案例库 · 法务与合规 · 法务决策 · 1984
这条还没译成中文，下面是英文原文。
Hatch-Waxman traded patent length for a fast generic pathway.
The 1984 law let generics piggyback on a brand's approval and challenge patents, while extending the brand's patent life, kick-starting generic competition.
U.S. Food and Drug Administration · branded and generic pharmaceutical firms
那一手
Generic drugs cost less, but the rules made them nearly impossible to launch because a copy had to repeat years of clinical testing.
The 1984 Drug Price Competition and Patent Term Restoration Act let a generic file an abbreviated application showing only that it is bioequivalent, gave the first firm to challenge a brand patent 180 days of exclusivity, and added patent term back to brands for time lost in review.
The trade created a booming generic industry and a structured contest over patents, turning litigious brand-generic disputes into a regulated market.
为什么管用
- An ANDA that relies on brand data removes a huge barrier to entry
- Paragraph IV lets a generic fight a patent instead of waiting for it to expire
- 180-day exclusivity rewards the first firm that takes the risk to challenge
- Patent-term restoration keeps the brand innovating despite the challenge
可以搬走什么
When one rule blocks competition and another blocks innovation, trade them — shorten the copycat path and lengthen the pioneer's patent, so both sides gain.
后来呢
Hatch-Waxman turned generics into a large, predictable share of US prescriptions and made the Paragraph IV battle and 180-day exclusivity a repeated feature of drug markets, though it is also blamed for evergreening tactics and lengthy patent litigation.
资料来源
- The Hatch-Waxman Playbook: Paragraph IV Certifications, 180-Day Exclusivity, and the Generic Drug Race
- Patent Certifications and Suitability Petitions
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