Generic 'Rewards' Added To, 'Evergreening' Requirements Dropped From North American Trade Deal
USMCA is looking more and more like a win for generic firms, who hope it will be template for future trade agreements.
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The first phase of a major trade agreement just signed by the US and China obliges the latter to implement a system linking pharma patent enforcement to marketing authorization procedures as well as to offer patent-term extensions.
Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.
Trade Pact War: Generic Stakeholders Push For Changes To US-Mexico-Canada Deal, Seek FDA Intervention
AAM wants Orange Book-like registry of patents and exclusivities, Bolar and "best mode" provisions; consulting group urges FDA to step in and ensure the trade pact does not benefit originators over generic/biosimilar makers.