UK experimental use exemptions: part 1—the original

Section 60(1) of the Patents Act 1977 (UKPA) provides that use in the UK of a product or process falling within the scope of the claims of a granted patent, without the consent of the proprietor, is an infringement of those claims. However, Section 60 also provides that in certain circumstances, including, and of particular relevance to the life sciences sector, experimental uses of the invention—permitted acts that would otherwise constitute an infringement.

There are in fact three categories of experimental use exemptions from infringement, and we discuss each of these in a series of four articles. In this article, we address the original experimental use exemption provided under Section 60(5)(b) of the UK Patents Act (UKPA) 1977.

Original experimental use exemption

Section 60(5)(b) of the UKPA 1977 recites: “An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if […] (b) it is done for experimental purposes relating to the subject-matter of the invention.”

This has been held to mean that trials carried out in order to discover something unknown about the patented invention, to test a hypothesis about it or to find out whether a patented invention which is known to work in specific conditions will work in different condition are “experiments” exempted from infringement (Monsanto Co v Stauffer Chemical Co [1985]).

Thus, this experimental use exemption covers experiments that have the purpose of discovering something new about the subject matter of the invention, and not to verify something already known. This exemption also applies only to research which has a real and direct connection with the invention found in the claims of the patent (Smith Kline & French Laboratories Ltd v Evans Medical Ltd [1989]).

Furthermore, this exemption only applies to experiments relating to the subject matter of the invention and does not apply to experiments that merely use the patented process or product as a part of some other product or process. In other words, exempted experiments are those into or on the patented invention and not those which merely use the patented invention.

It should also be noted that exempted experiments can have a commercial end in view and are not limited to experiments in a non-commercial setting, so long as they meet the criteria of being for finding out something new about the invention.

However, tests carried out in order to further the commercial exploitation, for example, to obtain marketing authorisation, of the product in question are unlikely to be exempt from infringement (Monsanto Co v Stauffer Chemical Co [1985]).

Similarly, tests or trials which are intended to obtain information on the invention in order to satisfy a third party (eg a customer), or which are for demonstrating to a third party that the invention works, are unlikely to fall within the exemption provided by Section 60(5)(b).

In particular, in Corevalve v Edwards, the judge held that, where the potential infringer had several purposes for carrying out the act in question, it is the “preponderant purposes” which matter in assessing whether the act is exempted from being an infringing act. In that case, the act in question was done to further the commercialisation of the product, to generate revenue and to gain information about the product itself. However, the purpose of gaining information about the product was not considered to be the preponderant purpose and the judge considered that the act in question would therefore not be exempted from infringing the patent.

There is little case law relating to the experimental use exemption, such that it is not necessarily simple to predict which acts would fall under this exemption from infringement. However, examples of activities that might benefit from this exemption include tests to discover which amino acid residues of a patented protein are essential for its function, or how an enzyme’s activity can be optimised. Experiments aimed at discovering the mechanism of action of a drug might also be able to benefit from this experimental use exemption.

However, late-stage clinical trials, particularly those aimed at obtaining regulatory approval, are unlikely to be able to benefit from this exemption from infringement. But clinical trials may benefit from other experimental use exemptions, as discussed in other articles in this series.

While the original experimental use exemption provided for by Section 60(5)(b) UKPA 1977 is relatively narrow, UK researchers and R&D departments will be pleased to know that this exemption is not affected by the UK’s recent exit from the European Union.

Part two of this series, on the Bolar exemption, will be published on LSIPR next week.

Sophie Topham is an associate at Marks & Clerk. She can be contacted at  stopham@marks-clerk.com