By NextBestFitUse government march-in and compulsory licensing
For publicly funded drugs or extreme prices, license patents to other manufacturers (28 U.S.C. §1498, Bayh-Dole march-in).
Draft decision:RejectedConfidence: low · not yet reviewed
Weakens patent certainty; negotiation covers most cases.
To review: Could be kept as a backstop.
Review ledgerHow this path connects
This path
Use government march-in and compulsory licensing
Concrete changes if chosen
What would actually have to change in law, agencies, payment rules, or systems.
- Define march-in triggers for price and access
- Use 28 U.S.C. 1498 for government-use licenses
- Set royalty formulas
Effects
Each effect has its own page: the evidence, the case that it is or isn't a real cost, and whom it affects.
What it fixes
- Patent thickets and evergreening delay generics
Licensing patents to other manufacturers targets extreme drug prices and publicly funded drugs. The possibility of licensing provides a strong bargaining threat even when rarely used.
What it creates or worsens
- Slower access to new drugs and technology
Licensing patents to other manufacturers weakens patent certainty for investors.
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 - Faces political, industry, or legal opposition
Government licensing of drug patents can lead to trade disputes with partners.
Who's affected
Who gains
- 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.
Who loses
- 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.
Other ways to soften the losses
- Pay reasonable royalties
Where it has been tried
- Thailand, Brazil: Compulsory licenses for HIV drugs.
- Thailand: A compulsory license granted in 2006 enabled Thailand to import 66,000 bottles of generic efavirenz at half the price offered by Merck.