The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), Соединенное Королевство

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Английский The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471)

The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020

S T A T U T O R Y I N S T R U M E N T S

2020 No. 1471

EXITING THE EUROPEAN UNION

PATENTS

The Supplementary Protection Certificates (Amendment) (EU

Exit) Regulations 2020

Made - - - - 7th December 2020

Coming into force in accordance with regulation 1(2)

The Secretary of State makes these Regulations in exercise of the powers conferred by section

8C(1)(a) of the European Union (Withdrawal) Act 2018(b).

In accordance with paragraph 8F(1) of Part 1A of Schedule 7(c) to the European Union

(Withdrawal) Act 2018, a draft of this instrument has been laid before Parliament and approved by

resolution of each House of Parliament.

Citation and commencement

1.—(1) These Regulations may be cited as the Supplementary Protection Certificates

(Amendment) (EU Exit) Regulations 2020.

(2) This regulation and regulations 2 and 3 come into force immediately before IP completion

day and regulations 4 to 7 come into force on IP completion day.

Amendments to the Patents (Amendment) (EU Exit) Regulations 2019

2.—(1) Part 6 of the Patents (Amendment) (EU Exit) Regulations 2019(d) (supplementary

protection certificates for plant protection products – amendments to Regulation (EC) No

1610/96) is amended as follows.

(2) In the following paragraphs, a reference to an Article or a paragraph is to that of Regulation

(EC) 1610/96(e) and a reference to a regulation is to a regulation of the Patents (Amendment) (EU

Exit) Regulations 2019.

(3) In Article 1 (definitions), as amended by regulation 20(3), omit paragraph 15.

(4) In Article 2(b) (scope), as inserted by regulation 22, for “UK”, substitute “GB or NI”.

(5) In Article 3(1) (conditions for obtaining a certificate), as amended by regulation 23—

(a) Section 8C was inserted by section 21 of the European Union (Withdrawal Agreement) Act 2020 c. 1. (b) 2018 c. 16 as amended by the European Union (Withdrawal Agreement) Act 2020 c. 1. (c) Paragraph 8F of Part 1A of Schedule 7 was inserted by section 41(4) of, and paragraph 5 of Schedule 5 to, the European

Union (Withdrawal Agreement) Act 2020 c. 1. (d) S.I. 2019/801, as amended by S.I. 2020/1050. (e) EUR 1996/1610, as amended by S.I. 2019/801 and S.I. 2020/1050. This is a reference to the retained version of Regulation

(EC) 1610/96. That retained version is online at http://www.legislation.gov.uk/eur/1996/1610/contents

(a) in sub-paragraph (b), for “UK”, substitute “GB or NI”;

(b) in sub-paragraph (d)—

(i) omit “UK”;

(ii) insert at the end “in the territory of England and Wales and Scotland or the territory

of Northern Ireland as the case may be”.

(6) In Article 8 (content of the application for a certificate), as amended by regulation 24(2)—

(a) in paragraph 1(a)(iv)—

(i) for “UK authorization”, substitute “GB or NI authorisation or both GB and NI

authorisations”;

(ii) after “3(1)(b)”, insert “and (d)”;

(b) in paragraph (1)(a)(v)—

(i) for “UK”, substitute “GB or NI”;

(ii) after “authorization”, in the second place it occurs, insert “as referred to in Article

3(1)(b) and (d)”.

(7) In Article 8, as amended by regulation 24(3)—

(a) in paragraph (b)—

(i) for “UK authorization”, substitute “GB or NI authorisation or both GB and NI

authorisations”;

(ii) after “3(1)(b)”, insert “and (d)”;

(b) in paragraph (c)—

(i) for “UK”, substitute “GB or NI ”;

(ii) after “3(1)(b)”, insert “and (d)”.

(8) In Article 9 (lodging of an application for a certificate), as amended by regulation 25(4)—

(a) for paragraph 2(d), substitute—

“(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”;

(b) in paragraph (e), for “the UK authorisation”, substitute “any GB or NI authorisation

provided under Article 8(1)(b)”.

(9) In Article 10 (grant of the certificate or rejection of the application), as amended by

regulation 26, omit paragraph 6.

(10) In regulation 27(3), omit sub-paragraph (a) of that regulation.

(11) In Article 11(1)(e), as amended by regulation 27(3), for “the UK authorization”, substitute

“any authorisation provided under Article 8(1)(b)”.

(12) In Article 14(1) (expiry of the certificate), as amended by regulation 30—

(a) at the end of paragraph (c), insert “or”;

(b) in paragraph (d), for “the appropriate authorization or” substitute “all”.

(13) In regulation 30, omit paragraph 4 of that regulation.

3.—(1) Part 8 of the Patents (Amendment) EU Exit Regulations 2019 (supplementary protection

certificates for medicinal products – amendments to Regulation (EC) No 469/2009) is amended as

follows.

(2) In the following paragraphs, a reference to an Article or a paragraph is to that of Regulation

(EC) 469/2009(a) and a reference to a regulation is to a regulation of the Patents (Amendment)

(EU Exit) Regulations 2019.

(3) In Article 1, in the definition of “UK authorisation” in paragraph (j) inserted by regulation

52(3), after “market”, insert “in the United Kingdom”.

(4) In Article 2 (scope), in paragraph (b), as inserted by regulation 54, after “UK”, insert “, GB

or NI”.

(5) In Article 3 (conditions for obtaining a certificate), as inserted by regulation 54—

(a) in sub-paragraph (b), after “UK”, insert “, GB or NI”;

(b) in sub-paragraph (d)—

(i) after “UK”, insert “, GB or NI”;

(ii) insert at the end “in 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”.

(6) In Article 8 (content of the application for a certificate), as amended by regulation 55(2)—

(a) for paragraph 1(a)(iv), substitute—

“(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);”;

(b) in paragraph (1)(a)(v)—

(i) after “UK”, insert “, GB or NI”;

(ii) after “authorisation”, in the second place it occurs, insert “as referred to in Article

3(b) and (d)”.

(7) In Article 8(1), as amended by regulation 55(3)—

(a) in paragraph (b)—

(i) after “UK”, insert “, GB or NI authorisation or, where there is more than one such

authorisation, of each”;

(ii) after “3(b)” insert “and (d)”;

(b) in paragraph (c)—

(i) after “UK”, insert “, GB or NI”;

(ii) after “3(b)” insert “and (d)”.

(8) In Article 9 (lodging of an application for a certificate), as amended by regulation 56(4)—

(a) for paragraph 2(d), substitute—

“(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”;

(b) in paragraph (e), for “the UK authorisation”, substitute “any UK, GB or NI authorisation

provided under Article 8(1)(b)”.

(9) In Article 10 (grant of the certificate or rejection of the application for a certificate) as

amended by regulation 57, omit paragraph 7.

(10) In Article 11 (publication), as amended by regulation 58(3)—

(a) for 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)

(a) EUR 2009/469, as amended by S.I. 2019/801 and S.I. 2020/1050. This is a reference to the retained version of Regulation EUR 2009/469. That retained version is online at http://www.legislation.gov.uk/eur/2009/469/contents

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) in paragraph (e), for “the UK authorisation”, substitute “any UK, GB or NI authorisation

provided under Article 8(1)(b)”.

(11) In Article 14(1) (expiry of the certificate), as amended by regulation 61—

(a) at the end of sub-paragraph (c), insert “or”;

(b) in sub-paragraph (d), for “the appropriate authorisation or” substitute “all UK, GB and

NI”.

