S.I. No. 50/2006 - European Communities (Limitation of Effect of Patent) Regulations 2006
European Communities (Limitation of Effect of Patent) Regulations 2006 | ||||||||
I, Micheál Martin, Minister for Enterprise, Trade and Employment, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purposes of giving effect to Article 10.6 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20011 (as last amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 20042 ) and Article 13.6 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 20013 (as last amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 20044 ), hereby make the following regulations: 1. These Regulations may be cited as the European Communities (Limitation of Effect of Patent) Regulations 2006. 2. Section 42 of the Patents Act 1992 (No.1 of 1992) is amended - | ||||||||
(a) in paragraph (f), by substituting “,” for “.”, and | ||||||||
(b) by inserting the following paragraph after paragraph (f): | ||||||||
“(g) acts done in relation to the subject matter of the relevant patented invention which consist of: | ||||||||
(i) acts done in conducting the necessary studies, tests and trials which are conducted with a view to satisfying the application requirements of paragraphs 1, 2, 3 and 4 of Article 10 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20015 (as last amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 20046 ) for a marketing authorisation in respect of a medicinal product for human use, or | ||||||||
(ii) acts done in conducting the necessary studies, tests and trials which are conducted with a view to satisfying the application requirements of paragraphs 1 to 5 of Article 13 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 20017 (as last amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 20048 ) for a marketing authorisation in respect of a veterinary medicinal product, or | ||||||||
(iii) any other act which is required as a consequence of the acts referred to in subparagraph (i) or (ii) for the purposes specified in those subparagraphs, as appropriate.”. | ||||||||
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Explanatory Note | ||||||||
This note is not part of the Instrument and does not purport to be a legal interpretation | ||||||||
These Regulations, made pursuant to the European Communities Act, 1972 , amend Section 42 of the Patents Act, 1992 to limit the rights conferred by a patent where certain acts are undertaken to fulfil the application requirements of Article 10 of Directive 2001/83/EC (as last amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004) for a marketing authorisation for a generic or similar biological medicinal product for human use and Article 13 of Directive 2001/82/EC (as last amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004) for a marketing authorisation for a generic or similar biological medicinal product for veterinary use. | ||||||||
1 OJ No. L311, 28.11.2001, p.67 2 OJ No. L136, 30.4.2004, p.34 3 OJ No. L311, 28.11.2001, p.1 4 OJ No. L136, 30.4.2004, p.58 5 OJ No. L311, 28.11.2001, p.67 6 OJ No. L136, 30.4.2004, p.34 |