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Supplementary protection certificate for plant protection products (recast)

TA-9-2024-0098 · P9_TA(2024)0098 · PE753.705

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Parliament's position at first reading on a proposed regulation recasting the rules on supplementary protection certificates for plant protection products. It keeps national certificate applications and adds a centralised procedure run by the European Union Intellectual Property Office for European patents, including unitary patents. A certificate extends the protection of a basic patent for a product authorised for placing on the market, for a maximum of 5 years and an overall maximum of 15 years of exclusivity from the first Union marketing authorisation. The centralised procedure allows one application designating several Member States, examined by a panel of Office and national examiners, with third-party observations, opposition and appeal before the Office's Boards of Appeal. The regulation repeals Regulation (EC) No 1610/96 and sets a register, fees, language rules and a transition period for the centralised procedure.

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 a certificate: the product is protected by a basic patent in force, a valid marketing authorisation has been granted, no prior certificate covers the product, and the authorisation is the first for that product.
  3. No more than one certificate may protect the same product in a Member State; holders of different patents may each obtain one only if they are not economically linked, and a third party's consent is needed where it holds the authorisation.
  4. The certificate confers the same rights as the basic patent and covers the product and equivalent derivatives such as salts, esters, ethers, isomers, mixtures of isomers or complexes, within the limits of the basic patent.
  5. The application is lodged within 6 months of the marketing authorisation, or of the patent grant if the authorisation came first, and must contain the specified information including any third-party consent.
  6. The certificate takes effect at the end of the basic patent for the period between the patent filing and the first Union marketing authorisation reduced by 5 years, and may not exceed 5 years.
  7. A centralised application may be filed with the Office on the basis of a European patent, designating the Member States where certificates are sought, and is examined against the conditions for each designated Member State.
  8. The examination opinion is not adopted earlier than 18 months after filing; where no authorisation exists in a designated Member State, the Office suspends proceedings and resumes them on request before the basic patent expires.
  9. Third parties and Member States may submit written observations within 3 months of publication of the centralised application, and any person may file an opposition within 2 months of publication of the examination opinion.
  10. Examination and opposition panels include one Office member and two examiners from different national authorities; examiners must be impartial and declare conflicts of interest.
  11. Parties adversely affected by an Office decision, including an examination opinion, may appeal to the Boards of Appeal within 2 months, with a statement of grounds within 3 months, and then bring an action before the General Court within 2 months.
  12. A register holds information on centralised applications and certificates in all official Union languages, and the Office charges fees for applications, oppositions and appeals.

Who is affected

  • Holders of national or European patents on plant protection products, who may apply for a certificate and gain up to 5 years of extra protection.
  • Competent national authorities, which grant or reject certificates and may 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 oppositions or challenge certificate validity before national courts.
  • Applicants and representatives, who must use the Office's forms, languages and time limits in centralised proceedings.

Figures and deadlines

  • Overall maximum of 15 years of exclusivity from the first Union marketing authorisation.
  • Certificate duration may not exceed 5 years from the date it takes effect.
  • Application lodged within 6 months of the marketing authorisation or of the patent grant.
  • Examination opinion not adopted earlier than 18 months after the centralised application was filed.
  • Third-party observations within 3 months after publication of the centralised application.
  • Opposition filed within 2 months following publication of the examination opinion.
  • Appeal notice filed within 2 months of notification; statement of grounds within 3 months.
  • Action before the General Court within 2 months of notification of the Boards of Appeal decision.

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