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:
“A country survives its legislation. That truth should not comfort the conservative nor depress the radical. For it means that public policy can enlarge its scope and increase its audacity, can try big experiments without trembling too much over the result. This nation could enter upon the most radical experiments and could afford to fail in them.”
—Walter Lippmann (1889–1974)
“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)
“As the creative adult needs to toy with ideas, the child, to form his ideas, needs toys—and plenty of leisure and scope to play with them as he likes, and not just the way adults think proper. This is why he must be given this freedom for his play to be successful and truly serve him well.”
—Bruno Bettelheim (20th century)