The mere filing of an application for marketing authorization of a generic drug does not constitute an infringing activity., although of a preparatory nature as, aAlthough it is true that the filing of such an application may constitute the basis for the marketing of the drug, there still is the possibility that the eventual act…
On 27 October 2010 the Court of Rome issued a decision in the Janssen – Menarini v. EG case concerning the active substance nebivolol. This is one of the few reported cases on enantiomer patents in Italy. In more detail, the basic patent inter alia disclosed an AB compound (so called compound 84) formed of…
Do we need a Community Patent? Do we need a European Patent Litigation System? Or does the current fragmented system have a hidden wisdom behind it? Judge for yourself!
By way of follow up of my many posts on the “intersections” between Italian patent law and the administrative procedures aimed at the authorisation of generic drugs (e.g. here, here and here), it is interesting to note another means by which the Italian Medicines Agency (AIFA) attempts to remain outside any patent dispute that may…
I have already written about the investigation launched last October by the Italian antitrust authority (AGCM) on an alleged abuse of a dominant position by Pfizer in relation to the manner in which Pfizer enforced or attempted to enforce its patent rights. Well, this is actually the first case of this type in Italy, but…
In a recent post of mine I have reported that by decision of 29 July 2010, the Italian Supreme Administrative Court (Consiglio di Stato) had tackled the issue of whether the Italian drugs regulatory authority (Agenzia Italiana del Farmaco – AIFA) should or should not consider the existence of a patent when adopting decisions relating…
In Italy, patent cases are heard by judges of the IP Chambers of 12 district courts distributed in the Italian territory. Italian judges are therefore IP specialists, but they have a merely legal, and not technical, background. This is why in all patent cases judges appoint court experts to review the technical issues at stake…
In the past, Italian courts have regularly dismissed motions for interlocutory (pre trial) declaratory judgements of non infringement in IP cases. The firm belief of the courts was that interlocutory proceedings could not be used to obtain DJ orders for a number of procedural reasons. The Scott Paper decisions of the Italian provincial court of…
The Italian Antitrust Authority (Autorità Garante della concorrenza e del mercato) announced on 26 October that it commenced proceedings against Pfizer following a complaint filed by Ratiopharm alleging that Pfizer’s behaviour in the enforcement of its patent rights amounts to abuse of a dominant position. It is too soon to make comments on this case….
The amendments of the Italian IP Code introduced by Legislative Decree no. 131 of 13 August 2010 are many and I tend to believe that there is no Italian IP lawyer who is sure to have already counted them all. Each time I have to consider a new issue for a client, I find some…
