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Adopted text

Supplementary protection certificate for medicinal products (recast)

TA-9-2024-0099 · P9_TA(2024)0099 · PE753.704

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Parliament's position on a proposed regulation recasting the rules on supplementary protection certificates for medicinal products. It keeps national certificate applications and adds a centralised procedure run by the European Union Intellectual Property Office for European patents and centralised marketing authorisations. The certificate extends a basic patent by up to 5 years, with an overall maximum of 15 years of exclusivity from first Union marketing authorisation, and can be extended by 6 months for paediatric use. It creates an exception letting makers established in the Union make and store generics and biosimilars for export to third countries or for day-one Union entry, subject to notification, labelling and due diligence duties. It sets up a register, fees, examination panels, opposition and appeal procedures, and rules on duration, invalidity, lapse and evaluation.

Key points

  1. A certificate is granted by each Member State at the request of the holder of a national or European patent, including a unitary patent, for a product with a marketing authorisation.
  2. Conditions for grant: the product is protected by a basic patent in force, has a valid marketing authorisation, has not already been the subject of a certificate, and that authorisation is the first to place the product on the market.
  3. No more than one certificate may protect the same product in a Member State; holders of more than one patent for the same product get only one certificate, unless they are not economically linked.
  4. The certificate confers the same rights as the basic patent and covers the product and therapeutically equivalent derivatives such as salts, esters, ethers, isomers, mixtures of isomers, complexes and biosimilars.
  5. A centralised application may be filed with the Office where the basic patent is a European patent, including a unitary patent, and the marketing authorisation is centralised; national applications are then prohibited in those Member States.
  6. The Office examines the application, issues a reasoned positive or negative opinion for each designated Member State, and national authorities grant or reject the certificate accordingly.
  7. Third parties may submit observations within 3 months of publication and file opposition within 2 months of the examination opinion; appeals go to the Boards of Appeal and then the General Court.
  8. The exception allows making a product for export to third countries or, no earlier than 6 months before certificate expiry, for storing for day-one Union entry, plus related acts strictly necessary for that making, export or storing.
  9. The maker must notify the national authority and inform the certificate holder at least 3 months before starting, affix a logo for exports, and ensure products for export do not bear an active unique identifier.
  10. The exception does not cover placing the product on the Union market during the certificate, re-importation, or import merely for repackaging and re-exporting.
  11. The exception applies to certificates applied for on or after 1 July 2019, and to earlier applications that take effect on or after that date only from 2 July 2022; it does not apply to certificates that took effect before 1 July 2019.
  12. A public electronic register holds information on centralised applications and certificates, and the Commission evaluates the exception and the centralised procedure every 5 years.

Who is affected

  • Holders of national or European patents for medicinal products, who may obtain a certificate extending protection by up to 5 years.
  • Makers of generics and biosimilars established in the Union, who may make and store products for export or day-one entry under the exception.
  • Competent national authorities, which grant or reject certificates and participate in the centralised examination.
  • The European Union Intellectual Property Office, which runs the centralised procedure, register and Boards of Appeal.
  • Third parties, who may submit observations, file opposition or challenge certificate validity.

Figures and deadlines

  • Overall maximum of 15 years of exclusivity from the time the medicinal product first obtains a Union marketing authorisation.
  • Certificate duration may not exceed 5 years from the date it takes effect.
  • Duration is extended by 6 months where the paediatric extension applies.
  • Application for a certificate must be lodged within 6 months of the marketing authorisation or, if later, of the patent grant.
  • Third parties may submit observations within 3 months after publication of the centralised application.
  • Opposition may be filed within 2 months following publication of the examination opinion.
  • Appeal notice must be filed within 2 months of notification of the decision.
  • Making for storing may start no earlier than 6 months before the expiry of the certificate.

Legal basis: Article 114(1) of the Treaty on the Functioning of the European Union.