Will changes to patent infringements attract drug research in the UK?

Abstract

Ever since the introduction of the ‘Bolar’ exemption into the national laws of the EU Member States, the UK has been perceived to be a relatively difficult territory in which to conduct clinical trials, as compared to EU territories having very broad ‘Bolar’ exemptions, such as France and Germany. This problem for the UK has now been comprehensively eliminated by an amendment to UK patent law that came into force on 1 October 2014. However, whilst addressing a problem faced by the pharmaceutical industry in connection with conducting clinical trials, the manner in which UK patent law has been amended raises important but as yet unanswered questions about the knock-on effects for enforcement of European patents having unitary effect, if and when the laws governing such patents come into force.

Keywords:

• bolar
• exemptions
• experimental use
• patent enforcement
• patent infringement
• unitary patent

Declaration of interest

The author has no relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript that may affect the views expressed in the article. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.