17 dicembre 2014 IAM Nadia Gualeni

In a recent communication the Italian Patent and Trademark Office agreed to accept and consider third-party observations during the pendency of a patent application or during the process for obtaining supplementary protection certificates for medicinal products. 

The decision may augur the introduction of a true opposition procedure for patents in Italy.

With increasing frequency, the Italian Patent and Trademark Office (IPTO) receives Thirdparty observations contesting the validity of applications for patents, utility models and supplementary protection certificates (SPCs). Such observations are intended to convince the IPTO not to grant the patent, utility model or SPC.

In July 2014 the IPTO addressed for the first time the fact that the Industrial Property Code sets down no procedure for oppositions or thirdparty observations for patents, utility models or SPCs. The IPTO noted that it is for the legislature to decide whether to provide for such procedures. This is in contrast to trademark registrations and applications for new plant varieties, for which the legislature has established specific procedures. The IPTO observed that it was not possible to apply procedures relating to other IP rights to patents, utility models and SPCs without the code permitting stating this. Therefore, the IPTO could not comment on the relevance of such observations; nor could it allow such observations to be considered during substantive examination of an Italian patent application.

The IPTO decided to place thirdparty observations in the file of a patent application or utility model, but stated that it would not consider such observations during substantive examination.

Recent developments

Just four months later, on November 11 2014, the IPTO reconsidered the issue and expanded on its previous position. In particular, with respect to thirdparty observations received during the granting procedure for patents and SPCs, the IPTO decided to accept such observations and will now assess their relevance during substantive examination.

If the IPTO Examining Division is of the opinion that thirdparty observations are relevant to the examination procedure (eg, for novelty, inventive step, industrial application or extension of subject matter), and that, in view of the observations, the application does not meet these requirements, the Examining Division will invite the applicant to file its own observations and amendments pursuant to Article 173(1) of the code.

During the procedure for granting patents for inventions, utility models and SPCs, the IPTO will now evaluate thirdparty observations and make them available to the public; but it is not required to respond to third parties or to pass the observations to the applicant. This also applies to thirdparty observations submitted during the procedure for issuing SPCs; however, if the IPTO ascertains that the relevant regulatory agency has withdrawn marketing approval for the product, the IPTO will declare that the SPC has lapsed.

Proposal

The recent changes to IPTO procedure suggest that it may be open to a proposal made by the Italian Industrial Property Consultants Institute to introduce an opposition procedure for patents in Italy. Since the European Patent Office (EPO) already conducts prior art searches for patent applications first filed in Italy (according to a 2007 agreement), it seems reasonable that the EPO could manage such procedure, at least with respect to the substantive examination of opposition grounds.