Proposed changes to the UK Patents Act laid before the parliament on 6 May 2014 are set to provide freedom for life science innovators to perform clinical trials of new medicaments with a view to obtaining market approval without risk of infringing UK Patents.
Current UK law exempts from infringement certain acts relating to the development of medicinal products. These exemptions are, however, interpreted narrowly and there is also considerable uncertainty as to exactly what acts are exempt. The proposed changes seek to change this by significantly broadening and clarifying the exemption, with clear benefits for innovator companies.
The changes, if enacted in their present form, will effectively allow companies to perform clinical trials for the purpose of obtaining market approval for new drugs in the UK, and will also allow parties to undertake activities required for health technology assessments (HTAs) without being sued for infringement, representing one of the most significant changes to the UK Patents Act in recent years from a life sciences perspective. The proposed changes to the wording of the act can be found on the Government's website.
According to present UK law, otherwise infringing acts that are undertaken to obtain market approval for a generic medicament in line with the EU Bolar Directive are exempt from infringement under Section 60(5)(i) UKPA. In limiting this provision only to acts performed in obtaining market approval for generic medicaments, the UK has implemented the Bolar Directive narrowly compared to other major EU member states, such as France and Germany. The UK provision therefore provides no exemption for innovators seeking to perform experiments and trials needed to obtain market approval for a new medicament in the UK and sets the UK apart from other EU member states that would exempt such experiments and acts under the EU Bolar Directive.
The UK Patents Act also provides an “experimental purpose” exemption set out in Section 60(5)(b) UKPA, which exempts acts “done for experimental purposes relating to the subject matter of the invention”. Developments in UK case law have, however, led to this exemption being interpreted narrowly, such that clinical trials would not generally fall within this provision.
Clearly, current UK law does not provide a comfortable environment for innovators seeking to trial new drugs, motivating innovator companies to perform such studies overseas.
As we reported previously, the government proposed to amend the law in 2013. In the wake of a UKIPO consultation, where a large majority of responses favoured the broadening of the exemptions, a draft Legislative Reform Order was laid before the UK parliament on 6 May 2014. The effect of the Order will be to amend Section 60 UKPA and it is expected to take effect on 1 October 2014.
The proposed changes would in particular broaden the “experimental purpose” exemption under Section 60(5)(b) UKPA to cover any acts done for the purpose of a “medical product assessment”, which is defined broadly in the revised wording. The “Bolar exemption” under Section 60(5)(i) of the Act will, however, remain unchanged.
The broad definition given to the term “medical product assessment” would mean that companies would be able to engage in a range of acts relating to delivery of medicaments to the market without risk of infringement, including conducting clinical trials to obtain market approval for new or generic drugs, and undertaking activities required for health technology assessments (HTAs) for new drugs.
The proposed changes promise to make the UK a much more attractive place to trial new medicaments, which is hoped will bring significant economic benefits to the UK.
Whilst these changes, if enacted, will provide a significant change to UK law, it remains to be seen how such acts will continue to be treated elsewhere in the EU. Our recent article discusses a recent referral to the CJEU, which seeks clarity as to how the EU Bolar Directive should be interpreted.
It will also be interesting to see how the prospective Unified Patent Court (“UPC”) will treat such acts in relation to infringement of prospective granted Unitary Patents. It appears for instance that the UPC intends to adopt a narrow approach to interpretation of the Bolar Directive, which would make the provisions for infringement in the proposed revised UK Act at odds with the law on infringement of Unitary Patents, in some respects undoing the positive steps taken by the UK government in proposing this reform. This may also have an effect on the choice of innovators to use a Unitary Patent to protect their medicaments in Europe as opposed to using the present system under the EPC to obtain a cluster of national patents.