{
  "url": "https://openlegislation.uk/medicines-marketing-authorisations-etc-amendment-regulations-2005/regulation-3",
  "json_url": "https://openlegislation.uk/medicines-marketing-authorisations-etc-amendment-regulations-2005/regulation-3.json",
  "legislation": "uksi/2005/2759",
  "legislation_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005",
  "legislation_url": "https://openlegislation.uk/medicines-marketing-authorisations-etc-amendment-regulations-2005",
  "path": "regulation/3",
  "kind": "regulation",
  "number": "3",
  "heading": "Amendments of the Patents Act 1977",
  "text": "In section 60 of the Patents Act 1977 (meaning of infringement)—\n(a) in subsection (5), after paragraph (h), insert the following—\n“(i) it consists of—\n(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\n(ii) any other act which is required for the purpose of the application of those paragraphs.”, and\n(b) in subsection (7), at the end insert the following—\n““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;\n“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”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "1977 c. 37."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No. L311, 28.11.2001, p.1."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ No. L136, 30.4.2004, p.58."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2005/2759/regulation/3",
    "retrieved_at": "2026-10-29T04:49:21.883121+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}