(12) In regulation 61, omit paragraph (4) of that regulation.

Amendments to Regulation (EC) 1610/96

4. Regulation (EC) 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 Part 1 of the Schedule.

Amendments to Regulation (EC) 469/2009

5. Regulation (EC) 469/2009 of the European Parliament and of the Council of 6th May 2009

concerning the supplementary protection certificate for medicinal products is amended as set out

in Part 2 of the Schedule.

Amendment to the Patents Rules 2007

6. In the Patents Rules 2007(a), in rule 116A, as inserted by regulation 42 of the Intellectual

Property (Amendment etc.) (EU Exit) Regulations 2020(b)—

(a) the existing text is numbered as paragraph 1;

(b) after paragraph 1, insert—

“(2) Notifications under Article 13A of Regulation (EC) 1610/96 and Article 13A of

Regulation (EC) 469/2009 must be made on Patents Form SP6.”.

Transitional provisions

7.—(1) Where an application for an authorisation is made before IP completion day under—

(a) Directive 2001/83/EC(c) of the European Parliament and of the Council of 6 November

2001 on the Community code relating to medicinal products for human use,

(b) Directive 2001/82/EC(d) of the European Parliament and of the Council of 6 November

2001 on the Community code relating to veterinary medicinal products, or

October 2009 concerning the placing of plant protection products on the market,

but the authorisation is not granted until on or after IP completion day, these Regulations apply to

any application for a supplementary protection certificate made in respect of the authorisation.

(2) These Regulations apply to an application for a supplementary protection certificate made on

or after IP completion day in respect of a UK authorisation granted or having effect as if granted

before IP completion day.

(a) S.I. 2007/3291, as by S.I. 2011/2052; there are other amending instruments but none are relevant. (b) S.I. 2020/1050. (c) OJ L311, 28.11.2001, p.67. (d) OJ L311, 28.11.2001, p.1. (e) OJ L309, 24.11.2009, p.1.

(3) The former regulations continue to apply to an application for a supplementary protection

certificate made, but not determined, before IP completion day in respect of a UK authorisation

granted or having effect as if granted before IP completion day.

(4) Where on or after IP completion day a UK authorisation granted or having effect before IP

completion day is withdrawn and replaced with a GB authorisation and a NI authorisation, any

certificate granted in respect of the UK authorisation does not lapse.

(5) For the purposes of paragraphs (2), (3) and (4), “UK authorisation” means an authorisation

granted or having effect as if granted under—

(a) 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,

(b) 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, or

October 2009 concerning the placing of plant protection products on the market,

and references to a UK, GB or NI authorisation, where they occur in these Regulations (but not

including this regulation) are to be treated as meaning a “UK authorisation” as defined in this

paragraph.

(6) For the purposes of paragraphs (4) and (7)—

(a) “GB authorisation” has the meaning ascribed to it in paragraph 15 of Article 1 of

Regulation (EC) 1610/96, as amended by regulation 4 of, and paragraph 2 of the

Schedule to, these Regulations, and paragraph (ja) of Article 1 of Regulation (EC)

469/2009 as amended by regulation 5 of, and paragraph 9 of the Schedule to, these

Regulations; and

(b) “NI authorisation” has the meaning ascribed to it in paragraph 16 of Article 1 of

Regulation (EC) 1610/96, as amended by regulation 4 of, and paragraph 2 of the

Schedule to, these Regulations and paragraph (jb) of Article 1 of Regulation (EC)

469/2009 as amended by regulation 5 of, and paragraph 9 of the Schedule to, these

Regulations.

(7) For the purposes of paragraph (4), where the former regulations apply to a “UK

authorisation” as defined in paragraph (5), the UK authorisation includes a GB authorisation and

NI authorisation in combination.

(8) For the purposes of this regulation, “former regulations” means Regulation (EC) 1610/96

and Regulation (EC) 469/2009 without the amendments made by these Regulations but including

the amendments made by the Patents (Amendment) (EU Exit) Regulations 2019 and the

Intellectual Property (Amendment etc.) (EU Exit Regulations) 2020.

Amanda Solloway

Parliamentary Under Secretary

7th December 2020 Department for Business, Energy and Industrial Strategy

SCHEDULE Regulations 4 and 5

Amendments to Regulations on Supplementary Protection Certificates

PART 1

Amendments to Regulation (EC) 1610/96

Interpretation of Part 1

1. In this Part, a reference to an Article or a paragraph is to that of Regulation (EC) 1610/96.

Article 1: definitions

2. In Article 1, after the definition of “patent” in paragraph 14, as inserted by regulation 20(3) of

the Patents (Amendment) (EU Exit) Regulations 2019, insert—

“15. “GB authorisation” means an authorisation, to place a plant protection product on the

market in England and Wales and Scotland, granted or having effect as if granted under

Regulation (EC) 1107/2009(a);

16. “NI authorisation” means an authorisation, to place a plant protection product on the

market in Northern Ireland, granted or having effect as if granted in accordance with

Regulation (EC) 1107/2009 as it has effect by virtue of the Protocol on Ireland/Northern

Ireland in the EU withdrawal agreement;

17. “prescribed” means prescribed by rules under section 123 of the Patents Act 1977.”.

Article 4: subject matter of protection

3. In Article 4—

(a) for “authorizations”, substitute “GB or NI authorisation or both GB and NI

authorisations”;

(b) after “authorized”, insert “in the United Kingdom”.

Article 5: effects of the certificate

4. In Article 5—

(a) the existing text is numbered as paragraph 1;

(b) in paragraph 1, after “Article 4”, insert “and paragraphs 2 and 3”;

“2. The protection conferred by a certificate in accordance with paragraph 1 shall extend

only to the territory in respect of which a valid GB or NI authorisation has been issued and

the authorisation—

(a) is the first authorisation for the product in the territory in accordance with Article

3(1)(b) and (d), and

(b) has been issued before the certificate takes effect in accordance with Article 13(1).

3. Where after the submission of an application for a certificate in accordance with

Article 7 and before the certificate takes effect in accordance with Article 13(1), a GB or NI

authorisation is granted in respect of the same product and the authorisation would have

(a) EUR 2009/1107. This is a reference to the retained version of Regulation (EC) 2009/1107. That retained version is online at http://www.legislation.gov.uk/eur/2009/1107/contents.

met the requirements of Article 3(b) and (d) had it been granted on the date of submission

of the application, the protection conferred by a certificate in accordance with paragraph 1

shall extend to the territory of England and Wales and Scotland or the territory of Northern

Ireland as the case may be.”.

Article 7: application for a certificate

5. In Article 7, paragraph (1)—

(a) before “authorization”, insert “GB or NI”;

(b) after “3(1)(b)”, insert “and (d)”;

“Where more than one such authorisation is granted before the application for a certificate

is lodged, the application shall be lodged within six months of the date of grant of the

earliest of such authorisations.”.

Article 11: publication

6. In Article 11, for paragraph (d), substitute—

“(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;”.

Article 13A: authorisation granted after submission of an application for a certificate

7. After Article 13, insert—

“Article 13A

Authorisation granted after submission of an application for a certificate

1. Where after the submission of an application under Article 7(1), but before the grant of

a certificate under Article 10(1) in relation to a GB authorisation, a valid NI authorisation is

granted which, at its date of grant, is the first authorisation to place the product on the

market as a plant protection product in the territory of Northern Ireland, the applicant shall

notify the comptroller of the grant of the NI authorisation, within six months of its date of

grant and before the certificate takes effect under Article 13(1), and provide the details set

out in Article 8(1)(a)(iv) and (b) on the prescribed form.

