S T A T U T O R Y  I N S T R U M E N T S  
2019 No. 801 
EXITING THE EUROPEAN UNION 
PATENTS 
The Patents (Amendment) (EU Exit) Regulations 2019 
Made  - - - - 4th April 2019 
Coming into force in accordance with regulation 1 
A draft of these Regulations has been approved by r esolutions of both Houses of Parliament 
pursuant to paragraph 1(1) of Schedule 7 to the Eur opean Union (Withdrawal) Act 2018( a). 
The Secretary of State, in exercise of the powers c onferred by section 8(1) of the European Union 
(Withdrawal) Act 2018, makes the following Regulati ons: 
PART 1 
INTRODUCTORY 
1.  These Regulations may be cited as the Patents (Ame ndment) (EU Exit) Regulations 2019 and 
come into force on exit day. 
PART 2 
AMENDMENTS TO THE PATENTS ACT 1977 
2.  The Patents Act 1977 is amended follows. 
3.  In section 128A (EU compulsory licences)— 
(a)  in the heading for “an “EU compulsory”, substitute “a “compulsory pharmaceutical”; 
(b)  in subsection (1), for “an EU compulsory”, substitu te “a compulsory pharmaceutical”; 
(c)  in subsection (2)— 
(i)  for “EU compulsory”, substitute “compulsory pharmac eutical”; 
(ii)  “an EU compulsory”, substitute “a compulsory pharma ceutical”; 
(d)  in subsection (5), for “an EU compulsory”, substitu te “a compulsory pharmaceutical”. 
4.  In paragraph 1 of Schedule A1 (derogation from pat ent protection in respect of 
biotechnological inventions), in the definition of “Council Regulation”, at the end, insert, “as it 
had effect immediately before exit day”. 
                                                                                                                                            
(a) 2018 c.16.  2PART 3 
AMENDMENT TO THE COPYRIGHT, DESIGNS AND PATENTS ACT  1988 
5. —(1) Section 281 (power of comptroller to refuse to  deal with certain agents) of the 
Copyright, Designs and Patents Act 1988( a) is amended as follows. 
(2)  In subsection (5), for the words from the words “an other” to the end, substitute “a member 
State”( b). 
PART 4 
AMENDMENTS TO THE PATENTS AND PLANT VARIETY RIGHTS 
(COMPULSORY LICENSING) REGULATIONS 2002 
6.  The Patents and Plant Variety Rights (Compulsory L icensing) Regulations 2002( c) are 
amended as set out in this Part. 
7. —(1) Regulation 2 (interpretation) is amended as fo llows. 
(2)  In paragraph (1)— 
(a)  omit the definition of “Community plant variety rig ht”; 
(b)  omit the definition of “Council Regulation”; 
(c)  for the definition of “plant breeders’ rights”, sub stitute— 
““plant breeders’ right” means any right granted un der, or having effect as if granted 
under, section 3 of the 1997 Act (including existin g rights as defined by section 40(4) 
of that Act);”. 
8. —(1) Regulations 3 (applications) and 6 (grant) are  amended as follows. 
(2)  Omit “or a Community plant variety right” and “or C ommunity plant variety right” wherever 
they occur. 
9.  In regulation 7 (conditions), omit paragraphs (4) and (5). 
10.  Omit regulation 15 (Community plant variety rights .). 
11.  In regulation 16 (variation and revocation), omit paragraphs (4) to (7). 
12.  In regulation 17, for paragraph (2), substitute— 
“(2) Where a decision of the controllers relates to  a compulsory patent licence or cross 
licence ordered to be granted under regulation 7(2)  or 7(3), an appeal may be made to the 
court.”. 
13. —(1) Regulation 20 (extension of powers to make rul es 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 “regulatio n 8”; and 
(b)  for “regulations 9 and 16(5)”, substitute “regulati on 9”. 
14. —(1) Regulation 22 (application of existing rules a nd regulations) is amended as follows. 
