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
"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
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
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.
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