2. Where after the submission of an application under Article 7(1), but before the grant of

a certificate under Article 10(1) in relation to a NI authorisation, a valid GB authorisation is

granted which, at its date of grant, is the first authorisation to place the product on the

market as a plant protection product in the territory of England and Wales and Scotland, the

applicant shall notify the comptroller of the grant of the GB authorisation, within six

months of its date of grant and before the certificate takes effect under Article 13(1), and

provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

3. Where after the grant of a certificate under Article 10(1) in relation to a GB

authorisation, but before expiry of the basic patent, a valid NI authorisation is granted

which, at its date of grant, is the first authorisation to place the product on the market as a

plant protection product in the territory of Northern Ireland, the certificate holder shall

notify the comptroller of the NI authorisation, within six months of its date of grant and

before the certificate takes effect under Article 13(1), and provide the details set out in

Article 8(1)(a)(iv) and (b) on the prescribed form.

4. Where after the grant of a certificate under Article 10(1) in relation to a NI

authorisation, but before expiry of the basic patent, a valid GB authorisation is granted

which, at its date of grant, is the first authorisation to place the product on the market as a

plant protection product in the territory of England and Wales and Scotland, the certificate

holder shall notify the comptroller of the grant of the GB authorisation, within six months

of its date of grant and before the certificate takes effect under Article 13(1), and provide

the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

5. If the applicant or certificate holder fails to notify the comptroller of the grant of an

authorisation in accordance with any of paragraphs 1 to 4, the protection conferred by a

certificate granted under Article 10(1) shall not extend to any additional territory covered

by that authorisation.

6. On receipt of a notification under any of paragraphs 1 to 4, the comptroller shall

publish:

(a) the number and date of the authorisation,

(b) the product identified in that authorisation, and

effect as if granted.”.

Article 14: expiry of the certificate

8. In Article 14, after paragraph 1, insert—

“2. Where a UK authorisation is withdrawn and replaced simultaneously with a GB

authorisation and a NI authorisation, the certificate granted in respect of the UK

authorisation shall not lapse.

3. Where a UK, GB or NI authorisation is withdrawn, but one or more such authorisations

remain valid, the protection conferred by the certificate shall, as from the date of

withdrawal, no longer extend to the territory covered by the authorisation withdrawn but

shall continue in respect of the territory covered by any remaining authorisation.

4. For the purposes of paragraphs 2 and 3, “UK authorisation” means an authorisation to

place a plant protection product on the market in the United Kingdom, granted or having

effect as if granted, prior to IP completion day, under Regulation (EC) 1107/2009(a) of the

European Parliament and of the Council of 21 October 2009 concerning the placing of plant

protection products on the market.”.

Article 16: notification of lapse or invalidity

9. In Article 16—

(a) after “Article 14”, insert “(1)”;

(b) after “Article 15,” insert “or if the territorial extent of the certificate is limited in

accordance with Article 14(3),”.

PART 2

Amendments to Regulation (EC) 469/2009

Interpretation of Part 2

10. In this Part, a reference to an Article or a paragraph is to that of Regulation (EC) 469/2009.

Article 1: definitions

11. In Article 1—

(a) OJ L309, 24.11.2009, p.1.

(a) after the definition of “UK authorisation” in paragraph (j), as inserted by regulation 52(3)

of the Patents (Amendment) (EU Exit) Regulations 2019 and amended by regulation 3(3)

of these Regulations, insert—

“(ja)“GB authorisation” means, in relation to a product, an authorisation to place that

product on the market in England and Wales and Scotland as a medicinal product

granted or having effect as if granted in accordance with—

(i) Part 5 of the Human Medicines Regulations 2012(a); or

(ii) regulation 4(3) of, and Schedule 1 to, the Veterinary Medicines Regulations

2013(b) as they have effect in England and Wales and Scotland;

(jb) “NI authorisation” means, in relation to a product, an authorisation to place that

product on the market in Northern Ireland as a medicinal product granted or having

effect as if granted in accordance with Directive 2001/83/EC or Directive

2001/82/EC as they have effect by virtue of the Protocol on Ireland/Northern

Ireland in the EU withdrawal agreement;”;

(b) After paragraph (k), insert—

“(l) “prescribed” means prescribed by rules under section 123 of the Patents Act

1977(c).”.

Article 4: subject matter of protection

12. In Article 4—

(a) before “authorisation”, insert “UK, GB or NI”;

(b) after “authorised”, insert “in the United Kingdom”.

Article 5: effects of the certificate

13. In Article 5—

(a) In paragraph 1, after “Article 4”, insert “and paragraphs 1a and 1b”;

(b) after paragraph 1, insert—

“1a. The protection conferred by a certificate in accordance with paragraph 1 shall extend

only to the territory in respect of which a valid, UK, GB or NI authorisation has been issued

and where the authorisation—

(a) is the first authorisation for the product in the territory in accordance with Article

3(b) and (d), and

(b) has been issued before the certificate takes effect in accordance with Article 13(1).

1b. Where after the submission of an application for a certificate in accordance with

Article 7(1) or (2) and before the certificate takes effect in accordance with Article 13(1), a

GB or NI authorisation is granted in respect of the same product and the authorisation

would have met the requirements of Article 3(b) and (d) had it been granted on the date of

submission of the application, the protection conferred by a certificate in accordance with

paragraph 1 shall extend to the territory of England and Wales and Scotland or the territory

of Northern Ireland as the case may be.”;

(i) insert “prescribed” before “form”;

(ii) omit the words from “for” to the end.

Article 7: application for a certificate

14. In Article 7, paragraph (1)—

(a) before “authorisation”, insert “UK, GB or NI”;

(b) after “3(b)”, insert “and (d)”;

“Where more than one such authorisation is granted before the application for a certificate

is lodged, the application shall be lodged within six months of the date of grant of the

earliest of such authorisations.”.

Article 8: content of the application for a certificate

15. In Article 8—

(a) in paragraph 1(a)(ii), for “he”, substitute “the applicant”;

(b) in paragraph 1(d), after sub-paragraph (i), insert—

“(ii) details of the territory in respect of which the statement referred to in sub-

paragraph (i) has been made.”.

Article 9: lodging of an application for a certificate

16. In Article 9, paragraph 2, after sub-paragraph (f), insert—

“(g) where an indication is given in accordance with sub-paragraph (f), details of the

territory in respect of which an extension has been applied for.”.

Article 11: publication

17. In Article 11, after paragraph 3, insert—

“3a. Where notification is made that an extension of the duration of a certificate has been

granted, the notification shall specify the territory in respect of which the extension has

been granted.”.

Article 13: duration of the certificate

18. In Article 13, after paragraph 4 insert—

“5. An extension of the duration of a certificate in accordance with paragraph 3 in respect

of—

(a) a UK authorisation shall apply in the United Kingdom,

(b) a GB authorisation shall apply in only England and Wales and Scotland, and

on condition that the territorial protection conferred by the extension does not exceed that

conferred by the certificate.”.

