Experimental use exemptions in the UK

In the UK, certain acts undertaken for the regulatory approval of generic medicinal products are exempt from patent infringement. Historically, this exemption did not cover acts undertaken for the regulatory approval of new medicinal products, making the UK one of a few members of the European Union in which clinical trial activities for new medicinal products may infringe a patent. Although a separate “experimental purposes” exemption exists under the UK law, historically, this exemption has been narrowly interpreted leading to uncertainty for innovators about its application to trials and experimental activities.

The UK Patents Act 1977 (UK Act) provides for two different exemptions relevant to trials and experimental activities. Under sections 60(5)(b) and 60(5)(i) of the UK Act, an act will not infringe a patent if:

“S. 60(5)(b) it is done for experimental purposes relating to the subject-matter of the invention”

This is the UK’s so-called “experimental purpose” exemption.

“S. 60(5)(i) it consists of:

(i) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC [the abridged authorisation route for generics]; or

(ii) any other act which is required for the purpose of the application of those paragraphs.”

This is the UK’s so-called “Bolar” exemption.

Typically, the UK courts have taken a narrow view as to what constitutes an act done for “experimental purposes” and it has been necessary for innovators to attempt to rely upon this exemption in relation to UK clinical trials for new drugs. However, following a number of consultations, legislation to amend the UK Act has recently come into force in the UK.

The new legislation amends section 60 of the UK Patents Act 1977 and came into force on 1 October 2014. Rather than expand the “Bolar” exemption, the amendment expands the “experimental purpose” exemption, as follows:

S. 60

(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.

The amendments to UK legislation is welcome news to innovator companies wanting to conduct clinical trials in the UK. It is not yet known whether other European Member States which have narrowly interpreted exemptions will adopt a similar approach. What is clear, however, is that industry would welcome a broader implementation of the “Bolar” exemption across Europe.

With the imminent arrival of the Unified Patent Court careful consideration will need to be given to the subject of Bolar-type exemptions. Presently, the scope of the exemption under consideration is similar to the pre-1 October 2014 UK position.