'Bolar' Exemption to Patent Infringement Enacted in the UK

With time to spare, the European Directive (2004/27/EC) containing a ‘Bolar' exemption to patent infringement for generic pharmaceutical manufacturers (see Withers & Rogers IP Review, August 2005) has been enacted in the UK.

The amendments to the Patents Act 1977 will come into force on 30th October 2005.

The relevant statutory instrument (2005 No. 2759) specifies (Regulation 3) that section 60 of the Patents Act 1977 shall be amended such that:

  "An act which would constitute an infringement of a patent shall not do so if - 

(i) it consists of -

(i) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of [the relevant parts of the European Directives relating to the requirements for marketing approval of generic medicines], or

(ii) any other act which is required for the purpose of the application of those paragraphs."

Our IP Review listed a number of acts which, in the opinion of the Medicines and Healthcare Products Regulatory Agency at the time, would not constitute patent infringement. 

It remains to be seen how the UK courts will interpret the new law and the Directive to which it gives effect. In any event, the outlook for generic pharmaceutical manufacturers wishing to carry out studies in the UK must have improved.

In relation to the other EU member states, we understand from German colleagues that the implementation of the Bolar exemption may be even more pro-generic in Germany. It is possible that the German exemption will apply not only to generic products, but that trials conducted on patented, but not previously marketed, compounds may also be exempt. In addition, it could be that tests conducted in Germany, with a view to obtaining marketing authorisation outside Germany, may also benefit from the exemption. The position in Germany is not, however, clear as yet. Apparently, Italy could also be implementing the European Directive using a less literal interpretation than the UK.