There are a number of issues of direct patent infringement that frequently arise in the area of pharmaceuticals, biologics and medical devices. The answers to these are not, however, always straightforward and they may be treated differently in the UK to other national courts. We continue our series of short articles addressing some of these issues by looking at what constitutes making under Section 60(1)(a) Patents Act 1977.

Section 60(1)(a) states:

a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say -

(a) where the invention is a product, he makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise;

What does ʽmakesʼ mean for the purpose of this section? In particular, when does a permissible repair of a patented article become an infringing manufacture? This question has been addressed in recent years by both the Supreme courts of Germany and the UK. Those cases concerning intermediate bulk containers ("IBCs"), but they are equally relevant to some kinds of patented medical devices because they concern the secondary market in the supply of new parts for patented equipment generally.

IBCs consist of essentially two elements, a large plastic container and a metal cage that fits closely around the container in order to support and protect it. In a secondary reconditioning market, used IBCs were bought by third parties and re-bottled or cross-bottled and then resold to fillers, more cheaply than the IBCs made by the original manufacturers. The patent at issue in the IBC cases extended to both the bottle and the cage, although the inventive concept was stated to lie amongst other things in the idea of the flexible weld joints, which increase strength and durability, and other specific features of the cage. The question before the courts was whether this patent is infringed by the replacement of bottles in cages in the secondary market.

The German Supreme Court decision in this matter under parallel infringement provisions to those of the UK, Paletenbehálter II (Pallet Container II)1 , is authority that a consumer expectation that parts of a device must be replaced during its lifetime must be balanced against the extent to which the embodies the invention part being replaced:

Therefore, the replacement of a part subject to wear and tear that is usually replaced during the expected service life of the machine – sometimes repeatedly – does not usually constitute a new manufacture. The situation can be different, however, if this part in fact embodies essential elements of the inventive concept.

On this basis, the German Supreme Court held that essential elements of the invention were not found in the replacement part, the bottle.

In the UK case, Schutz (UK) Limited v Werit (UK) Limited, at first instance, Floyd J also decided that there was no infringement of the IBC. The judge held that the correct approach is to ask whether what is left when the replaced part is removed embodies the whole of the invention2 . However, the UK Supreme Court considered this ʽover-simplifiedʼ3. The Supreme Court also did not agree with the Court of Appeal, which held that there was infringement, saying that it had failed to recognise that making is a matter of fact and degree. As a hypothetical illustration, the court said that merely replacing a damaged lid on an IBC could not be considered an infringement. Conversely, if a Schutz made lid were placed on a bottle and cage newly made by the defendant, it could not be said that there is no infringement. It follows that it must be considered whether the replacement is such a subsidiary part of the patented article that its replacement does not involve making the new article. In this case, the bottle was found to be a relatively subsidiary part of the IBC viewed as a whole and there was held to be no infringement.

Rather than emphasising the essential elements of the invention and consumer expectations, as in Germany, the UK Supreme Court came to its decision by considering a number of factors: the bottle had a significantly lower life expectancy than the cage; the bottle was physically less substantial than the cage because it was made of plastic rather than metal; and, the purchaser of the IBC was entitled to assume that a component which is physically replaceable and relatively perishable may be replaced without infringement. It was only in addition to these other factors, that it was also significant that the bottle did not include any aspect of the inventive concept of the patent. Connected to this, was the fact that the non-inventive part of the IBC – the bottle – could easily be removed from the inventive part – the cage – such that there were essentially two products at issue4.

It can be seen from these cases, that although approaches to the question of infringement by repair can differ from one country to another, the replacement of spare parts is not automatically infringement in the UK or Germany. Instead, the courts will look at matters such as whether the spare part is an essential element of the invention, and consumer expectations (Germany) and other factors determining whether the replacement is merely a subsidiary part of the patented article (the UK).