Blockbuster Biologics Review

Blockbuster Biologics Review, produced by our intellectual property lawyers, covers developments in inter partes review (IPR) and patent litigation challenges to blockbuster biologic drugs.

These quarterly reports provide updates on the following topics:

• The current status of IPR challenges to blockbuster biologics
• The institution and invalidation rates for IPRs challenging blockbuster biologics
• The current status of patent litigations implicating blockbuster biologics

We will continue to monitor developments and provide updates regularly.

Read the current issue >>

Past Issues

2025

Issue 29 (December 2025) >>

Issue 28 (August 2025) >>

Issue 27 (May 2025) >>

Issue 26 (February 2025) >>

2024

Issue 25 (November 2024) >>

Issue 24 (August 2024) >>

Issue 23 (May 2024) >>

Issue 22 (February 2024) >>

2023

Issue 21 (November 2023) >>

Issue 20 (August 2023) >>

Issue 19 (March 2023) >>

2022

Issue 18 (December 2022) >>

Issue 17 (October 2022) >>

Issue 16 (July 2022) >>

Issue 15 (April 2022) >>

2021

Issue 14 (December 2021) >>

Issue 13 (August 2021) >>

Issue 12 (April 2021) >>

Issue 11 (February 2021) >>

For access to an issue prior to 2021, please contact IPPGBusinessDevelopmentLocal@morganlewis.com.

Additional Resources

News

• FDORA Effect? For Accelerated Approval Class of 2023, Most Confirmatory Trials at Least Underway, Pink Sheet – January 29, 2024

Thought Leadership

• Advertising and Promotion Considerations for Biologics, Biosimilars, and Interchangeable – April 30, 2024
• 2023 Drugs and Biologics Year in Review: Will FDA’s 2023 Evolution Usher in Swift Resolution For 2024? – January 2024
• Real-World Evidence: Non-Interventional Studies in Support of Substantial Evidence of Effectiveness – March 25, 2024
• Pharma’s Almanac: Forecast at the Turn of the Year – January 19, 2024