LexBlog IP

MARCH 6, 2024

On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval. 10,961,307, which claims methods of treating ulcerative colitis with ustekinumab. Amgen secured a 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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SpicyIP

MARCH 15, 2024

This post does not, in any manner, get into the arena of willingness or unwillingness of defendants to enter into a licensing agreement. Since parties could not arrive at a settlement, ID initiated patent infringement proceedings against the defendants in UK, Germany and India. That is a different matter altogether.

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LexBlog IP

NOVEMBER 5, 2023

Under the IRA, drugs selected for the Program remain “selected drugs” until HHS determines that there is at least one product that is both “approved or licensed” as a generic or biosimilar of the selected drug and “marketed pursuant to such approval or licensure.”

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The IPKat

FEBRUARY 29, 2024

Sony maintains that the worldwide copyright for the recordings is held by Experience Hendrix LLC and Authentic Hendrix LLC, who license the rights to exploit and distribute the recordings to them. It is likely therefore that it will stand to be determined by a High Court judge some time in 2025.

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LexBlog IP

JANUARY 25, 2024

FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications , including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first cell-based gene therapies for the treatment of sickle cell disease. As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023.

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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. No earlier than July 31, 2023 per settlement. No earlier than November 20, 2023 per settlement. . No earlier than June 30, 2023 per settlement.

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