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Biosimilar Maker Leverages IPR to Avoid Patent Dance and Obtain Early Market Entry

Bio Law Blog

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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Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

LexBlog IP

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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Minnesota’s Attempt to Copy California’s Constitutionally Defective Age Appropriate Design Code is an Utter Fail (Guest Blog Post)

Technology & Marketing Law Blog

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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Tuesday Tiddlywinks

The IPKat

Upcoming events Assimilate IP Autumn Courses and Webinars : Protecting Confidential Information, Trade Secrets and Know How : 11 September 2024 Freedom to Operate for Life Sciences and Pharma : 25 & 26 September 2024 Patent and Know How Licensing : 9 & 10 October 2024 IP Essentials – Patent or Trade Secret? Details here.

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Celltrion Stelara (Ustekinumab) Settlement With J&J

LexBlog IP

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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How plausible may be a conference on IP (and regulatory) exclusivity? Sufficiently

The IPKat

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.

IP 76
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Health Data: European Commission Proposes new Rules on Access and Use

LexBlog IP

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.