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[摘要]：Background: RNAi is an emerging and powerful technology with tremendous potential to treat a diverse number of diseases. There is little doubt about the potential commercial value of this technology; however, to fully exploit this potential, a carefully planned and executed patent strategy must be employed. Objective: Our objectives were to i) explore the requirements for patentability in the United States and apply these requirements to RNAi technology; ii) examine key differences between US and international patent systems that may be relevant to patenting RNAi technology in international venues; and iii) identify the areas of patent coverage that a company will need to acquire if it is to be successful in the RNAi field. Method: In view of the relatively recent emergence of the RNAi field, our analysis relied heavily on lessons learned from more mature technologies, such as monoclonal antibodies, gene therapy, and antisense technology, in order to identify the strengths and weaknesses of an RNAi patent estate. Results/conclusion: A successful RNAi patent position will require access to patents in the following three areas: i) general patents covering relatively broad aspects of RNAi action; ii) patents for platform technologies for exploiting RNAi; and iii) focused patents directed to specific diseases, RNAs and gene targets. While a patent position in one or even two of these areas might put a company into a blocking position, the key to commercial success will be possession of or access to patents in all three areas, as well as a proprietary position in at least one. |
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