Supplementary protection certificate (EU)

European Union, regulation, granted nationally. Supplementary protection certificates (SPCs) were created by Council Regulation (EEC) No 1768/92 and are now governed by Regulation (EC) No 469/2009 of 6 May 2009, as amended by Regulation (EU) 2019/933. Primary text: EUR-Lex.

How it works: the holder of a basic patent covering an authorised medicine may obtain, in each member state, a certificate that takes effect when the patent expires and lasts for the time between the patent filing and the first marketing authorisation in the European Economic Area minus five years, capped at five years, so that total protection after first authorisation cannot exceed fifteen years. Completing an agreed paediatric investigation plan adds six months. The 2019 manufacturing waiver lets generic and biosimilar makers manufacture in the EU during the SPC term for export outside the Union and, in the final six months, to stockpile for day-one launch in the EU.

Why it matters and the arguments: for most cancer medicines the SPC, not the patent, sets the year generics or biosimilars arrive in Europe, which is why the exclusivity timeline on this site records it. Litigation over what counts as a 'product' and whether combinations or new formulations earn certificates has repeatedly reached the Court of Justice. The Commission proposed a unitary SPC in 2023 alongside the pharmaceutical package, and generic makers argue the system, stacked with data protection, gives Europe the world's longest effective monopolies; innovators reply that development times keep growing.