LexBlog IP

AUGUST 16, 2023

On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed by J&J. Economic terms of the settlement were not disclosed in the press release.

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LexBlog IP

AUGUST 30, 2023

market on March 7, 2025, if approved by FDA. J&J also recently filed a confidential settlement and license agreement to terminate a Samsung Bioepis challenge to all claims of U.S.

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Bio Law Blog

JUNE 21, 2020

settled three Inter Partes Review (IPR) proceedings concerning patents covering Alexion’s blockbuster humanized monoclonal antibody drug Soliris®, with Amgen obtaining a royalty-free license for marketing a biosimilar prior to expiration of the patents at issue. and Alexion Pharmaceuticals Inc. an eculizumab product.

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LexBlog IP

FEBRUARY 1, 2024

In October 2023, Accord settled with Janssen Biotech under confidential terms that would allow Accord to launch its proposed ustekinumab biosimilar no later than May 15, 2025, pending FDA approval. Accord, a global subsidiary of Intas Pharmaceuticals, will be responsible for U.S. commercialization.

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The IPKat

NOVEMBER 14, 2022

The latter, contrary to what it might appear from its date of adoption (2014), is a regulation that is certainly topical, having started to take effect as of 31 July 2022, with a transitional period that will last until 31 January 2025, but which will see a first and fundamental provision entering into force on 31 January 2023.

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Technology & Marketing Law Blog

APRIL 28, 2023

If passed, the bill goes into effect July 1, 2024 with the first round of DPIAs due July 1, 2025. In an attempt to address this concern, Minnesota offers some protection by maintaining the confidentiality of information subject to attorney-client privilege. The bill is currently pending approval by both chambers.

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LexBlog IP

JANUARY 16, 2023

The European Commission expressed its hope that the provisions of the regulation will enter into force across all EU member states in 2025. These include, among others, the use to take decisions that may be detrimental to a natural person or the use for advertising or marketing.

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