Statutory Instruments
Exiting The European Union
Patents
Made
4th April 2019
Coming into force in accordance with regulation 1
A draft of these Regulations has been approved by resolutions of both Houses of Parliament pursuant to paragraph 1(1) of Schedule 7 to the European Union (Withdrawal) Act 2018 M1.
The Secretary of State, in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 2018, makes the following Regulations:
1. These Regulations may be cited as the Patents (Amendment) (EU Exit) Regulations 2019 and come into force on exit day.
Commencement Information
I1Reg. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
2. The Patents Act 1977 is amended follows.
Commencement Information
I2Reg. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
3. In section 128A (EU compulsory licences)—
[F1(a)in the heading for “EU compulsory”, substitute “Compulsory pharmaceutical”;
(b)in subsection (1), for “an “EU compulsory”, substitute “a “compulsory pharmaceutical”;]
(c)in subsection (2)—
(i)for “EU compulsory”, substitute “ compulsory pharmaceutical ”;
(ii)“an EU compulsory”, substitute “a compulsory pharmaceutical”;
(d)in subsection (5), for “an EU compulsory”, substitute “ a compulsory pharmaceutical ”.
Textual Amendments
F1Reg. 3(a)(b) substituted (31.12.2020 immediately before IP completion day) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 27
Commencement Information
I3Reg. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Prospective
F24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F2Reg. 4 omitted (31.12.2020 immediately before IP completion day) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 28
5.—(1) Section 281 (power of comptroller to refuse to deal with certain agents) of the Copyright, Designs and Patents Act 1988 M2 is amended as follows.
(2) In subsection (5), for the words from the words “another” to the end, substitute “ a member State ”M3 .
Commencement Information
I4Reg. 5 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M3Article 4 of S.I. 2011/1043 provided that references to the European Union are substituted for references to the European Communities.
6. The Patents and Plant Variety Rights (Compulsory Licensing) Regulations 2002 M4 are amended as set out in this Part.
Commencement Information
I5Reg. 6 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
7.—(1) Regulation 2 (interpretation) is amended as follows.
(2) In paragraph (1)—
(a)omit the definition of “Community plant variety right”;
(b)omit the definition of “Council Regulation”;
(c)for the definition of “plant breeders' rights”, substitute—
[F3““plant breeders’ right” means—
any right granted under, or having effect as if granted under, section 3 of the 1997 Act (including existing rights as defined by section 40(4) of that Act); and
any right which by virtue of regulation 3 of the Plant Breeders’ Rights (Amendment etc.) (EU Exit) Regulations 2019 is treated as if it were a plant breeders’ right granted in accordance with the 1997 Act and as if the variety were registered in accordance with regulations under section 18(1)(c) of the 1997 Act;”].
Textual Amendments
F3Words in reg. 7(2)(c) substituted (31.12.2020 immediately before IP completion day) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 29
Commencement Information
I6Reg. 7 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
8.—(1) Regulations 3 (applications) and 6 (grant) are amended as follows.
(2) Omit “or a Community plant variety right” and “or Community plant variety right” wherever they occur.
Commencement Information
I7Reg. 8 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
9. In regulation 7 (conditions), omit paragraphs (4) and (5).
Commencement Information
I8Reg. 9 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
10. Omit regulation 15 (Community plant variety rights.).
Commencement Information
I9Reg. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
11. In regulation 16 (variation and revocation), omit paragraphs (4) to (7).
Commencement Information
I10Reg. 11 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
12. In regulation 17, for paragraph (2), substitute—
“(2) Where a decision of the controllers relates to a compulsory patent licence or cross licence ordered to be granted under regulation 7(2) or 7(3), an appeal may be made to the court.”.
Commencement Information
I11Reg. 12 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
13.—(1) Regulation 20 (extension of powers to make rules and regulations) is amended as follows.
(2) In paragraph (a), for “regulations 3(1) and 15(1)”, substitute “ regulation 3(1) ”.
(3) In paragraph (b)—
(a)for “regulations 8 and 16(4)” substitute “ regulation 8 ”; and
(b)for “regulations 9 and 16(5)”, substitute “ regulation 9 ”.
Commencement Information
I12Reg. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
14.—(1) Regulation 22 (application of existing rules and regulations) is amended as follows.
(2) In paragraph (1), for “regulations 7(2), 7(3) and 15(3)”, substitute “ regulation 7(2) and 7(3) ”.
