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The concerned law results from the conversion into law of the decree-law of April 15, 2002 No. 63, published on April 17, 2002 in the Italian Official Journal, which contains some urgent measures taken by the Italian government in order to increase the fiscal income and reduce and rationalize the public expenditure. The measures taken in the pharmaceutical field are gathered under Article 3 (both in the decree-law and in the final law No. 112/2002). These include a 5% reduction of the price of those medicinal products available at the expenses of the National Health Service (fully reimbursed medicines), and, under paragraphs 8 and 8-bis through 8-quater, some measures connected with intellectual property rights. The latter are purportedly intended to bring the group of Italian national SPCs (about 400 filings in total) gradually in line, as far as their duration is concerned, with the SPCs granted under the EC Regulation No. 1768/92, and are aimed at fostering the adoption of cheaper generics instead of brand-name products. The text of Article 3, paragraph 8, as finally approved, provides for a reduction of the term of SPCs granted under the previous national law equal to “six months for each solar year, starting from January 1st 2004”. Compared with the previous version of this provision, present in the original decree-law and reciting that the SPC term was reduced by one year in 2002 and by two years for every solar year, starting from January 1st 2003, the present version greatly limits the intended effects of Article 3, paragraph 8. All SPCs which, under the Italian law No. 349 of October 19, 1991, were going to expire before January 1st 2004, will be unaffected by the change introduced by the law No. 112/2002. In all other cases the reduction will be quite limited. In any event, it should be noted that these provisions affect the validity and enforceability of a title already granted by the national Authority, and are also likely to be questioned from the point of view of certainty of law. Obviously, in considering the levelling down of the Italian national SPC protection to the European supplementary protection as an object, the concerned decree has not taken into account (nor it could have done differently) the fact that the first Italian Marketing Authorization (M.A.) is not necessarily the first M.A. in the European Community. This further advantage of the national law in comparison with the EC Regulation has been left untouched. The same paragraph 8 of the law No. 112/2002 contains another important provision intended to favor the generics producers. According to this provision, the firms interested in producing medicinal products outside the patent protection may start the procedure for obtaining the M.A. one year before the expiry of the supplementary patent protection on the active ingredient. This actually introduces an exception to the patent law principle according to which any activity having a commercial end connected with the exploitation of a patent is barred as long as the patent is in force, even when it is experimental activity or “paper work”. The final text of the law No. 112/2002 contains, in addition to the original text of the decree-law No. 63/2002, some provisions, gathered under paragraphs 8-bis through 8-quater, stipulating the possibility of producing an active ingredient still covered by a Supplementary Protection Certificate according to the Italian law No. 349/1991 for the purpose of exportation only toward countries where the concerned active ingredient is free from patent protection. The text of the law No. 112/2002 refers to a further act to be issued by the Ministry for Productive Activity in order to define the procedure for the issue of the licenses according to Article 8-bis. Pursuant to the above, the Ministry for Productive Activity issued a Decree, dated October 17, 2002, which has been published on October 28, 2002 in the Italian Official Gazette. The Decree concerns the grant of voluntary non exclusive licenses, to be granted for a consideration, valid for the exportation of active ingredients of medicaments covered by SPC, in Countries where the protection conferred by the patent and by the SPC has lapsed or does not exist, or where the exportation of the active ingredient does not amount to an infringement of the corresponding patent according to the provisions in force in the destination Country. The procedure for the grant of the license starts from the formal communication by the party interested to obtain the license to the Italian Patent and Trademark Office (PTO), with the specification of the active ingredient. The Italian PTO promptly informs all the potentially concerned parties. If the parties reach an agreement within 90 days from the date of receipt of the communication, a copy of the agreement shall be forwarded to the PTO. If the parties do not reach an agreement the Italian PTO can intervene in the procedure. In fact, if the parties inform the PTO that the negotiations have been unsuccessful, in accordance with Article 5 of the decree a Conciliation procedure starts. It should be noticed that the decree seems to expressly require that the communication of the failure of negotiations has to be given by all the potential signatories of the agreement, even if not jointly. This provision can be interpreted as a guarantee to the PTO to give its co-operation only in case of a real and concrete interest in reaching an agreement by all the parties. The Conciliation can end with an agreement or with another failure of negotiation. In this last case the records of the procedure will be sent to the Authority for Competition and Market . At this point, there remains to be seen (see article 7 of the
decree) what will be the real contribution of this decree to the
development of the generics market in Italy and to a concrete
saving for the National Health Service. |
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