The Legislative Reform (Patents) Order 2014 (the “Order”) is scheduled to come into force on 1 October 2014 (this may change during Parliamentary debate). The Order seeks to remove the risk of infringement to patents that could occur during an assessment of a medicinal product and is designed to bring clinical trials back to the UK.
The situation currently means that pharmaceutical companies are at risk of patent infringement when they are in the process of obtaining market approval for their new drugs/therapies. This risk of infringement has resulted in a drop in clinical trials and other tests related to new medicinal products.
Key changes under the Order
Clause 2 of the Order makes amendments to the Patents Act 1977. The main change being that anything done to conduct a medicinal product assessment (whether for human or veterinary use) will not be found to be an infringement of a patent as it will be classed as experimental. Therefore, any course of testing such as clinical trials or field trials which are attempting to gather data to obtain or vary authorisations to sell or supply, comply with a regulatory requirement or enable a organisation/individual to provide health technology assessments, advice or information about suitability of a product, will not be found liable of patent infringement.
These changes broaden the so-called ‘Bolar Exemption’, widening the remit in respect of health technology assessments and trials. A broader example of the Bolar Exemption is already in effect in a number of other EU member states and these changes will bring the UK further in line with these countries.
A number of issues were debated during the consultation. One concern raised was in relation to research tool patents and whether these tools should be exempt under the Order for the purposes of obtaining data for regulatory approval. The current wording of the Order is wide enough to cover their use.
The Order has been submitted for consideration by the relevant Parliamentary Committees and if the wording adopted for the Order is similar to the current draft, implementation should result in reduced costs for pharmaceutical companies as they will not have to ascertain possible infringement risks prior to conducting any assessment. The Order is also likely to encourage the pharmaceutical industry to conduct trials within the UK.