(3) In paragraph (2), for “other than in relation to an application under regulation 15(1), and with any other necessary modifications”, substitute “ with any necessary modifications ”.
Commencement Information
I13Reg. 14 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
15. In regulation 24, omit “or 15(1)”.
Commencement Information
I14Reg. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
16.—(1) Regulation 26 (application of 1977 and 1997 Acts) is amended as follows.
(2) In paragraph (1), in both places where it occurs, for “regulations 7(2), 7(3) and 15(3)”, substitute “ regulation 7(2) and 7(3) ”.
(3) In paragraph (3), for “regulations 15(1), 16(3) and 16(4)” substitute “ regulation 16(3) ”.
Commencement Information
I15Reg. 16 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Prospective
F417. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F4Reg. 17 omitted (31.12.2020 immediately before IP completion day) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 30
18.—(1) The Patents Rules 2007 M5 are amended as follows.
(2) In rule 85(1), omit from “, but not resident” to “the Civil Jurisdiction and Judgements Act 1982”.
(3) In rule 103(4), for “another EEA state”, substitute “ an EEA state ”.
(4) In Part 1 of Schedule 3—
(a)in the entry relating to Article 5(c) of the Compulsory Licensing Regulation, for “EU compulsory”, substitute “ compulsory pharmaceutical ”; and
(b)in the entries relating to Articles 6(1), 16(1) and 16(4), for “an EU compulsory”, substitute “ a compulsory pharmaceutical ”.
Commencement Information
I16Reg. 18 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M5S.I. 2007/3291. S.I. 2007/3291 has been amended on a number of occasions but only the amendments made by S.I. 2009/546, regulations 8 and 9 are relevant.
19. 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 is amended as set out in this Part.
Commencement Information
I17Reg. 19 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
20.—(1) Article 1 (definitions) is amended as follows.
(2) In paragraph 1(c), omit “Council or Commission”.
(3) After paragraph 10, insert—
“11. ‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;
[F512. ‘court’ means—
(a)as respects England and Wales, the High Court;
(b)as respects Scotland, the Court of Session;
(c)as respects Northern Ireland, the High Court in Northern Ireland];
13. ‘EEA authorization’ means an authorization to place a plant protection product on the market which has effect in an EEA state in accordance with Regulation(EC) No 1107/2009;
14. ‘patent’ means a patent which has effect in the United Kingdom;
F615. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.
Textual Amendments
F5Words in reg. 20(3) substituted (31.12.2020 immediately before IP completion day) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 31
F6Words in reg. 20(3) omitted (31.12.2020 immediately before IP completion day) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(3) (with reg. 7)
Commencement Information
I18Reg. 20 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Prospective
F721. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F7Reg. 21 omitted (31.12.2020 immediately before IP completion day) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 32
22. For Article 2, substitute—
A plant protection 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 [F8GB or NI] authorization prior to being placed on the market as a plant protection product.”.
Textual Amendments
F8Words in reg. 22 substituted (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), 2(4) (with reg. 7)
Commencement Information
I19Reg. 22 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
23. For Article 3(1), substitute—
“1. Where an application is submitted under Article 7, a certificate shall be granted if at the date of submission of the application—
(a)the product is protected by a basic patent in force;
(b)there is a valid [F9GB or NI] authorization to place the product on the market;
(c)the product has not already been the subject of a certificate;
(d)the authorization referred to in (b) is the first F10... authorization to place the product on the market as a plant protection product [F11in the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be].”.
Textual Amendments
F9Words in reg. 23 substituted (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), 2(5)(a) (with reg. 7)
F10Word in reg. 23 omitted (31.12.2020 immediately before IP completion day) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(5)(b)(i) (with reg. 7)
F11Words in reg. 23 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), 2(5)(b)(ii) (with reg. 7)
Commencement Information
I20Reg. 23 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
24.—(1) Article 8 (contents of the application for a certificate) is amended as follows.
(2) For paragraph 1(a)(iv), substitute—
“(iv)the number and date of the [F12GB or NI authorisation or both GB and NI authorisations] as referred to in Article 3(1)(b) [F13and (d)]; and
(v)the number and date of the earliest EEA authorization, the granting of which predates the granting of the [F14GB or NI] authorization [F15as referred to in Article 3(1)(b) and (d)];”.