(2)  In paragraph (1), for “regulations 7(2), 7(3) and 1 5(3)”, substitute “regulation 7(2) and 7(3)”. 
                                                                                                                                            
(a) 1988 c.48. 
(b) Article 4 of S.I. 2011/1043 provided that referen ces to the European Union are substituted for refer ences to the European 
Communities. 
(c) S.I. 2002/247  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”. 
15.  In regulation 24, omit “or 15(1)”. 
16. —(1) Regulation 26 (application of 1977 and 1997 Ac ts) is amended as follows. 
(2)  In paragraph (1), in both places where it occurs, f or “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)”. 
Transitional provision 
17. —(1) In this regulation “former regulations” means the Patents and Plant Variety Rights 
(Compulsory Licensing) Regulations 2002 without the  amendments made by these Regulations. 
(2)  The former regulations continue to apply for the pu rposes of— 
(a)  any application pursuant to regulation 15 made but not determined before exit day; and 
(b)  a cross licence granted— 
(i)  before exit day pursuant to regulation 15; or 
(ii)  after exit day pursuant to an application falling w ithin sub-paragraph (a). 
PART 5 
AMENDMENTS TO THE PATENTS RULES 2007 
18. —(1) The Patents Rules 2007( a) are amended as follows. 
(2)  In rule 85(1), omit from “, but not resident” to “t he 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 Compul sory 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”. 
PART 6 
SUPPLEMENTARY PROTECTION CERTIFICATES FOR PLANT PRO TECTION 
PRODUCTS – AMENDMENTS TO REGULATION (EC) No 1610/96  
19.  Regulation (EC) No 1610/96 of the European Parliam ent and of the Council of 23 July 1996 
concerning the creation of a supplementary protecti on certificate for plant protection products is 
amended as set out in this Part. 
20. —(1) Article 1 (definitions) is amended as follows.  
(2)  In paragraph 1(c), omit “Council or Commission”. 
(3)  After paragraph 10, insert— 
“11. ‘comptroller’ means the Comptroller-General of  Patents, Designs and Trade Marks; 
                                                                                                                                            
(a) S.I. 2007/3291. S.I. 2007/3291 has been amended o n a number of occasions but only the amendments mad e by S.I. 
2009/546, regulations 8 and 9 are relevant.  412. ‘court’ is to be interpreted in accordance with  Article 1A; 
13. ‘EEA authorization’ means an authorization to p lace a plant protection product on 
the market which has effect in an EEA state in acco rdance with Regulation (EC) No 
1107/2009; 
14. ‘patent’ means a patent which has effect in the  United Kingdom; 
15. ‘UK authorisation’ means an authorisation to pl ace a plant protection product on the 
market granted by the Secretary of State under Regu lation (EC) No 1107/2009.”. 
21.  After Article 1, insert— 
“Article 1A 
Meaning of court 
1. In this Regulation, ‘court’ is to be interpreted  in accordance with this Article. 
2. In a case where the basic patent is subject to t he jurisdiction of the Unified Patent 
Court by virtue of Schedule A4 to the Patents Act 1 977, ‘court’ means the Unified Patent 
Court. 
3. In any other case, ‘court’ means— 
(a) as respects England and Wales, the High Court; 
(b) as respects Scotland, the Court of Session; and  
(c) as respects Northern Ireland, the High Court in  Northern Ireland. 
4. In this Article, the reference in paragraph 2 to  the “Unified Patent Court” is to the 
court created under the Agreement on a Unified Pate nt Court made in Brussels on 19th 
February 2013.”. 
22.  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 i s— 
(a) protected by a patent; and 
(b) the subject of a UK authorization prior to bein g placed on the market as a plant 
protection product.”. 
23.  For Article 3(1), substitute— 
“1. Where an application is submitted under Article  7, a certificate shall be granted if at 
the date of submission of the application— 
(a) the product is protected by a basic patent in f orce; 
(b) there is a valid UK 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 fir st UK authorization to place the product on 
the market as a plant protection product.”. 
24. —(1) Article 8 (contents of the application for a c ertificate) is amended as follows. 
