LexBlog IP

AUGUST 16, 2023

In February 2023, Formycon announced its entry into a global license agreement with Fresenius Kabi to commercialize FYB202 in key global markets after successful regulatory approvals. According to the press release, Formycon plans to submit a biologics license application later in 2023 to seek regulatory approval for FBY202.

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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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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.

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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

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. If approved, the EHDS proposal would introduce a new regime for the compulsory licensing of health data to third parties.

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The IPKat

NOVEMBER 14, 2022

a wise cat that care about environment kindly provided in CC0 Public Domain license by Pixhere.com) Having to make a selection among the many topics covered, this GuestKat finds it interesting to note that during the conference the EPO case G2/21 on 'plausibility', was repeatedly discussed from different angles.

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Fish & Richardson Trademark & Copyright Thoughts

FEBRUARY 4, 2021

For the first time since FDA licensed the first biosimilar, Sandoz’s Zarxio ® (filgrastim-sndz), in 2015, the United States saw a decrease in annual biosimilar approvals in 2020. Legislation Relating to Biologics and Biosimilars. BPCIA Litigation. Antitrust Litigation. Post-Grant Challenges at the PTAB. Conclusion.

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