As discussed in our previous newsletter, Legislative Decree No. 131/2010 amending Italian IP Code (IPC) has added a new paragraph, “1bis”, to Art. 68 IPC. The new paragraph is entitled “Limitation of the patent right”, and states that: “The companies which intend to produce pharmaceutical products beyond the patent protection may start the registration procedure of the product containing the active principle one year before the expiration of the supplementary patent protection or, in its absence, of the patent protection related to the active ingredient, taking into account also possible further extensions of protection”.
Since Art. 68 IPC provides the exemption from patent infringement (as it highlights the activities that, if not exempted, would constitute infringement), this new paragraph would imply that even the mere filing of an MA application would amount to patent (or SPC) infringement if done more than one year before the patent (or SPC) expires.
However, on 14 March 2011 the European Commission commenced formal infringement proceedings against Italy under Article 258 of the Treaty on the Functioning of the European Union, with regard to Article 68.1 bis IPC. The Commission believes that this rule would be in contrast with EU law, in particular Directive 2004/27/EC (the ‘Directive’), and would constitute a case of patent linkage, which is an integral part of ‘evergreening’ strategies to delay generic competition. As stated by the European Commission itself in its pharmaceutical sector inquiry report, patent linkage would be a clear abuse of the EU regulatory system, as:
“Patent linkage refers to the practice of linking the granting of MA, the pricing and reimbursement status or any regulatory approval for a generic medicinal product, to the status of a patent (application) for the originator reference product. Under EU law, it is not allowed to link marketing authorization to the patent status of the originator reference product. Article 81 of the Regulation and Article 126 of the Directive provide that authorization to market a medicinal product shall not be refused, suspended or revoked except on the grounds set out in the Regulation and the Directive. Since the status of a patent (application) is not included in the grounds set out in the Regulation and in the Directive, it cannot be used as an argument for refusing, suspending or revoking MA”.
Furthermore, the conflict between Article 68.1 bis and EU law can also be found in the following Council statement concerning Art. 10.6 of the Directive: “in relation to the filing of the applications and the grant of an authorization, the Council deems that these activities, having and administrative nature do not violate the protection of the patents. The Council and the Committee have underlined such principle in a joint declaration. Therefore, it is not necessary and not appropriate to include these activities in a provision that is related to the exemptions to the patent protection”.
Italy now has two months to reply to the Letter of Formal Notice sent by the Commission, focusing on the compatibility of Article 68.1 bis IPC with EU law. If the Commission is not satisfied with the information provided by the Italian authorities in its reply, and therefore concludes that Italy is failing to fulfil its obligations under EU law, the Commission may then send a formal request to comply with EU law (a "Reasoned Opinion"), calling on the Member State to inform the Commission of the measures taken to comply within a specified period, usually two months.
 See http://ec.europa.eu/eu_law/eulaw/decisions/dec_20110314.htm - under Italy, ref. 2010/4188.
 See http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/communication_en.pdf
 See “(EC) Common Position no. 61/2003 which has been defined by the Council on the 29th of September 2003 in the perspective of the adoption of the 2003/…/EC Directive of the European Parliament and of the Council of the ….that modifies the 2001/83/EC Directive regarding a Community Code relative to medicines for human use” - GUCE, 9th of December 2003, C-297 E/41 and following.