Explanatory Note

(This note is not part of the Rules)

These Rules amend the Patents Rules 1995 (S.I. 1995/2093 as amended by S.I. 1999/1092, S.I. 1999/1899 and S.I. 1999/3197 (“the 1995 Rules”) in order to implement Articles 13 and 14 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”). Articles 13 and 14 of the Directive concern the deposit, access and re-deposit of biological material. Amendment is also made to the 1995 Rules to more closely align them with the parallel regulations on deposit of biological material under the European Patent Convention. The following amendments are made:

(a)  Rules 3, 4, 5 and 6 make consequential changes to references and terminology in the 1995 Rules,U.K.

(b)  Rule 7 substitutes updated versions of forms 8/77 and 8A/77 for those forms currently in Schedule 1 to the 1995 Rules,U.K.

(c)  Rule 8 substitutes a new Schedule 2 to the 1995 Rules.Schedule 2 to the 1995 Rules contains detailed provisions dealing with the deposit, access and re-deposit of biological material.U.K.

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.