The EU has two council regulations regarding SPCs: one concerning the creation of an SPC for human and veterinary medicinal products; and another concerning the creation of an SPC for plant protection products.
The European Union has two council regulations regarding supplementary protection certificates (SPCs): Council Regulation (EEC) No 469/2009, a codified version of the original Council Regulation (EEC) No 1768/92 of June 18, 1992, concerning the creation of an SPC for human and veterinary medicinal products; and Regulation (EC) No 1610/96 of the European Parliament and of the Council of July 23, 1996, concerning the creation of an SPC for plant protection products.
The two regulations do not comprise cross-references; they form two entirely separate protection systems. However, when considering the duration of an SPC, the notion of the first authorisation to place the product on the market in the Community (now the EU) plays a key role in both regulations.
The owner of a Hungarian patent filed an application for the grant of an SPC with regard to a compound which was granted Hungarian marketing authorisation as a plant protection product. The patentee referred to a Dutch marketing authorisation as the first authorisation to place the product on the market in the Community.
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Hungary, SPCs, medicinal products