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The Patents (Amendment) (EU Exit) Regulations 2019

S.I. 2019/801 · Made 4 April 2019 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 31 December 2020.

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:

Annotations to the whole text

Marginal citations

M1

2018 c.16.

Contents

  1. Part 1: INTRODUCTORY
  2. 1Regulation 1
  3. Part 2: AMENDMENTS TO THE PATENTS ACT 1977
  4. 2Regulation 2
  5. 3Regulation 3
  6. 4Regulation 4 Not yet in force
  7. Part 3: AMENDMENT TO THE COPYRIGHT, DESIGNS AND PATENTS ACT 1988
  8. 5Regulation 5
  9. Part 4: AMENDMENTS TO THE PATENTS AND PLANT VARIETY RIGHTS (COMPULSORY LICENSING) REGULATIONS 2002
  10. 6Regulation 6
  11. 7Regulation 7
  12. 8Regulation 8
  13. 9Regulation 9
  14. 10Regulation 10
  15. 11Regulation 11
  16. 12Regulation 12
  17. 13Regulation 13
  18. 14Regulation 14
  19. 15Regulation 15
  20. 16Regulation 16
  21. 17Transitional provision Not yet in force
  22. Part 5: AMENDMENTS TO THE PATENTS RULES 2007
  23. 18Regulation 18
  24. Part 6: SUPPLEMENTARY PROTECTION CERTIFICATES FOR PLANT PROTECTION PRODUCTS – AMENDMENTS TO REGULATION (EC) No 1610/96
  25. 19Regulation 19
  26. 20Regulation 20
  27. 21Regulation 21 Not yet in force
  28. 22Regulation 22
  29. 23Regulation 23
  30. 24Regulation 24
  31. 25Regulation 25
  32. 26Regulation 26
  33. 27Regulation 27
  34. 28Regulation 28
  35. 29Regulation 29
  36. 30Regulation 30
  37. 31Regulation 31
  38. 32Regulation 32
  39. 33Regulation 33
  40. 34Regulation 34
  41. 35Regulation 35
  42. 36Regulation 36
  43. Part 7: COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS - AMENDMENTS TO REGULATION (EC) NO 816/2006
  44. 37Regulation 37
  45. 38Regulation 38
  46. 39Regulation 39
  47. 40Regulation 40
  48. 41Regulation 41
  49. 42Regulation 42
  50. 43Regulation 43
  51. 44Regulation 44
  52. 45Regulation 45
  53. 46Regulation 46
  54. 47Regulation 47
  55. 48Regulation 48
  56. 49Regulation 49
  57. 50Regulation 50
  58. Part 8: SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS – AMENDMENTS TO REGULATION (EC) No 469/2009
  59. 51Regulation 51
  60. 52Regulation 52
  61. 53Regulation 53 Not yet in force
  62. 54Regulation 54
  63. 55Regulation 55
  64. 56Regulation 56
  65. 57Regulation 57
  66. 58Regulation 58
  67. 59Regulation 59
  68. 60Regulation 60
  69. 61Regulation 61
  70. 62Regulation 62
  71. 63Regulation 63
  72. 64Regulation 64
  73. 65Regulation 65
  74. 66Regulation 66
  75. 67Regulation 67
  76. 68Regulation 68
  77. 69Transitional provision
  78. Signature
  79. Explanatory note

1I1

These Regulations may be cited as the Patents (Amendment) (EU Exit) Regulations 2019 and come into force on exit day.

2I1

The Patents Act 1977 is amended follows.

3I1

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 ”.

4F1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5I1

(1)

Section 281 (power of comptroller to refuse to deal with certain agents) of the Copyright, Designs and Patents Act 1988 M1 is amended as follows.

(2)

In subsection (5), for the words from the words “another” to the end, substitute “ a member State ”M2 .

6I1

The Patents and Plant Variety Rights (Compulsory Licensing) Regulations 2002 M1 are amended as set out in this Part.

7I1

(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—

  • “ F1“plant breeders’ right” means—

    1. (a)

      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

    2. (b)

      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;”.

8I1

(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.

9I1

In regulation 7 (conditions), omit paragraphs (4) and (5).

10I1

Omit regulation 15 (Community plant variety rights.).

11I1

In regulation 16 (variation and revocation), omit paragraphs (4) to (7).

12I1

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.”.

13I1

(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 ”.

14I1

(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 ”.

15I1

In regulation 24, omit “or 15(1)”.

16I1

(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) ”.

17Transitional provisionF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18I1

(1)

The Patents Rules 2007 M1 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 ”.

19I1

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.

20I1

(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;

F112

‘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;

F215

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.

