A Follow-on Innovation Perspective in the Biopharmaceutical Industry
Chapter 3: The Patent System and Some Potential Safety Nets
3.1 Introduction to the patent safety nets Recent developments in biopharmaceutical R&D have raised concerns regarding the basic assumption of most patent systems that society benefits more from innovation than it is harmed by the grant of a legal monopoly. This chapter examines the safeguards in the system to ensure that follow-on innovation is not unduly impeded in the case of research tools. Before examining the means available within the patent system to ensure access to such research tools, it should be clarified that the analysis is limited to the patented tools used to develop biopharmaceutical products that do not physically incorporate the tool. In addition, the analysis is limited to the situations in which access to the patented tool is problematic. As it was shown, access has not proven to be problematic in most cases. None the less, access to research tools remains problematic in some cases. This may be due to the hesitation on the part of researchers to disclose the nature of their research in the course of obtaining a licence, to a refusal on the part of the tool holder to license it, or to placement of significant limitations on the licences, or to demanding a price amounting to an effective refusal to license. The analysis will centre largely on the mechanisms available in patent law to deal with a refusal to license. The mechanisms examined only involve potential remedies once a patent has been granted. Therefore, for example, considerations leading up to the grant...
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