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The Role of Intellectual Property Rights in Biotechnology Innovation

Edited by David Castle

Intellectual property rights (IPRs), particularly patents, occupy a prominent position in innovation systems, but to what extent they support or hinder innovation is widely disputed. Through the lens of biotechnology, this book delves deeply into the main issues at the crossroads of innovation and IPRs to evaluate claims of the positive and negative impacts of IPRs on innovation.
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Chapter 18: Watch What You Export: The History of Medical Exceptions from Patentability

Tina Piper


Tina Piper INTRODUCTION The analysis and implementation of intellectual property rights (IPRs) are often based on the assumption that IPRs will work similarly in different countries. For example, stated generally, patent protection which incentivizes innovation in the United States will spur innovation in the developing world. The export and implementation of IPRs may further rely on the notion that they are critical to the regulation of a particular industry or technology. Without the particular provision, useless or overbroad patents or no patents at all would be granted, unnecessarily blocking innovation and its commercialization. Both propositions rely on a common foundation. They presume that it is understood how and why particular IPRs function in the domestic regime. In fact, this may not often be the case. The patent law of the dominant law exporters (United States, United Kingdom, Europe) developed in response to local economic, political and social conditions. In addition, often limited work has been undertaken to understand the effect of particular provisions of the patent law under different political, social and economic conditions. This chapter presents a brief case-study of IPRs related to medical methods. Medical methods are an important exception to the general patentability of biotechnology subject matter. Medical methods are excluded from patentability by the patent laws of over 80 countries. Their exclusion is a common, almost automatic, feature in the harmonized, globalized intellectual property patent law world.1 While the medical exception purports to protect valuable, life-saving work from commercial interference through an exclusion from patentability, it...

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