Blockbuster Biologics Review | Issue 11
February 2021Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges (IPRs and PGRs) and patent litigations implicating blockbuster biologics in 4Q 2020. We will continue to monitor developments in these post-grant challenges and litigations and provide you with regular updates.
Inter Partes Reviews (IPRs) and Litigations
In this section, we break down IPRs and BPCIA litigations filed in the biologics space, including the types of claims being challenged, the number filed each year, and their outcome. Notably, the current institution rate for IPR challenges to patents that claim biologics, excluding IPRs that have settled or otherwise been terminated, stands at 38%.
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FDA: Biosimilar Approvals
This section tracks all US biosimilar approvals. This past quarter witnessed the approval of one biosimilar – Riabni, a rituximab biosimilar marketed by Amgen.
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Legislative Updates
In this section, we highlight the legislative updates in the United States touching on biosimilars, including the Consolidated Appropriations Act that was signed into law on December 27, 2020.
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Supporting Documents
This section provides a product-by-product breakdown of biologics-related patents that have been subject to an IPR, including the challenged claims.
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