Edited by Nari Lee, Niklas Bruun and Mingde Li
Chapter 9: The glocalization of patent linkage in China
AbstractPatent linkage is a system of administrative intellectual property (IP) protection that links the marketing approval of generic drugs to the status of patents covering the underlying technology. It was invented in the United States within an updated pharmaceutical regulatory regime that attempts to balance the competing demands of R & D cost, business motives and medical welfare under the Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act. This chapter examines how China has dealt with patent linkage. Contrary to conventional wisdom, China in fact adopted an ambitious set of patent linkage regulations as early as 2002 and became the first country outside North America to do so. As written, the Chinese patent linkage regulation conformed to the standard of patent linkage that US trade negotiators were then promoting in Chile and Australia. In fact the Chinese regulation offers even more protection to the patentee than US domestic patent linkage under the Hatch-Waxman Act. However the laws failed because its administrative apparatus was not up to the task of implementing the maximalist protection. What happened in China ostensibly supports the view of a system theorist like Teubner, however, there is no denying that the transplantation of patent law to China is itself ‘successful’ by some measure – it now processes more patents than any country in the world. The contrast between the maturation of an imported patent system and the failure of regulatory patent linkage presents a theoretical solution of when a transplanted legal regime is viable.
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