The UK government has tabled an amendment to the Patents Act which would exempt activities involved in preparing or running clinical trials for innovative drugs from patent infringement actions.
The Legislative Reform (Patents) Order 2014 was laid before Parliament earlier this month, following a consultation on the proposals by the UK Intellectual Property Office (IPO). This found an “overwhelming” desire to change Section 60(5) of the Patents Act 1977 – also know as the Research and Bolar Exemptions.
The government response to the consultation noted that 94% of responses had called for the amendment to allow activities carried out for regulatory approval to be exempted from patent infringement, while 63% also said that it should exempt activities which are conducted for health technology assessment (HTA). The government agreed that all these activities should be exempt, and that the law should therefore be changed to make the UK “a more attractive location for R&D, supporting growth and innovation.”
The UK Research and Bolar Exemptions were established 10 years ago by the European Union (EU)’s Directive 2004/27/EC, which states that trials necessary to get a medicine approved should be exempt from patent infringement actions. However, experts at patent and trade mark attorneys Withers & Rogers point out that the Directive has been interpreted narrowly in the UK to mean that only clinical trials conducted to support market approval of generic drugs would be exempt from infringement, while other EU countries, such as Germany and Italy, have interpreted the Directive “more broadly.”
Welcoming the draft amendment, patent attorney Dr Nicholas Jones, a partner with Withers & Rogers, said it is likely to lead to more research projects taking place in the UK, and should also help to avoid delays when bringing new drugs and treatments to market.
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, and 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,” said Dr Jones.
Ministers are proposing that the Legislative Reform (Patents) Order 2014 will come into effect on October 1 this year.