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PART 8U.K.SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS – AMENDMENTS TO REGULATION (EC) No 469/2009

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

I1Reg. 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 M1 ”.

(3) After paragraph (e) insert—

“(f)‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;

[F1(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 [F2in the United Kingdom] as a medicinal product granted [F3or 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 M2.”.

Textual Amendments

F1Words 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)

F3Words 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

I2Reg. 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

M1S.I. 2012/1916. Regulation 58A is inserted by S.I. 2019/775, reg. 64.

Prospective

F453.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F4Reg. 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—

“Article 2U.K.Scope

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 [F5, GB or NI] authorisation prior to being placed on the market as a medicinal product.

Article 3U.K.Conditions for obtaining a certificate

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 [F6, 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 [F7, GB or NI] authorisation to place the product on the market as a medicinal product [F8in 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

F5Words 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)

Commencement Information

I3Reg. 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—

[F9“(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 [F10, GB or NI] authorisation [F11as referred to in Article 3(b) and (d)];”.

(3) For paragraph 1(b) and (c), substitute—

“(b)a copy of the UK [F12, 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) [F13and (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 [F14, GB or NI] authorisation referred to in Article 3(b) [F15and (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

Commencement Information

I4Reg. 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—

[F16“(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 [F17any UK, GB or NI authorisation provided under Article 8(1)(b)], the number and date of the earliest EEA authorisation;”.

Textual Amendments

F16Words 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)

F17Words 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

I5Reg. 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—

F18“7.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.

Textual Amendments

F18Words 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

I6Reg. 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)[F19for 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 [F20any UK, GB or NI authorisation provided under Article 8(1)(b)], the number and date of the earliest EEA authorisation;”.

Textual Amendments

F19Words 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)

Commencement Information

I7Reg. 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

I8Reg. 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

I9Reg. 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; [F21or]

(d)if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of [F22all 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.”.

F23(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Commencement Information

I10Reg. 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 “F24... the body responsible under national law for the revocation of the corresponding basic patent” substitute “ the comptroller or the court ”.

Textual Amendments

F24Word 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

I11Reg. 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

I12Reg. 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

I13Reg. 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

I14Reg. 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

I15Reg. 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

I16Reg. 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

I17Reg. 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

Transitional provisionU.K.

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 [F25IP completion day]; and

(b)An extension of the duration of a certificate granted—

(i)before [F25IP completion day]; or

(ii)after [F25IP 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

F25Words 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

I18Reg. 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