Proposed Unified Patent Court in UK Moves Forward to Foster Expansion of Life Sciences Industry
A proposal for a United Kingdom (UK) Unified Patent Court has been under consideration by the British Parliament in recent weeks. The proposal would amend the UK Patents Act to allow life science companies to perform broader clinical testing without risking patent infringement. Supporters of the proposal suggest that the amended provisions will foster greater innovation and limit patent disputes within the medical device and pharmaceutical industry.
Currently, the UK Patent Acts exempts experimental acts related directly to a new medical invention from patent infringement violations. However, recent case law interpreted this exemption very narrowly to exclude clinical trials.
The European Union (EU) Bolar Directive also exempts acts performed in the pursuit of market approval for generic drugs. The Bolar Directive, however, only applies to EU member states and not to the UK. Therefore, UK life science companies can only enjoy this exemption when conducting trials for market approval in the EU, outside of the UK.
These developments have discouraged life science development and innovation in the UK and have frozen much of the clinical testing performed within the country. In an effort to make the business and legal environment more attractive to the industry, the UK proposed amendments last year to the UK Patents Act to exempt clinical trials from patent infringement. The proposal was well received by politicians, the business community and other stakeholders, and is currently awaiting approval in Parliament. If the legislation moves forward on schedule, it will take effect in October 2014. The amendments could reasonably achieve the intended objective of expanding pharmaceutical and medical device development and innovation in the UK.
- Draft Legislative Reform Order to the UK Patents Act – http://www.legislation.gov.uk/ukdsi/2014/9780111114537/pdfs/ukdsi_9780111114537_en.pdf