The Government consultancy paper "The Patent Research Exception: A Consultation" comes in the wake of "The Gowers Review of Intellectual Property", which made a number of suggestions for alterations to the intellectual property system.
Recommendation 1 related to the lack of clarity of the current research exception under section 60(5)(b) 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:
(b) it is done for experimental purposes relating to the subject-matter of the invention;"
The Gowers Review comments that it is unclear which uses fall into the scope of the experimental use exception and that there is very little case law on what amounts to experimental use. This supports the earlier view from "Patents for Genetic Sequences: The Competitiveness of current UK Law and Practice"(1) that the law on the research exception is unclear and requires clarification.
The exception is to allow experimentation in order to discover developments and foster further endeavour even if to an ultimately commercial result. What will not be allowed under the exception however, is the mere proof that the invention works as it was intended (and as set out in its patent). In Monsanto v Stauffer(2), Stauffer had developed a market alternative to Monsanto's patented weed-killer. Stauffer held tests in their research farm and further tests outside of the research farm, where interested parties could observe. Monsanto brought an action for breach of patent, which was successful on the tests completed outside their research farm but failed on the testing done in the research farm. Dillon LJ held:
"Trials carried out in order to discover something unknown or to test a hypothesis or even in order to find out whether something which is known to work in specific conditions, e.g. of soil or weather, will work in different conditions can fairly, in my judgement, be regarded as experiments. But trials carried out in order to demonstrate to a third party that a product works or, in order to amass information to satisfy a third party, whether a customer or a body regulating the safety etc of such products, that the product works as its maker claims are not, it was held, to be regarded as acts done `for experimental purposes'."
The Community Patent Convention states that rights conferred on a patent "shall not extend to acts done for experimental purposes relating to the subject-matter of the patented invention." Despite not being implemented, many European countries follow this draft convention. The US, however, has no statutory guidelines, and although there is case law for the exemption of scientific experiments, this is limited and varies resulting in difficulties. Although Europe does have statutory guidance on the exemption, it is unclear. This lack of clarity inhibits the ability of research groups, particularly in the US and smaller groups with limited budgets, due to the threat of costly legal actions.
"The Ethics of Patenting DNA"(3) suggests that in order to counter this problem, companies work together to uphold the research exception whilst allowing patented DNA or inventions to be unrestricted for any research lacking in commercial intentions. At the same time, the US should put into place a statutory provision whilst the European statutes are clarified to ensure protection for patent holders whose products could potentially be used for commercial profit. However, research must not be impeded by a desire to protect the patent-holders.
One possible alternative the Gowers Review puts forwarded is adopting wording similar to that of the Swiss legislated exception:
"The effects of a patent do not extend:
(b) to acts undertaken for experimental and research purposes in order to obtain knowledge about the object of the invention, including its possible utilities; in particular all scientific research concerning the object of the invention is permitted;"
Responses to the UK Intellectual Property Office (UK IPO) regarding the "Patent Research Exception: A Consultation" are due by 7th November 2008 after which the UK IPO intends to release a report and perhaps enter into further formal consultation depending on the responses received to this initial consultation.
(1) The Department of Trade and Industry (DTI) (2004) - a study to strengthen the body of evidence on the positive impact of the implementation (in 2000) in the UK of the EU Directive for the Legal Protection of Biotechnological Inventions noted that there was “evident uncertainty….about the extent of the patent research exemption, which is widely seen as problematic". The Gowers review considered this report “found that the law on research exemption was widely seen as unclear and in need of clarification”.
(2)  RPC 515
(3) The Nuffield Council (2002) - this discussion paper looked at, inter alia, the research exception in Europe and the US and concluded that “[Even in Europe]…the scope of the exemption is not clear”