A proposed amendment which would significantly impact on what acts are exempt from infringement in the UK was laid in Parliament on 6 May 2014 for consideration by the relevant Parliamentary committees.
Under current UK law, trials done for the purposes of obtaining marketing approval for generic medicinal products are exempt from infringement. This so called “Bolar” exemption is very narrow, in contrast to corresponding exemptions that are in force in other EU states such as Germany, which also exempt trials relating to new, non-generic, drugs from infringement. As previously reported here, in early 2013 the government announced a proposal to amend the law in order to allow clinical and field trials and health technology assessment for new drugs to be carried out without any risk of being sued for patent infringement. The aim is to make the UK are more attractive location for carrying out such trials and to provide greater legal certainty for industry.
The text of the proposal which is being considered by Parliament can be found here and the key passages are shown below.
Proposed amendments of the Patents Act 1977
In section 60 of the Patents Act 1977(a) (meaning of infringement), after subsection (6C) insert -
"(6D) For the purposes of subsection (5)(b) [which exempts from infringement acts done for experimental purposes relating to the subject matter of the invention], 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 -< >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); complying with any regulatory requirement imposed (whether in the United Kingdom or elsewhere) in relation to such an authorisation; 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 -providing health care on behalf of such a government or public authority, or 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. "medicinal product for human use" has the meaning given by article 1 of Directive 2001/83/EC(b); "veterinary medicinal product" has the meaning given by article 1 of Directive 2001/82/EC(c).
(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)."
It is intended that the law change will come into force in October 2014. This proposal will no doubt be welcomed by many, although it remains to be seen whether Parliament will make any significant changes before enacting this legislation. It must also be remembered that the Agreement on the Unified Patent Court contains a somewhat different and arguably narrower exemption, raising the question as to what the scope of the exemption will be if and when the Agreement on the Unified Patent Court comes into force.