Brexit – how may it affect SPCs?
In the European Union (EU), supplementary protection certificates (SPCs) are granted to patented medicinal and plant protection products which have required marketing authorisation (regulatory approval) prior to being placed on the market.
SPCs extend the lifetime of the patent (for the approved product) for up to five years, extended by an additional six months for medicinal products if paediatric studies are carried out on the product – their value to the pharmaceutical and agricultural industries is therefore of great significance, as the term of the SPC is typically when the product achieves its peak sales.
Although SPCs are national rights, the legal basis for SPCs is two EU Regulations. An SPC can be granted based on either a national marketing authorisation or (for medicinal products) an EU-wide authorisation granted by the European Medicines Agency. At this early stage, it is difficult to be certain exactly how SPCs will be impacted – this will depend somewhat on the terms of the UK's exit. However, current SPCs will remain in force until the UK exits the EU, which may take several years.
Moreover, the UK's exit from the EU does not change the underlying purpose for which the SPC Regulation was created – namely, to compensate the patent holder for the investment in research and the patent term lost caused by the need to obtain regulatory approval before the product can be placed on the market. Typically, pharmaceutical products take 10-15 years of research and development to reach market and R&D costs are in the region of $500 million to $1 billion, making the term extension that SPCs provide vital to enable the industry to obtain a return on this investment. It is also worth noting that a number of non-EU countries, such as Switzerland, allow SPCs based on their national law, under provisions that essentially parallel those of the EU Regulations.
Accordingly, given the vital importance of the pharmaceutical industry to the UK, it would appear likely that the UK government will enact new legislation to allow for UK national SPCs under provisions similar to that currently provided under the EU SPC Regulations. It is also likely that transitional provisions will be enacted to maintain in force SPCs granted or pending under the EU Regulations. The UK's exit from the EU may even give the UK the opportunity to lead the way in legislating to fix the number of issues the SPC Regulation has faced in recent years.
The UK Government will be advised by the major IP institutions, including the UK's Chartered Institute of Patent Attorneys (CIPA) on the road ahead. At D Young & Co we have a specialist team of patent attorneys with significant experience in SPCs and will have the opportunity to contribute to the discussion. In the meantime, our advice is that applicants continue to apply for SPCs in the UK as normal.