In 2012 Italy implemented a rule - Article 11 of the so-called "Balduzzi Decree", converted into Law no. 189/2012 – which provides that generic products cannot be classified as reimbursed [reimbursable?] by the National Health System before the expiry of the patent/Supplementary Protection Certificate (“SPC”) claiming the reference originator product.
In interpreting Article 11, the Italian Administrative Court limited its scope specifying that the rule could only apply in cases of a patent/SPC covering active ingredients and not a patent claiming a process (see, inter alia, decisions of Lazio Administrative Court no. 6359/2013 and no. 6739/2014).
By a recent decision in a case regarding the sustained release of quetiapine, no. 4394/2014 dated 27 August 2014, the Administrative Supreme Court confirmed that a strict interpretation of Article 11 of the Balduzzi Decree was necessary. In this case, during the infringement/invalidity proceedings on the merits between AstraZeneca - the proprietor of the patent claiming a sustained release formulation of quetiapine, EP 0 907 364 ("EP '364") - and Teva - the generic company who launched the relevant generic product – which were pending before the Italian IP Court, the originator company filed administrative proceedings against the insertion of Teva's product into the transparency list and the consequent reimbursement of that product in compliance with the Balduzzi Decree.
Furthermore, in these proceedings the Administrative Supreme Court confirmed that the existence of a process patent is irrelevant for the reimbursement of a generic medicinal product.
Moreover, in cases of a patent not covering a process, the Administrative Supreme Court highlighted the necessity to assess if the active ingredient claimed by the patent has a different and further therapeutic effect compared with that of the drug(s) already on the market.
In light of the above, the Administrative Supreme Court disagreed that EP '364 could be an obstacle for the reimbursement of Teva’s generic product, containing the sustained release formulation of quetiapine, because the patent in question does not protect an active ingredient per se but rather formulations which do not have a significant clinical benefit in comparison with the existing product. As a matter of fact the Administrative Supreme Court noted that the sole therapeutic effects of sustained release quetiapine claimed by EP '364 are the same as an immediate release quetiapine claimed by a previous patent of AstraZeneca.
In summary however, the interpretation of Article 11 of Balduzzi Decree adopted by this decision – which appears to not be straightforward – requires a delicate assessment of the therapeutic effect of a drug and will very likely raise a number of problems in the future.