(2)  For paragraph 1(a)(iv), substitute— 
 “(iv)the number and date of the UK authorization a s referred to in Article 3(1)(b); and 
 (v) the number and date of the earliest EEA author ization, the granting of which 
predates the granting of the UK authorization;”. 
(3)  For paragraph 8(1)(b) and (c), substitute—  5“(b) a copy of the UK authorization to place the pr oduct on the market, as referred to in 
Article 3(1)(b), in which the product is identified , containing in particular the number 
and date of the authorization and the summary of th e product characteristics listed in 
Commission Regulation 283/2013, Part A, section 1, points 1 to 7 or Part B, Section 1 
points 1 to 5; 
(c) where the product is the subject of one or more  EEA authorizations granted prior to the 
UK authorization referred to in Article 3(1)(b), th e applicant must provide in relation 
to the earliest of any such EEA authorizations— 
 (i) information regarding the identity of the prod uct thus authorised; 
 (ii) information regarding the legal provision und er which the authorization procedure 
took place; and 
 (iii) a copy of the notice publishing the authoriz ation in the appropriate official 
publication or, failing such a notice, any other do cument 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. 
25. —(1) Article 9 (lodging of an application for a cer tificate) is amended as follows. 
(2)  For paragraph 1, substitute— 
“1. An application for a certificate shall be lodge d with the comptroller.” 
(3)  In the introductory words of paragraph 2, for “auth ority referred to in paragraph 1” substitute 
“comptroller”. 
(4)  For sub-paragraphs (d) and (e) of paragraph 2, subs titute— 
“(d) the number and date of the UK authorization an d the product identified in that 
authorization; 
(e) where there are EEA authorizations granted befo re the UK authorization, the number 
and date of the earliest EEA authorization;”. 
26. —(1) Article 10 (grant of the certificate or reject ion of the application) is amended as 
follows. 
(2)  In paragraphs 1 to 3, for “the authority referred t o 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 p rescribed fee relating to the application has 
not been paid”. 
(5)  Omit paragraph 5. 
(6)  At the end of the Article, insert— 
“6. References in this Article to a “prescribed fee ” are to a fee prescribed under section 
123 of the Patents Act 1977.”. 
27. —(1) Article 11 (publication) is amended as follows . 
(2)  In paragraphs 1 and 2, for “the authority referred to in Article 9(1)” substitute “the 
comptroller”. 
(3)  In paragraph 1— 
(a)  in sub-paragraph (d) insert “UK” before “authorizat ion” where it first occurs; 
(b)  for sub-paragraph (e), substitute— 
“(e) where there are EEA authorizations granted bef ore the UK authorization, the number 
and date of the earliest EEA authorization;”. 
28.  Omit Article 12 (annual fees).  629.  In paragraph 1 of Article 13 (duration of the cert ificate), for “the Community”, substitute 
“the area comprising the European Economic Area and  the United Kingdom”. 
30. —(1) Article 14 (expiry of the certificate) is amen ded as follows. 
(2)  The existing text is numbered as paragraph 1. 
(3)  For sub-paragraphs (c) and (d) of the renumbered pa ragraph 1, substitute— 
“(c) if the prescribed annual fee is not paid in ti me; 
(d) if and as long as the product covered by the ce rtificate may no longer be placed on the 
market following the withdrawal of the appropriate authorization or authorizations to 
place on the market in accordance with Article 28 o f Regulation 1107/2009. The 
comptroller may decide on the lapse of the certific ate either of the comptroller’s own 
motion or at the request of a third party.”. 
(4)  After paragraph 1, insert— 
“2. In this Article, “prescribed” means prescribed by rules made under section 123 of the 
Patents Act 1977.”. 
31.  In paragraph (2) of Article 15 (invalidity of cert ificate), for “the body responsible under 
national law for the revocation of the correspondin g basic patent” substitute “the comptroller or 
the court”. 
32.  In Article 16 (notification of lapse or invalidity ), for “the authority referred to in Article 
9(1)”, substitute “the comptroller”. 
