本人博客(http://pharmip.fyfz.cn)中的一篇日志.
http://pharmip.fyfz.cn/blog/pharmip/
专利法修订稿第七十四条增加了bolar例外类似条款，即“（五）专为获得和提供药品或者医疗器械的行政审批所需要的信息而制造、使用、进口专利药品或者专利医疗器械的，以及为其制造、进口并向其销售专利药品或者专利医疗器械的。”
在国外，bolar例外是指为获得和提供药品或者医疗器械的行政审批所需信息而实施专利的行为不视为侵犯专利权，其中的专利既包括产品专利，也包括方法专利，且并未局限为“专利药品”和“专利医疗器械”。如美国35 USC 271(e)(1)中使用的是“patented invention”,并没有限制为药品或医疗器械的专利。
修订稿中对可免责的专利进行了限制，并不完全符合bolar例外的设立初衷。
附几个国家专利法中的bolar例外条款：
Argentina: Law No. 24.766, Article 8
Article 8 -- In the case of a product or process protected by patent, any third party may use the invention prior to its patent expiration for experimental purposes and to obtain the information required for the approval of a product or process by the competent authority so that it may be marketed following the patent expiration.
Canada Patents Act, Article 55.2(2)
It is not an infringement of a patent for any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1) to make, construct or use the invention, during the applicable period provided for by the regulations, for the manufacture and storage of articles intended for sale after the date on which the term of the patent expires.
United States 35 USC 271(e)(1)
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products. |
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