Draft Order laid before Parliament under section 14 (1) of the Legislative and Regulatory Reform 
Act 2006 for approval by resolution of each House o f Parliament. 
D R A F T  S T A T U T O R Y  I N S T R U M E N T S  
2014 No. XXXX 
PATENTS 
The Legislative Reform (Patents) Order 2014 
Made  - - - - *** 
Coming into force  - - *** 
The Secretary of State for Business, Innovation and  Skills (“the Secretary of State”) makes the 
following Order, in exercise of the powers conferre d by section 1 of the Legislative and 
Regulatory Reform Act 2006( a) (“the 2006 Act”). 
For the purposes of section 3(1) of the 2006 Act, t he Secretary of State considers that the 
conditions under section 3(2), where relevant, are satisfied. 
The Secretary of State has consulted in accordance with section 13(1) of the 2006 Act. 
The Secretary of State laid a draft Order and an ex planatory document before Parliament in 
accordance with section 14(1) of the 2006 Act. 
Pursuant to section 15 of the 2006 Act, the affirma tive resolution procedure (within the meaning 
of Part 1 of that Act) applies in relation to the m aking of the Order. 
In accordance with section 17(2) of the 2006 Act, t he draft has been approved by resolution of 
each House of Parliament after the expiry of the 40 -day period referred to in that provision. 
Citation, commencement and extent 
1. —(1) This Order may be cited as the Legislative Ref orm (Patents) Order 2014. 
(2)  This Order comes into force on 1st October 2014. 
(3)  This Order extends to the whole of the United Kingd om. 
(4)  The amendments made by Article 2 extend to the Isle  of Man. 
                                                                                                                                            
(a) 2006 c.51; section 13(1) has been amended by the Government of Wales Act 2006 (Consequential Modific ations and 
Transitional Provisions) Order 2007 (S.I. 2007/1388 ), Schedule 1, paragraph 147; see section 32 for th e definition of 
“Minister of the Crown”.  2 Amendments of the Patents Act 1977 
2.  In section 60 of the Patents Act 1977( a) (meaning of infringement), after subsection (6C) 
insert— 
“(6D) For the purposes of subsection (5)(b), anythi ng done in or for the purposes of a 
medicinal product assessment which would otherwise constitute an infringement of a patent 
for an invention is to be regarded as done for expe rimental purposes relating to the subject-
matter of the invention. 
(6E) In subsection (6D), “medicinal product assessm ent” means any testing, course of 
testing or other activity undertaken with a view to  providing data for any of the following 
purposes— 
(a) obtaining or varying an authorisation to sell o r supply, or offer to sell or supply, a 
medicinal product (whether in the United Kingdom or  elsewhere); 
(b) complying with any regulatory requirement impos ed (whether in the United 
Kingdom or elsewhere) in relation to such an author isation; 
(c) enabling a government or public authority (whet her in the United Kingdom or 
elsewhere), or a person (whether in the United King dom or elsewhere) with 
functions of— 
 (i) providing health care on behalf of such a gove rnment or public authority, or 
 (ii) providing advice to, or on behalf of, such a government or public authority 
about the provision of health care, 
to carry out an assessment of suitability of a medi cinal product for human use for 
the purpose of determining whether to use it, or re commend its use, in the 
provision of health care. 
(6F) In subsection (6E) and this subsection— 
“medicinal product” means a medicinal product for h uman use or a veterinary 
medicinal product; 
“medicinal product for human use” has the meaning g iven by article 1 of Directive 
2001/83/EC( b); 
“veterinary medicinal product” has the meaning give n by article 1 of Directive 
2001/82/EC( c). 
(6G) Nothing in subsections (6D) to (6F) is to be r ead as affecting the application of 
subsection (5)(b) in relation to any act of a kind not falling within subsection (6D).”. 
 
 
 Name  
 Parliamentary Under Secretary of State 
Date Department for Business, Innovation and Skills 
 
 
 
EXPLANATORY NOTE 
(This note is not part of the Order) 
This Order is made under section 1 of the Legislati ve and Regulatory Reform Act 2006 (c.51) to 
amend section 60 of the Patents Act 1977 (c.37) on infringement of patents. Section 60(5)(b) of 
the Patents Act 1977 provides an exemption from inf ringement in relation to acts done for 
experimental purposes relating to the subject-matte r of the invention. 
                                                                                                                                            
(a) 1977 c.37; relevant amending instruments are S.I.  2000/2037, S.I. 2005/2759, and S.I. 2013/2602. 
(b) OJ No L 311, 28.11.2001, p 67. 
(c) OJ No L 311, 28.11.2001, p 1.  3 Article 2 amends section 60 to ensure that the exce ption to patent infringement in subsection 
(5)(b) applies to anything done in or for the purpo ses of a medicinal product assessment. Article 2 
inserts new subsections (6D) to (6G) in section 60.  
New subsection (6D) provides that anything done in or for the purposes of a medicinal product 
assessment is to be regarded as done for experiment al purposes relating to the subject-matter of 
the invention. 
New subsection (6E) defines what is meant by “medic inal product assessment”. A medicinal 
product assessment includes acts done in the United  Kingdom or the Isle of Man in testing or in a 
course of testing or other activity undertaken with  a view to providing data for a specified purpose. 
The purposes specified are as follows— 
1) obtaining or varying an authorisation for a medi cinal product to sell or supply, or offer to 
sell or supply a medicinal product (whether in the United Kingdom or elsewhere); 
2) complying with any regulatory requirement impose d (whether in the United Kingdom or 
elsewhere) in relation to such an authorisation; 
3) enabling a government or public authority (wheth er in the United Kingdom or elsewhere), 
or a person (whether in the United Kingdom or elsew here) with functions of— 
• providing healthcare on behalf of such a governmen t or public authority, or 
• providing advice to, or on behalf of, such a gover nment or public authority about the 
provision of health care, 
to carry out an assessment of suitability of a medi cinal product for human use for the 
purpose of determining whether to use it, or recomm end its use, in the provision of health 
care. 
New subsection 6(F) defines the meaning of “medicin al product” by reference to Directives 
2001/82/EC and 2001/83/EC defined currently in sect ion 60(7). 
New subsection (6G) provides that nothing in subsec tions (6D) to (6F) is to be read as affecting 
the application of subsection (5)(b) in relation to  any act of a kind not falling within subsection 
(6D). 
A full impact assessment of the effect that this Or der will have on the cost of business is 
available from the Intellectual Property Office, Co ncept House, Cardiff Road, Newport, South 
Wales, NP10 8QQ and is annexed to the Explanatory D ocument which is available alongside the 
instrument on the Legislation UK website at www.leg islation.gov.uk. 
  
  
© Crown copyright 2014 
Printed and published in the UK by The Stationery O ffice Limited under the authority and superintenden ce of Carol Tullo, 
Controller of Her Majesty’s Stationery Office and Q ueen’s Printer of Acts of Parliament. £4.25 
UK201405011   05/2014   19585 
http://www.legislation.gov.uk/id/ukdsi/2014/9780111 114537  
