STATUTORY INSTRUMENTS 
2007 No. 3293 
PATENTS 
The Patents (Compulsory Licensing and Supplementary 
Protection Certificates) Regulations 2007 
Made  - - - - 19th November 2007 
Laid before Parliament  22nd November 2007 
Coming into force  - - 17th December 2007 
The Secretary of State has been designated for the purposes of section 2(2) of the European 
Communities Act 1972( a) in relation to intellectual property (including both registered and 
unregistered rights)( b). 
The Secretary of State makes the following Regulations under the powers conferred by that 
section as read with paragraph 1A of Schedule 2 to that Act. 
These Regulations make provision for a purpose menti oned in that section and it appears to the 
Secretary of State that it is expedient for certain references to Community instruments to be construed as references to those instruments as amended from time to time. 
Citation, commencement and extent 
1.—(1) These Regulations may be cited as the Patents (Compulsory Licensing and 
Supplementary Protection Ce rtificates) Regulations 2007. 
(2) These Regulations come into force on 17th December 2007. 
(3) These Regulations have the same extent as the Patents Act 1977( c), except that they do not 
extend to the Isle of Man. 
Amendments to the Patents Act 1977 
2.—(1) The Patents Act 1977 is amended as follows. 
(2) After section 128 insert— 
“128A.  EU compulsory licences  
(1) In this Act an “EU compulsory licence” means a compulsory licence granted under 
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 
                                                                                                                                                              
 
 
(a) 1972 c. 68. 
(b) SI 2006/608. 
(c) 1977 c. 37.  2 products for export to countries with public health problems( a) (referred to in this Act as 
“the Compulsory Licensing Regulation”). 
(2) In the application to EU compulsory licen ces of the provisions of this Act listed in 
subsection (3)— 
(a) references to a licence under a patent, (b) references to a right under a patent, and (c) references to a proprietary interest under a patent, 
include an EU compulsory licence. 
(3) The provisions referred to in subsection (2) are— 
sections 32 and 33 (registra tion of patents etc); 
section 37 (determination of right  to patent after grant); 
section 38 (effect of transfer etc of pate nt under section 37), apart from subsection 
(2) and subsections (3) to (5) so far as relating to subsection (2); 
section 41 (amount of compensation); section 46(2) (notice of application for ent ry that licences are available as of right); 
section 57(1) and (2) (rights of third parties in respect of Crown use). 
(4) In the following provisions references to this Act include the Compulsory Licensing 
Regulation— 
sections 97 to 99B, 101 to 103, 105 and 107 (legal proceedings); 
section 119 (service by post); section 120 (hours of business and excluded days); section 121 (comptroller’s annual report); section 123 (rules); section 124A (use of elect ronic communications); 
section 130(8) (disapplication of Part 1 of Arbitration Act 1996). 
(5) In section 108 (licences granted by order of comptroller) the reference to a licence 
under section 11, 38, 48 or 49 includes an EU compulsory licence. 
(6) References in this Act to the Compulso ry Licensing Regulation are to that Regulation 
as amended from time to time. 
128B.  Supplementary protection certificates  
(1) Schedule 4A contains provision about the appli cation of this Act in relation to 
supplementary protection cer tificates and other provisi on about such certificates. 
(2) In this Act a “supplementary protection certificate” means a cer tificate issued under— 
(a) Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of 
a supplementary protection certif icate for medicinal products( b), or 
(b) Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 
July 1996 concerning the creation of a supplementary protecti on certificate for 
plant protection products( c).”. 
(3) After Schedule 4 insert— 
                                                                                                                                                              
 
 
