Italian Intellectual Property Code: Tougher Times For Generics

The Italian Intellectual Property Code was recently amended and the changes include the addition of a new provision introducing limitations on the right of generics companies to file early Marketing Authorisation (MA) applications.

Relevant provision is Article 68 (1-bis) of the newly amended Italian IP Code, which was introduced by Legislative Decree no. 131 of 13 August 2010, effective since 2 September, and reads as follows:

"Companies intending to manufacture pharmaceutical products outside patent protection may commence the regulatory procedure concerning the product containing the active ingredient one year before expiry of the supplementary protection or – in the absence of the latter - one year before patent expiry of the active substance also taking into consideration possible further extensions"