Article 13A: authorisation granted after submission of an application for a certificate

19. After Article 13, insert—

“Article 13A

Authorisation granted after submission of an application for a certificate

1. Where after the date of submission of an application under Article 7(1) or (2), but

before the grant of a certificate under Article 10(1) in relation to a NI authorisation, a valid

UK or GB authorisation is granted which, at its date of grant, is the first authorisation to

place the product on the market as a medicinal product in the territory of the United

Kingdom or the territory of England and Wales and Scotland as the case may be, the

applicant shall notify the comptroller of the grant of the authorisation, within six months of

its date of grant and before the certificate takes effect under Article 13(1), and provide the

details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

2. Where after the submission of an application under Article 7(1) or (2), but before the

grant of a certificate under Article 10(1) in relation to a UK or GB authorisation, a valid NI

authorisation is granted which, at its date of grant, is the first authorisation to place the

product on the market as a medicinal product in the territory of Northern Ireland, the

applicant shall notify the comptroller of the grant of the authorisation, within six months of

its date of grant and before the certificate takes effect under Article 13(1), and provide the

details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.

3. Where after the grant of a certificate under Article 10(1) in relation to a UK or GB

authorisation, but before expiry of the basic patent, a valid NI authorisation is granted

which, at its date of grant, is the first authorisation to place the product on the market as a

medicinal product in the territory of Northern Ireland, the certificate holder shall notify the

comptroller of the grant of the authorisation, within six months of its date of grant and

before the certificate takes effect under Article 13(1), and provide the details set out in

Article 8(1)(a)(iv) and (b) on the prescribed form.

4. Where after the grant of a certificate under Article 10(1) in relation to a NI

authorisation, but before expiry of the basic patent, a valid UK or GB authorisation is

granted which, at its date of grant, is the first authorisation to place the product on the

market as a medicinal product in the territory of the United Kingdom or the territory of

England and Wales and Scotland as the case may be, the certificate holder shall notify the

comptroller of the grant of the NI authorisation, within six months of its date of grant and

before the certificate takes effect under Article 13(1), and provide the details set out in

Article 8(1)(a)(iv) and (b) on the prescribed form.

5. If the applicant or the certificate holder fails to notify the comptroller of the grant of an

authorisation in accordance with paragraph 1, 2, 3 or 4 the protection conferred by a

certificate granted under Article 10 shall not extend to any additional territory covered by

that authorisation.

6. On receipt of a notification under any of paragraphs 1 to 4, the comptroller shall

publish:

(a) the number and date of the authorisation,

(b) the product identified in that authorisation, and

if granted.

Article 13B

Extension of the duration of a certificate

1. Where after an application for an extension of the duration of a certificate in

accordance with Article 7(3) or (4) has been made in respect of a GB authorisation, but

before the application is granted, an application is also made for an extension of the

duration of the certificate in respect of a NI authorisation in accordance with Article 7(3) or

(4), the duration of the certificate, if the extension is granted, shall be extended in

accordance with Article 13(3) and (5) to include the territory of Northern Ireland.

2. Where after an application for an extension of the duration of a certificate in

accordance with Article 7(3) or (4) has been made in respect of a NI authorisation, but

before the application is granted, an application is also made for an extension of the

duration of the certificate in respect of a GB authorisation in accordance with Article 7(3)

or (4), the duration of the certificate shall be extended in accordance with Article 13(3) and

(5) to include the territory of England and Wales and Scotland.

3. Where after the grant in accordance with Article 10(6) of an application for an

extension of the duration of a certificate in respect of a GB authorisation, an application is

made, in accordance with Article 7(4), for an extension of the certificate in respect of a NI

authorisation, the duration of the certificate shall be extended in accordance with Article

13(3) and (5) to include the territory of Northern Ireland.

4. Where after the grant, in accordance with Article 10(6) of an application for an

extension of the duration of a certificate in respect of a NI authorisation, an application is

made, in accordance with Article 7(4), for an extension of the certificate in relation to a GB

authorisation, the duration of the certificate shall be extended in accordance with Article

13(3) and (5) to include the territory of England and Wales and Scotland.”.

20. In Article 14, after paragraph (1), insert—

“2. Where a UK authorisation is withdrawn and replaced simultaneously with a GB

authorisation and a NI authorisation, the certificate granted in respect of the UK

authorisation shall not lapse.

3. Where a UK, GB or NI authorisation is withdrawn, but one or more such authorisations

remain valid, the protection conferred by the certificate shall, as from the date of

withdrawal, no longer extend to the territory covered by the authorisation withdrawn but

shall continue in respect of the territory covered by any remaining authorisation.”.

21. In Article 17, in paragraph (1)—

(a) after “Article 14”, insert “(1)”;

(b) after “Article 15,” insert “or if the territorial extent of the certificate is limited in

accordance with Article 14(3),”.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations deal with matters arising out of the Protocol on Ireland/Northern Ireland

(“Protocol”) in the Agreement on the withdrawal of the United Kingdom of Great Britain and

Northern Ireland from the European Union and the European Atomic Energy Community of 19

October 2019. Union law which applies to the United Kingdom in respect of Northern Ireland

under Article 5(4) of the Protocol includes the following EU Directives and Regulations on

medicinal products and plant protection products in paragraphs 20 and 24 of Annex 2 to the

Protocol:

— 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 (OJ L311,

28.11.2001, p.1);

— 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 (OJ L311,

28.11.2001, p.67);

— Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12

December 2006 on medicinal products for paediatric use (OJ L378, 27.12.2006, p.1);

— 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 (OJ

L309, 24.11.2009, p.1).

The grant of a supplementary protection certificate in relation to these products may be dependent

on marketing authorisations provided under these Directives and Regulations.

Regulations 2 and 3 amend the Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801)

in relation to supplementary protection certificates for medicinal products and plant protection

products. The Patents (Amendment) (EU Exit) Regulations 2019 come into force on IP

completion day. The changes made by these Regulations to the Patents (Amendment) EU Exit

Regulations come into effect prior to IP completion day (Regulation 1(2)).

Regulation 4 and Part 1 of the Schedule amend 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.

Regulation 5 and Part 2 of the Schedule amend 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.

Regulation 6 amends the Patents Rules 2007 (S.I. 2007/3291) to provide for a new form to notify

the comptroller of any authorisations granted after submission of an application for a

supplementary protection certificate. This change is effected by amending regulation 42 of the

Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050).

Regulation 7 provides for transitional provisions.

Regulations 4 to 7 come into force on IP completion day.

Paragraph 2 of Part 1 of the Schedule amends Article 1 of Regulation (EC) No 1610/96 and

paragraph 11 of Part 2 of the Schedule amends Article 1 of Regulation (EC) No 469/2009 to

introduce new definitions of “GB authorisation” and “NI authorisation”. A “GB authorisation”

covers the territory of Great Britain (England and Wales and Scotland) and a NI authorisation

covers the territory of Northern Ireland.

Paragraph 4 of Part 1 of the Schedule amends Article 5 of Regulation (EC) No 1610/96 and

paragraph 13 of Part 2 of the Schedule amends Article 5 of Regulation (EC) No 469/2009 to

provide that the protection conferred by a certificate extends only to the territory in respect of

which a valid marketing authorisation has been granted.

Paragraph 7 of Part 1 of the Schedule inserts a new Article 13A in Regulation (EC) No 1610/96

and paragraph 19 of Part 2 of the Schedule inserts a new Article 13A in Regulation (EC) No

469/2009. These provisions deal with the situation where a marketing authorisation has been

applied for or granted in respect of e.g. Great Britain (GB), and a later authorisation is applied for

or granted for Northern Ireland (NI). In these circumstances, the comptroller must be notified of

the later authorisation so that this may be published.

