As the UK prepares to leave the EU, the House of Lords is debating the Patents (Amendment) (EU Exit) Regulations 2018 Statutory Instrument which the ABPI says would weaken the UK’s IP framework and damage the country’s reputation as leader in life sciences.
SPCs – or Supplementary Patent Certificates – are extensions for patents of medicines. They provide additional patent life to compensate for the period of market exclusivity lost during the essential regulatory approval process.
The ABPI has raised concerns that the statutory instrument damages the reputation of the UK’s commitment to be a leading life sciences hub, and more widely as a global leader on IP protection.
SPCs are a key part of the intellectual property framework for pharmaceutical research, introduced in EU to maintain and stimulate research by offsetting some of the effective patent term lost during the development of a medicine.
The ABPI and its members are concerned that the proposed changes to the SPC regulation will reduce periods of actual exclusivity in the UK and therefore the value of patents for innovators, and the attractiveness of the UK as a market.
It says that the UK currently has a reputation as a global leader in encouraging innovators through intellectual property rules but changes, such as those in this SI, pose a substantial risk to this.
Mike Thompson, the Chief Executive of the ABPI, has said: “Britain is internationally renowned for its strong IP framework and this has made it an attractive home for investment from all industrial sectors, including pharmaceuticals. We’re concerned that these measures are a step backwards and seriously undermine the strong life sciences sector that we’ve worked so hard to build over the past 70 years.”