Testing Times in the UK: Will Clinical Trials Infringe?

Most European national patent laws provide for an "experimental use exemption" to patent infringement, in many cases based on the Community Patent Convention (CPC).

In the UK, the exemption can be found in section 60(5) of the Patent Act 1977 which provides that:

"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

…"

In general terms, the effect of this provision is that it will not be an infringement of a patent to use a patented product or process for experimental purposes relating to the subject matter of the invention. This defence to patent infringement is of particular interest to the pharmaceutical and agrochemical fields, where some sort of testing activity must be undertaken before a new drug or pesticide can be placed on the market.