Researches On Pharmaceutical Invention Patents Of Experimental Use Exception System

Pharmaceutical invention patents of experimental use exception as a new defense to patent infringement, it means that before the pharmaceutical invention patent's protection period is expired, the third part for the purpose of providing those important information which are needed in administrative examination and approval have the immunity rights to make, use and import patent pharmaceuticals or medical apparatus,or specifically for the purpose of doing that. The specific contents of this system include the application'scope of pharmaceutical invention patents of experimental use exception, patent term of compensation and patent linkage system. It is in the protection of the interests of original pharmaceutical patent holders, allowing the generic drugs's pre-clinical studies before the patent's protection period is expired, which directly makes up the shortage of medicines on the markets when the patent holders's protection period is expired, and increases public availabilities of the drugs. In a word, it achieves balances of interests between patent pharmaceuticals manufacturers, generic pharmaceuticals manufacturers and the general public.In 1984,the case of Roche v. Bolar in the United States pressed the birth of "Bolar exception", so the United States was the founding member of this system. After 20 years of developments, the legislative contents of this system in the United States, Germany, Japan, Taiwan of China and so on are very comprehensive, judicial experiences are very mature. In comparison, our country until December 27,2008 in the patent law of the third amendment increased pharmaceutical invention patents of experimental use exception as a new exemption to patent infringement. Currently, the scope of this system is still unclear, the relevant provisions of the patent term of compensation is still deficiency and the patent linkage is not smooth. Therefore, baseing on China's national conditions, encouraging competition in the pharmaceutical industry and meeting public health needs, referring to foreign and relevant areas of legislation and judicial practice, we should:clarify experimental use exception's application to the subject, the subjective purpose and the external performance action; increase provisions on patent term of compensation, and regulate specificly its application's object, calculation methods and the right to limit in this period; set transparent information system, scientifiOOc relief procedures, and increase the provision which provides necessary market incentives to first generic to improve our patent linkage procedure.