UK experimental use exemptions: Part 2—the Bolar exemption
As mentioned in the first of this four-part series of articles discussing the experimental use exemption from infringement in the UK, Section 60 UKPA 1977 in fact provides for three categories of experimental use exemption from infringement.
This article looks at the second category, which is commonly referred to as “the Bolar exemption”.
Bolar exemption
The Bolar exemption is provided for by Section 60(5)(i) UKPA 1977, which reads:
An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if […]
(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, or
(ii) any other act which is required for the purpose of the application of those paragraphs…
This sub-section provides an exemption for some clinical trials on medicinal products for human use and for trials on veterinary products.
However, it should be noted that this provision extends only to studies, tests, and trials that are required in order to take advantage of the abridged regulatory approval procedures available for generic and biosimilar medicines.
Thus, the exemption would apply where trials are required to show that the generic product is bioequivalent to an approved patented product (where this is required to obtain marketing authorisation), and to providing supplementary data for biosimilars.
However, the exemption does not extend to trials of new medicinal products that have not previously received a marketing authorisation, or of new indications for a previously authorised product.
While there has not, so far, been any case law on the implementation of the Bolar exemption, the UK Intellectual Property Office (IPO) issued a practice notice, which sets out a list of exemplary activities that the IPO considers are covered by the Bolar exemption. This list includes:
- the carrying out of chemical and biological synthetic processes suitable for the making, disposal or keeping of an active substance,
- the manufacture or the import of batches in quantities sufficient to provide material for preparing investigative batches of a medicinal product and to validate processes to the satisfaction of the competent authorities
- the development of the final pharmaceutical composition and manufacturing processes for a medicinal product to be marketed,
- the making, disposal or keeping or import of medicinal product batches in quantities sufficient to conduct the necessary pre-clinical tests, clinical and bioavailability trials and stability studies of the medicinal product and to validate the processes to the satisfaction of the competent authorities, and
- the manufacture and supply to the competent authorities of samples of active substances, their precursors, intermediates or impurities and of finished product samples.
Although there is no case law on this experimental use exemption, the scope of the exemption is, in one respect, very narrow and only covers acts required and carried out for the purpose of an abridged regulatory approval.
On the other hand, within that context the exemption is broad and covers any acts required to take advantage 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 (ie, abridged regulatory approval).
However, although the IPO has provided some examples of acts which it considers would be exempted from being infringing acts (as discussed above), it should be borne in mind that the UK courts may not agree.
While the Bolar exemption in the UK has its origins in an EU directive, The European Union (Withdrawal) Act 2018 provides, at section 2(1), that domestic law derived from EU law and which is in effect in the UK before December 31, 2020, will continue to have effect in domestic law. This means that the Bolar exemption will continue to apply in its domestic form.
One question that has not yet been considered by the courts is whether an application for abridged regulatory approval to the Medicines and Healthcare products Regulatory Agency will continue to be treated as an application under one of the two directives specified in the Bolar exemption, and thus whether the exemption will apply when abridged approval is only being sought in the UK.
However, this is unlikely to be of significance, as the expanded experimental use exemption discussed in part three of this series would normally apply in such circumstances.
Part three of this series, on the expanded exemption, will be published on LSIPR next week.
Sophie Topham is an associate at Marks & Clerk. She can be contacted at stopham@marks-clerk.com
