Tagged as: IPR

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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REGENXBIO and Sarepta Agree to Stay Litigation Pending Outcome of Sarepta’s IPR Petition

As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product, ELEVIDYS (delandistrogene moxeparvovec-rokl).  On September 19,…

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Updates on Aflibercept BPCIA Litigation

Regeneron’s request for multi-district litigation As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a motion seeking to establish a multi-district litigation (“MDL”) encompassing the aflibercept BPCIA cases it has filed in the U.S. District Court for the Northern District of West Virginia and transfer its case against…

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Genentech and Partners Voluntarily Dismiss IPR Appeals Related to Genentech’s ACTEMRA® (Tocilizumab)

Full frame of molecular structure of liquids in motion.

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579.  The appeals concerned IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were…

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PTAB Institutes Celltrion and Biocon IPRs on Regeneron Aflibercept Dosing Patent

Late last month, a Patent Trial and Appeal Board (“PTAB”) panel instituted two petitions that were filed separately by Celltrion and Biocon for inter partes review (“IPR”) of Regeneron’s U.S. Patent 11,253,572 (“the ’572 patent”) and joined the two IPR proceedings with a pending IPR proceeding filed by Samsung Bioepis…

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PTAB Issues Final Written Decisions Finding Claims of Aflibercept-related Patents Invalid

On January 9, 2024, the PTAB issued final written decisions in IPR2022-01225 and IPR2022-01226, filed by Mylan on two Regeneron patents directed to dosing of aflibercept — U.S. Patent Nos. 10,130,681 and 10,888,601.  The PTAB ruled that all challenged claims of the ’681 patent (claims 1, 3-11, 13, 14, 16-24,…

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Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 1. STELARA® (ustekinumab) Four months after Janssen Biotech, Inc. settled to terminate Samsung Bioepis Co., Ltd.’s inter partes review (IPR) challenge of U.S….

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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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PTAB Issues Final Written Decisions Finding Claims of Tocilizumab-related Patents Invalid

On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc.  The ’264 patent claims are directed to…

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