(a) OJ No L 157, 9.6.2006, pl. 
(b) OJ No L 182, 2.7.92, pl. 
(c) OJ No L 198, 8.8.96, p30.  3 “SCHEDULE 4A 
SUPPLEMENTARY PROTECTION CERTIFICATES 
References to patents etc 
1.—(1) In the application to supplementary protec tion certificates of the provisions of this 
Act listed in sub-paragraph (2)— 
(a) references to a patent are to a supplem entary protection certificate; 
(b) references to an application or the applicant for a patent are to an application or the 
applicant— 
(i) for a supplementary prot ection certificate, or 
(ii) for an extension of the dura tion of a supplementary protection 
certificate; 
(c) references to the proprietor of a patent are to the holder of a supplementary 
protection certificate; 
(d) references to the specification of a patent are to the text of a supplementary 
protection certificate; 
(e) references to a patented product or an inventi on (including a patented invention) 
are to a product for which a supplem entary protection certificate has effect; 
(f) references to a patent having expired or having been revoked are to a 
supplementary protection certif icate having lapsed or having been declared invalid; 
(g) references to proceedings for the revocation of a patent are to proceedings— 
(i) for a decision that a supplement ary protection certificate has lapsed, or 
(ii) for a declaration that a supplementary protection certificate is invalid; 
(h) references to the issue of the validity of a patent include the issue of whether a 
supplementary protection certifi cate has lapsed or is invalid. 
(2) The provisions referred to in sub-paragraph (1) are— 
section 14(1), (9) and (10) (making of application); section 19(1) (general power to amend application before grant); 
sections 20A and 20B (reinsta tement of applications); 
section 21 (observations by third party on patentability); section 27 (general power to amend specification after grant); section 29 (surrender of patents); sections 30 to 36, 37(1) to (3) and (5) to (9) and 38 (property in patents and 
applications, and registration); 
sections 39 to 59 (employees’ inven tions, licences of right and compulsory 
licences and use of patented inventions for services of the Crown); 
sections 60 to 71 (infringement); section 74(1) and (7) (proceedings in which valid ity of patent may be put in issue); 
section 75 (amendment of patent in infringement or revocation proceedings); sections 103 and 105 (privilege for communications relating to patent 
proceedings); 
section 108 (licences granted by order of comptroller); 
sections 110 and 111 (unauthorised claim of patent rights or that patent has been 
applied for); 
section 116 (immunity of depart ment as regards official acts);  4 sections 117 to 118 (administrative provisions); 
section 123 (rules); section 130 (interpretation). 
2.—(1) In the case of the provisions of this Act listed in sub-paragraph (2), paragraph 1 
applies in relation to an application for a supplementary protection cer tificate only if the 
basic patent expires before th e certificate is granted. 
(2) The provisions referred to in sub-paragraph (1) are— 
section 20B(3) to (6A) (effect of reinstatement under section 20A); section 55(5) and (7) (use of patented inventions for services of the Crown); section 58(10) (disputes as to Crown use); section 69 (infringement of rights conferred by publication of application); 
section 117A(3) to (7) (effect of resuscitating a withdrawn application under 
section 117). 
References to this Act etc 
3.—(1) In the provisions of this Act listed in sub-paragraph (2)— 
(a) references to this Act include the Medicin al Products Regulation and the Plant 
Protection Products Regulation, and 
(b) references to a provision of this Act include any equivalent provision of the 
Medicinal Products Regulation and the Plant Protection Products Regulation. 
(2) The provisions referred to in sub-paragraph (1) are— 
sections 20A and 20B (reinsta tement of applications); 
section 21 (observations by third party on patentability); section 69 (infringement of rights conferred by publication of application); 
section 74(1) and (7) (proceedings in which valid ity of patent may be put in issue); 
sections 97 to 99B, 101 to 103, 105 and 107 (legal proceedings); 
section 116 (immunity of depart ment as regards official acts); 
sections 117 and 118 to 121 (administrative provisions); section 122 (Crown’s right to sell forfeited articles); section 123 (rules); section 124A (use of elect ronic communications); 
section 130 (interpretation). 
Other references 
4.—(1) In the application of section 21(1) (observations by third party on patentability) to 
supplementary protection certifi cates, the reference to the question whether the invention is 
a patentable invention is to the ques tion whether the product is one for which a 
supplementary protection certif icate may have effect. 
(2) In the application of section 69(2) (cond itions for infringement of rights conferred by 
publication of application) to supplementary protection certificates, the condition in paragraph (b) is that the act would, if the certif icate had been granted on the date of the 
publication of the application, have infringed not  only the certificate as granted but also the 
certificate for which the application was made. 
Fees 
5. A supplementary protection certif icate does not t ake effect unless—  5 (a) the prescribed fee is paid before the end of the prescribed period, or 
(b) the prescribed fee and any prescribed additional fee are paid before the end of the 
period of six months beginning immedi ately after the prescribed period. 
Interpretation 
6.—(1) Expressions used in this Act that are defined in the Medicinal Products 
Regulation or the Plant Protection Products Regul ation have the same meaning as in that 
Regulation. 
(2) References in this Act to, or to a provisi on of, the Medicinal Products Regulation or 
the Plant Protection Produ cts Regulation are to that Regulation or that provision as 
amended from time to time. 
7. In this Act— 
(a) “the Medicinal Produ cts Regulation” means Council Regulation (EEC) No 
1768/92 of 18 June 1992 concerning the crea tion of a supplementary protection 
certificate for medi cinal products, and 
(b) “the Plant Protection Products Regul ation” means Regulation (EC) No 1610/96 of 
the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection cer tificate for plant protection products.”. 
Amendments to the Patents and Plant Variety Right s (Compulsory Licensing) Regulations 
2002 
3.—(1) The Patents and Plant Variety Ri ghts (Compulsory Licensing) Regulations 2002( a) are 
amended as follows. 
(2) In regulation 2(1)— 
(a) for the definition of “Patents Fees Rules” substitute— 
““Patents (Fees) Rules” means the Patents (Fees) Rules 2007( b);”; and 
(b) for the definition of “Patents Rules” substitute— 
““Patents Rules” means the Patents Rules 2007( c);”. 
(3) In regulation 22(2), omit the words “in rul e 71(1) of the Patents Rules and”. 
Revocations 
4. The following instruments are revoked— 
(a) the Patents (Supplementary Protection Certif icate for Medicinal Pr oducts) Regulations 
1992( d); and 
(b) the Patents (Supplementary Protection Certif icate for Plant Protection Products) 
Regulations 1996( e). 
 
