Search for Absolution

Under UK law it is an infringement to make, sell, offer for sale, use, import or keep a product covered by a patent while that patent is in force. Generally speaking, the patent laws of most major territories define the range of infringing acts in similar terms. There are obvious advantages for pharmaceutical manufacturers, particularly those in the generics sector, to be in a position to launch competing products as soon as possible following patent expiry. However, regulatory regimes dictate that at least basic trials (for example to demonstrate bioequivalence with the marketed product) are undertaken in order to obtain marketing approval. Clearly, it is undesirable for such manufacturers to have to wait until patent expiry to begin the necessary trials – indeed, some have argued that this situation amounts to an effective extension of the duration of the patent monopoly. Accordingly, the availability and scope of exemptions from patent infringement has become increasingly important in this area.

A number of non-specific statutory exemptions from patent infringement have been available in the UK and elsewhere for some time. More recently, however, a European Community Directive (2004/27/EC, hereafter referred to as ‘the Directive’) has come into force, which aims to provide a specific exemption from infringement for activities relating to obtaining marketing approval for medicinal products (a socalled ‘Bolar exemption’). This article looks at the potential scope of the exemptions that may be available to pharmaceutical manufacturers, both generic and innovating, in various countries both within and outside Europe.

THE EUROPEAN PICTURE – PRE-DIRECTIVE

Prior to the introduction of the Directive, exemptions from patent infringement were solely a matter for national legislation. Most countries have an exemption for acts that are done for private and non-commercial purposes. As with any statutory exclusion, however, the scope of this exemption is regarded in narrow terms and hence, as far as pharmaceutical manufacturers are concerned, it is unlikely that this provision could be relied upon.