33.  In Article 17 (appeals), omit paragraph 1. 
34.  In Article 18 (procedure), for paragraph 1 substit ute— 
“1. In the absence of procedural provisions in this  Regulation, the procedural provisions 
applicable to the corresponding basic patent (as mo dified by section 128B of, and Schedule 
4A to, the Patents Act 1977) shall apply to the cer tificate.”. 
35.  Omit Articles 19 and 20 (transitional provisions).  
36.  After Article 21 (entry into force), omit “This Re gulation shall be binding in its entirety and 
directly applicable in all Member States.”. 
PART 7 
COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS - 
AMENDMENTS TO REGULATION (EC) NO 816/2006 
37.  Regulation (EC) No 816/2006 of the European Parlia ment 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. 
38. —(1) Article 1 (scope) is amended as follows. 
(2)  For “Member States”, substitute “The competent auth ority”. 
39. —(1) Article 2 (definitions) is amended as follows.  
(2)  For the definition of “competent authority” in para graph (4), substitute— 
““competent authority” for the purposes of Articles  1 to 11, 16 and 17 means the 
Comptroller-General of Patents, Designs and Trade M arks;”. 
(3)  After paragraph (4), insert— 
“(5) “patent” means “a patent under the Patents Act  1977;  7(6) “supplementary protection certificate” means a supplementary protection certificate 
issued under Regulation (EC) No 469/2009 of the Eur opean Parliament and of the Council 
of 6 May 2009 concerning the supplementary protecti on certificate for medicinal products”. 
(4)  Omit Article 3 (competent authority). 
40.  In Article 4 (eligible importing countries), for “ Commission”, substitute “United Kingdom”. 
41. —(1) Article 5 (extension to least-developed and de veloping countries which are not 
members of the WTO) is amended as follows. 
(2)  In paragraph (a), for “Commission”, substitute “Sec retary 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,”. 
42. —(1) Article 6 (application for a compulsory licenc e) is amended as follows. 
(2)  For paragraph 1, substitute— 
“1. Any person may submit an application for a comp ulsory licence under this 
Regulation to the competent authority in a case whe re that person’s intended activities of 
manufacture and sale for export are covered by a pa tent or a supplementary protection 
certificate.”. 
(3)  In paragraph 2, for “each application”, substitute “the application made to the competent 
authority”. 
(4)  Omit paragraph 4. 
43.  In Article 8 (verification), for “Commission”, whe rever it occurs, substitute “United 
Kingdom”. 
44. —(1) Article 10 (compulsory licence conditions) is amended as follows. 
(2)  In paragraph 5, for “Member States”, substitute “Un ited Kingdom”. 
(3)  In paragraph 8, omit “or on its own initiative, if national law allows the competent authority 
to act on its own initiative.”. 
45. —(1) Article 12 (notification) is amended as follow s. 
(2)  For “Member State”, substitute “Secretary of State” . 
(3)  Omit “through the intermediary of the Commission”. 
46.  In Article 13 (prohibition of importation), in par agraph 1, for “Community”, substitute 
“United Kingdom”. 
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 th e authority to review whether such 
importation is taking place”. 
(3)  In paragraph 2, for “national provisions on”, subst itute “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. 
48. —(1) Article 16 (termination or review of the licen ce) is amended as follows. 
(2)  In paragraph 2, for “through the intermediary of th e Commission”, substitute “by the 
Secretary of State”. 
(3)  In paragraph 3, omit— 
(a)  “or any other body appointed by the Member State”; and  8(b)  “or by another body appointed by the Member State,” . 
49.  Omit Articles 17 to 19. (appeals, safety and effic acy of medicinal products and review) 
50.  After Article 20 (entry into force), omit “This Re gulation shall be binding in its entirety and 
directly applicable in all Member States”. 
PART 8 
SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL  
PRODUCTS – AMENDMENTS TO REGULATION (EC) No 469/200 9 
51.  Regulation (EC) No 469/2009 of the European Parlia ment and of the Council of 6 May 2009 
concerning the supplementary protection certificate  for medicinal products is amended as follows. 
