Overview:

On January 15, 2020, China and the United States signed the “Economic and Trade Agreement between the Government of the People’s Republic of China and the Government of the United States of America.” ​ The agreement stipulates the patent system related to medicines, especially the “drafted infringement rules.” 

What are Patent Linkages Measures?

Patent Linkage Measures is a draft policy addressing the relationship between market approval of generic drugs and the patent status of branded equivalents, issued by the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA).

What Products Does it Apply to ?

Chemical drugs, biologics, and traditional Chinese medicines.

What is it’s Purpose?

  • Improves the system for settling patent disputes while also providing generic drugs a market pathway.
  • Promotes the delay approval for a generic until the patent term on the branded equivalent has expired, or until the relevant authority has determined the branded drug’s patent will not be infringed or is invalid.
  • Bolster protections rarely enforced by Chinese authorities in the past.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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