Paragraph 19 of Part 2 of the Schedule also inserts a new Article 13B in Regulation (EC) No

469/2009 to deal with extensions of the duration of certificates granted in respect of paediatric

uses of medicinal products. An extension of the duration of a certificate in respect of a GB

authorisation is extended, in certain circumstances, to include Northern Ireland and vice versa the

extension of the duration of a certificate in respect of a NI authorisation is extended to include

Great Britain.

The changes made by these Regulations supplement other changes made to UK law in relation to

supplementary protection certificates by Parts 6 and 8 of the Intellectual Property (Amendment

etc.) (EU Exit) Regulations 2020 which come into force on IP completion day.

An impact assessment has not been produced for this instrument as no, or no significant, impact

on the private, public and voluntary sectors is foreseen.

An explanatory memorandum is available alongside this instrument on the Legislation UK website

at www.legislation.gov.uk.

Printed and published in the UK by The Stationery Office Limited under the authority and superintendence of Jeff James,

Controller of Her Majesty’s Stationery Office and Queen’s Printer of Acts of Parliament.

£6.90

UK202012081008 12/2020 19585

http://www.legislation.gov.uk/id/uksi/2020/1471

ISBN 978-0-34-821680-6

Explanatory Memorandum to the Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020

DExEU/EM/7-2018.2 1

EXPLANATORY MEMORANDUM TO

THE SUPPLEMENTARY PROTECTION CERTIFICATES (AMENDMENT) (EU

EXIT) REGULATIONS 2020

2020 No. 1471

1. Introduction

1.1 This explanatory memorandum has been prepared by the Intellectual Property Office

(IPO), an executive agency of the Department for Business, Energy & Industrial

Strategy, and is laid before Parliament by Command of Her Majesty.

2. Purpose of the instrument

2.1 This instrument changes legislation concerning supplementary protection certificates

(SPCs) which protect some patented medicines and agrochemicals. Specifically, it

amends the Patents Rules 2007 (SI 2007/3291), the Patents (Amendment) (EU Exit)

Regulations 2019 (SI 2019/801), Regulation (EC) No 469/2009 in relation to

supplementary protection certificates for medicinal products, and 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.

2.2 The changes to the SPC system are needed to take account of changes to the

regulation of medicines and agrochemicals when the Northern Ireland Protocol comes

into effect. This will see the introduction of new marketing authorisations that will be

valid for only part of the territory of the UK. A marketing authorisation is required for

the grant of an SPC; an SPC has effect UK wide, but current legislation does not

account for authorisations that are not valid UK wide. The amendments make only the

changes which are necessary to provide certainty to users of the system when the

Northern Ireland Protocol comes into effect.

2.3 The changes are intended to maintain the balance of interests between all users of the

system; this includes patent holders and applicants for SPCs, third parties with an

interest in SPC-protected products (such as generic medicine manufacturers) and

consumers of medicines (including the NHS) or agrochemicals.

Explanations

What did any relevant EU law do before exit day?

2.4 The relevant EU law provided for an SPC system for patented medicines and

agrochemicals, under which SPCs are granted nationally. SPCs are valuable

intellectual property rights which take effect when a patent expires. SPCs are granted

when a patent holder is delayed from using their patent (bringing a product to market)

until a marketing authorisation is granted from the relevant regulatory authority.

2.5 Under the EU Regulations, an SPC can be granted for a product which is protected by

a patent and which has a valid authorisation to place that product on the market. One

of the qualifying criteria for an SPC is therefore to have a valid marketing

authorisation (MA) for the UK.

DExEU/EM/7-2018.2 2

Why is it being changed?

2.6 Until the end of the transition period, the only MA valid in the UK is one which

applies across the whole of the UK; this is irrespective of whether it has been granted

by European agencies or domestic agencies. Following the transition period, under the

Northern Ireland Protocol, Northern Ireland will still be bound by EU law for the

authorisation of medicines and plant protection products, while Great Britain (GB)

will not. This means there will be separate MAs for NI and GB alongside UK MAs,

which SPC law will need to reflect so that SPCs can be granted and enforced with

legal certainty in the UK.

What will it now do?

2.7 The aim is to provide SPC applicants and third parties with a system which is as

similar as possible to the current regime, while adjusting for new MAs that will be

valid in the UK.

2.8 The proposed change will allow an SPC to be granted based on whichever GB/UK/NI

authorisation or combination of authorisations the applicant has at the point of

application. If the SPC enters into force with an MA covering only one of GB or NI,

the protection provided by the SPC extends only to that territory. Up until the SPC

comes into force, an applicant can submit an additional MA, allowing protection to

extend to the whole of the UK.

3. Matters of special interest to Parliament

Matters of special interest to the Joint Committee on Statutory Instruments

3.1 None.

Matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House

of Commons relating to Public Business (English Votes for English Laws)

3.2 The territorial application of this instrument includes Scotland and Northern Ireland.

3.3 The powers under which this instrument is made cover the entire United Kingdom

(see section 24(1) of the European Union (Withdrawal) Act 2018) and the territorial

application of this instrument is not limited either by the Act or by the instrument.

4. Extent and Territorial Application

4.1 The territorial extent of this instrument is all of the United Kingdom.

4.2 The territorial application of this instrument is all of the United Kingdom.

5. European Convention on Human Rights

5.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP has made the following statement regarding

Human Rights:

“In my view the provisions of the Supplementary Protection Certificate (Amendment)

(EU Exit) Regulations 2020 are compatible with the Convention rights.”

DExEU/EM/7-2018.2 3

6. Legislative Context

6.1 Section 8C(1) of the European Union (Withdrawal) Act 20181 provides Ministers with

the power to make provision in connection with the Protocol. Although the changes to

the SPC system are not required to fulfil obligations under the Protocol, they are

matters arising out of the Protocol’s obligations in respect of regulation of medicines

and agrochemicals, and so the power is engaged.

6.2 Regulations 469/2009 and 1610/96 have previously been amended to resolve

inoperabilities arising from the retention of EU law at the end of the transition period,

using the powers in section 8 of the European Union (Withdrawal) Act 2018. The

Patents (Amendment) (EU Exit) Regulations 2019 and the Intellectual Property

(Amendment etc.) (EU Exit) Regulations 2020 (SI 2020/1050) both made changes to

the two SPC Regulations. These changes will come into effect on IP completion day.

If approved, this instrument will supplement or replace those changes.

6.3 The substantive requirements for the six-month SPC term extension rewarding

completion of paediatric testing, as discussed in paragraph 7.5, are provided by

separate legislation – currently, this is Article 36 of Regulation (EC) No 1901/2006.

At the end of the transition period, this will be replaced by regulation 58A of the

Human Medicines Regulations 20122. As the Protocol specifically excludes Article 36

from applying to Northern Ireland, the requirements for the extension will remain a

matter for domestic law. Subject to Parliamentary approval, further amendments to

regulation 58A will be made by the Human Medicines (Amendment etc.) (EU Exit)

Regulations 20203. The amendments in the present instrument make changes only to

the administrative requirements for the grant of the extension which are set out in the

SPC Regulations.

6.4 This instrument does not address the effects of the Protocol on the regulatory system

itself. These will be dealt with by way of other statutory instruments coming before

Parliament, namely:

• the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020;

• the Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations

2020; and

• the Pesticides (Amendment) (EU Exit) Regulations 2020.

7. Policy background

What is being done and why?

