The line between experimental use and pure exploitation is drawn differently in different jurisdictions in the EU. Most countries in the EU have a legislated experimental use exception. This is as a result of the Community Patent Convention 1975 ('CPC'). However, as the CPC was never implemented, there is no EU-wide harmonised exception and the width of the exception differs from country to country. For example, Austria has no experimental use exception but the UK and Germany have one which uses almost the same wording as that set out in Article 27 of the CPC although Germany has a very liberal interpretation of the exception as opposed to the UK.
However, in order to ensure the viability of the European generics pharmaceutical industry as against the same industry in the US, Article 10 of the Directive 2001/83/EC of the European Parliament and Council of 6 November 2001 on the Community code relating to medicinal products for human use ("Directive") was amended in 2004 to include a European version of the US Bolar exemption as new Article 10(6). In contrast to the US, the EU Bolar exemption only applies to generics' use of patented products for the purposes of filing abbreviated new drug applications based on the clinical trial evidence of the patented and authorised product previously submitted by the owners of the patented products to regulatory authorities. This led to a new section 60(5)(i) of the Patents Act 1977 (UK) in 2005 which includes by reference the wording used in the amended Directive and thus the Bolar exemption was introduced into UK law as a specific type of experimental use exception or research exemption. This is to be contrasted with Germany's approach to the research exemption which after implementing Article 10 of the Directive still remains wide enough so that pharmaceutical innovators may also to take advantage of it (as opposed to in the UK where they cannot).
The UK government has been consulting on this exemption in various forms since 2004. Now, on 24 October 2012, as a result of the responses to the most recent 2011 UK IPO informal consultation, a formal consultation has been launched by the UK IPO on the Research and Bolar Exceptions in the UK regarding expanding the Bolar exemption to cover clinical and field trials for new drugs (in addition to generic drugs). The consultation consists of ten questions seeking input on the type of changes to section 60(5) of the Patents Act 1977 (UK), and the impact of the changes in terms of costs savings (where an innovator could run trials which involve a patented product) and possible losses (where an innovator could not prevent another innovator from using the first innovator’s patented product as part of the other innovator’s trial).
Extending the exemption is a double-edged sword for innovators as they may benefit by being able to run some of their trials earlier but they could also lose as other innovators could also run their studies earlier thus getting their competing or improvement products into the market earlier.
However, these questions have been asked before when the players were not competing innovators, they were generics competing with innovators and this gateway was opened for the generics to obtain this cost and timing advantage. Therefore, to have a truly level pharmaceutical playing field, perhaps the answer is to let all the players onto that field without risk of patent infringement when running clinical or field trials. This not only levels the playing field in the UK within the industry but levels the playing field with countries such as Germany and the US in an effort to attract valuable pharmaceutical trial budgets to be spent in the UK.
Responses to this latest UK IPO consultation are due by 19 December 2012 with proposed legislative changes to be implemented by 1 October 2013. It is anticipated that the responses are unlikely to be surprising. However, any (further) erosion of legitimate patent rights should always be contemplated carefully.