Definition of the Scope of Application of China's medicine Patent Term Extension System

中国药品专利期限补偿制度适用客体范围的界定

The legislative purpose of Patent Term Extension is to stimulate the development of innovative drugs in China to increase the diversity of domestic medicines. However, the scope of the applicable object of the system is not clear, and the applicable medicine type in China is only for human medicines; the invention patent of “pharmacological active substance” is not clear; the definition of “new medicines” conflicts between the Implementation Regulations of the Pharmaceutical Administration Law of the People's Republic of China and Guidelines for Patent Examination. As a traditional agricultural country, China's social demand for pesticides, veterinary drugs and medical devices is increasing, and the innovation requirements for agriculture and veterinary drugs are constantly upgraded. This field also needs to stimulate innovation, which can learn from the experience of countries outside the region and bring it into the scope of applicable object of PTE. Secondly, the applicable patent type and “new medicines” of the system should be clearly stipulated in the legislation, so as to provide a basis for the efficient operation of the subsequent judicial practice.

药品专利期限补偿制度的立法宗旨是为了激励国内的创新药的发展，以增加国内药品的多样性。但是该制度的适用客体范围界定不够清晰，在中国适用药品类型仅限为人用药品；适用的专利类型中对于其中“药物活性物质”的发明专利却不够明确，晶型专利是否适用并无明确规定；在《药品管理法实施条例》与《专利审查指南》之间关于“新药”的定义相互冲突。中国作为传统的农业大国，当前社会农药、兽药以及医疗器械的需求量不断增加，对农、兽药等领域的创新度要求不断升级，该领域同样需要刺激创新，可以借鉴域外国家经验，将其纳入PTE 的适用客体范围。其次，应当在立法中明文规定该制度的适用专利类型和“新药”，对后续司法实践的高效运行提供基础。