Patent Law Amendment Could Increase UK Clinical Trials

A major change to UK patent law which took effect yesterday could help attract more clinical studies to the UK.

The amendment to the patent law allows organisations to use a patented product when carrying out clinical trials, removing the risk of infringement claims.

The amendment is an addition to the existing ‘Bolar Exemption’, a European Union directive which protected generic drugmakers from infringement lawsuits if they conducted clinical trials on a patented product.

The new change now also protects the research-based pharmaceutical industry conducting clinical studies in the UK, putting the UK on an equal standing to other European countries and allowing research-based pharmaceutical companies the same protection as generics drugmakers.

Nicholas Jones, partner and patent attorney at Withers & Rogers, acknowledged that the change is good news for the UK, adding that the fact that it could lead to attracting more clinical trials to the UK “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.”

Stephen Bennett, a partner in Hogan Lovells London IP practice, also commented that “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.”

The change in patent law for the UK therefore provides a research-based companies with a “more straightforward exercise to clear trials in the UK for patent purposes”, which gives them “more certainty in the planning stage.”


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