The Italian Merck Case. Research Papers in Law, 1/2007

From the Introduction. Regulation 1768/921 created supplementary protection certificates (hereinafter, ‘SPCs’) for medicinal products (hereinafter, “pharmaceuticals”) protected by patents. SPCs afford the same exclusive rights as those conferred by patents once these expire and may be granted for a maximum of five years.2 Italy enacted similar legislation in 1991, the most salient difference between both texts being that, pursuant to Law No. 349/91,3 holders of Italian patents for pharmaceuticals could be granted supplementary protection for a maximum period of 18 years after the expiration of the patent. Following the enactment of Regulation 1768/92, SPCs granted by the Italian authorities were brought in line with the period provided for in that text. However, pharmaceuticals for which supplementary protection was sought in the lapse between the adoption of Law No. 349/91 and Regulation 1768/92 (around 400 products) continued to enjoy the protection provided for in the former text.4 Several steps were taken by the Italian authorities to progressively reduce the length of protection granted to these products.