The Bolar Exemption

United Kingdom implementing legislation

The United Kingdom implementing legislation came into force on the 30 October 2005 and amends Sections 60(5) and 60(7) of the Patents Act 1977.

Paragraph (h) of Section 60(5) will be followed by new paragraph (i) which reads:

"(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 paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC, or

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

and Section 60(7), the following will be inserted:

"Directive 2001/82/EC" means Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, as amended by Directive 2004/28 of the European Parliament and of the Council;”

"Directive 2001/83/EC" means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended by Directive 2002/98/EC of the European Parliament and of the Council, by Commission Directive 2003/63/EC and by Directives 2004/24/EC and 2004/27/EC of the European Parliament and of the Council".

Activities associated with the development of any of the products supported by 'abridged’ dossiers relying on data for reference products without consent, and submitted under the new amendments would qualify for this exemption where otherwise patent rights or supplementary protection certificates are in force in the UK.