How the SPC system currently works

7.1 A patent protects an invention and lets the owner of that patent take legal action

against anyone who makes, uses, sells or imports that invention without the owner’s

permission – this is known as infringement of the patent. A patent can provide such

protection for up to twenty years.

7.2 Supplementary protection certificates (SPCs) provide a period of additional protection

for patented medicines and agrochemicals (referred to below as “products”), to reflect

the need for such products to undergo lengthy regulatory approval procedures during

1 C.16; as inserted by section 21 of the European Union (Withdrawal Agreement) Act 2020 (c. 1). 2 As inserted by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/775). 3 Laid in draft on [15 October 2020].

DExEU/EM/7-2018.2 4

the patent lifetime before they can be sold and research investment recouped. The

SPC gives the approved product the same rights and protection as the original patent

for up to five years after the patent expires. SPCs are provided by EU Regulations but

operate as individual national rights.

7.3 For an SPC to be granted in the UK, there must be i) a patent which provides

protection for the active ingredient of the product, and ii) regulatory approval for the

product which allows it to be sold in the UK. This regulatory approval, in the form of

a marketing authorisation (MA), may come from the UK regulator or, in the case of

medicines, it may come from the European Medicines Agency, which grants approval

EU-wide. The MA must be the first which allows the product to be sold in the UK.

7.4 An application for an SPC to be granted must be filed at the Intellectual Property

Office. The application must be filed within six months of either the patent being

granted or the MA being approved, whichever is later. The application is then

examined against the statutory requirements and granted or refused.

7.5 The granted SPC takes effect at the end of the patent term for a maximum of five

years, depending on how long it has taken for the MA to be granted. If the product is a

medicine, and it has been tested for use in paediatric populations, a further six-month

extension can be granted if the relevant requirements are met. This extension must be

applied for no later than two years before the expiry of the SPC.

Why the Northern Ireland Protocol requires changes to be made

7.6 At the end of the transition period, the Northern Ireland Protocol takes effect as part of

the Withdrawal Agreement. Article 5(4) of the Protocol states that the provisions of

EU law which are listed in Annex 2 to the Protocol shall apply to, and in, Northern

Ireland. The provisions which are listed largely relate to regulatory requirements for

placing products on the market; these form part of ensuring there is no hard border

between Northern Ireland and the Republic of Ireland.

7.7 Regulations 469/2009 and 1610/96 concerning SPCs are not included in the list of

provisions. However, EU Directives and Regulations relating to the regulation of

human and veterinary medicines and agrochemicals, and the Regulations relating to

the operation of the European Medicines Agency, are included.

7.8 Products which are subject to regulatory approval before they can be placed on the

market in Northern Ireland must therefore be assessed in accordance with EU law, to

ensure that they are free to move between Northern Ireland and the Republic of

Ireland. Approval may be given by the UK regulator acting on behalf of Northern

Ireland or by the European Medicines Agency.

7.9 This means that products which can be sold in at least part of the UK may have a

marketing authorisation granted under EU law.

7.10 A product may potentially be covered by a UK-wide marketing authorisation (“UK

authorisation”), an authorisation allowing the product to be sold in England, Wales

and Scotland only (“GB authorisation”), or an authorisation allowing the product to

be sold only in Northern Ireland (“NI authorisation”). A specific product may have

two authorisations relating to it covering different territories – in most cases, a GB

authorisation and an NI authorisation.

7.11 The current SPC system is not designed to accommodate marketing authorisations

which cover only part of the UK. It is therefore necessary to amend the existing

DExEU/EM/7-2018.2 5

legislation as an indirect effect of the regulatory arrangements established by the

Protocol.

How the SPC system will change as a result

7.12 With the changes being made by this instrument, an SPC may be granted if there is a

marketing authorisation which allows the product to be sold somewhere within the

UK. This marketing authorisation must fulfil the same requirements as in the current

system – it must be valid for placing the product on the market and must be the first

such authorisation for its particular territory.

7.13 SPCs will remain a UK-wide right – there will not be separate SPCs for GB and NI.

However, it is important to preserve the principle that an SPC must be underpinned by

a marketing authorisation with effect in the relevant territory. So, the protection

conferred by a granted SPC will extend only to the territory where that authorisation

allows the product to be sold. For example, an SPC based solely on an NI

authorisation would provide protection only in Northern Ireland.

7.14 That does not mean that the territory where protection applies is fixed at the point of

applying for the SPC. The protection can be extended further if an authorisation for

that product has been granted covering a different part of the UK, and the IPO is

notified of it. This can be done either when making the initial application, if all the

authorisations have been granted at that time, or at any time before the SPC comes

into effect.

7.15 For the protection to extend to the additional territory, that authorisation must meet the

same requirements – it must be a valid authorisation to place the product on the

market in its particular territory, and must be the first authorisation to place the

product on the market in that territory. The only difference is that those requirements

must be met as of the date the additional authorisation was granted, rather than the

date of the SPC application.

7.16 The ability to extend the territory will end at the point the SPC takes effect. The

territory in which the protection of the SPC has effect will then be fixed for as long as

the certificate lasts. This ensures that rightsholders and third parties have certainty

about where protection applies. This deadline aligns with the last point at which an

SPC application can be filed; this flexibility is therefore not expected to put third

parties at any additional disadvantage in terms of transparency.

7.17 In relation to the six-month extension for paediatric testing, the territory in which the

paediatric extension has effect will match that of the SPC, provided that the necessary

requirements have been met for all authorisations within that territory, and the

relevant applications have been made by the two-year deadline mentioned in

paragraph 7.5. If the requirements have only been met for part of that territory, then

the paediatric extension will only apply to that part. It will not be possible for the

paediatric extension to provide protection in a part of the UK where the SPC does not.

7.18 Transitional arrangements mean that SPC applications pending at the end of the

transition period will be considered based on the existing requirements. Changes that

have previously been made to the SPC Regulations for the end of the transition

period4 will still apply to these applications, as these ensure the existing requirements

remain operable. Any SPC application filed after the end of the transition period will

4 As discussed in paragraph 6.2.

DExEU/EM/7-2018.2 6

be considered based on the updated requirements. All granted SPCs will be subject to

the updated requirements.

Changes to the SPC Regulations

7.19 This instrument amends Regulations 469/2009 and 1610/96 either directly, or

indirectly by amending provisions of the Patents (Amendment) (EU Exit) Regulations

2019 which act on them.

7.20 Both Regulations have nearly identical numbering, so references to a particular Article

in the following paragraphs are to the same Article in both Regulations unless

otherwise indicated. References to a regulation are to those in this instrument;

paragraphs refer to the Schedule.

7.21 Article 1 contains definitions which are used in the rest of the Regulation. Paragraphs

2 and 11 of the Schedule amend Article 1 to add definitions of GB authorisation and

NI authorisation.

7.22 Articles 2 and 3 set out the key principles of the system which determine whether an

SPC may be granted, as discussed in paragraph 7.3. Regulations 2(4), 2(5)(a), 3(4),

and 3(5)(a) ensure that the MA on which an SPC may be based can be any of a UK,

GB, or NI authorisation. Regulations 2(5)(b) and 3(5)(b) make it clear that the

authorisation needs only to be the first authorisation in its particular territory.

7.23 Article 4 sets out that an SPC only protects the specific product which has been

authorised for sale, as well as any further uses of that product which are authorised

before the SPC expires. Paragraphs 3 and 12 of the Schedule amend this so that the

SPC protects the product which has been authorised in any of the MAs associated

with the SPC, and any further uses authorised in the UK. This scope of protection

applies in all territories where SPC protection extends.

