Huge Boost To Clinical Research With Landmark Law Change

Landmark UK patent law change will boost clinical research

A massive breakthrough in terms of attracting drug research back to the UK happened yesterday, on the 1st of October a amendment to UK patent law took effect.


The new amendment removes the risk of infringement claims and allows companies to use a patented product when carrying our clinical trials. The change is an addition to the existing ‘Bolar Exemption’, a European Union directive which only protected generic drugmakers from the risk of infringement lawsuits if they conducted trials on a patented product.
The change has removed intellectual property barriers to the research based pharmaceutical industry carrying out clinical trials in the UK. This news also will put the UK on a level playing field with other EU countries with generics players.

Stephen Bennett, a partner in Hogan Lovells London IP practice, told PharmaTimes

one of the issues that drives location for clinical trials is whether that work will escape the risk of patent infringement claims, injunctions stopping trials part way through or ‘stop-go’ injunctions and damages imposed after the event”. This is now “a much more straightforward exercise to clear trials in the UK for patent purposes”, giving research-based companies “more certainty in the planning stage and removes one of the tricky issues from the matrix of factors that need to be addressed to get trials off the ground”.

He added that “although this is a move that the innovator industry will welcome, it is not clear what effect it will have when the new Unitary Patent Court comes into effect”, slated for 2015. Mr Bennett went on to say that the legislation which sets up that system “has its own Bolar provision that is squarely aimed only at trials to generate data for generic authorisation. Given that existing patents end up in this new system by default, there is potential for the revised Bolar to have a short life”.(Original Quote

This news is surely going to be good for the UK and is likely it is going to lead to more research projects taking place in the UK. With further good news in terms of developments in the UK with the announcement of a new alliance to help develop advanced therapies, things look on the up. Also with the change of the patent laws is going to be a big factor in helping new drugs and treatments to the market quicker and avoiding delays. As well as this its always been important to try and attract research projects here in the UK so we retain research skills and expertise and don’t lose these people to other EU nations.

Alex Carson


PiR Resourcing leaders in senior life science resourcing. For more news and information, you can follow us on Twitter and LinkedIn  For all our latest roles in the Life Science sector please click here.


Leave a Reply