Experimental use provision

Patent systems were designed to encourage and reward innovation. A system that prevents research into the subject matter covered by a patent would be inconsistent with such goals, and so the patent systems of most countries contain a provision that exempts from infringement experiments performed relating to the subject matter of a patent. In this article, the extent of the exclusion for experimental acts in Europe, particularly the UK, is discussed. I consider what constitutes an experimental act and to what extent the experimental use provision can effect scientific development.

The UK experimental use exemption

According to the UK Patents Act of 1977, a patent is infringed if, for instance, a person 'makes or uses' a product covered by the patent within the UK. However, an exemption is provided such that “an act which... would constitute an infringement of a patent for an invention shall not do so if... it is done for experimental purposes relating to the subject matter of the invention.”

UK case law

In interpreting the meaning of the terms 'experimental purposes' and 'subject matter of the invention', certain decisions of the UK courts are relied upon. In particular, the case still used for the interpretation of the scope of these terms is Monsanto versus Stauffer (see Box 1), which is now 20 years old. In the case in question, Stauffer wished to undertake field trials using a herbicide that was known to infringe a patent held by Monsanto in order to obtain regulatory clearance for this product.

This case established the principle that experiments carried out for the purpose of gaining regulatory approval for a product would not be exempt from being regarded as acts of infringement in the UK, because they could not be regarded as acts which were done for 'experimental purposes'. However, it seems that 'experiments' performed to find out something new — that is, which advance scientific knowledge — might be exempt from being regarded as acts of infringement, in so far as they relate to the subject matter of the invention. According to this case, an exempt act can have 'an ultimate commercial purpose'

With respect to the meaning of the term the 'subject matter of the invention', the UK courts currently consider that the nature of the subject matter should be assessed by considering the contents of the patent as a whole. Furthermore, it is considered that the experimental purpose must have a 'real and direct' connection with that subject matter. There is an important distinction between research relating to the invention, which is exempted, and research using the invention, which is not. For example, use of a patented sequencing technology in an experiment to further develop sequencing technologies might be exempted, but it is very unlikely that the use of the same technology in an experiment to determine the sequence of a nucleic acid would be exempted.

Practically, what does the 'experimental use' exemption in the UK permit? It is clear that the scope of the exemption is currently interpreted narrowly: experiments that are performed to further scientific knowledge and discover 'something new' can be exempted from being classed as an infringing act, in so far as the experiments performed have a 'direct' connection with the invention described in the patent. However, experiments performed purely for gaining regulatory approval, such as field trials or clinical trials, might not be considered to be exempt from being classed as an infringing act in the UK at present.

Exemption in other parts of Europe

In other parts of Europe, recent decisions indicate that the 'experimental use' exemption is being interpreted more generously. For example, recent decisions in Germany have indicated that clinical trials on a patented compound to find out whether the compound is effective in other indications, or to obtain further information about certain characteristics of a compound, can be considered exempt from infringement irrespective of whether the clinical trials are carried out for commercial purposes.

Moreover, a recent decision in France has deemed that under certain circumstances Phase III clinical trials can be exempted from infringement.

The pharmaceutical regulatory directive

On 11 March 2004 the EU adopted a new European pharmaceutical regulatory directive apparently with the aim of facilitating the movement of generic products to the European market. The directive provides that “conducting the necessary studies and trials... shall not be regarded as contrary to patent rights.” This exemption applies to generic medicinal products and also to non-generics, but only those that are similar to the reference product and which do not fulfil the generic definition for specified reasons.

It seems, then, that the effect of this directive might be to provide a more generous interpretation of the experimental use provision, in the UK at least. But beware, the directive does not have to be implemented until 30 October 2005!

Summary

Experiments can be performed using patented products, but only with caution. Experiments designed to elicit new knowledge — that is, which can be considered to advance scientific knowledge — might be exempted. However, at least in the UK, those experiments performed purely for commercial purposes currently do not benefit from the 'experimental use' exemption. It is hoped that the new EU directive will clarify the position.

Box 1: Monsanto versus Stauffer: Reports of Patent Cases [1985] 515

The case in question related to the testing of a particular herbicide, Touchdown, which was being produced by Stauffer. Tests were being performed using Touchdown in an attempt to seek regulatory approval for the product. Monsanto sued Stauffer for infringement. Stauffer argued that the act of performing field trials using Touchdown was exempt from infringement because the trials were “done for experimental purposes relating to the subject matter of the invention.” The UK Court of Appeal held that experiments exempt from infringement can have a commercial purpose, such as experiments designed to establish whether “the experimenter could manufacture a quality product commercially in accordance with the... patent.” However, it was further held that the field trials being performed for the purpose of obtaining regulatory approval of Touchdown could not be considered to be performed for these purposes and therefore were considered acts of infringement.