Explanatory note
(This note does not form part of the Regulations)
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.
The following changes are made to the Patents Act 1977—
in section 1 (patentable inventions), new subsections are substituted for subsections (3) and (4). The provision in the Directive which is implemented by this amendment to the Act, (exclusions on the grounds of morality or public policy), corresponds to article 27(2) of TRIPS. However, article 27(2) of TRIPS, and the new subsections, apply to all inventions (regulation 3);
in section 60 (meaning of infringement), after subsection (5) paragraph (f) are inserted two paragraphs providing a derogation from infringement of a patent where an otherwise infringing act consists of the use by a farmer of:
the product of his harvest for propagation or multiplication by him on his own farm, where there has been a sale of plant propagating material to the farmer by the proprietor of the patent or with his consent for agricultural use subject to conditions set out in new Schedule A1 to the Act;
an animal or animal reproductive material by a farmer for an agricultural purpose following a sale to the farmer, by the proprietor of the patent or with his consent, of breeding stock or other animal reproductive material which constitutes or contains the patented invention (regulation 4);
after section 76 is inserted a new section 76A which provides that any provision of, or made under, the Act is to have effect in relation to a patent or an application for a patent which concerns a biotechnological invention, subject to the provisions of new Schedule A2 (regulation 5);
section 125A (disclosure of invention by specification: availability of samples of micro-organisms), is modified so as to substitute “biological material” for “micro-organism” where it occurs (regulation 6);
in section 130 (interpretation) definitions of “biological material” and “biotechnological invention” are inserted in proper alphabetical order (regulation 7);
two new schedules are inserted into the Act. Schedule A1 contains detailed provision for the operation of the derogation contained in section 60(5)(g) (use by a farmer of the product of his harvest for propagation or multiplication by him on his own farm). Schedule A2 contains provisions in accordance with which all other provisions of the Act must be interpreted when they are to have effect in relation to a patent or an application for a patent which concerns a biotechnological invention (regulation 8).
A regulatory impact assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies of the assessment are also available from the Intellectual Property Policy Directorate of the Patent Office, Room 3B38, Concept House, Cardiff Road, Newport NP10 8QQ.