By NextBestFitLimit patent thickets and evergreening
Limit the number of patents asserted per drug, end exclusivity extensions for minor changes, and ban pay-for-delay deals.
Limits thickets and pay-for-delay; keeps core patents.
Review ledgerHow this path connects
Concrete changes if chosen
What would actually have to change in law, agencies, payment rules, or systems.
- Limit the number of patents asserted per drug
- End exclusivity extensions for minor changes
- Ban pay-for-delay settlements
Effects
Each effect has its own page: the evidence, the case that it is or isn't a real cost, and whom it affects.
- Patent thickets and evergreening delay generics
Limiting asserted patents, exclusivity extensions for minor changes, and pay-for-delay deals brings generics and biosimilars to market earlier while retaining core patents and their innovation incentive.
- Slower access to new drugs and technology
Limiting patents and exclusivity extensions may reduce rewards for incremental innovations such as new drug forms.
3 paths soften this
Cover new treatments at launch, then reassessSlower access to new drugs and technologyChosenRecycle part of drug savings into researchSlower access to new drugs and technologyChosenRequire timely U.S. launch as a condition of market accessPrice limits can cause shortages, launch delays, or exitsRejected - Adds paperwork, coordination, or complexity
Patent limits and restrictions on exclusivity extensions require new capacity in patent offices and courts.
Who's affected
- People with ongoing or specialist care needs
- Patent thickets and evergreening delay generics: Extended monopolies keep them paying monopoly prices longer.
- Health insurers, brokers, and their shareholders
- Patent thickets and evergreening delay generics: Extended monopolies keep them paying monopoly prices longer.
- Slower access to new drugs and technology: Strict value assessment lowers payment for new products in the short run.
- Taxpayers and public budgets
- Patent thickets and evergreening delay generics: Extended monopolies keep them paying monopoly prices longer.
- Slower access to new drugs and technology: Strict value assessment lowers payment for new products in the short run.
- Drug and device makers
- Patent thickets and evergreening delay generics: Secondary patents extend brand manufacturers’ monopolies.
- Slower access to new drugs and technology: Lower prices reduce research returns for biotech workers and investors.
- People with ongoing or specialist care needs
- Slower access to new drugs and technology: Strict value assessment can delay or refuse new therapies.
Where it has been tried
- Europe: Humira had far fewer patents in Europe; biosimilars entered years earlier.Sources: I-MAK (advocacy group) (2020)