Intellectual Property (Miscellaneous Provisions) Act 2014

Amendment of section 42 of Act of 1992

2. (1) Section 42 of the Act of 1992 is amended—

(a) in paragraph (g) (inserted by Regulation 2(b) of the European Communities (Limitation of Effect of Patent) Regulations 2006 ( S.I. No. 50 of 2006 )) of subsection (1), by the substitution of “appropriate;” for “appropriate.”,

(b) by the insertion of the following paragraph after paragraph (g) of subsection (1):

“(h) insofar as paragraph (g) does not apply, acts done in relation to the subject matter of the relevant patented invention which consist of—

(i) acts done in conducting studies, tests, experiments and trials (including clinical trials and field trials) with a view to satisfying the application requirements for a marketing authorisation or similar instrument (howsoever described) that is required by the law of the State or of any other state in order to sell or supply or offer to sell or supply—

(I) a medicinal product for human use, within the meaning of subsection (2), or

(II) a veterinary medicinal product, within the meaning of subsection (2),

or

(ii) any other act done which is required as a consequence of the acts referred to in subparagraph (i) for the purposes specified in that subparagraph, as appropriate.”,

and

(c) by the insertion of the following subsection:

“(2) In this section (other than paragraph (g) of subsection (1))—

‘medicinal product for human use’ means—

(a) any substance or combination of substances having or purporting to have properties for treating or preventing disease in human beings, or

(b) any substance or combination of substances which may be used on or be administered to human beings with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

‘substance’ means any matter of—

(a) human origin (including human blood and human blood products),

(b) animal origin (including micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products),

(c) vegetable origin (including micro-organisms, plants, parts of plants, vegetable secretions and extracts), or

(d) chemical origin (including elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis);

‘veterinary medicinal product’ means—

(a) any substance or combination of substances having or purporting to have properties for treating or preventing disease in animals, or

(b) any substance or combination of substances which may be used on or be administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”.

(2) Section 42 of the Act of 1992 as it stood immediately before the passing of this section shall be referred to as subsection (1) of the said section 42 and, accordingly, references in any enactment passed before the passing of this Act to section 42 of the Act of 1992 shall be construed as references to subsection (1) of section 42 of that Act.