21F1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22I1

For Article 2, substitute—

“Article 2

Scope

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 F1GB or NI authorization prior to being placed on the market as a plant protection product.”.

23I1

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 F1GB 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 F2... authorization to place the product on the market as a plant protection product F3in the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.”.

24I1

(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 F1GB or NI authorisation or both GB and NI authorisations as referred to in Article 3(1)(b) F2and (d); and

(v)

the number and date of the earliest EEA authorization, the granting of which predates the granting of the F3GB or NI authorization F4as referred to in Article 3(1)(b) and (d);”.

(3)

For paragraph 8(1)(b) and (c), substitute—

“(b)

a copy of the F5GB or NI authorisation or both GB and NI authorisations to place the product on the market, as referred to in Article 3(1)(b) F6and (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, F7Part 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 F8GB or NI authorization referred to in Article 3(1)(b) F9and (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.

25I1

(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—

“F1(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 F2any GB or NI authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorization;”.

26I1

(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—

“

F16

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.

27I1

(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—

F1(a)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)

for sub-paragraph (e), substitute—

“(e)

where there are EEA authorizations granted before F2any authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorization;”.

28I1

Omit Article 12 (annual fees).

29I1

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 ”.

30I1

(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; F1or

(d)

if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of F2all 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.”.

F3(4)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31I1

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 ”.

32I1

In Article 16 (notification of lapse or invalidity), for “the authority referred to in Article 9(1)”, substitute “ the comptroller ”.

33I1

In Article 17 (appeals), omit paragraph 1.

34I1

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.”.

35I1

Omit Articles 19 and 20 (transitional provisions).

36I1

After Article 21 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

37I1

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.

38I1

(1)

Article 1 (scope) is amended as follows.

(2)

For “Member States”, substitute “ The competent authority ”.

39I1

(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).

40I1

In Article 4 (eligible importing countries), for “Commission”, substitute “ United Kingdom ”.

41I1

(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,”.

42I1

(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.

43I1

In Article 8 (verification), for “Commission”, wherever it occurs, substitute “ United Kingdom ”.

44I1

(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.”.

45I1

(1)

Article 12 (notification) is amended as follows.

(2)

For “Member State”, substitute “ Secretary of State ”.

(3)

Omit “through the intermediary of the Commission”.

46I1

In Article 13 (prohibition of importation), in paragraph 1, for “Community”, substitute “ United Kingdom ”.

47I1

(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.

48I1

(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,”.

49I1

Omit Articles 17 to 19. (appeals, safety and efficacy of medicinal products and review)

50I1

After Article 20 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States”.

51I1

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.

52I1

(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.”.

53F1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

54I1

For Articles 2 (scope) and 3 (conditions for obtaining a certificate), substitute—

“Article 2

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 F1, GB or NI authorisation prior to being placed on the market as a medicinal product.

Article 3

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 F2, GB or NI authorisation to place the product on the market;

(c)

the product has not already been the subject of a certificate;

(d)

the authorisation referred to in point (b) is the first UK F3, GB or NI authorisation to place the product on the market as a medicinal product F4in the territory of the United Kingdom, the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.”.

55I1

(1)

Article 8 (content of application for a certificate) is amended as follows.

(2)

For paragraph 1(a)(iv), substitute—

“F1(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 F2, GB or NI authorisation F3as referred to in Article 3(b) and (d);”.

(3)

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

“(b)

a copy of the UK F4, 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) F5and (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 F6, GB or NI authorisation referred to in Article 3(b) F7and (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).

56I1

(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—

“F1(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 F2any UK, GB or NI authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorisation;”.

57I1

(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—

“

F17

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.

58I1

(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)

F1for 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 F2any UK, GB or NI authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorisation;”.

59I1

Omit Article 12 (annual fees).

60I1

(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 ”.

61I1

(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; F1or

(d)

if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of F2all 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.”.

F3(4)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

62I1

In paragraph 2 of Article 15 (invalidity of the certificate), for “F1... the body responsible under national law for the revocation of the corresponding basic patent” substitute “ the comptroller or the court ”.

63I1

(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 ”.

64I1

For references in Article 17 (notification of lapse or invalidity) to “the authority referred to in Article 9(1)”, substitute “ the comptroller ”.

65I1

Omit Article 18 (appeals).

66I1

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.”.

67I1

Omit Articles 20 (enlargement of the Community) and 21 (transitional provisions).

68I1

After Article 23 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”

69Transitional provisionI1

(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 F1IP completion day; and

(b)

An extension of the duration of a certificate granted—

(i)

before IP completion day; or

(ii)

after IP 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 ”.

Signature

Chris Skidmore

Minister of State

Department for Business, Energy and Industrial Strategy

Explanatory note

(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.