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Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

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As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

Goodwin

Year in Review: Top Legal Developments of 2023

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​​​​​​​As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more

Goodwin

Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

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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....more

Venable LLP

Stelara® Biosimilar Updates: IPR Petition Challenging U.S. Patent No. 10,961,307 Filed and SB17 Settlement and Launch Date...

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On November 22, 2023, Biocon Biologics Inc. (“Biocon”) submitted a Petition for Inter Partes Review of claims 1-34 of U.S. Patent No. 10,961,307 (“the ’307 patent”), assigned to Janssen Biotech, Inc. (“Janssen”), requesting...more

Knobbe Martens

Federal Circuit Vacates PTAB’s Decisions in Axonics, Inc. v. Medtronic, Inc.

Knobbe Martens on

Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues. After California-based Axonics Inc. (“Axonics”) entered the sacral neuromodulation market...more

Rothwell, Figg, Ernst & Manbeck, P.C.

COVID-19 Vaccine Leader Moderna “Not Aware of Any Significant Intellectual Property Impediments” in Development of its Vaccine...

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Moderna, one of the global leaders in developing a safe and effective vaccine to combat COVID-19, appears poised to get through clinical trials with a vaccine that is based on mRNA technology. As was recently announced,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It?

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Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine, made the following statement regarding enforcement of its patents: We feel a special obligation under the current...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Silicon Valley Challenges the PTAB’s NHK-Fintiv Rule: Can IPRs Be Denied Based on Non-Statutory Factors?

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Last week, four major technology companies – Apple, Cisco, Google, and Intel – brought suit against the United States Patent and Trademark Office (“USPTO”), challenging its authority to reject petitions for inter...more

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