Report
Blockbuster Biologics Review
2018–2024
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
2023
2022
2021
2020
2019
2018
Additional Resources
News
- Toothful or Toothless? Biden's Biosimilar Bills Under the Microscope, The Center for Biosimilars – April 27, 2021
- The BPCIA and Declaratory Judgment: The Real Dance Partners?, Biosimilar Development – February 17, 2021
- Fed. Circ. Instructive on Transitional Phrases in Patent Claims, Law360 – February 18, 2020
- Patent Opportunities in FDA Bispecific Antibody Guidance, Law360 – August 13, 2019
- Pharmaceutical Litigation, IP Litigator – November/December 2019
Thought Leadership
- Taking Advantage of the New Purple Book Patent Requirements for Biologics – April 26, 2021
- FDA COVID-19 Guidance Roundup For Drug and Biologics – June 29, 2020
- USPTO Announces Further COVID-19 Relief for Large and Small Entities – June 4, 2020
- Federal Circuit: Inherency in an Obviousness Analysis – January 15, 2020
- Federal Circuit: Open Transitional Phrases and Markush Groups in Pharmaceutical Claims – January 13, 2020
- Federal Circuit: Finding the Safe Harbor in Drug Development’s Choppy Waters – December 24, 2019
- Federal Circuit: ‘Consisting Essentially of’ Risks Indefiniteness and No Intent From ANDA Label’s Permissive Use – October 14, 2019
- Lawmakers Propose Changes to Framework of Sections 101 on Patent Eligibility and 112(f) on Functional Claiming – May 20, 2019
- Cleveland Clinic Foundation v. True Health Diagnostics, LLC – April 3, 2019
- What’s in a Name? FDA Proposes Updates To Its Biosimilar Naming Policy – March 18, 2019
- FDA Sings the Orange Book Blues to Announce a Potential New Patent Listing Approach, As Prescribed Blog Post – March 8, 2019