The Patents (Amendment) (EU Exit) Regulations 2019

PART 7 U.K. COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS - AMENDMENTS TO REGULATION (EC) NO 816/2006

37.  Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems is amended as set out in this Part.

Commencement Information

I1 Reg. 37 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

38.—(1) Article 1 (scope) is amended as follows.

(2) For “Member States”, substitute “ The competent authority ”.

Commencement Information

I2 Reg. 38 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

39.—(1) Article 2 (definitions) is amended as follows.

(2) For the definition of “competent authority” in paragraph (4), substitute—

““competent authority” for the purposes of Articles 1 to 11, 16 and 17 means the Comptroller-General of Patents, Designs and Trade Marks;”.

(3) After paragraph (4), insert—

“(5) “patent” means “a patent under the Patents Act 1977;

(6) “supplementary protection certificate” means a supplementary protection certificate issued under Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products”.

(4) Omit Article 3 (competent authority).

Commencement Information

I3 Reg. 39 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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

Commencement Information

I4 Reg. 40 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

41.—(1) Article 5 (extension to least-developed and developing countries which are not members of the WTO) is amended as follows.

(2) In paragraph (a), for “Commission”, substitute “ Secretary of State ”.

(3) In paragraph (c), omit “or on its own initiative if national law allows the competent authority to act on its own initiative,”.

Commencement Information

I5 Reg. 41 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

42.—(1) Article 6 (application for a compulsory licence) is amended as follows.

(2) For paragraph 1, substitute—

“1.   Any person may submit an application for a compulsory licence under this Regulation to the competent authority in a case where that person's intended activities of manufacture and sale for export are covered by a patent or a supplementary protection certificate.”.

(3) In paragraph 2, for “each application”, substitute “ the application made to the competent authority ”.

(4) Omit paragraph 4.

Commencement Information

I6 Reg. 42 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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

Commencement Information

I7 Reg. 43 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

44.—(1) Article 10 (compulsory licence conditions) is amended as follows.

(2) In paragraph 5, for “Member States”, substitute “ United Kingdom ”.

(3) In paragraph 8, omit “or on its own initiative, if national law allows the competent authority to act on its own initiative.”.

Commencement Information

I8 Reg. 44 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

45.—(1) Article 12 (notification) is amended as follows.

(2) For “Member State”, substitute “ Secretary of State ”.

(3) Omit “through the intermediary of the Commission”.

Commencement Information

I9 Reg. 45 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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

Commencement Information

I10 Reg. 46 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

47.—(1) Article 14 (action by customs authorities) is amended as follows.

(2) In paragraph 1—

(a) for “Community” substitute “ United Kingdom ”; and

(b) omit “Member States shall ensure that a body has the authority to review whether such importation is taking place”.

(3) In paragraph 2, for “national provisions on”, substitute “ the law relating to ”.

(4) In paragraph 3, for “Community”, substitute “ United Kingdom ”.

(5) In paragraph 4, omit “, in accordance with national legislation,”.

(6) Omit paragraph 6.

Commencement Information

I11 Reg. 47 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

48.—(1) Article 16 (termination or review of the licence) is amended as follows.

(2) In paragraph 2, for “through the intermediary of the Commission”, substitute “ by the Secretary of State ”.

(3) In paragraph 3, omit—

(a) “or any other body appointed by the Member State”; and

(b) “or by another body appointed by the Member State,”.

Commencement Information

I12 Reg. 48 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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

Commencement Information

I13 Reg. 49 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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

Commencement Information

I14 Reg. 50 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1