7.24 Article 5(1) establishes that a granted SPC provides the same protection as the patent

on which it is based. Paragraphs 4 and 13 of the Schedule insert new paragraphs 2 and

3 to Reg 1610/96 and 1a and 1b to Reg 469/2009 respectively. These new paragraphs

set out that this protection will only extend to territory within the UK where i) an MA

has been granted for the product before the SPC takes effect, and ii) that MA meets

the requirements set out in Article 3. The second new paragraph enables the

protection to apply in additional territory if an MA for the product which meets the

requirements set out in Article 3 is granted in that territory after an application for an

SPC is filed. Because those requirements must normally be met as of the date the SPC

application is filed, and a later MA will not have been granted at that time, the second

new paragraph establishes that the later MA must meet them as of the date it is

granted.

7.25 Article 7 sets the timescale for when an SPC application must be made (as discussed

in paragraph 7.7). Paragraphs 5 and 14 of the Schedule amend the Article so that, if

the applicant has multiple MAs granted before they file an application, the application

must be filed within six months of the earliest of those MAs being granted for it to be

accepted.

7.26 Articles 8, 9 and 11 set out the documentary requirements for an SPC application, and

the information which the IPO is obliged to publish when the application is received

and when the SPC is granted. Regulations 2(6), 2(7), 2(8), 3(6), 3(7), 3(8), and 3(10),

and paragraph 6 of the Schedule, amend these Articles to require details on all MAs

filed with the application to be provided and published. For applications for a

DExEU/EM/7-2018.2 7

paediatric extension, paragraphs 15-17 of the Schedule add requirements to provide

and publish information on the territory where the conditions for the extension are

met.

7.27 Article 13 defines the duration of an SPC, including when the six-month paediatric

extension applies. To qualify for the paediatric extension, the MA for the product

must contain a statement that the paediatric testing has been carried out in accordance

with an agreed plan. This is usually done by updating the original authorisation used

for the SPC application. Paragraph 18 of the Schedule adds a provision that the

extension will provide protection in the territory of the updated authorisation, but only

as far as the SPC itself provides protection. If only one MA associated with an SPC

has been updated, the extension will only provide protection in its territory, even if the

SPC is wider.

7.28 Paragraphs 7 and 19 of the Schedule insert new Article 13A. This new Article

provides the mechanism by which information on additional MAs can be provided to

the IPO. The applicant or SPC holder must provide this information within six months

of the MA being granted and by the time the SPC takes effect; if the applicant fails to

meet this deadline, the protection will not extend to the relevant territory. This

information will be published by the IPO for the benefit of third parties.

7.29 Paragraph 19 of the Schedule also adds new Article 13B to Regulation 469/2009.

Article 13B provides a mechanism by which a further application can be made for the

paediatric extension to also provide protection in the territory of another MA

associated with the SPC, if the conditions for granting the extension have been met

for that MA. This application must still be filed by the two-year deadline.

7.30 Article 14 sets out when an SPC ceases to have effect or “lapses”. An SPC can lapse if

the MA underpinning the SPC is withdrawn. Regulations 2(12) and 3(11) modify this

condition so that all the MAs associated with the SPC must have been withdrawn for

this to happen. Those regulations also set out what happens if not all MAs are

withdrawn – the SPC continues to have effect, but its protection will only extend to

the territory where an MA remains valid. The IPO will publish a notification if it is

made aware that this has happened; paragraph 8 of the Schedule amends Article 16 of

Reg 1610/96, whilst paragraph 20 amends Article 17 of Reg 469/2009, to facilitate

this.

7.31 Several of the new provisions require applicants or SPC holders to provide

information to the IPO; to ensure that the information is provided consistently, a new

statutory form will be created. Forms are prescribed in the Patents Rules 2007, and

Regulation 6 makes the necessary amendments to add the form to the rules on SPCs.

7.32 Transitional provisions are set out in regulation 7. These establish that the new

provisions will apply to all SPC applications filed after IP completion day; this

includes applications based on MAs granted before that date. Applications which are

pending on IP completion day will be determined based on the legislation as

previously amended, in accordance with Article 60 of the Withdrawal Agreement. In

addition, the regulatory changes arising from the Protocol may result in an MA which

underpins an existing SPC being replaced by authorisations covering separate

territories; regulation 7(4), 7(7) and 7(8) ensure that, if this happens, it will not affect

the continuing validity of the SPC.

DExEU/EM/7-2018.2 8

8. European Union (Withdrawal) Act/Withdrawal of the United Kingdom from the

European Union

8.1 This instrument is not being made to address a deficiency in retained EU law but

relates to the withdrawal of the United Kingdom from the European Union because it

is being made under Section 8C of the European Union (Withdrawal) Act 2018. The

Minister has made any relevant statements in Part 2 of the Annex to this Explanatory

Memorandum.

9. Consolidation

9.1 No consolidation of the relevant legislation is planned at present. Informal

consolidated texts of domestic intellectual property legislation are publicly available

for free on the gov.uk website5.

9.2 The IPO has prepared, and will be making publicly available, informal consolidated

texts of Regulations 469/2009 and 1610/96 which take into account all legislative

changes for the end of the transition period. A draft of this material has been laid in

the Libraries of both Houses to assist with Parliamentary scrutiny.

10. Consultation outcome

10.1 Consultation with stakeholders on the indirect effects of the Protocol on the SPC

system began following publication of the Command Paper, “The UK’s Approach to

the Northern Ireland Protocol”6. There was also close collaboration with Government

departments and regulatory bodies involved in the authorisation of medicines

(veterinary and human) and agrochemicals - namely, Defra, MHRA and DHSC – to

ensure that information on the interaction with the regulatory regime could be

provided.

10.2 IPO officials contacted the presidents of key Intellectual Property stakeholder groups

with a known interest in patents, IP professionals who had engaged with IPO

previously on SPC matters, and businesses operating in the relevant industries based

on contacts provided by the other Government departments. Given that SPCs apply to

products in just two specific fields of technology, this was considered an appropriate

approach. Officials set out the problem to be addressed and invited comments, in

order to better understand potential impacts for users of the system.

10.3 Officials then met with representatives of those groups which had responded to this

initial contact, to discuss the Government’s proposed approach in more detail. These

were: the Association of the British Pharmaceutical Industry; the Chartered Institute

of Patent Attorneys; the British Generic Manufacturers’ Association and the

BioIndustry Association. These groups cover the innovative/originator pharmaceutical

sector, generic pharmaceutical manufacturers and the patent attorney profession

(which represents businesses in both the pharmaceutical and agrochemical fields).

10.4 All those involved agreed that intervention would be appropriate and supported the

approach proposed, describing it as “flexible” and “pragmatic”. None identified clear

winners or losers of the described process, although. concerns were raised that it

should not be so flexible that applicants risked their applications being rejected on

purely administrative grounds. Discussions also noted the need for third parties to

have early certainty about the territorial scope of granted SPCs and the intent of the

5 https://www.gov.uk/topic/intellectual-property/law-practice 6 CP226, https://www.gov.uk/government/publications/the-uks-approach-to-the-northern-ireland-protocol

DExEU/EM/7-2018.2 9

SPC applicant on that issue. Another area of concern raised was the interaction

between the SPC legislation and the paediatric legislation in relation to the six-month

paediatric extension; IPO officials have worked closely with DHSC on a coordinated

approach to the extension.

