On May 27, 2021, Chris Loh was quoted in Bloomberg Law on changes to changes to Chinese patent law designed to ramp up legal protections for drug manufacturers and build on the country’s efforts to bolster its intellectual property system.
According to the article, China will establish a patent linkage system resembling the framework established by the Hatch-Waxman Act of 1984, which created the modern U.S. regulatory framework. The Hatch-Waxman Act helped make low-cost generics more available in the U.S., while also rewarding innovator companies with stronger protections. The Chinese law is designed to strike a similar balance, while providing more clarity for litigation.
There are still some significant differences between the U.S. and Chinese systems. Unlike the Hatch-Waxman framework, which includes only small-molecule drugs, China’s system includes biologic medicines. Another difference is that in the U.S. there is an automatic 30-month stay on regulatory approval once a lawsuit is filed. China has proposed a stay of nine months.
Some attorneys doubt that Chinese courts can resolve infringement or validity issues that fast. That is one of the lingering questions about how effective the system will be. “If they aren’t able to issue decisions on those issues at the nine-month mark, then this change to Chinese patent law might not necessarily be the panacea that innovator companies are looking for,” Loh said.
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