In China it is difficult to rely on supplemental data provided after the filing of a patent application. It is also difficult to defend a granted patent where the data show that a pharmaceutical invention is plausible, or also to prove superiority and thus inventive step over prior art. Such late filing was hitherto not allowed according to the guidelines of the Chinese Patent Office.

 

However, as contained in a recently signed agreement, the “ECONOMIC AND TRADE AGREEMENT BETWEEN THE UNITED STATES OF AMERICA AND THE PEOPLE’S REPUBLIC OF CHINA”, under Section C: Pharmaceutical-Related Intellectual Property:

 

Article 1.10: Consideration of Supplemental Data

1. China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step, during patent examination proceedings, patent review proceedings, and judicial proceedings.
2. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.

 

Click here for the Full Agreement 

 

Thus, much will depend on how the US’s treatment of this clause will be seen in China. In the future will it be possible to rely on data provided e.g. by Declarations or scientific publications made available after the filing of a patent application, and to what extent?

 

It will be interesting to observe how this arrangement will be handled in practice by both sides.

 

 

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