The Intellectual Property Office (IPO) is proposing to lift the restrictions on the use of existing drugs in pharmaceutical R&D by means of a Legislative Reform Order (LRO) under section 1 of the Legislative and Regulatory Reform Act 2006 (LRRA).
The IPO believes that this will make it easier for companies to compare a new drug to a branded product that is not their own or to test a combination of both drugs.
The proposed amendments to the Patents Act by the IPO would rule that the use of a branded drug in a clinical or field trial does not infringe copyright, which has the backing of the pharmaceutical industry.
At the moment, UK law allows limited use of patented drugs in tests required for the regulatory approval of generic drugs, but not of new brands, so the IPO is aiming to create a better environment for pharmaceutical R&D in the UK.
The purpose of the consultation is to get stakeholders’ views on proposals to amend section 60(5) of the Patents Act 1977 to provide an exception to patent infringement for activities involved in preparing or running clinical or field trials which use innovative, or non-generic, drugs. It is also seeking evidence of the costs and specific examples of the burdens which current legislation places on stakeholders.
The Government has already prepared an initial assessment of the impacts of the measures proposed in the consultation and the IPO is seeking more thorough evidence through the consultation on which to base policy decisions and legislation.
The consultation is directed at all interested parties including owners of pharmaceutical patents and bodies involved in the organisation or performance of clinical or field trials using pharmaceuticals in the UK and ends on 19 December.
For more information about intellectual property law, speak to our solicitor Chloe Bunn.