News from Abroad: Drug Patent Linkage System in New Chinese Patent Law

By Miao Li* — The 4th amendment to the Chinese Patent Law (“New CN Patent Law”) will take effect on June 1, 2021. This amendment represents a significant milestone in the evolution of the patent regulatory framework in China, given the unprecedented level of protection to which patent owners will become entitled. A particularly notable change is the introduction of a drug patent linkage system in China, modeled on the U.S. Hatch Waxman Act. The drug patent linkage system includes several key components, namely: term extension eligibility for drug patents, a patent registration platform for approved drugs, and an early…