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China Commits To Patent Linkage And Extensions

Data Protection Also Included In Deal

 
• By Aidan Fry

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.   

Trade Deal
Patent linkage and patent extensions are enshrined in a new US-China trade deal • Source: Shutterstock

Commitments to implement a patent-linkage system notifying originators of generic filings as well as patent-term extensions to compensate for regulatory and patent review periods are key measures in a section on pharmaceutical intellectual-property protection included in ‘Phase One’ of a trade agreement signed between China and the US on 15 January. Pharmaceutical data protection is also included in the deal.

Patent-linkage and data exclusivity provisions had been both absent from an amended Drug Administration Law passed by China’s National People’s Congress at the end of August last year. 

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