52. —(1) Article 1 (interpretation) is amended as follo ws. 
(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 o n medicinal products for paediatric use”, 
substitute “regulation 58A(3) of the Human Medicine s Regulations 2012( a)”. 
(3)  After paragraph (e) insert— 
“(f) ‘comptroller’ means the Comptroller-General of  Patents, Designs and Trade Marks; 
(g) ‘court’ is to be interpreted in accordance with  Article 1A; 
(h) “EEA authorisation” means an authorisation to p lace a medicinal product on the 
market which has effect in an EEA state in accordan ce 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 prod uct, an authorisation to place that 
product on the market as a medicinal product grante d in accordance with— 
 (i) Part 5 of the Human Medicines Regulations 2012 ; or 
 (ii) regulation 4(3) of, and Schedule 1 to, the Ve terinary Medicines Regulations 
2013( b).”. 
53.  After Article 1(interpretation), insert— 
“Article 1A 
Meaning of ‘court’ 
1. In this Regulation the expression ‘court’ is to be interpreted in accordance with this 
Article. 
2. In a case where the basic patent is subject to t he jurisdiction of the Unified Patent 
Court by virtue of Schedule A4 to the Patents Act 1 977, ‘court’ means the Unified Patent 
Court. 
3. In any other case, ‘court’ means— 
(a) as respects England and Wales, the High Court; 
(b) as respects Scotland, the Court of Session; and  
(c) as respects Northern Ireland, the High Court in  Northern Ireland. 
4. The reference in paragraph 2 to the Unified Pate nt Court is to the court created under 
the Agreement on a Unified Patent Court made in Bru ssels on 19th February 2013.”. 
                                                                                                                                            
(a) S.I. 2012/1916. Regulation 58A is inserted by S.I . 2019/775, reg. 64. 
(b) S.I. 2013/2033.  954.  For Articles 2 (scope) and 3 (conditions for obtai ning a certificate), substitute— 
“Article 2 
Scope 
A product may, under the terms and conditions provi ded 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 authorisation prior to bein g 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 f orce; 
(b) there is a valid UK 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 t he first UK authorisation to place the 
product on the market as a medicinal product.”. 
55. —(1) Article 8 (content of application for a certif icate) is amended as follows. 
(2)  For paragraph 1(a)(iv), substitute— 
 “(iv)the number and date of the UK authorisation a s referred to in Article 3(b); and 
 (v) the number and date of the earliest of any EEA  authorisation, the granting of 
which predates the granting of the UK authorisation ;”. 
(3)  For paragraph 1(b) and (c), substitute— 
“(b) a copy of the UK authorisation to place the pr oduct on the market, as referred to in 
Article 3(b), in which the product is identified, c ontaining in particular the number and 
date of the authorisation and the summary of the pr oduct characteristics listed in 
Article 11 of Directive 2001/83/EC, Article 14 of D irective 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 authorisation referred to in Article 3(b), the a pplicant must provide in relation to 
the earliest of any such EEA authorisations— 
 (i) information regarding the identity of the prod uct thus authorised; 
 (ii) information regarding the legal provision und er which the authorisation procedure 
took place; and 
 (iii) a copy of the notice publishing the authoris ation 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 Regula tions 2012”; and 
(b)  omit paragraph (ii). 
(5)  Omit paragraph (4). 
56. —(1) Article 9 (lodging of an application for a cer tificate) is amended as follows. 
(2)  For paragraph 1 substitute—  10 “1. An application for a certificate (or an extensi on 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, subs titute— 
“(d) the number and date of the UK authorisation an d the product identified in that 
authorisation; 
(e) where there are authorisations granted in the E EA before the UK authorisation, the 
number and date of the earliest EEA authorisation;” . 
57. —(1) Article 10 (grant of the certificate or reject ion of the application for a certificate) is 
amended as follows. 
