By NextBestFitPatent thickets and evergreening delay generics
Manufacturers file many secondary patents to extend monopolies. Humira had 247 U.S. patent applications, 89% after approval; biosimilars reached Europe in 2018 but the U.S. only in 2023.
Evidence
- Humira: 247 U.S. patent applications, 89% filed after FDA approval.Sources: I-MAK (advocacy group) (2020)
Who's affected
Who is hurt
- People with ongoing or specialist care needs: Extended monopolies keep them paying monopoly prices longer.
- Health insurers, brokers, and their shareholders: Extended monopolies keep them paying monopoly prices longer.
- Taxpayers and public budgets: Extended monopolies keep them paying monopoly prices longer.
Who gains while it lasts
- Drug and device makers: Secondary patents extend brand manufacturers’ monopolies.
Under your mix of paths
Paths that fix or soften it
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Root causes
- Patent office standards
- Cost of challenging many patents
Related costs
Open questions
- Should drug patents exist as they do now, be shortened, be limited to one per product, or be replaced by prizes or public funding?
Solution paths (3)
Open a path for what it fixes, what it creates or worsens, who gains and who loses, precedents, and how it connects to other paths. See all paths as a decision tree.
Limit the number of patents asserted per drug, end exclusivity extensions for minor changes, and ban pay-for-delay deals.
- +Patent thickets and evergreening delay generics
- −Slower access to new drugs and technology
- −Adds paperwork, coordination, or complexity
For publicly funded drugs or extreme prices, license patents to other manufacturers (28 U.S.C. §1498, Bayh-Dole march-in).
- +Patent thickets and evergreening delay generics
- −Slower access to new drugs and technology
- −Faces political, industry, or legal opposition
Keep the current patent systemRejected
Leave patents unchanged and control prices through negotiation instead.
- −Brand-name drug prices far above production cost