What is the Humira "patent thicket"?
AbbVie filed 250 patents on Humira — about 90% after the drug was approved — with protection claimed until 2037, then used litigation threats to keep US biosimilars out until 2023, four years after European competitors launched.
The core patent on adalimumab expired in the US in 2016, but AbbVie had built a dense web of secondary patents on manufacturing, formulations and uses. The House report found AbbVie filed 250 patents on Humira, about 90% of them after the drug was approved, with protection claimed until 2037. Internal documents showed that by 2014 executives had expected three to five biosimilar competitors by 2017.
Instead, AbbVie used the threat of litigation on dozens of patents to negotiate settlements. In one case it listed 61 patents in pre-litigation exchanges against Amgen's biosimilar. Members of both parties at the 2021 hearing challenged CEO Richard Gonzalez on the patents, suggesting potential bipartisan agreement on reform. AbbVie argued the patents covered genuine improvements.