The Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007

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 Regulation (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 problems (“Compulsory Licensing Regulation”) (OJ No L 157, 9.6.2006, p1). The Compulsory Licensing Regulation implements a Decision of 30 August 2003 of the General Council of the World Trade Organisation (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 Rights (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 apply 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 provisions 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 make it clear how that Act applies in relation to supplementary protection certificates for medicinal and plant protection products. It also gives effect to changes made to the supplementary protection 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 amending 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 Variety Rights (Compulsory Licensing) Regulations 2002 which implemented Article 12 of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological 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 2007/3291) and Patents (Fees) Rules 2007 (SI 2007/3292).

Regulation 4 then revokes the Patents (Supplementary Protection Certificate 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 supplementary protection certificate for medicinal products and Council Regulation 1610/96 on a supplementary protection certificate for plant protection products respectively.

An impact assessment has been prepared and copies placed in the libraries of both Houses of Parliament. Copies of the assessment are also available from Patents Legal Section, Concept House, Cardiff Road, Newport NP10 8QQ.