In order to satisfy the public need for generic medicines to obtain approval and reach the market immediately on patent expiry, a statutory EU Bolar exemption was established. This provides exemption from patent infringement for studies, tests or trials conducted with a view to obtaining approval of medicinal products using the generic, hybrid or biosimilar routes and their consequential requirements.
Since the exemption was provided in a EU Directive it was left to each individual EU member state to implement the legislation as it saw fit. This has led, somewhat paradoxically, to a situation where the exemption is defined very differently across the various EU member states.
This legislation was implemented in the UK as Section 60(5) of the Patents Act 1977, which uses almost identical language to the EU Directive and exempts specified acts done with a view to obtaining approval via the generic, hybrid or biosimilar routes only. There appears to be no exemption for approval of existing products for use in new indications, and it is broadly accepted that there is none provided for approval of innovative medicinal products. This stands in stark contrast to the corresponding German statutory provisions, which exempts all acts carried out with a view to obtaining approval of any medicinal product anywhere in the world.
Amid feelings that the EU playing field was not quite even, the UKIPO began a public consultation process in mid-2011 to address concerns over risks of patent infringement when carrying out trials for non-generic products. The results confirmed a reluctance to conduct such trials in the UK and indicated consensus around the need for legislative change, with similar scope to the German law being heavily favoured.
As a result of the consultation, the UK government accepted the need to extend the exemption from infringement to include acts carried out with a view to obtaining approval of innovative medicinal products in any country, and that the exemption should cover activities required for assessment and approval to ensure reimbursement for those drugs.
In the time since the need to amend the legislation on patent infringement was acknowledged, the UK has signed the agreement on the Unified Patent Court (“the UPC Agreement”). Ratification of this agreement will require that UK law on patent infringement is consistent with its infringement provisions. The UPC Agreement includes a Bolar provision exempting only generic, hybrid and biosimilar approvals, and therefore the UK government has been faced with a tricky challenge in providing a meaningful amendment to the Patents Act.
How the government sought to reconcile the requirements of the UPC Agreement with the outcome of the UKIPO consultation was made clear when the draft amendment to the Patents Act was laid before Parliament in April. The changes, which are proposed to come into effect on 1 October, leave the Bolar exemption itself untouched and aims to achieve its objective by legislating for a broadened experimental use exemption.
This exemption, provided by section 60(5) (b) of the Patents Act and corresponding to Article 27(b) of the UPC Agreement, states that an act which would constitute an infringement of a patent shall not do so if “it is done for experimental purposes relating to the subject-matter of the invention.” What constitutes an experimental purpose relating to the subject matter of the invention is not defined in either statute.
However, the proposed new subsection 6D in section 60 of the Patents Act provides that “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.”
New subsection 6E defines “medical product assessment” very broadly as including any testing, course of testing or other activity undertaken with a view to providing data for:
(a) obtaining or varying a marketing authorisation for a medicinal product in the UK or elsewhere;
(b) complying with any regulatory requirements in the UK or elsewhere in relation to such an authorisation; and
(c) enabling a government or public authority in the UK or elsewhere to carry out an assessment of the suitability of a medicinal product for human use for the purpose of determining whether to use it or to recommend its use.
In taking this approach it appears that a conflict between the UK statute and the UPC Agreement has been avoided, and this approach may have succeeded in providing the broader exemption sought while satisfying the need to remain consistent with the Agreement.
Initially the proposed changes to the Patents Act are likely to be met with widespread approval. Activities carried out to obtain approval for any medicinal product will be exempt from patent infringement, as will those for post-approval regulatory requirements, and these exemptions apply when approval is sought or regulatory requirements are set in any country. Exempt activities are therefore expected to include carrying out clinical and non-clinical trials, making, supplying, stocking and importing medicinal products specifically for use in such trials and for studies to determine whether to use or recommend use of a drug.
However, there may be some dissatisfaction among owners of research tool patents, since the consultation produced disagreement over whether their use should be exempt. It appears likely that they are, and this will impact the value and commercial relevance of such patents.
The longer term consequences of the changes remain unclear. Basing exemptions on experimental use attempts to maintain consistency of infringement provisions between UK law and the UPC Agreement. Both statutes provide a narrow Bolar exemption and an exemption for acts “done for experimental purposes relating to the subject matter of” the invention. It remains to be seen if the UK approach of defining acts that constitute experimental uses gives rise to inconsistency with different exemptions being available within the UK depending on whether an act is alleged to infringe a national patent, an opted out European patent, a non-opted out European patent, a unitary patent or a SPC.
Infringement of unitary patents will be determined by the UPC according to “the law applied to European patents with unitary effect in the participating Member State whose national law is applicable to the European patent with unitary effect as an object of property” (Article 5(3) Reg (EU) No 1257/2012). If the court determines that the amended Patents Act qualifies as “law applied to European patents with unitary effect” it will then face a challenge in harmonising this most tricky of areas.