international regulatory enforcement
What Drug Companies Should Be Thinking About After the U.S. - China Trade Deal
By Melanie Rupert, Mi Zhou & Jake Silvers
On January 15, 2020, the United States and China announced an economic and trade deal (“Phase One Trade Agreement”) that could significantly improve the ability of U.S. and non-U.S. drug companies to protect their intellectual property rights and market their innovative pharmaceutical products in China. As part of the Phase One Trade Agreement, China has committed to providing a “patent linkage” mechanism (which echoes the Hatch Waxman Act) for the early resolution of patent disputes before competitor drugs may be launched. In addition, China has agreed to provide patent term extensions to compensate for “unreasonable delays” in patent grant and regulatory review periods.