In an earlier post, I reported the news that a new piece of legislation (the so called “Balduzzi Decree”, Law No. 189/12 of 8 November 2012 confirming Law Decree 158/12 of 13 September 2012 – a consolidated version of the Decree is available here) introduced a rule which some have already labelled as “reimbursement price linkage”. In substance, according to Article 11 of the Balduzzi Decree, the Italian regulatory Authority will refrain from granting a reimbursable price to approved generic drugs when the reference product is still covered by a patent or SPC.
Last week, AIFA officially confirmed that it will apply such a rule, by issuing a communication to all pharmaceutical compan [...]
By decision of 21 February 2013, the Court of Turin clarified the test for prima facie case in search proceedings and the test for urgency in search proceedings and preliminary proceedings in general. In the case at issue, 4B-Four Bind had obtained an ex-parte search order aimed at inspecting post-print binding machines of competitor KGS, alleged to be infringing 4B’s patents. During the inter-partes hearing which took place after the execution of the search, KGS argued that the legal requirements of prima facie case and urgency had not been met and this gave the court the occasion to extensively clarify, also in general terms and not only by reference to the specific circumstances involve [...]
In one of my earlier posts I gave the news that, after years of uncertainty as to the admissibility of interlocutory (pre trial) declaratory judgements of non infringement in IP cases (here), the amendments introduced to the Italian IP Code in 2010 made it clear that such proceedings are admissible as now explicitly contemplated by statutory provisions. Therefore, DJ actions can be instituted by means of interlocutory proceedings, leading to a declaration of non infringement after a fast-track process. The courts have now experimented this tool on quite some occasions and it is now clear that in order for motions for interlocutory declarations of non infringement not to be rejected on proced [...]
By order of 16 October 2012 in Sperotto v. Bolpagni , the Court of Turin stated, in line with a few other of its recent decisions, that patent infringement ordinary proceedings (even if including a cross-claim of revocation) must be stayed until the conclusion of EPO opposition proceedings pending on the allegedly infringed patent, in application of Article 120 IP Code.
In fact, Article 120 IP Code literally says something different. In the Italian system, infringement cases can be brought before the grant of the patent, as soon as the patent application has become public or has been served on the alleged infringer. Article 120 IPCode therefore establishes that no ruling in ordinary proceed [...]
On 11 December 2012 Advocate General Yves Bot delivered his conclusions on the complaints brought by Italy and Spain against the Coucil’s decision to proceed through enhanced cooperation to the adoption of the unitary patent regulation, and proposed the CJEU to reject the complaints.
As many will remember, the discussions on the adoption of the unitary patent regulation took the turn of enhanced cooperation (a procedure contemplated by the Treaties whereby a limited group of Member States proceed to the adoption of a specific piece of legislation which will eventually have effect only in their territories, and not in those of the non participating Member States) when it became apparent tha [...]
Recently approved “Balduzzi Decree” (Law No. 189/12 of 8 November 2012 (confirming Law Decree 158/12 of 13 September 2012 – a consolidated version of the Decree is available here) seems to have changed quite a lot in terms of the protection of pharmaceutical patents in Italy, making it totally Inconvenient for generics to launch at risk.
The relevant provision is Article 11.1. It is in fact quite a complex provision, which literally states that by June 2013, the so called “Prontuario Farmaceutico Nazionale” (in substance, the catalogue listing all medicinal products approved for sale in Italy and reimbursed by the National Health Service) will be subject to an extraordinary revision [...]