Section 357BB | Rights to which this Part applies F1
From legislation.gov.uk
(1)This Part applies to the following rights—F1
(a)a patent granted under the Patents Act 1977,F1
(b)a patent granted under the European Patent Convention,F1
(c)a right of a specified description which corresponds to a right within paragraph (a) or (b) and is granted under the law of a specified EEA state,F1
(d)a supplementary protection certificate, andF1F2
(e)any plant breeders' rights granted in accordance with Part 1 of the Plant Varieties Act 1997,F1
(2)Where—F1
(a)directions are in force under section 22 of the Patents Act 1977 (information prejudicial to national security or safety of public) with respect to an application for a patent under that Act, andF1
(b)the person making the application has been notified under section 18(4) of that Act that the application complies with the requirements of the Act and the rules,F1
the person is to be treated for the purposes of this Part as if the person had been granted the patent under that Act.
(3)Where a product benefits from marketing protection (see subsection (4)) or data protection (see subsection (5)), the person who holds the relevant marketing authorisation in respect of the product (see subsection (6A)) 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.F1F4
(4)A product benefits from marketing protection if—F1F4
(a)a marketing authorisation under the Human Medicines Regulations 2012 has been granted in respect of the product and the period during which a generic of the product may be prevented from being sold by reason of regulation 51(8) of those Regulations has not expired;F1F4
(b)an orphan marketing authorisation under the Human Medicines Regulations 2012 has been granted in respect of the product and the prohibition arising in connection with that authorisation under regulation 58D(1) of those Regulations remains in force;F1F4
(c)a marketing authorisation to which paragraph 6 of Schedule 33A to the Human Medicines Regulations 2012 applies has been granted in respect of the product and the holder of the authorisation continues to benefit from marketing exclusivity by reason of sub-paragraph (4)(f) or (7) of that paragraph;F1F4
(d)a marketing authorisation under the Veterinary Medicines Regulations 2013 has been granted in respect of the product and the period during which an equivalent of the product may be prevented from being placed on the market by paragraph 11(3) of Schedule 1 to those Regulations has not expired.F1F4
(5)A product benefits from data protection if—F1F4
(a)a marketing authorisation in respect of the product under the Human Medicines Regulations 2012 has been granted or varied in circumstances giving rise to the prohibition in regulation 51(16) or 64A(3) of those Regulations and that prohibition remains in force;F1F4
(b)a marketing authorisation under Regulation (EC) No 1107/2009 has been granted in respect of the product and data relating to the product benefits from data protection under Article 59 of that Regulation.F1F4
(6)The reference to data in subsection (5)(b) 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.F1F5
(6A)In subsection (3) the relevant marketing authorisation is the marketing authorisation by reference to which it is determined that the product benefits from marketing protection or data protection.F1F6
“European Patent Convention” means the Convention on the Grant of European Patents,
“Regulation (EC) No 1107/2009” means 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,
“rules” means rules made under section 123 of the Patents Act 1977,
“specified” means specified in an order made by the Treasury, and
“supplementary protection certificate” means a certificate issued under—
(a)Council 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, or
(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.
(8)The Treasury may by order—F1
(a)amend this section so as to make provision about the circumstances in which a product benefits from marketing or data protection for the purposes of subsection (3);F1F8
(9)An order made under this section may make any incidental, supplemental, consequential, transitional or saving provision, including provision amending or modifying this Part.F1