The new Chinese Patent Law is confirmed to take effect on June
1, 2021. While there are 20 plus changes on different aspects of
the patent system, the pharmaceutical patent linkage system is
particularly conspicuous, as this is a completely new system which
has never been implemented before.
Historically, the linkage system was originated from the
Hatch-Waxman act of the U.S, and its objective is an early
resolution of pharmaceutical patent disputes and attempts to
achieve a balance between the interests of innovative pharma
companies and generic pharma companies.
For the moment, the detailed measures of how to implement the
linkage system in China are still under discussion and seeking for
public opinions. Nonetheless, the general guideline has already
been jointly published by the NMPA and the CNIPA on September 11,
2020, and the final version will probably be quite similar to
that.
