Research Exemption for Patent Infringement
The UK IPO has just announced a consultation on whether to put in place legislation to extend (or even increase) the clinical trials exemption (the 'Bolar' exemption) that already exists for generic medicines to innovative medicines as well.
Historically, the UK Patents Court has been regarded as giving a narrow interpretation of what constitutes an 'experimental use' under s.60(5)(b) Patent Act 1977 (at least in contrast to some other countries, such as Germany). Whether the UK law is as narrow as the Consultation suggests may be questionable, but the UK IPO feels that clarification is necessary and that our law should be brought into line with other countries in the EU (although there is, in fact, no consistent approach in all countries).
The Consultation proposes 3 different ways to 'extend' the exemption:
- to cover all activities needed for regulatory approval in all countries;
- to cover all activities needed for regulatory approval just in EU/EEA; and
- to cover all activities needed not just for regulatory approval but also 'health technology assessment'.
This latter suggestion could be controversial, especially as whether the exception should apply not just to clinical trials but also for 'data for marketing and/or use for public health procurement' (eg, to satisfy NICE criteria).
A less controversial proposal is to extend any exemption to 'field trials' for veterinary medicines under field conditions in target animals.
The Consultation is available at http://www.ipo.gov.uk/pro-policy/consult/consult-live/consult-2012-bolar.htm and closes on 19 December 2012.