The Legislative Reform (Patents) Order was approved by Parliament in July 2014 and will come into force on 1 October 2014. The Order clarifies that activities relating to medicinal product assessments are within scope of the experimental use exception (also known as the research exception).
The changes will allow companies to use a patented product, when carrying out medicinal product assessments, either to provide information to the regulatory authorities or for health technology assessment.
The changes meet a government commitment to ensure the IP system supports the life sciences sector.
Changes to patent law
The Legislative Reform (Patents) Order introduces changes to the Patents Act which clarify that medicinal product assessments are exempt from patent infringement by virtue of the existing research exception.
Supporting information
Further information can be found in on changes to patents legislation made by the Legislative Reform (Patents) Order 2014.