Edited by Stefan Luginbuehl and Peter Ganea
Exceptions and limitations in patent law, combined with exclusions on patentable subject matter, both provide policy makers with the means to balance the incentive of the patent monopoly with the interests of the public and the desire to promote the dissemination of technology. The increasing harmonization of patent law internationally around patentable subject matter and the need to include new forms of technology means that in many countries, outright exclusions to patentability are becoming increasingly narrow. Exceptions and limitations to infringement, provided that they fall within the broad prescriptions of TRIPS, remain as a flexible policy tool for countries to maintain this balance. As noted in Chapter 1, in the third amendment to its Patent Law, China has clearly set its priorities in favour of dissemination of technology in crafting its catalogue of exceptions, most explicitly in relation to patented drugs. While China’s stated ambition is to become a global innovation leader, the codification of a so-called ‘naked Bolar’ exemption for regulatory approval and the introduction of international exhaustion, demonstrates that it still prioritizes its needs in terms of a developing country. Those who followed the many rounds of drafting of the third amendment of the Patent Law will know that the exceptions in the current law are in fact very much watered down from earlier versions which intended to create some very significant limitations to patentees’ rights. The current law then should be seen in the context of having already scaled back.
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