(3) For paragraph 8(1)(b) and (c), substitute—
“(b)a copy of the [F16GB or NI authorisation or both GB and NI authorisations] to place the product on the market, as referred to in Article 3(1)(b) [F17and (d)], in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Commission Regulation 283/2013, [F18Part A section 1, points 1.1 to 1.7 or Part B, Section 1 points 1.1 to 1.4.3];
(c)where the product is the subject of one or more EEA authorizations granted prior to the [F19GB or NI] authorization referred to in Article 3(1)(b) [F20and (d)], the applicant must provide in relation to the earliest of any such EEA authorizations—
(i)information regarding the identity of the product thus authorised;
(ii)information regarding the legal provision under which the authorization procedure took place; and
(iii)a copy of the notice publishing the authorization in the appropriate official publication or, failing such a notice, any other document proving that the authorization has been issued, the date on which it was issued and the identity of the product authorized.”.
(4) Omit paragraph 2.
Textual Amendments
F12Words in reg. 24(2) substituted (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), 2(6)(a)(i) (with reg. 7)
F13Words in reg. 24(2) 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), 2(6)(a)(ii) (with reg. 7)
F14Words in reg. 24(2) substituted (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), 2(6)(b)(i) (with reg. 7)
F15Words in reg. 24(2) 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), 2(6)(b)(ii) (with reg. 7)
F16Words in reg. 24(3) substituted (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), 2(7)(a)(i) (with reg. 7)
F17Words in reg. 24(3) 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), 2(7)(a)(ii) (with reg. 7)
F18Words in reg. 24(3) substituted (31.12.2020 immediately before IP completion day) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 33
F19Words in reg. 24(3) substituted (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), 2(7)(b)(i) (with reg. 7)
F20Words in reg. 24(3) 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), 2(7)(b)(ii) (with reg. 7)
Commencement Information
I21Reg. 24 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
25.—(1) Article 9 (lodging of an application for a certificate) is amended as follows.
(2) For paragraph 1, substitute—
“1. An application for a certificate shall be lodged with the comptroller.”
(3) In the introductory words of paragraph 2, for “authority referred to in paragraph 1” substitute “ comptroller ”.
(4) For sub-paragraphs (d) and (e) of paragraph 2, substitute—
[F21“(d) the number and date of the GB or NI authorisation or both a GB and a NI authorisation provided under Article 8(1)(b), the product identified in the authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted;]
(e)where there are EEA authorizations granted before [F22any GB or NI authorisation provided under Article 8(1)(b)], the number and date of the earliest EEA authorization;”.
Textual Amendments
F21Words in reg. 25(4) substituted (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), 2(8)(a) (with reg. 7)
F22Words in reg. 25(4) substituted (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), 2(8)(b) (with reg. 7)
Commencement Information
I22Reg. 25 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
26.—(1) Article 10 (grant of the certificate or rejection of the application) is amended as follows.
(2) In paragraphs 1 to 3, for “the authority referred to in Article 9(1)”, substitute “ the comptroller ”.
(3) In paragraph 2, after “in this Regulation”, insert “ or any prescribed fee is not paid ”.
(4) In paragraph 3, after “Article 8”, insert “ or the prescribed fee relating to the application has not been paid ”.
(5) Omit paragraph 5.
(6) At the end of the Article, insert—
F23“6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.
Textual Amendments
F23Words in reg. 26(6) omitted (31.12.2020) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(9) (with reg. 7)
Commencement Information
I23Reg. 26 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
27.—(1) Article 11 (publication) is amended as follows.
(2) In paragraphs 1 and 2, for “the authority referred to in Article 9(1)” substitute “ the comptroller ”.
(3) In paragraph 1—
F24(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(b)for sub-paragraph (e), substitute—
“(e)where there are EEA authorizations granted before [F25any authorisation provided under Article 8(1)(b)], the number and date of the earliest EEA authorization;”.
Textual Amendments
F24Reg. 27(3)(a) omitted (31.12.2020 immediately before IP completion day) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(10) (with reg. 7)
F25Words in reg. 27(3)(b) substituted (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), 2(11) (with reg. 7)
Commencement Information
I24Reg. 27 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
28. Omit Article 12 (annual fees).
Commencement Information
I25Reg. 28 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
29. In paragraph 1 of Article 13 (duration of the certificate), for “the Community”, substitute “ the area comprising the European Economic Area and the United Kingdom ”.
