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Supplementary Protection Certificates


In some specific areas of technology where the commercial exploitation of an invention is subject to a marketing approval, the national patent laws and the European Community Regulations have provided a means for recovering, at least partially, the time lost in waiting for the completion of the regulatory approval process. A supplementary protection certificate is, in general, a title extending the duration of patents in specific fields beyond their original 20 years term. So far, the interested fields in the European Community are two: the pharmaceutical field and that of plant protection products.

A national system providing for an extension of the term for patents concerning medicinal products has been in force in Italy since November 1991, and has been superseded as of January 2, 1993 by the EC Regulation No. 1768/92, directly applicable throughout the European Community. At present, SPCs granted under the previous Italian law, more favourable to the patent owner, have maintained their validity and duration, until june 16, 2002, when the decree N° 63/02 has been approved. The letter, within a framework of financial provisions, has provided for a (small) reduction of the duration of SPC granted according to the Italian rules and still in force on December 31, 2003. Obviously, each SPC application for medical products filed after January 2, 2003 is considered with the Italian patent and trademark office according to the community regulation.

The second EC Regulation, No. 1610/96, dealing with SPCs on plant protection products, entered into force on February 8, 1997.
In both cases, a SPC application may be filed in connection with a basic patent covering the concerned product (or a process for its production, or a use of the same, etc.) within six months from the grant of the first marketing approval in the Community.

 
 
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