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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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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.

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