Countries after countries are adopting a controversial regulatory system of linking the market approval for pharmaceuticals to the status of potentially blocking patents as part of their bilateral and multilateral trade agreement package with the United States. Surprisingly, China took up pharmaceutical patent linkage in the absence of any treaty obligations and became the first country to adopt this regulatory regime outside of North America, despite the presence of a flourishing generics pharmaceutical industry and its developing country status. In fact, the Chinese regulation promised more intellectual property ("IP") protection than what even the United States FDA is capable of deliver under the Hatch-Waxman Act. This quest for more IP protection may have destabilized the food and drug administrative system and led to reduced IP protection in actuality. Although China can benefit from some form of patent linkage given the current state of its technological development, it must revise the current rules towards greater administrative feasibility—a poignant lesson that is applicable to other developing countries in the process of adopting pharmaceutical patent linkage.
Benjamin P. Liu, Fighting Poison with Poison? The Chinese Experience with Pharmaceutical Patent Linkage, 11 J. Marshall Rev. Intell. Prop. L. 623 (2012)