Commencement Information
I26Reg. 29 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
30.—(1) Article 14 (expiry of the certificate) is amended as follows.
(2) The existing text is numbered as paragraph 1.
(3) For sub-paragraphs (c) and (d) of the renumbered paragraph 1, substitute—
“(c)if the prescribed annual fee is not paid in time; [F26or]
(d)if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of [F27all] authorizations to place on the market in accordance with Article 28 of Regulation 1107/2009. The comptroller may decide on the lapse of the certificate either of the comptroller's own motion or at the request of a third party.”.
F28(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F26Word in reg. 30(3) 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), 2(12)(a) (with reg. 7)
F27Word in reg. 30(3) substituted (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), 2(12)(b) (with reg. 7)
F28Reg. 30(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 2(13) (with reg. 7)
Commencement Information
I27Reg. 30 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
31. In paragraph (2) of Article 15 (invalidity of certificate), for “the body responsible under national law for the revocation of the corresponding basic patent” substitute “ the comptroller or the court ”.
Commencement Information
I28Reg. 31 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
32. In Article 16 (notification of lapse or invalidity), for “the authority referred to in Article 9(1)”, substitute “ the comptroller ”.
Commencement Information
I29Reg. 32 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
33. In Article 17 (appeals), omit paragraph 1.
Commencement Information
I30Reg. 33 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
34. In Article 18 (procedure), for paragraph 1 substitute—
“1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable to the corresponding basic patent (as modified by section 128B of, and Schedule 4A to, the Patents Act 1977) shall apply to the certificate.”.
Commencement Information
I31Reg. 34 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
35. Omit Articles 19 and 20 (transitional provisions).
Commencement Information
I32Reg. 35 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
36. After Article 21 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.
Commencement Information
I33Reg. 36 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
37. Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems is amended as set out in this Part.
Commencement Information
I34Reg. 37 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
38.—(1) Article 1 (scope) is amended as follows.
(2) For “Member States”, substitute “ The competent authority ”.
Commencement Information
I35Reg. 38 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
39.—(1) Article 2 (definitions) is amended as follows.
(2) For the definition of “competent authority” in paragraph (4), substitute—
““competent authority” for the purposes of Articles 1 to 11, 16 and 17 means the Comptroller-General of Patents, Designs and Trade Marks;”.
(3) After paragraph (4), insert—
“(5) “patent” means “a patent under the Patents Act 1977;
(6) “supplementary protection certificate” means a supplementary protection certificate issued under 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”.
(4) Omit Article 3 (competent authority).
Commencement Information
I36Reg. 39 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
40. In Article 4 (eligible importing countries), for “Commission”, substitute “ United Kingdom ”.
Commencement Information
I37Reg. 40 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
41.—(1) Article 5 (extension to least-developed and developing countries which are not members of the WTO) is amended as follows.
(2) In paragraph (a), for “Commission”, substitute “ Secretary of State ”.
(3) In paragraph (c), omit “or on its own initiative if national law allows the competent authority to act on its own initiative,”.
Commencement Information
I38Reg. 41 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
42.—(1) Article 6 (application for a compulsory licence) is amended as follows.
(2) For paragraph 1, substitute—
“1. Any person may submit an application for a compulsory licence under this Regulation to the competent authority in a case where that person's intended activities of manufacture and sale for export are covered by a patent or a supplementary protection certificate.”.
(3) In paragraph 2, for “each application”, substitute “ the application made to the competent authority ”.
(4) Omit paragraph 4.
Commencement Information
I39Reg. 42 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
43. In Article 8 (verification), for “Commission”, wherever it occurs, substitute “ United Kingdom ”.
Commencement Information
I40Reg. 43 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
44.—(1) Article 10 (compulsory licence conditions) is amended as follows.
(2) In paragraph 5, for “Member States”, substitute “ United Kingdom ”.
(3) In paragraph 8, omit “or on its own initiative, if national law allows the competent authority to act on its own initiative.”.
Commencement Information
I41Reg. 44 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
45.—(1) Article 12 (notification) is amended as follows.
(2) For “Member State”, substitute “ Secretary of State ”.
(3) Omit “through the intermediary of the Commission”.
Commencement Information
I42Reg. 45 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
46. In Article 13 (prohibition of importation), in paragraph 1, for “Community”, substitute “ United Kingdom ”.
Commencement Information
I43Reg. 46 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
47.—(1) Article 14 (action by customs authorities) is amended as follows.
