The Legislative Reform (Patents) Order 2014 was tabled in Parliament (6th May 2014) and is backed by an existing EU directive, which had been applied in a restricted manner in the UK. This proposed amendment will significantly broaden the exemption that applies under current UK legislation when testing medicinal products and make the position at least as generous as that in some other parts of the EU.
The UK Intellectual Property Office (UKIPO) has been calling for patent law to be changed for some time and in February 2013 the Government confirmed that action was needed to ‘make the UK a more attractive location for research and development, supporting growth and innovation.’
Specifically, the draft exemption relates to an EU Directive often referred to as the ‘Bolar provision’ which was passed in 2004 before being implemented into national law. This Directive states that trials necessary to get approval of a medicine should be exempt from patent infringement actions. However, this was interpreted narrowly in the UK to mean that only clinical trials conducted to support market approval of a ‘generic’ product would be exempt from infringement. Other countries, such as Germany and Italy, interpreted the Directive more broadly.
Dr Nicholas Jones, partner and patent attorney at Withers & Rogers, said:
“The draft amendment is good news for UK research and is likely to lead to more research projects taking place here. This is important because we need to retain research skills and expertise and it should also help to avoid delays when bringing new drugs and treatments to market.”
Commenting on the impact of delays when preparing to bring a new drug or treatment to market, Dr Nicholas Jones added:
“In order to bring a new drug to market, pharmaceutical companies have to invest very large sums of money in research and development. This is a high-risk process, with a high probability of failure. Prior to the introduction of this amendment, companies were faced with the additional risk of being sued for patent infringement if the drug fell within a competitor’s patent. This could prevent clinical trials from taking place. If the amendment is passed into law, patent infringement risks will be greatly reduced when conducting clinical trials. This should make it easier for the industry to bring new products to market employing research carried out in the UK.”