GHP September 2016

ghp September 2016 | 59 Regulation and the UK would need to actively ‘opt-in’ to reflect this legislation in national law, post-Brexit. Such an ‘opt-in’ would indicate the UK’s commitment to rewarding research into rare diseases. SPCs Like orphan market exclusivity, supplementary protection certificates (SPCs) exist by virtue of an EU Regulation. Carrying a maximum of five years’ additional exclusivity at the end of the life of the basic patent, SPCs are considered to be hugely important by innovator companies, but equally are subject to frequent challenges from the generics industry who can access the market earlier if the SPC on a product can be knocked out. SPCs compensate the originator for the R&D time involved in getting a new drug to market, which take up a significant amount of the ordinary 20 years’ patent monopoly period. If the UK wishes to maintain its commitment to rewarding pharmaceutical research and innovation, it is to be expected that a parallel SPC system would be retained. However, this is not a foregone conclusion and innovators should ensure that their government affairs teams are fully apprised of the significance of SPCs to their business. Assuming that UK SPCs continue in parallel to the EU system, will the numerous existing European Court (CJEU) decisions in this heavily litigated area continue to apply? Whilst those references from the UK are embedded in the national case law, the fate of refer- ences from other countries, and pending references is unclear. We envisage that, until the national courts diverge, they will see the existing CJEU cases as of useful (but not precedential) value. This undoubtedly provides an opportunity for the UK courts to impose some clarity on an area where the CJEU has at times generated confusion. The path forward… Whilst the UK’s preferred Brexit model remains un- known (and Article 50 has not been triggered) a defin- itive assessment of the impact on the pharmaceutical industry is, as in many other industries, unclear. How- ever, whilst the status quo prevails, businesses can prepare by ensuring that their key areas of interest are raised with the UK government. Whilst divergence from Europe in many areas (such as clinical trials) is not desirable due to the international nature of the pharmaceutical industry, Brexit may provide the op- portunity to simplify other areas, in particular around SPCs, and the provision for additional data exclusivity periods. Even if, ultimately, the outcome of Brexit is a re-negotiated EU membership or an EEA arrangement (Brexit-lite), increased engagement with government stakeholders can only improve the relationship be- tween the pharma industry and those who regulate it. Company: Hogan Lovells Name: Helen Kimberley and Laura Whiting Email: [email protected] [email protected] Web Address: www.hoganlovells.com Telephone: +44 20 7296 5306