(2)  In paragraphs 1 to 3, for “the authority referred t o 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 p rescribed fee relating to the application has 
not been paid”. 
(5)  In paragraph 4, for “the authority”, substitute “th e comptroller”. 
(6)  Omit paragraph 5. 
(7)  After paragraph 6, insert— 
“7. References in this Article to a “prescribed fee ” are to a fee prescribed under section 
123 of the Patents Act 1977.”. 
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)  in sub-paragraph (d) insert “UK” before “authorisat ion” where it first occurs; 
(b)  for sub-paragraph (e), substitute— 
“(e) where there are EEA authorisations granted bef ore the UK authorisation, the number 
and date of the earliest EEA authorisation;”. 
59.  Omit Article 12 (annual fees). 
60. —(1) Article 13 (duration of the certificate) is am ended as follows. 
(2)  In paragraph 1, for “the Community”, substitute “th e 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”. 
61. —(1) Article 14 (expiry of the certificate) is amen ded as follows. 
(2)  The existing text is numbered as paragraph 1. 
(3)  For sub-paragraphs (c) and (d) of the renumbered pa ragraph 1, substitute— 
“(c) if the prescribed annual fee is not paid in ti me; 
(d) if and as long as the product covered by the ce rtificate may no longer be placed on the 
market following the withdrawal of the appropriate authorisation or 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 o f a third party.”. 
(4)  After paragraph 1, insert—  11 “2. In this Article, “prescribed” means prescribed by rules made under section 123 of the 
Patents Act 1977.”. 
62.  In paragraph 2 of Article 15 (invalidity of the ce rtificate), for “before the body responsible 
under national law for the revocation of the corres ponding basic patent” substitute “the 
comptroller or the court”. 
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 nat ional law for the revocation of the 
corresponding basic patent”, substitute “the comptr oller or the court”. 
64.  For references in Article 17 (notification of laps e or invalidity) to “the authority referred to 
in Article 9(1)”, substitute “the comptroller”. 
65.  Omit Article 18 (appeals). 
66.  For paragraph 1 of Article 19 (procedure), substit ute— 
“1. In the absence of procedural provisions in this  Regulation, the procedural provisions 
applicable to the corresponding basic patent (as mo dified by section 128B of, and Schedule 
4A to, the Patents Act 1977) shall apply to the cer tificate.”. 
67.  Omit Articles 20 (enlargement of the Community) an d 21 (transitional provisions). 
68.  After Article 23 (entry into force), omit “This Re gulation shall be binding in its entirety and 
directly applicable in all Member States.” 
Transitional provision 
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 exit day; and 
(b)  An extension of the duration of a certificate grant ed— 
(i)  before exit day; or 
(ii)  after exit 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 m ade by these Regulations. 
(3)  Where paragraph (1) applies— 
(a)  Article 8(1)(d)(ii) is to be read as if, for the wo rds “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 substitut ed “the United Kingdom and all 
Member States”. 
 
 
 Chris Skidmore 
 Minister of State 
4th April 2019 Department for Business, Energy and Industrial Strategy 
 
 
  12 £6.90 
UK201904041007   04/2019   19585 
http://www.legislation.gov.uk/id/uksi/2019/801 EXPLANATORY NOTE 
(This note is not part of the Regulations) 
These Regulations are made in exercise of the power s in section 8(1) of the European Union 
(Withdrawal) Act 2018 (c.18) in order to address fa ilures 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 in cluding supplementary protection certificates. 
Part 1 of the Regulations contains introductory pro visions. 
Part 2 of the Regulations makes amendments to the P atents 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 Va riety 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 Regul ation (EC) No 1610/96 of the European 
Parliament and of the Council of 23 July 1996 conce rning the creation of a supplementary 
protection certificate for plant protection product s. 
Part 7 makes amendments to Regulation (EC) No 816/2 006 of the European Parliament and of the 
Council of 17 May 2006 on compulsory licensing of p atents relating to the manufacture of 
pharmaceutical products for export to countries wit h 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 supplement ary 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. 
  
  
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