Blockbuster Biologics Review | Issue 19
March 2023Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to biosimilars in Q1 2023. We will continue to monitor developments in these post-grant challenges and litigations and provide you with regular updates.
Post-Grant Challenges and Litigations
In this section, we break down post-grant challenges and Biologics Price Competition and Innovation Act (BPCIA) litigations, including the types of claims being challenged, the number filed each year, and their outcome. Notably, the current institution rate for inter partes review (IPR) challenges to patents that claim biologics—excluding IPRs that have settled or otherwise been terminated—stands at 37%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 40, with no biosimilars approved in Q1 2023.
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Legislative and Regulatory Updates
In this section, we highlight the Preserve Access to Affordable Generics and Biosimilars Act, the Stop STALLING Act, and the Affordable Prescriptions for Patients Act of 2023, as well as Senator Elizabeth Warren’s push for the US Patent and Trademark Office to scrutinize Merck’s Keytruda patents.
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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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