3. In section 60 of the Patents Act 1977(1) (meaning of infringement)—
(a)in subsection (5), after paragraph (h), insert the following—
“(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
(b)in subsection (7), at the end insert the following—
““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(2) as amended by Directive 2004/28 of the European Parliament and of the Council(3);
“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”.