  
 Triesman  
 Parliamentary Under Secretary of Stat e for Intellectual Property and Quality 
19th November 2007 Department for Innovation, Universities and Skills 
                                                                                                                                                               
 
(a) SI 2002/247. 
(b) SI 2007/3292 
(c) SI 2007/3291 
(d) SI 1992/3091. 
(e) SI 1996/3120.  6 EXPLANATORY NOTE 
(This note is not part  of the Regulations) 
These Regulations make provision to give effect to  Community legislation in relation to 
compulsory licences and supplementary protection certificates. 
The European Parliament and Council adopted Regul ation (EC) No 816/2006 of 17 May 2006 
on compulsory licensing of patents relating to the manufacture of pharmaceutical products for 
export to countries with public health problem s (“Compulsory Licensing Regulation”) (OJ No L 
157, 9.6.2006, p1). The Compulsory Licensing Regulati on implements a Decision of 30 August 
2003 of the General Council of the World Trade Organ isation (WTO) on the implementation of 
paragraph 6 of the Doha Declaration of 14 November 2001 on the Agreement on Trade-Related 
Aspects of Intellectual Property Ri ghts (TRIPS) and Public Health. TRIPS is an integral part of 
the Agreement establishing the WTO signed at Marrakesh on 15 April 1994 which is published in 
OJ L 336, 23.12.94, p1. 
Regulation 2 amends the Patents Act 1977 to a pply certain procedural provisions of that Act in 
relation to applications and other proceedings under the Compulsory Licensing Regulation. The 
Regulations do not purport to implement provisi ons of the Compulsory Licensing Regulation that 
are directly applicable and thus already enforceable in relation to UK patents. 
Regulation 2 also amends the Patents Act 1977 to ma ke it clear how that Act applies in relation 
to supplementary protection certifi cates for medicinal an d plant protection product s. It also gives 
effect to changes made to the supplementary protecti on certificate regime by Regulation (EC) No 
1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use amendi ng Regulation (EEC) No 1768/92, Directive 2001/20/EC, 
Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ No L 378, 27.12.2006, p1). 
Regulation 3 amends the Patents and Plant Va riety Rights (Compulsor y Licensing) Regulations 
2002 which implemented Article 12 of Directiv e 98/44/EC of the European Parliament and of the 
Council on the legal protection of biotechnol ogical measures (OJ No L 213, 30.7.98, p13). These 
changes are needed to replace the references in those Regulations to the Patents Rules 1995 (SI 
1995/2093) and the Patents (Fees) Rules 1998 (SI 1998/1778) by references to the new Patents 
Rules 2007 (SI 2007/[ ]) and Patents (Fees) Rules 2007 (SI 2007/[—]). 
Regulation 4 then revokes the Patents (Supplem entary Protection Cer tificate for Medicinal 
Products) Regulations 1992 and the Patents (Supplementary Protection Certificate for Plant 
Protection Products) Regulations 1996 which implemented the relevant provisions of Council 
Regulation 1768/92 on a supplem entary protection certificate for medicinal products and Council 
Regulation 1610/96 on a supplement ary protection certificate for plant protection products 
respectively. 
An impact assessment has been prepared and copies pl aced in the libraries of both Houses of 
Parliament. Copies of the assessment are also ava ilable from Patents Legal Section, Concept 
House, Cardiff Road, Newport NP10 8QQ. £3.00 
¤ Crown copyright 2007 
Printed and published in the UK by The Stationery Office Limited 
under the authority and superintendence of Carol Tullo, Controller of Her Majesty’s 
Stationery Office and Queen’s Printer of Acts of Parliament. 
E1607 11/2007  171607T  19585 STATUTORY INSTRUMENTS 
2007 No. 3293 
PATENTS 
The Patents (Compulsory Licensing and Supplementary 
Protection Certificates) Regulations 2007