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There are currently no known outstanding effects for the The Patents (Amendment) (EU Exit) Regulations 2019, Section 54.
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54. For Articles 2 (scope) and 3 (conditions for obtaining a certificate), substitute—
A product may, under the terms and conditions provided for in this Regulation, be the subject of a certificate if it is—
(a)protected by a patent; and
(b)the subject of a UK [F1, GB or NI] authorisation prior to being placed on the market as a medicinal product.
Where an application is submitted under Article 7, a certificate shall be granted if, at the date of submission of that application—
(a)the product is protected by a basic patent in force;
(b)there is a valid UK [F2, GB or NI] authorisation to place the product on the market;
(c)the product has not already been the subject of a certificate;
(d)the authorisation referred to in point (b) is the first UK [F3, GB or NI] authorisation to place the product on the market as a medicinal product [F4in the territory of the United Kingdom, the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be].”.
Textual Amendments
F1Words in reg. 54 inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(4) (with reg. 7)
F2Words in reg. 54 inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(5)(a) (with reg. 7)
F3Words in reg. 54 inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(5)(b)(i) (with reg. 7)
F4Words in reg. 54 inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(5)(b)(ii) (with reg. 7)
Commencement Information
I1Reg. 54 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
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