The UK government has just announced proposals to expand the scope of section 60(5) of the UK Patents Act 1977 (which exempts certain acts from patent infringement). The proposals, should they be implemented, will mean that activities relating to the preparation and running of clinical trials for innovative drugs will be exempt from patent infringement in the UK.
UK law already provides certain, very limited, exemptions from patent infringement. These include acts ‘done for experimental purposes relating to the subject matter of the invention’ (the ‘experimental use exemption’ – section 60(5)(b) of the Act) but this provision has been interpreted very narrowly by the UK Courts and generally does not apply to acts done in order to obtain regulatory approval for a new drug.
There is also a specific exemption (section 60(5)(i) of the Act) relating to the activities needed to obtain regulatory approval for generic drugs, in accordance with certain EU Directives (commonly called the ‘Bolar exemption’). However, this provision does not extend to acts performed in order to obtain regulatory approval for innovative drugs.
As explained in the press release from the Department of Business, Innovation and Skills (BIS): “There are many instances where a company may legitimately need to use a patented drug in a clinical trial, for example to compare their new drug to a patented product, or to develop therapies which combine the use of their new drug and a patented product. Currently, if a pharmaceutical company uses a patented product as part of their trial they risk being sued by the patent holder…”
The changes to the law now being proposed by the UKIPO would result in a broader exemption, which applies to activities involved in preparing or running clinical or field trials which use innovative drugs.
The press release from the Department of Business, Innovation and Skills can be read here and the UKIPO consultation paper can be found here. The formal consultation process will last 8 weeks, from 24 October 2012.