Scholarlink

<p>In matters concerning limitations on patent rights and the interpretation and application of Art. 68(1)(b) Code of Industrial Property pursuant to Legislative Decree No. 30 of 10 February 2005, resulting from the transposition in Italy of Directive 2001/83/EC (Art. 10.6), subsequently amended by Directive 2004/27/EC, the rationale of the “Bolar exemption”, according to which the testing of a patented medicinal product is permitted, for the purposes of obtaining an MA which is intended to operate after the expiry of a third party’s patent, is to facilitate the timely market entry of generic medicinal products. The aim is to avoid prolonging, in effect, the duration of the patent rights by allowing generics manufacturers to commence any preparatory administrative and experimental activities to obtain an MA, even while the reference patent is in force, by introducing limits on the right of exclusivity. The Bolar exemption may be regarded as also applying to the activities of third-party producers of the API of the patented medicinal product, not for their own registration purposes but for those of third-party generics producers who do not have the facilities to produce the ingredient on their own account but wish to enter the market once the exclusive patent rights expire. However, in order to state that the purposes of the Bolar exemption encompass the production of the API <i>ab origine</i> and <i>ex ante</i>, that broad interpretation of the exemption assumes, in addition to a prior request by the generics producer, that the registration purpose is made know at the brokerage stage as a limitation on use, as an indicator of the commitment to use the API in accordance with the Bolar purposes.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

“Spiriva”

  • 期刊论文

  • 发表日期：

    2025年5月13日

查看全文

摘要

In matters concerning limitations on patent rights and the interpretation and application of Art. 68(1)(b) Code of Industrial Property pursuant to Legislative Decree No. 30 of 10 February 2005, resulting from the transposition in Italy of Directive 2001/83/EC (Art. 10.6), subsequently amended by Directive 2004/27/EC, the rationale of the “Bolar exemption”, according to which the testing of a patented medicinal product is permitted, for the purposes of obtaining an MA which is intended to operate after the expiry of a third party’s patent, is to facilitate the timely market entry of generic medicinal products. The aim is to avoid prolonging, in effect, the duration of the patent rights by allowing generics manufacturers to commence any preparatory administrative and experimental activities to obtain an MA, even while the reference patent is in force, by introducing limits on the right of exclusivity. The Bolar exemption may be regarded as also applying to the activities of third-party producers of the API of the patented medicinal product, not for their own registration purposes but for those of third-party generics producers who do not have the facilities to produce the ingredient on their own account but wish to enter the market once the exclusive patent rights expire. However, in order to state that the purposes of the Bolar exemption encompass the production of the API ab origine and ex ante, that broad interpretation of the exemption assumes, in addition to a prior request by the generics producer, that the registration purpose is made know at the brokerage stage as a limitation on use, as an indicator of the commitment to use the API in accordance with the Bolar purposes.