[Autom. eng. transl.] The work deals with the subject of the subjective scope of one of the exceptions to the exclusive right conferred by the invention patent: the so-called Bolar clause, which allows companies that intend to market a generic drug upon the expiry of the relative patent to start, before that expiry, the activities necessary for obtaining the authorization for the marketing of the generic drug, including the production of active ingredients and / or samples necessary for the preparation of the dossier to be presented to the competent authorities in the sector. In its first part, the work sets out the terms of the problem in the light of the Italian and European regulatory framework, posing the following interpretative question: the Bolar clause operates only if the discriminated activities are conducted directly by the company that will request the AIC or the exception can it also be invoked by anyone who, at the request of that company, carries out all or part of the activities in question? The possible interpretations are illustrated in the central part, on the basis of decisions made on this point in Poland and Germany. The issue is finally addressed in the light of the Italian provisions, in particular of art. 68 paragraph 1 letter. b) of the Industrial Property Code, which precisely provides for the Bolar clause. The Author argues that literal, systematic and teleological arguments support the thesis of the extension of this provision to third parties which the generic drug manufacturer uses for the implementation, in whole or in part, of the discriminated activities; and concludes with a series of general reflections on the limitations to industrial property rights that support this interpretation.
|Translated title of the contribution||[Autom. eng. transl.] Why you can Bolar also with third parties. Reflections on the subjective scope of art. 68.1 b) CPI|
|Number of pages||16|
|Journal||RIVISTA DI DIRITTO INDUSTRIALE|
|Publication status||Published - 2016|
- Bolar clause
- Eccezioni e limitazioni