Scope
According to Article 4 of Council Regulation (EEC) No 1768/92, the scope of an SPC extends "only to the product covered by the authorization to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate".
The European Court of Justice has decided, however, that the scope of an SPC is sometimes capable of encompassing more than just the single form of the active ingredient that is included in the medicinal product authorised for sale. Thus, in case C-392/97, the European Court of Justice held that: "where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and esters, as medicinal products, in so far as they are covered by the protection of the basic patent".
Read more about this topic: Supplementary Protection Certificate
Famous quotes containing the word scope:
“Revolutions are notorious for allowing even non- participants—even women!—new scope for telling the truth since they are themselves such massive moments of truth, moments of such massive participation.”
—Selma James (b. 1930)
“For it is not the bare words but the scope of the writer that gives the true light, by which any writing is to be interpreted; and they that insist upon single texts, without considering the main design, can derive no thing from them clearly.”
—Thomas Hobbes (1579–1688)
“Every person is responsible for all the good within the scope of his abilities, and for no more, and none can tell whose sphere is the largest.”
—Gail Hamilton (1833–1896)