Since no national legislation was in place before January 1, 2007, the following provision article 19(l) of the amended 1768/92 regulation, was applicable:
“Any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 January 2007.”
Accordingly, between January 1 and June 30, 2007, roughly 90 SPC applications were filed with the Romanian State Office for Inventions and Trademarks (OSIM) on the basis of a first marketing authorisation (MA) in Romania issued after January 1, 2000.