Sep 17, 2025EXHIBITPETITIONER

Excerpts from the Prosecution History of the 036 patent Part 1 of 8

Sep 17, 2025EXHIBITPETITIONER

Excerpts from the Prosecution History of the 036 patent Part 2 of 8

Sep 17, 2025EXHIBITPETITIONER

Excerpts from the Prosecution History of the 036 patent Part 3 of 8

Sep 17, 2025EXHIBITPETITIONER

Excerpts from the Prosecution History of the 036 patent Part 4 of 8

Sep 17, 2025EXHIBITPETITIONER

Excerpts from the Prosecution History of the 036 patent Part 5 of 8

Sep 17, 2025EXHIBITPETITIONER

Excerpts from the Prosecution History of the 036 patent Part 6 of 8

Sep 17, 2025EXHIBITPETITIONER

Excerpts from the Prosecution History of the 036 patent Part 7 of 8

Sep 17, 2025EXHIBITPETITIONER

Excerpts from the Prosecution History of the 036 patent Part 8 of 8

Sep 17, 2025EXHIBITPETITIONER

US Patent 7,608,261 (Furfine)

Sep 17, 2025EXHIBITPETITIONER

US Patent 8,921,316 (Dix)

Sep 17, 2025EXHIBITPETITIONER

US Publication 2016/0144025 A1 (Vitti)

Sep 17, 2025EXHIBITPETITIONER

Eylea Clinical Review, Center for Drug Evaluation and Research

Sep 17, 2025EXHIBITPETITIONER

AU Eylea Label

Sep 17, 2025EXHIBITPETITIONER

US Publication 2015/0071920 A1 (Larson)

Sep 17, 2025EXHIBITPETITIONER

US Publication 2017/0232199 A1 (Fiedler)

Sep 17, 2025EXHIBITPETITIONER

WO 2016/154288 to Ingber et al. 

Sep 17, 2025EXHIBITPETITIONER

PTE Application US Patent 7374758, (App 11/016,503)

Sep 17, 2025EXHIBITPETITIONER

Avery 2014

Sep 17, 2025EXHIBITPETITIONER

Awwad 2017

Sep 17, 2025EXHIBITPETITIONER

Brown 2015

Sep 17, 2025EXHIBITPETITIONER

CATT 2011

Sep 17, 2025EXHIBITPETITIONER

Celik 2015

Sep 17, 2025EXHIBITPETITIONER

Cohen 2016

Sep 17, 2025EXHIBITPETITIONER

Das 2015

Sep 17, 2025EXHIBITPETITIONER

Dear 2017

Sep 17, 2025EXHIBITPETITIONER

Duh 2017

Sep 17, 2025EXHIBITPETITIONER

Elwes 2018

Sep 17, 2025EXHIBITPETITIONER

Falavarjani 2013

Sep 17, 2025EXHIBITPETITIONER

He 2011

Sep 17, 2025EXHIBITPETITIONER

Ho 2014 - HARBOR

Sep 17, 2025EXHIBITPETITIONER

Hong 2018

Sep 17, 2025EXHIBITPETITIONER

Inoue 2014

Sep 17, 2025EXHIBITPETITIONER

Jin 2017

Sep 17, 2025EXHIBITPETITIONER

Lehman Brothers Presentation 2009

Sep 17, 2025EXHIBITPETITIONER

Miller 2017

Sep 17, 2025EXHIBITPETITIONER

Narasimhan 2012

Sep 17, 2025EXHIBITPETITIONER

Neergaard 2013

Sep 17, 2025EXHIBITPETITIONER

Nguyen 2009

Sep 17, 2025EXHIBITPETITIONER

Nguyen 2012

Sep 17, 2025EXHIBITPETITIONER

Gutierrez and Ferrara 2023

Sep 17, 2025EXHIBITPETITIONER

Salinas 2010

Sep 17, 2025EXHIBITPETITIONER

Stewart 2012

Sep 17, 2025EXHIBITPETITIONER

Sun 2012

Sep 17, 2025EXHIBITPETITIONER

Trichonas 2013

Sep 17, 2025EXHIBITPETITIONER

Varma 2014

Sep 17, 2025EXHIBITPETITIONER

Viswanath 2007

Sep 17, 2025EXHIBITPETITIONER

Wang 2015

Sep 17, 2025EXHIBITPETITIONER

Wykoff Feb 2018

Sep 17, 2025EXHIBITPETITIONER

Macugen 2011 Label

Sep 17, 2025EXHIBITPETITIONER

Beovu 2019 Label

Sep 17, 2025EXHIBITPETITIONER

Eylea 2011 Label

Sep 17, 2025EXHIBITPETITIONER

Eylea 2012 Label

Sep 17, 2025EXHIBITPETITIONER

Eylea 2014 Label

Sep 17, 2025EXHIBITPETITIONER

Eylea 2016 Label

Sep 17, 2025EXHIBITPETITIONER

Eylea HD 2024 Label

Sep 17, 2025EXHIBITPETITIONER

Lucentis 2017 Label

Sep 17, 2025EXHIBITPETITIONER

Vabysmo 2022 Label

Sep 17, 2025EXHIBITPETITIONER

Assessment Report, Eylea aflibercept

Sep 17, 2025EXHIBITPETITIONER

Eylea Pharmacology Review

Sep 17, 2025EXHIBITPETITIONER

EMA Annex I, Summary of Product Characteristics

Sep 17, 2025EXHIBITPETITIONER

Loureiro 2017

Sep 17, 2025EXHIBITPETITIONER

Ferrara 2010

Sep 17, 2025EXHIBITPETITIONER

Channa 2011

Sep 17, 2025EXHIBITPETITIONER

Rhoades 2017

Sep 17, 2025EXHIBITPETITIONER

Wang 2021

Sep 17, 2025EXHIBITPETITIONER

Declaration of Dr. Donald Joseph D'Amico

Sep 17, 2025EXHIBITPETITIONER

Declaration of Dr. Robert J. Falconer

Sep 17, 2025EXHIBITPETITIONER

Notice: Power of Attorney

Sep 17, 2025PAPERPETITIONER

Clinical Study Protocol NCT04126317

Sep 17, 2025EXHIBITPETITIONER

Petition: as filed

Sep 17, 2025PAPERPETITIONER

Declaration of June Anne Munford

Sep 17, 2025EXHIBITPETITIONER