The UK Intellectual Property Office has recently launched a consultation entitled “The Research and Bolar Exceptions”.  While all patent practitioners may have got as far as the end of the title, the profession will split into two groups after reading the subtitle, “A formal consultation on patent infringement in clinical and field trials”, indicating that this is another exercise in sculpting patent law specifically for the pharmaceutical industry.

This all relates to the interpretation of s.60(5)(b) of the Patents Act 1977, which states that:

“An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if… it is done for experimental purposes relevant to the subject-matter of the invention;”

Most European countries have a similar provision as a result of the harmonisation in European patent law associated with the creation of the Community Patent and European Patent Conventions in the 1970s.  Different countries, however, interpret this provision in quite different ways.  The UK courts have interpreted this exception narrowly, leading to widespread concern that the UK is out of step in not having a clear exception for clinical trials.

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