P. 52-57 /

The scope of protection of an SPC according to Losartan case

Armengaud & Guerlain lawfirm, 12 Avenue Victor Hugo, Paris, 75116, France

The supplementary protection certificate (SPC) is a titlewhich has been established in order to compensate thetime during which the patented medicine, waiting for itsmarketing authorization (MA), cannot be commercialized.The SPC was put in place in France by the law dated 25June 1990 (1) (and also in Italy (2) ) and these laws werede facto abrogated on the 1st of January 1993 when theCommunity Regulation dated 18th June 1992 (3) (hereafterthe “Regulation”) came into effect.French law contained several pitfalls which have beenextensively discussed in the literature (4). One of them wasthat, for the same active ingredient, several SPCs that at leastpartially overlapped were issued, thus providing (at leastpartially) a “double protection”, despite implementation ofthe decree of 19th November 1991 (5), which neverthelessenounces the principle of the prohibition of such “doubleprotection”.The Regulation has sought to put an end to this practice byspecifying that: “A certificate shall be granted if […]: (c) theproduct has not already been the subject of a certificate”(article 3c) of the Regulation).More generally, the Community legis ...