These Regulations amend the Patents Act 1977 in order to make provision for the implementation of Articles 1 to 11 of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (“the Directive”) and for implementation of article 27(2) of the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) annexed to the Agreement establishing the World Trade Organisation (Cm. 2556-59, 2561-69, 2571-74). Implementation of Articles 12 to 14 of the Directive is to be by way of other statutory instruments.