Supplementary Protection Certificate (SPC)

By accession of the Republic of Croatia to European Union, with effect from 1 July 2013, SIPO has become the authority responsible for issuing Supplementary protection certificate (SPC) based on the application of the provisions of Regulation (EC) No. 469/09 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products intended for humans or animals, and the Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996, concerning the creation of a supplementary protection certificate for plant protection products.

Supplementary protection certificate  is  issued in cases where a basic patent had been granted for a product which is a component part of a medicinal product intended for humans or animals or for a plant protection product, the placing on the market of which requires prior authorisation of the competent State authority.

In the case of medicines and plant protection products, the usage of a new product comprised by a protected invention must be delayed until  granting  an authorisation for placing such a product on the market issued by the competent health and agricultural authorities is. For this reason, precisely for the period of time required for   issuing first authorisation to place on the market,  protection is being extended by issuing a Supplementary protection certificate.

It should be emphasized that within the limits of the protection conferred by the basic patent, the protection conferred by Certificate will not extend the duration of the whole patent, but exclusively protection ensued from a basic patent for the active substance or plant protection product.

For maintenance of a Supplementary protection certificate prescribed charges have to be paid regularly.