Update on Clinical Trials Legislative Reform Order

5 December 2013

You may have heard that there are plans in place to broaden the scope of exceptions to infringement in the UK Patents Act in relation to clinical trials and health technology assessment. These changes are intended to bring UK legislation more in line with some other EU member countries, for example to exempt infringement by clinical trials of innovative drugs in addition to the current exception for generic drugs. We have learnt via one of our partners, Simon Wright, who is on CIPA Council that consultation with interested parties resulted in a decision to go forward with changes to the legislation but there will now be some delay compared to the original timescale which envisaged legislation in April 2014. The proposal for legislative reform will now be put before Parliament in the first half of 2014, such that the changes will be implemented at the earliest in October 2014.

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