(2) In paragraph 1—
(a)for “Community” substitute “ United Kingdom ”; and
(b)omit “Member States shall ensure that a body has the authority to review whether such importation is taking place”.
(3) In paragraph 2, for “national provisions on”, substitute “ the law relating to ”.
(4) In paragraph 3, for “Community”, substitute “ United Kingdom ”.
(5) In paragraph 4, omit “, in accordance with national legislation,”.
(6) Omit paragraph 6.
Commencement Information
I44Reg. 47 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
48.—(1) Article 16 (termination or review of the licence) is amended as follows.
(2) In paragraph 2, for “through the intermediary of the Commission”, substitute “ by the Secretary of State ”.
(3) In paragraph 3, omit—
(a)“or any other body appointed by the Member State”; and
(b)“or by another body appointed by the Member State,”.
Commencement Information
I45Reg. 48 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
49. Omit Articles 17 to 19. (appeals, safety and efficacy of medicinal products and review)
Commencement Information
I46Reg. 49 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
50. After Article 20 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States”.
Commencement Information
I47Reg. 50 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
51. 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 is amended as follows.
Commencement Information
I48Reg. 51 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
52.—(1) Article 1 (interpretation) is amended as follows.
(2) In paragraph (e) for “Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use”, substitute “ regulation 58A(3) of the Human Medicines Regulations 2012 M6 ”.
(3) After paragraph (e) insert—
“(f)‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;
[F29(g) ‘court’ means—
(i)as respects England and Wales, the High Court;
(ii)as respects Scotland, the Court of Session;
(iii)as respects Northern Ireland, the High Court in Northern Ireland;]
(h)“EEA authorisation” means an authorisation to place a medicinal product on the market which has effect in an EEA state in accordance with Directive 2001/83/EC or Directive 2001/82/EC;
(i)‘patent’ means a patent which has effect in the United Kingdom;
(j)‘UK authorisation’ means, in relation to a product, an authorisation to place that product on the market [F30in the United Kingdom] as a medicinal product granted [F31or having effect as if granted] in accordance with—
(i)Part 5 of the Human Medicines Regulations 2012; or
(ii)regulation 4(3) of, and Schedule 1 to, the Veterinary Medicines Regulations 2013 M7.”.
Textual Amendments
F29Words in reg. 52(3) substituted (31.12.2020 immediately before IP completion day) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 34(a)
F30Words in reg. 52(3) 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(3) (with reg. 7)
F31Words in reg. 52(3) inserted (31.12.2020 immediately before IP completion day) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 34(b)
Commencement Information
I49Reg. 52 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M6S.I. 2012/1916. Regulation 58A is inserted by S.I. 2019/775, reg. 64.
Prospective
F3253. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F32Reg. 53 omitted (31.12.2020 immediately before IP completion day) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 35
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 [F33, 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 [F34, 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 [F35, GB or NI] authorisation to place the product on the market as a medicinal product [F36in 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
F33Words 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)
F34Words 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)
F35Words 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)
F36Words 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
I50Reg. 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
55.—(1) Article 8 (content of application for a certificate) is amended as follows.
(2) For paragraph 1(a)(iv), substitute—
[F37“(iv) the number and date of the UK, GB or NI authorisation, or where there is more than one such authorisation, of each authorisation as referred to in Article 3(b) and (d);]
(v)the number and date of the earliest of any EEA authorisation, the granting of which predates the granting of the UK [F38, GB or NI] authorisation [F39as referred to in Article 3(b) and (d)];”.
(3) For paragraph 1(b) and (c), substitute—
“(b)a copy of the UK [F40, GB or NI authorisation or, where there is more than one such authorisation, of each] authorisation to place the product on the market, as referred to in Article 3(b) [F41and (d)], in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC, Article 14 of Directive 2001/82/EC, Part 2 to Schedule 8 of the Human Medicines Regulations 2012 or Part 1 of Schedule 1 to the Veterinary Medicines Regulations 2013;
(c)where the product is the subject of one or more EEA authorisations granted prior to the UK [F42, GB or NI] authorisation referred to in Article 3(b) [F43and (d)], the applicant must provide in relation to the earliest of any such EEA authorisations—
(i)information regarding the identity of the product thus authorised;
(ii)information regarding the legal provision under which the authorisation procedure took place; and
(iii)a copy of the notice publishing the authorisation in the appropriate official publication;”.
