Italy: a marketing authorisation as patent or SPC infringement?


By means of Legislative Decree No. 131/ 2010 which came into force on 2 September 2010, the Italian Government[1] amended the Italian IP Code (IPC). 

One of these amendments directly affects the problem of the possible interference between the administrative procedure for the granting of a Market Authorisation (MA) and a third party’s patent or Supplementary Protection Certificate (SPC). This has been a much debated problem in Italy in recent years, especially between originators and manufacturers of generics. Indeed, according to some originators the mere filing of an MA application would amount to a patent infringement, being an act not covered by the so-called experimental use exception (Bolar exception).

In June 2009 the Court of Milan went some way to resolving the debate and held that: “the simple filing of a market authorisation application does not constitute evidence of an infringing activity…It consists only of a request for an administrative act which may not be identified as a preparatory act of a commercial activity … The marketing authorisation application … is a premature data in relation to the asserted infringing activity” (Court of Milan 11 June 2009, Eli Lilly v. Synthon and others[2]).

However, the situation has been since confused again by the amendments to the IPC made by Legislative Decree No. 131/2010.

The legal framework prior to Legislative Decree No. 131/2010

Art. 68.1 IPC, which implemented Article 10.6 of the 2004/27/EC Directive, expressly states that ownership of a patent does not allow the owner to oppose the experimental activities aimed at obtaining an MA and the “consequent practical acts”. It does not, explicitly mention the filing of an MA application.

However, according to the opinion expressed by the European Council in the Common Position No. 61/2003, “In relation to submission of applications and granting of an authorisation, the Council believes that these activities, being of an administrative nature, will not infringe patent protection. The Council and the Commission have underlined this in a joint statement. Thus, it is neither necessary nor appropriate to include those activities in a provision on exemptions from patent protection. [3].

Art. 61.5 IPC (before it was amended) provided that: “The companies which intend to produce pharmaceutical products after the expiry of the patent may start the registration procedure of the product containing the active ingredient one year before the expiration of the supplementary patent protection related to the active ingredient”. Art. 61 only applied to active ingredients protected by an SPC issued under Italian Law no. 349/1991[4].

The present situation

Legislative Decree No. 131/2010 has effectively re-organised the IPC so that the wording that used to make up Art 61.5, has now been added as a new paragraph,“1bis”, to Art. 68 IPC: “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”.

Art 61.5 used to apply only to active ingredients protected by an SPC issued under Italian Law no. 349/1991. However, the wording is now within Art 68, which is a provision that applies to patents generally. Art. 68 IPC actually provides the exemptions from patent infringement, pointing out all those activities that, where not exempted, would constitute patent infringements according to Art. 66 IPC, as economical exploitations of the product (or process) which is the subject of a patent or of an SPC.

Therefore, the restriction on only being able to start the registration procedure within the last year of the period of protection conferred by the patent, is now a general rule, since the principle originally directed to govern only the few SPCs granted according to Law No. 349/1991 has been extended to all cases of MA for (generic) medicinal products submitted where the active ingredient is protected by any exclusive right: national SPC, Community SPC as well as the basic patent[5].

This implies that, if not exempted, even the mere filing of an MA application amounts to patent (or SPC) infringement if done more than one year before the patent (or SPC) expiry.

In theory, this could also apply to an MA application filed through a European procedure, such as the decentralised procedure provided by the Directive (EC) No. 2001/83, in which Italy is indicated as Concerned Member State. Therefore, if such procedure is started more than one year before the patent (or SPC) expiry, it could be considered - as far as the Italian phase is concerned - as patent (or SPC) infringement according to the new text of Art. 68.1bis IPC.

In the light of the above and from a different point of view, Art. 68.1bis IPC could be considered to be in conflict with the European competition rules – the same MA, filed (and granted) through the decentralised procedure, could be completely lawful and effective in all European Member States, except Italy.

[1] In execution of a specific delegated law (Article 19 of Law No. 99/2009).
[2] Please note that this decision has been appealed by Eli Lilly and the appeal proceeding is still ongoing.
[3] See “Common Position (EC) No 61/2003 of 29 September 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use” - in GUCE, 9 December 2003, C-297 E/41 and following.
[4] It concernsthe approximately 400 SPCs which have been granted according to such regulation before the coming into force of Regulation (EC) No. 1768/92 and the last of which will lapse on 31 December 2010.
[5] And that this was the real intention of the legislator is confirmed by the fact that, in the text of paragraph 1bis of Art. 68 IPC an explicit reference to “patent protection” had been included.