Patent linkage: has it returned to Italy?

The SPC Blog is again in debt to the kindness of our very good friend Micaela Modiano (Modiano & Partners) for the following information and insight from Italy with regard to patent linkage:

"Only very recently, the Italian Parliament had abolished a provision contained in the Italian IP Code and corresponding to a form of patent linkage.  This provision indicated that an application for a generic marketing authorization could be filed only within the last year of life of the patent or SPC protecting the originator product, also taking into account any paediatric extension filed with respect to the SPC. The abolition of this provision followed from an infringement procedure started by the EU Commission against Italy.

Now, on 8 November 2012, the Italian Parliament has passed a law entitled "Urgent measures for promoting the development of the [Italian] State by way of a higher level of health protection".  Among other things, this law provides that the Italian Regulatory Authority (Agenzia Italiana del Farmaco, AIFA) shall carry out an extraordinary review of the national list of authorized pharmaceutical products, so as to more clearly identify any therapeutically obsolete medicinal products. 

 When carrying out such extraordinary revision, and on the occasion of any subsequent revision of the national list of authorized pharmaceutical products, Art. 11(1) of the new law provides that [per Micaela's English translation]:

 "the medicinal products which are equivalent, according to the law, to medicinal products whose patent or SPCs is yet to expire/about to expire [translator's note: the Italian terms of the law are not clear on this point!] cannot be classified as reimbursed by the Italian national health service prior to the patent or SPC expiry date published by the Ministry of Economic Development [translator's note: this is the Ministry encompassing the Italian PTO] according to the provisions of law."

 The new law therefore does not appear to introduce a patent linkage regarding when a generic marketing authorization should be filed or when it should be granted; nevertheless, the language of Art. 11(1) appears to introduce a patent linkage regarding when a generic product can be reimbursed by the national health service. 

 While the law was under discussion at the Italian Parliament, the Italian Antitrust Authority had sent a formal communication to the Parliament proposing that the provision of Art. 11(1) be abolished given that, in the Authority's own words, such provision "introduces ... a clear form of 'patent linkage'". Despite this comment by the Authority, the provision was maintained and is still part of the new law. 

 The full text of the new law as published in the Italian OJ of November 8, 2012 can be found here.

Art. 11(1) of the new law should be read and assessed also in the context of Art. 14 of the current version of the Proposal for a Directive of the European Parliament and of the Council  relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems, which can be found here. 

 Interestingly enough, Art. 14 is entitled "Non interference of intellectual property rights...". It will be watching carefully to see how Art. 11(1) of the new Italian law will be reconciled with the text of Art. 14 of this draft directive. 

 Surely this will not be the last we hear regarding Italy and patent linkage!"