By a decision of 15 April 2009 issued in a preliminary injunction proceeding, the Court of Milan held that the mere grant of a Marketing Authorisation (MA) for a generic pharmaceutical product does not constitute an imminent threat of patent infringement.
According to the Italian Intellectual Property Code “whatever the subject matter of the invention, the exclusive right granted by the patent right shall not extend: a) to acts performed in private and for non commercial purposes, or for experimental uses even though aimed at obtaining, even in foreign countries, the authorisation for the commercialisation of a medical product and for the subsequent practical fulfilment, including therein the preparation and the use of the pharmacologically active raw materials strictly necessary for that purpose (…)”.
It has been a matter of debate whether the grant of an MA alone constituted an act of patent infringement.
The only recent decision on the issue, also issued in the course of a preliminary injunction proceeding, was rendered by the Court of Rome. In that case, the Court of Rome held that the application for the MA had to be considered as an act of patent infringement. This decision has been highly criticised, among other reasons, because it relied on case law rendered before the change made to the Intellectual Property Code as set out above.
The decision of the Court of Milan, which is still subject to an appeal, was rendered in an application for a preliminary injunction made by Novartis AG against Mylan s.p.a. and Generics UK Ltd. Novartis alleged that the filing of an application for, and then the subsequent grant of the MA for a generic version of fluvastatin, interfered with the scope of protection of its fluvastatin formulation patent and implied an imminent threat of damage such as to justify the court granting a preliminary injunction against the two generic companies.
In rejecting the application for the preliminary injunction, the Court of Milan affirmed that “the mere acquisition of the regulatory title required for the commercialisation of the generic drug is not enough, given that it does not per se imply an effective and concrete start of the marketing activity”.
The Judge stated that a threat of imminent infringement could, for example, consist of the warehousing of the product or of the beginning of a marketing campaign at medical institutions. However, he pointed out that no such activity was even mentioned by the patent owner in this case.
Moreover, the Judge stated that the preliminary relief being requested would mean in effect the non-application of the regulatory measures under which the MA was granted. He said that this outcome would be highly questionable both with regard to the jurisdiction of a Civil Court and also with regard to the fact that the law provides an exception to infringement namely activities connected to the practical requirements aimed at obtaining an MA.