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"

Article 68 sets down what are known as "statutory limitations" on the patent rights arising from article 31(a) and (b) of the European Patent Convention. The new article seems to be stating that Italy, unlike other European jurisdictions, is taking a narrow approach to the experimental use defense, which for patents covering active ingredients appears to be limited to acts undertaken for experimental and research purposes, but not to the administrative procedure before the Italian Medicines Agency (AIFA) to obtain the MA.         

The most important feature of Art. 68 (1 bis) is the clarification of the scope of the Bolar Exception under Italian law from a regulatory point of view. This new provision clarifies the meaning of the former Art. 61 (5) of the IP Code, which provided the general regulation of Italian Supplementary Protection Certificates (SPCs) for medicinal products.

The previous law had given rise to conflicting interpretations between the Courts of Rome and Milan.

In particular, former Art. 61 (5) IP Code was at the basis of the so called Pronova case law initiated by the Court of Rome. In Pronova v. Chiesi (interlocutory order of 23 October 2006) the Court of Rome stated that Art. 61 (5) IP Code established the principle that the filing of a MA application was an act of infringement (being a preparatory act of marketing). The Court of Rome also clarified that this interpretation was not inconsistent with the Bolar Exception. According to the Court of Rome, the latter only meant that the experimental use exception extended to the experimental activity to be carried out by the generic company in order to prepare the marketing of the generic drug, but it did not provide that the same extended to the filing with the regulatory authority of the application resulting from this.

However, in 2009 the Court of Milan ruled that Art. 61 (5) IP Code had to be interpreted narrowly.  In particular, in the case Eli Lilly v. Ratiopharm et Al. (decision 7645 of 11 June 2009), the Court of Milan stated that "the mere filing of an application for marketing authorisation does not constitute infringing activity, although of a preparatory nature" as "although it is true that the filing of such an application, when the procedure is completed and after a possible experimental activity, may constitute the basis for the marketing of the drug,  in the case at issue there is a prevalence of the lack of actuality of the manufacture and sale and there still is the possibility that the eventual act of marketing of the drug will not occur in practice". The Court added that the Bolar Exception would seem to justify the filing of the MA application even before the expiry of the patent rights.

The recent amendment of Article 68 supports an interpretation that the Italian legislator accepted in substance the approach of the Court of Rome in "Pronova". In addition, the Italian legislator seems to have taken the occasion to specify that the legal concept of exclusivity to be taken into account is broad enough to include not only the SPC protection but also other extensions of the patent  protection, such as the paediatric extension.

The new Art. 68 IP Code seems to support the conclusion that the Italian legislator wanted to strike a balance between the interest of the generics companies to commence the regulatory process early enough to enable them to launch their generic product immediately after expiry of the patent rights and the right of the originators to avoid MAs being granted to generics companies when the patent rights are still in force. 

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.