SPCs, which were introduced by European legislation, may be granted to extend the period of protection...
SPCs, which were introduced by European legislation, may be granted to extend the period of protection under a patent in respect of a specified pharmaceutical (or plant protection) product that is protected by the patent.
The intention is to compensate the patentee for at least some of the period of patent term that has expired after patent filing while it undergoes the lengthy process of getting its product authorised and on the market.
The protection granted under an SPC commences on expiry of the basic patent. Its duration is the period equal to the time lost between the date of patent filing and first marketing approval anywhere in the Community, minus five years, to a maximum of five years’ extension.
SPCs (in the present context) are governed by Council Regulation (EEC) 1768/92 (‘the Regulation’). Under Article 3(a) of the Regulation, ‘a certificate shall be granted if, in the Member State in which the application … is submitted … the product is protected by a patent in force’.
‘Product’ is defined in Article 1(b) as ‘the active ingredient or combination of active ingredients of a medicinal product’.
In order to obtain the grant of a certificate, the product to which the application relates must meet the conditions laid down in the Regulation.
Extension Denied: Gilead Sciences' SPC Application for Combination Anti-Retrovirals.