Following the enactment of the Italian Intellectual Property Code (IPC) in 2005, the Italian legislator carried out a thorough revision of the current regulation in light of the limits and inconsistencies experienced during the first years of its application. The new IPC was issued on 13 August 2010 and entered in force on 2 September 2010.
Although the revision was intended to adjust the existing regulation, it includes, apart from some minor and other changes widely supported by the Italian IP practitioners, some amendments which seem more substantial and, in some cases, complicate rather than simplify old issues.
This is the case with the new regulation of the exemption for experimental use and the so-called "Bolar" exemption in Article 68 IPC.
The Old Regulation
Article 68 IPC provides for a general exemption for the experimental use of a patent and also for the use of a patent in order to obtain a Marketing Authorization (MA) for a generic medical product, i.e. such use does not constitute a patent infringement. The requirements for the exemption are almost identical to the requirements in Article 10(6) EC Directive 2004/27. Hence, Article 68 IPC represents its implementation in the Italian law system.
A pharmaceutical company which wants to apply for a MA (waiting for the expiry of the relevant patent) also needs to consider Article 61(5) IPC. According to this provision, "it is allowed" to file for a MA application up to one year before the expiry of the Supplementary Protection Certificate (SPC) - which can be interpreted, in reverse, that any earlier filing would infringe the SPC and, per analogy, also the patent.
The provision was considered to be inconsistent with Article 68 IPC and the EC Directive as these allow for the accomplishment of any "consequential practical requirements" necessary to obtain a MA (and, according to the prevailing opinion, also the filing of a MA application) without any time limit, whereas Article 61(5) IPC prohibits the filing of a MA application before one year of the expiry of the SPC.
This unclear legislation caused a number of proceedings dealing with the legitimacy of the filing of a MA application before the "grace period" of Article 61(5) IPC. The Court of Milan decided this issue in three different decisions. In particular, in the leading case decided on 11 June 2009 (Eli Lilly v. Ratiopharm et al.), the court ruled that the filing of a MA before the expiry of the patent was covered by the exemption of Article 68 IPC as it "set out a principle which overcomes the one-year limit of article 61 (5) IPC". The court did not examine in detail why such principle should prevail. However, it was reasonable to assume that this was based on the EC legislation background of Article 68 IPC.
The New Regulation
The new regulation intends to remove any inconsistencies between Articles 68 and 61(5) IPC. It clarifies that while the exemption in Article 68 IPC refers to the use of the patent in clinical trials and any other tests necessary to obtain a MA, Article 61(5) is concerned with the administrative requirements thereto. In other words, any activities directed at obtaining a MA are exempted by article 68 - apart form the filing of the MA application which is only allowed one year before the expiry of the patent (or the Supplementary Protection Certificate).
We welcome the new provision as it is a step forward for the protection of the rights of the patent owners in the pharmaceutical field. However, the possible conflict with EC law still needs to be investigated.