10.5 Further dialogue between the IPO and stakeholders included the sharing of a draft of

the legislation, inviting feedback on the proposed drafting. This feedback was

considered and used to finalise the text of the legislation.

11. Guidance

11.1 The IPO will be providing guidance to businesses who use the SPC system to explain

the changes that will result from this legislation and the indirect effects of the

Protocol. This is expected to be available, subject to when the instrument is approved,

at the end of November 2020.

11.2 Any new or updated statutory forms will be made available on gov.uk for 1 January

2021.

12. Impact

12.1 The impact on business, charities or voluntary bodies is small.

12.2 The impact on the public sector is small.

12.3 An Impact Assessment has not been prepared for this instrument because the effect of

the instrument is estimated to fall below the threshold for a formal assessment; a de

minimis analysis has been conducted. The changes made by this SI are largely driven

by the regulatory arrangements established in the Northern Ireland Protocol. The

impacts of needing different authorisations for medicines and agrochemicals are

therefore associated with the effects of the Protocol and do not fall within the scope of

the assessment. Only the changes to fit those arrangements into the SPC system, set

out in this SI, are applicable to the analysis.

12.4 The Government believes that the impact of the changes made by this SI is low, as it

is limited mainly to administrative costs arising from the need to supply evidence of

new marketing authorisations to the IPO following an initial SPC application.

12.5 On average, the IPO receives around 70 applications for SPC protection annually7,

meaning that the number of applications made by businesses per year is relatively

small. There could be additional administrative costs for businesses applying for

SPCs, as they may need to supply IPO with an additional marketing authorisation in

comparison with the present system. However, businesses will not have to pay any

statutory fees beyond what is currently required - the IPO is not adjusting fees for

SPCs as a consequence of this SI or charging any additional fees for the work to be

undertaken. Competing businesses could face some administrative costs in order to

check the territorial scope of the SPC when it comes into force.

12.6 There will be a small impact on the IPO in processing information about an additional

MA for an SPC application. As the IPO operates as a Trading Fund, these costs are

expected to be absorbed by existing fees and require no central government funding to

accommodate.

7 IPO internal statistics. Median for the years 2010-2019 (inclusive)

DExEU/EM/7-2018.2 10

13. Regulating small business

13.1 The legislation applies to activities that are undertaken by small businesses.

13.2 No specific action is proposed to minimise regulatory burdens on small businesses.

13.3 The basis for the final decision on what action to take to assist small businesses is that

the statutory requirements that must be met for the grant of an SPC should be

consistent for all applicants. In addition, SPCs are limited to specific technical fields;

the small number of businesses which interact with the system are highly engaged

with its operation. Whilst some familiarisation with the new processes may be

required, this is not expected to provide any additional burden to small businesses

operating in these technical fields over larger ones.

14. Monitoring & review

14.1 The approach to monitoring of this legislation is to assess the effect of the changes

being made as part of the course of normal departmental business. In particular, as the

authority responsible for the SPC application, examination, and granting process, the

IPO will closely monitor how it operates and whether any practical issues arise.

14.2 As this instrument is made under the EU Withdrawal Act 2018, no review clause is

required.

15. Contact

15.1 Michael Warren or Richard Sewards at the Intellectual Property Office Telephone:

01633 813988 or 01633 813536 or email: michael.warren@ipo.gov.uk or

richard.sewards@ipo.gov.uk can be contacted with any queries regarding the

instrument.

15.2 James Porter, Divisional Director for Policy and Legal at the Intellectual Property

Office can confirm that this Explanatory Memorandum meets the required standard.

15.3 Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation) Amanda Solloway MP at the Department for Business, Energy &

Industrial Strategy can confirm that this Explanatory Memorandum meets the required

standard.

DExEU/EM/7-2018.2 11

Annex Statements under the European Union (Withdrawal) Act

2018

Part 1

Table of Statements under the 2018 Act

This table sets out the statements that may be required under the 2018 Act.

Statement Where the requirement sits To whom it applies What it requires

Sifting Paragraphs 3(3), 3(7) and

17(3) and 17(7) of Schedule

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) to make a Negative SI

Explain why the instrument should be

subject to the negative procedure and, if

applicable, why they disagree with the

recommendation(s) of the SLSC/Sifting

Committees

Appropriate-

ness

Sub-paragraph (2) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

A statement that the SI does no more than

is appropriate.

Good Reasons Sub-paragraph (3) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

Explain the good reasons for making the

instrument and that what is being done is a

reasonable course of action.

Equalities Sub-paragraphs (4) and (5)

of paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

Explain what, if any, amendment, repeals

or revocations are being made to the

Equalities Acts 2006 and 2010 and

legislation made under them.

State that the Minister has had due regard

to the need to eliminate discrimination and

other conduct prohibited under the

Equality Act 2010.

Explanations Sub-paragraph (6) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

In addition to the statutory

obligation the Government has

made a political commitment

to include these statements

alongside all EUWA SIs

Explain the instrument, identify the

relevant law before exit day, explain the

instrument’s effect on retained EU law and

give information about the purpose of the

instrument, e.g., whether minor or

technical changes only are intended to the

EU retained law.

Criminal

offences

Sub-paragraphs (3) and (7)

of paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9, and

Set out the ‘good reasons’ for creating a

criminal offence, and the penalty attached.

DExEU/EM/7-2018.2 12

23(1) or jointly exercising

powers in Schedule 2 to create

a criminal offence

Sub-

delegation

Paragraph 30, Schedule 7 Ministers of the Crown

exercising sections 10(1), 12

and part 1 of Schedule 4 to

create a legislative power

exercisable not by a Minister

of the Crown or a Devolved

Authority by Statutory

Instrument.

State why it is appropriate to create such a

sub-delegated power.

Urgency Paragraph 34, Schedule 7 Ministers of the Crown using

the urgent procedure in

paragraphs 4 or 14, Schedule

Statement of the reasons for the Minister’s

opinion that the SI is urgent.

Explanations

where

amending

regulations

under 2(2)

ECA 1972

Paragraph 14, Schedule 8 Anybody making an SI after

exit day under powers outside

the European Union

(Withdrawal) Act 2018 which

modifies subordinate

legislation made under s. 2(2)

ECA

Statement explaining the good reasons for

modifying the instrument made under s.

2(2) ECA, identifying the relevant law

before exit day, and explaining the

instrument’s effect on retained EU law.

Scrutiny

statement

where

amending

regulations

under 2(2)

ECA 1972

Paragraph 15, Schedule 8 Anybody making an SI after

exit day under powers outside

the European Union

(Withdrawal) Act 2018 which

modifies subordinate

legislation made under s. 2(2)

ECA

Statement setting out:

a) the steps which the relevant authority

has taken to make the draft instrument

published in accordance with paragraph

16(2), Schedule 8 available to each House

of Parliament,

b) containing information about the

relevant authority’s response to—

(i) any recommendations made by a

committee of either House of Parliament

about the published draft instrument, and

(ii) any other representations made to the

relevant authority about the published draft

instrument, and,

c) containing any other information that

the relevant authority considers appropriate

in relation to the scrutiny of the instrument

or draft instrument which is to be laid.

DExEU/EM/7-2018.2 13

Part 2

Statements required when using enabling powers

under the European Union (Withdrawal) 2018 Act

1. Explanations

1.1 The explanations statement has been made in section 2 of the main body of this

explanatory memorandum.

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