Tagged as: Pfizer

GSK Sues Pfizer, Pharmacia & Upjohn & BioNTech for Infringing mRNA Vaccine Patents

Late last week, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC filed suit in the District of Delaware alleging that Pfizer, Pharmacia & Upjohn, BioNtech SE, BioNtech Manufacturing GMBH, and BioNTech US, Inc. infringe five U.S. patents directed to mRNA vaccine technology.  The Patents-In-Suit are U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401;…

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Moderna Litigation Against BioNTech and Pfizer Stayed Pending IPR

We previously reported on the litigation brought by ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna”) against BioNTech SE, BioNTech Manufacturing GmbH, BioNTech US Inc. (collectively, “BioNTech”), and Pfizer Inc. (“Pfizer”) related to Moderna’s mRNA technology and the subsequent inter partes review (IPR) petitions filed by BioNTech and Pfizer.  Those…

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Year in Review: Top Regulatory Developments of 2023

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023.  Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…

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Acuitas Files Suit Against CureVac Alleging Incorrect Inventorship on COVID MRNA-LNP Vaccine Patent Family

Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint on November 13 against CureVac in the U.S. District Court for the Eastern District of Virginia, alleging incorrect inventorship of four U.S. Patents related to COVID-19 mRNA-LNP vaccines and assigned to CureVac, namely U.S. Patent Nos. 11,241,493, 11,471,525, 11,576,966, and 11,596,686, (collectively, the…

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Recent Adalimumab Biosimilar Developments

FDA grants interchangeable designation to Pfizer’s adalimumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). ABRILADA was originally approved by the FDA in November 2019. The new interchangeable designation was…

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Update on mRNA Vaccine Patent Litigation

We previously reported on patent infringement litigations between Alnylam and Moderna.  Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna. First, in a patent action brought by Alnylam Pharmaceuticals, Inc. (“Alnylam”) against Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc. (collectively, “Moderna”), the parties entered a…

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GSK Sues Pfizer for Patent Infringement over RSV Vaccine

GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, “GSK”) recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO infringes four U.S. patents covering GSK’s rival RSV vaccine, AVREXY.  According to the complaint, AVREXY and ABRYSVO were approved by the U.S….

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Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging mRNA-Delivery Specific Patents

Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus), challenging U.S. Patent Nos. 9,364,435; 8,058,069; 8,492,359; 8,822,668; 9,006,417; 9,504,651; 9,518,272; 11,141,378; 11,298,320; and 11,318,098 relating to…

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HUMIRA (adalimumab) Biosimilar Launches

In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA (adalimumab-bwwd); Coherus Biosciences’s YUSIMRY (adalimumab-aqvh); Celltrion’s YUFLYMA (adalimumab-aaty); Fresenius Kabi’s IDACIO (adalimumab-aacf); and Biocon’s HULIO (adalimumab-fkjb).  With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there…

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Alnylam Files New COVID-19 Vaccine Infringement Lawsuits Against Pfizer and Moderna

Last Friday, Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in Delaware alleging their COVID-19 vaccine lipid nanoparticle technology infringes Alnylam’s patent rights. The patents-in-suit are U.S. Patent…

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