Blockbuster Biologics Review | Issue 14
December 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 3Q 2021. 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. The number of approved US biosimilars is 31, with two new approvals in Q3 2021.
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Legislative Updates
In this section, we highlight the legislative updates in the United States touching on biosimilars, including a bill by the Senate which would prohibit biological product manufacturers from compensating biosimilar companies in exchange for the biosimilar company delaying entry into the market.
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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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