Change to UK Patents Act Removes Infringement For Use Of Clinical Trial Data

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The United Kingdom government has announced a change to the UK Patents Act that it says will help keep the country’s life sciences industry at the forefront of innovation by removing certain risks of drug development companies infringing patents.

The change announced on 26 February came in response to a UK Intellectual Property Office consultation on research and Bolar exceptions that showed overwhelming support for the change. The belief is that removal of these risks will make the UK more attractive for running clinical (for human products) and field trials (for veterinary products).

“The problem of patent infringement in clinical trial and research is that there is no equivalent exception to Bolar in the UK patent law for work needed to approve new, innovative medicines where this work involves using medicines covered by patents belonging to someone else,” the IP office said.

Most other European Union countries exempt all clinical or field trial work with medicines from patent infringement, making the UK uncompetitive, it said.

The consultation ran for eight weeks from 24 October to 19 December 2012 and can be found here.

The full response to the consultation can be found here [pdf].

The Bolar exception “allows the research needed to gain regulatory approval to sell generic medicines to be undertaken without infringing any patented medicines,” the UKIPO said.

Creative Commons License"Change to UK Patents Act Removes Infringement For Use Of Clinical Trial Data" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

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