(4) In paragraph 1(d)—
(a)in paragraph (i), for “Article 36(1) of Regulation (EC) No 1901/2006” substitute “ regulation 58A(2)(a) of the Human Medicines Regulations 2012 ”; and
(b)omit paragraph (ii).
(5) Omit paragraph (4).
Textual Amendments
F37Words in reg. 55(2) substituted (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(6)(a) (with reg. 7)
F38Words in reg. 55(2) 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(6)(b)(i) (with reg. 7)
F39Words in reg. 55(2) 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(6)(b)(ii) (with reg. 7)
F40Words in reg. 55(3) 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(7)(a)(i) (with reg. 7)
F41Words in reg. 55(3) 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(7)(a)(ii) (with reg. 7)
F42Words in reg. 55(3) 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(7)(b)(i) (with reg. 7)
F43Words in reg. 55(3) 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(7)(b)(ii) (with reg. 7)
Commencement Information
I51Reg. 55 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
56.—(1) Article 9 (lodging of an application for a certificate) is amended as follows.
(2) For paragraph 1 substitute—
“1. An application for a certificate (or an extension of the duration of a certificate) shall be lodged with the comptroller.”.
(3) In the introductory words of paragraph 2, for “the authority referred to in paragraph 1”, substitute “ the comptroller ”.
(4) For sub-paragraphs (d) and (e) of paragraph 2, substitute—
[F44“(d) the number and date of the UK, GB or NI authorisation or, where there is more than one such authorisation, each authorisation provided under Article 8(1)(b), the product identified in the authorisation or each authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted];
(e)where there are authorisations granted in the EEA before [F45any UK, GB or NI authorisation provided under Article 8(1)(b)], the number and date of the earliest EEA authorisation;”.
Textual Amendments
F44Words in reg. 56(4) substituted (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(8)(a) (with reg. 7)
F45Words in reg. 56(4) substituted (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(8)(b) (with reg. 7)
Commencement Information
I52Reg. 56 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
57.—(1) Article 10 (grant of the certificate or rejection of the application for a certificate) is amended as follows.
(2) In paragraphs 1 to 3, for “the authority referred to in Article 9(1)”, substitute “ the comptroller ”.
(3) In paragraph 2, after “in this Regulation”, insert “ or any prescribed fee is not paid ”.
(4) In paragraph 3, after “Article 8”, insert “ or the prescribed fee relating to the application has not been paid ”.
(5) In paragraph 4, for “the authority”, substitute “ the comptroller ”.
(6) Omit paragraph 5.
(7) After paragraph 6, insert—
F46“7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.
Textual Amendments
F46Words in reg. 57(7) omitted (31.12.2020 immediately before IP completion day) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(9) (with reg. 7)
Commencement Information
I53Reg. 57 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
58.—(1) Article 11 (publication) is amended as follows.
(2) In paragraphs 1 and 2, for “the authority referred to in Article 9(1)” substitute “ the comptroller ”.
(3) In paragraph 1—
(a)[F47for paragraph (d), insert—
“(d)the number and date of the UK, GB or NI authorisation or, where there is more than one such authorisation, of each authorisation provided under Article 8(1)(b) or Article 13A(1), the product identified in the authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted;”];
(b)for sub-paragraph (e), substitute—
“(e)where there are EEA authorisations granted before [F48any UK, GB or NI authorisation provided under Article 8(1)(b)], the number and date of the earliest EEA authorisation;”.
Textual Amendments
F47Words in reg. 58(3)(a) substituted (31.12.2020 immediately before IP completion day) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(10)(a) (with reg. 7)
F48Words in reg. 58(3)(b) substituted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(10)(b) (with reg. 7)
Commencement Information
I54Reg. 58 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
59. Omit Article 12 (annual fees).
Commencement Information
I55Reg. 59 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
60.—(1) Article 13 (duration of the certificate) is amended as follows.
(2) In paragraph 1, for “the Community”, substitute “ the area comprising the European Economic Area and the United Kingdom ”.
(3) In paragraph 3, for “Article 36 of Regulation (EC) No 1901/2006”, substitute “ regulation 58A of the Human Medicines Regulations 2012 ”.
