On 24th October 2012, the UK Intellectual Property Office (IPO) launched a formal consultation on proposals to amend the Patents Act. The proposed changes would allow clinical and field trials for new drugs to be carried out without the risk of patent infringement. The proposal is of course relevant to patent holders in the pharmaceutical field.
The proposal is also relevant to organisations undertaking clinical or field trials in the UK, such as pharmaceutical companies, and clinical research organisations etc, who undertake trials on behalf of clients. This formal consultation is in response to concerns by these organisations, that the current UK regulatory framework puts them at risk of patent infringement when running clinical or field trials. This in turn results in an unwillingness to conduct them in the UK.
The consultation document can be found here and it is possible to comment on the proposal submit comments via annex B of the document. The deadline for submitting comments is 19th December 2012.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.