Skip to content
Adopted text

Unitary supplementary certificate for medicinal products

TA-9-2024-0097 · P9_TA(2024)0097 · PE753.703

Official HTML ↗ PDF DOCX
✦ In shortFull text
✦ In short · AI summary of this text, generated 29 Sept 2026

Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

Parliament's amended version of a proposed regulation creates a unitary supplementary protection certificate for medicinal products protected by a European patent with unitary effect. The certificate is granted by the European Union Intellectual Property Office on the basis of a basic patent and a centralised marketing authorisation, and has uniform effect in all Member States where the patent has unitary effect. It lasts up to 5 years from the end of the patent's lawful term, with a 6-month extension for paediatric use, and may be extended only once. It does not confer protection against making for export to third countries or for storing before expiry, subject to conditions including notification and a logo. Third parties may submit observations within 3 months, file opposition within 2 months, and apply for a declaration of invalidity; appeals go to the Boards of Appeal and then the General Court.

Key points

  1. A unitary certificate is granted by the Office on the basis of a basic patent if the product is protected, has a valid marketing authorisation, has not already been the subject of a certificate, and the authorisation is the first for that product.
  2. The holder of more than one patent for the same product may not be granted more than one certificate, but two holders not economically linked may each be granted one.
  3. The certificate confers the same rights as the basic patent and has unitary character, providing uniform protection in all Member States where the patent has unitary effect.
  4. The certificate does not confer protection against making for export to third countries, related acts, or making for storing no earlier than 6 months before expiry, if the maker notifies the Office and the certificate holder and affixes a logo.
  5. The application must be lodged within 6 months of the marketing authorisation or of the attribution of unitary effect, and applications for extension of duration have separate deadlines.
  6. The Office examines the application, publishes it, and issues a reasoned examination opinion; third parties may submit observations within 3 months, or six weeks under the expedited procedure.
  7. Any person may file opposition within 2 months of publication of the examination opinion, and the Office must decide within 6 months unless the case is complex.
  8. The certificate takes effect at the end of the lawful term of the basic patent for a period equal to the time between filing and first marketing authorisation minus 5 years, capped at 5 years, extendable by 6 months for paediatric use.
  9. The certificate lapses if the holder surrenders it, the annual fee is not paid, or the marketing authorisation is withdrawn; it is invalid if granted contrary to Articles 3 and 6(2), if the basic patent lapses early, or if the patent is revoked or limited.
  10. Any person may apply for a declaration of invalidity, and the Office must decide within 6 months unless the case is complex.
  11. Appeals against Office decisions, including examination opinions, may be filed within 2 months; decisions of the Boards of Appeal may be challenged before the General Court within 2 months.
  12. The Commission may adopt delegated acts on appeal procedures, oral proceedings, evidence, notification, time limits and resumption of proceedings, and implementing acts on fees, application forms and examination procedures.

Who is affected

  • Applicants for unitary certificates, who must lodge applications electronically within 6 months of marketing authorisation.
  • Holders of unitary certificates, who must pay annual fees and may license rights voluntarily.
  • Makers of generics and biosimilars, who may make products for export or storing under conditions.
  • Competent national authorities, which may be appointed as participating offices and designate examiners.
  • Third parties, who may submit observations, file opposition or apply for a declaration of invalidity.

Figures and deadlines

  • 6 months: period to lodge an application for a unitary certificate after marketing authorisation.
  • 5 years: maximum duration of the unitary certificate from the date it takes effect.
  • 6 months: extension of duration for paediatric use.
  • 3 months: period for third parties to submit observations after publication.
  • 2 months: period to file opposition after publication of the examination opinion.
  • 6 months: period for the Office to decide on opposition or invalidity, unless complex.
  • 2 months: period to file an appeal against a decision of the Office.
  • 6 months: period before expiry during which making for storing is allowed.

Legal basis: Article 118, first paragraph, of the Treaty on the Functioning of the European Union.