Unitary supplementary certificate for medicinal products
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With the Council of the EU, which is preparing its first-reading position.
Last active 04 Jun 2026
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What this bill does
In plain terms: what it changes and who it affects.
Creates a single EU-level add-on patent certificate for authorised medicinal products protected by a unitary patent.
Who it affects
Pharmaceutical and biotech companies developing patented human or veterinary medicines, generic and biosimilar manufacturers, and businesses relying on certainty about medicine patent extensions.
Core of the proposal
- Allows one unitary certificate based on a unitary patent and centralised marketing authorisation.
- EUIPO examines applications through panels including national patent-office examiners.
- Creates third-party observations, opposition, appeal, invalidity, and conversion procedures.
- Keeps certificate duration capped at five years, with possible six-month paediatric extension.
Key provisions
- Transitional law
- Application of the Regulation is to be deferred to let EUIPO prepare the procedure, but no date is provided.
Articles changed · 7 across 3 laws
- Regulation (EU) 2017/1001 (32017R1001)
- art. 151(1): replaces point (c) and adds points (f) and (g)
- art. 152(1): replaces the first subparagraph
- Regulation (EU) No 608/2013 (32013R0608)
- art. 2(1): replaces points (f) and (g); inserts points (m) and (n)
- Regulation (EC) No 1901/2006 (32006R1901)
- art. 2(4): replaces point (4)
- art. 8: replaces the first paragraph
- art. 36(1): replaces the first subparagraph
- art. 36(4): replaces the first sentence
Latest update
09 Jun 2026The most recent development in this bill's progress.
1st reading – Council of the EU → 1st reading – Council of the EU
1st reading – Council of the EU → 1st reading – Council of the EU
Documents
1 recentSourcesOEILEUR-LexEU Law Tracker