AbbVie and Pfizer Settle Adalimumab Biosimilar Patent Disputes

Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab.  According to the press releases, AbbVie has granted Pfizer a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States and other countries.  All litigation pending between the parties will be dismissed.  Pfizer’s U.S. license will begin on November 20, 2023 and will not be accelerated by the entry of companies who have already taken a license, and in the EU, Pfizer can launch upon approval from the European Medicines Agency.  According to AbbVie, “Pfizer will pay royalties to AbbVie for licensing its Humira® patents and acknowledges the validity of the licensed patents.”

This is the seventh patent license agreement into which AbbVie has entered to authorize a biosimilar of Humira® in the United States.  As we previously reported, AbbVie previously authorized the following U.S. license dates:

  1. Amgen: January 31, 2023
  2. Samsung Bioepis: June 30, 2023
  3. Mylan: July 31, 2023
  4. Fresenius Kabi: September 30, 2023
  5. Sandoz: September 30, 2023
  6. Momenta: November 20, 2023
  7. Pfizer: November 20, 2023