Report
Blockbuster Biologics Review
2018–2025
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.
Past Issues
2024
2023
2022
2021
2020
Issue 10 (September 2020) >>
For access to an issue prior to September 2020, 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
- FDA-USPTO Collaboration: Stakeholders Want More Clarity on Orange Book Patent Listings, Pink Sheet – October 23, 2023
- A Greater Power: US FDA May Become More Insistent on Timing of Accelerated Approval Confirmatory Trials, Pink Sheet – January 25, 2023
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
- FDA Rounds Out 2023 with Advanced Manufacturing Technologies Designation Program Guidance – December 20, 2023
- FDA Guidance Confirms That Multiple Roads Lead to Substantial Evidence of Effectiveness – November 14, 2023
- Regulatory Spotlight for Biotech: On the Horizon for CBER – September 26, 2023