Section 357BBA | Rights to which this Part applies: EU rights F1F2
From legislation.gov.uk
31 December 2020
(1)This Part applies to the following rights—F1F2
(a)an EU supplementary protection certificate, andF1F2
(b)any Community plant variety rights granted under Council Regulation (EC) No 2100/94.F1F2
(a)a person holds a marketing authorisation in respect of any product in accordance with any legislation having effect in EU law, andF1F2
(b)the product benefits from EU marketing protection (see subsection (3)) or EU data protection (see subsection (4)),F1F2
the person is to be treated for the purposes of this Part as having been granted a right to which this Part applies in respect of the product.
(3)A product benefits from EU marketing protection if—F1F2
(a)the product benefits from marketing protection by virtue of Article 14.11 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medical products for human use, orF1F2
(b)any of the following prohibitions is in force—F1F2
(i)the prohibition on placing on the market a generic of the product imposed by Article 10.1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use,F1F2
(ii)the prohibition imposed by Article 8.1 of Regulation (EC) No 141/2000 of the European Parliament and the Council of 16 December 1999 on orphan medicinal products, andF1F2
(iii)the prohibition on placing on the market a generic of the product imposed by Article 13.1 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products.F1F2
(4)A product benefits from EU data protection if—F1F2
(a)the product benefits from the data exclusivity conferred by Article 10.5 of Directive 2001/83/EC of the European Parliament and of the Council,F1F2
(b)the prohibition on referring to the results of tests or trials in relation to the product imposed by Article 74a of that Directive is in force, orF1F2
(c)data relating to the product benefits from data protection under Article 59 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market.F1F2
(5)The reference to data in subsection (4)(c) does not include a study necessary for the renewal or review of a marketing authorisation granted in respect of the product in accordance with Regulation (EC) No 1107/2009.F1F2
(6)In this section “EU supplementary protection certificate” means a certificate issued under—F1F2
(a)Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, orF1F2
(b)Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products.F1F2
(7)A reference in this section to any EU legislation is a reference to that legislation as it has effect in EU law.F1F2
(8)The Treasury may by regulations—F1F2
(a)amend this section so as to make provision about the circumstances in which a product benefits from EU marketing protection or EU data protection for the purposes of subsection (2);F1F2
(b)make such provision amending any reference in this section to EU legislation as appears to the Treasury appropriate in consequence of any EU legislation amending or replacing that EU legislation.F1F2
(9)Regulations under subsection (8) may make any incidental, supplemental, consequential, transitional or saving provision, including provision amending or modifying this Part.F1F2