The Legislative Reform (Patents) Order 2014

Amendments of the Patents Act 1977

2.  In section 60 of the Patents Act 1977(1) (meaning of infringement), after subsection (6C) insert—

“(6D) For the purposes of subsection (5)(b), anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subject-matter of the invention.

(6E) In subsection (6D), “medicinal product assessment” means any testing, course of testing or other activity undertaken with a view to providing data for any of the following purposes—

(a) obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the United Kingdom or elsewhere);

(b) complying with any regulatory requirement imposed (whether in the United Kingdom or elsewhere) in relation to such an authorisation;

(c) enabling a government or public authority (whether in the United Kingdom or elsewhere), or a person (whether in the United Kingdom or elsewhere) with functions of—

(i) providing health care on behalf of such a government or public authority, or

(ii) providing advice to, or on behalf of, such a government or public authority about the provision of health care,

to carry out an assessment of suitability of a medicinal product for human use for the purpose of determining whether to use it, or recommend its use, in the provision of health care.

(6F) In subsection (6E) and this subsection—

“medicinal product” means a medicinal product for human use or a veterinary medicinal product;

“medicinal product for human use” has the meaning given by article 1 of Directive 2001/83/EC(2);

“veterinary medicinal product” has the meaning given by article 1 of Directive 2001/82/EC(3).

(6G) Nothing in subsections (6D) to (6F) is to be read as affecting the application of subsection (5)(b) in relation to any act of a kind not falling within subsection (6D).”.

(1)

1977 c.37; relevant amending instruments are S.I. 2000/2037, S.I. 2005/2759, and S.I. 2013/2602.

(2)

OJ No L 311, 28.11.2001, p 67.

(3)

OJ No L 311, 28.11.2001, p 1.