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Does Every Experiment Need a Test Tube?

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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.

There are reasons why the pharmaceutical industry would have particular concerns about this piece of law: patents will typically be in force while clinical trials are still ongoing, and clinical trials will often have enough of a public aspect that it will be clear to an unfriendly patent owner that the trials are taking place.  However, there are many other technical areas where it may be important to demonstrate to third parties how well an invention works in the real world – one example would be in standardisation of communications technology, where it may be important to experiment with use of different proprietary technologies together in order to reach a best overall solution.  It isn’t clear that this would qualify as “experimental purposes relevant to the subject-matter of the invention” – it could well do under the leading case of Monsanto v. Stauffer Chemical [1985] RPC 515 CA (which looks to the creation of new knowledge as critical), but it might not, and it would be nice to know.

While there’s a consultation for s.60(5)(b), there isn’t one for s.60(5)(a), which provides an exception to infringement for private and non-commercial acts.  The view is often expressed that this protects academic research, but cannot protect any research carried out by, for example, a corporate research laboratory.  This interpretation does not appear to match up well with reality, in which universities commercialise much research activity through licensing and carry out contract research, and in which corporate research labs may carry out a significant amount of “blue sky” research with no direct commercialisation path.  Can a public body carry out a commercial act (probably) or a commercial body carry out a non-commercial act (not so clear)?  Again, it would be nice to know without having to ask a court.


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