Amendments of the Patents Act 19773

In section 60 of the Patents Act 197718 (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.

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 products19 as amended by Directive 2004/28 of the European Parliament and of the Council20;

  • “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