SPCs, CJEU and the impact of Brexit

In this week's Expert View piece, Charlotte Tillett and Astrid Arnold of UK law firm Stevens & Bolton look at the way the European Court of Justice (CJEU) has interpreted the application of Supplementary Protection Certificates (SPC) for drugmakers in the region.

A Supplementary Protection Certificate (SPC) is an extremely valuable prize for the pharmaceutical patent owner as it extends the patent life of an authorized medicine for up to five years at a time when a successful drug is likely to be well established and at the top of its earning power.

SPCs, which compensate the patent owner for time lost between the patent’s filing date and the date of authorization, were introduced in the European Union in 1992 to encourage research into new medicines and establish the EU as a good place for research-based pharmaceutical and biologics companies to operate. However, since then, the courts have struggled to define the conditions for the grant of a valid SPC.

This has led to serious uncertainties both for research-based companies that rely on them and for generic/biosimilar companies that seek to challenge them, making investment decisions riskier and leading to high-cost litigation. It is important for organizations to acknowledge the key points arising from the often-confusing fog of litigation that surrounds this topic, while also considering the impact of Brexit.