Explanatory note

These Regulations amend the references in section 128B(2) of, and paragraph 7(a) of Schedule 4A to, the Patents Act 1977 (“the Act”) to Council Regulation (EEC) No 1768/92 of 18th June 1992 concerning the creation of a supplementary protection certificate for medicinal products. This Regulation, as amended, was codified in Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products (“codified version”).

Section 128B(2)(a) of the Act has been amended to refer to supplementary protection certificates issued under the codified version. The definition in paragraph 7(a) of Schedule 4A has been updated to refer to the codified version.

The reference to the codified version will be ambulatory to include such amendments as are made to it from time to time. This derives from paragraph 6(2) of Schedule 4A to the Act.

A new paragraph 8 has been added to Schedule 4A to the Act to make transitional provision to provide for a reference in the Act to the codified version to be read as being or including a reference to Council Regulation (EEC) No 1768/92 in relation to times, circumstances or purposes in relation to which that Regulation had effect. Other than in relation to such times, circumstances or purposes, anything done, or having effect as if done, under Council Regulation (EEC) No 1768/92 will, after these Regulations come into force, have effect for the purposes of the Act as if done under the codified version.

A full regulatory impact assessment has not been produced for this instrument as no impact on the private or voluntary sectors is foreseen.