Commencement Information
I56Reg. 60 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
61.—(1) Article 14 (expiry of the certificate) is amended as follows.
(2) The existing text is numbered as paragraph 1.
(3) For sub-paragraphs (c) and (d) of the renumbered paragraph 1, substitute—
“(c)if the prescribed annual fee is not paid in time; [F49or]
(d)if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of [F50all UK, GB and NI] authorisations to place on the market. The comptroller may decide on the lapse of the certificate either of the comptroller's own motion or at the request of a third party.”.
F51(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F49Word in reg. 61(3) 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(11)(a) (with reg. 7)
F50Words in reg. 61(3) substituted (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(11)(b) (with reg. 7)
F51Reg. 61(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(12) (with reg. 7)
Commencement Information
I57Reg. 61 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
62. In paragraph 2 of Article 15 (invalidity of the certificate), for “F52... the body responsible under national law for the revocation of the corresponding basic patent” substitute “ the comptroller or the court ”.
Textual Amendments
F52Word in reg. 62 omitted (31.12.2020 immediately before IP completion day) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 36
Commencement Information
I58Reg. 62 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
63.—(1) Article 16 (revocation of an extension of the duration) is amended as follows.
(2) In paragraph 1, for “Article 36 of Regulation (EC) No 1901/2006”, substitute “ regulation 58A(3) of the Human Medicines Regulations 2012 ”.
(3) In paragraph 2, for “the body responsible under national law for the revocation of the corresponding basic patent”, substitute “ the comptroller or the court ”.
Commencement Information
I59Reg. 63 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
64. For references in Article 17 (notification of lapse or invalidity) to “the authority referred to in Article 9(1)”, substitute “ the comptroller ”.
Commencement Information
I60Reg. 64 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
65. Omit Article 18 (appeals).
Commencement Information
I61Reg. 65 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
66. For paragraph 1 of Article 19 (procedure), substitute—
“1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable to the corresponding basic patent (as modified by section 128B of, and Schedule 4A to, the Patents Act 1977) shall apply to the certificate.”.
Commencement Information
I62Reg. 66 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
67. Omit Articles 20 (enlargement of the Community) and 21 (transitional provisions).
Commencement Information
I63Reg. 67 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
68. After Article 23 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”
Commencement Information
I64Reg. 68 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
69.—(1) This regulation applies to—
(a)An application for an extension of the duration of a certificate, filed in accordance with Article 7 but not determined before [F53IP completion day]; and
(b)An extension of the duration of a certificate granted—
(i)before [F53IP completion day]; or
(ii)after [F53IP completion day], pursuant to an application falling within sub-paragraph (a);
(2) Where this regulation applies, Articles 1(e), 8(1)(d), 13(3), and 16(1) of Regulation 469/2009 continue to apply without the amendments made by these Regulations.
(3) Where paragraph (1) applies—
(a)Article 8(1)(d)(ii) is to be read as if, for the words “all other Member States”, there were substituted “ all Member States ”;
(b)Articles 13(3) and 16(1) are to be read as if, for the words “all Member States” in Article 36(3) of Regulation 1901/2006, there were substituted “ the United Kingdom and all Member States ”.
Textual Amendments
F53Words in reg. 69 substituted (31.12.2020 immediately before IP completion day) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), regs. 1(2), 37
Commencement Information
I65Reg. 69 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Chris Skidmore
Minister of State
Department for Business, Energy and Industrial Strategy
(This note is not part of the Regulations)
These Regulations are made in exercise of the powers in section 8(1) of the European Union (Withdrawal) Act 2018 (c.18) in order to address failures of retained EU law to operate effectively and other deficiencies arising from the withdrawal of the United Kingdom from the European Union in relation to patents and connected areas including supplementary protection certificates.
Part 1 of the Regulations contains introductory provisions.
Part 2 of the Regulations makes amendments to the Patents Act 1977.
Part 3 of the Regulations makes an amendment to the Copyright, Designs and Patents Act 1988.
Part 4 makes amendments to the Patents and Plant Variety Rights (Compulsory Licensing) Regulations 2002.
Part 5 of the Regulations makes an amendment to the Patents Rules 2007.
Part 6 of the Regulations makes amendments to 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.
Part 7 makes amendments to Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems.
Part 8 of the Regulations amends 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.
An impact assessment has not been produced for this instrument as no, or no significant, impact on the private or voluntary sector is foreseen.