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REPORT (COM(2023)0231 – C90146/2023 – 2023/0130(COD))

On the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)

A-9-2024-0022

Committee on Legal Affairs · Rapporteur: Tiemo Wölken

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Parliament's amended version of the Commission proposal for a regulation on the supplementary protection certificate for medicinal products (recast) sets out its first-reading position. It clarifies how a product must be protected by the basic patent, limits protection to one certificate per product per member state, and extends protection to biosimilars with the same International Nonproprietary Name. It allows making for export to third countries and making no earlier than 6 months before expiry for storing, and sets fees, examination panels, an expedited procedure and appeal rules. It requires a searchable public register, transparency in opposition and appeal proceedings, and adds information on public financial support. It asks the Commission to evaluate Chapter III five years after application and to report to Parliament, the Council and the Economic and Social Committee.

Committee position. The Committee on Legal Affairs adopts Parliament's position at first reading with amendments to the Commission proposal, and considers that the proposal contains a straightforward codification of existing texts without substantive changes other than those identified.

Key points

  1. A product must fall within the scope of one or more claims of the basic patent as interpreted by a person skilled in the art; each active ingredient of a combination must be specifically identifiable.
  2. No more than one certificate, national or unitary, may protect the same product in a member state; the product or any derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars must not have been the subject of a prior certificate.
  3. For a biological medicinal product identified by its International Nonproprietary Name, protection extends to all biosimilar products with the same name, irrespective of minor differences.
  4. The Office may charge fees for centralised applications, extensions for paediatric medicinal products, oppositions and appeals, laid down by implementing act.
  5. Examination is conducted by a panel including one Office member and two examiners from national patent offices; examiners must have relevant expertise and sufficient experience.
  6. An expedited examination procedure may be requested in urgent situations, including where the basic patent expiry is imminent; the Office must adopt an opinion within 6 months, or 4 months for an expedited unitary certificate application.
  7. The certificate does not confer protection against making for export to third countries, related acts strictly necessary for that making or export, or making no earlier than 6 months before expiry for storing, and related acts for storing.
  8. Applicants must provide, if applicable, consent of a third party and information on direct public financial support received for research related to the product's development.
  9. The Office must publish applications in the Register without undue delay and no later than five working days after; examination opinions must be published without undue delay.
  10. Oppositions may be filed only on the grounds that conditions in Article 3 or 6 are not fulfilled; the Office must issue a reasoned decision within 6 months and deal with multiple oppositions jointly.
  11. Appeals must be filed within 2 months, grounds within 3 months, replies within 3 months, and the Office must issue a written decision within 3 months of the oral hearing or reply.
  12. A searchable public register must be maintained with information on applications, opinions, oppositions, appeals and public financial support; public authorities must not use it for patent linkage.

Who is affected

  • Applicants for supplementary protection certificates, who must provide additional information and may request expedited examination.
  • Holders of basic patents, who may not obtain more than one certificate per product unless not economically linked.
  • Manufacturers of generics and biosimilars, who may make products for export or storing under conditions.
  • National patent offices, which participate in examination and must grant or reject certificates before patent expiry.
  • The Office, which charges fees, examines applications, publishes opinions and maintains the register.

Figures and deadlines

  • 6 months before the expiry of the certificate: earliest time for making for storing.
  • 6 months: deadline for the Office to adopt an examination opinion after publication.
  • 4 months: deadline for an examination opinion under the expedited procedure for a unitary certificate.
  • six weeks: deadline for observations under the expedited procedure.
  • 6 months: deadline for the Office to issue a decision on opposition.
  • 2 months: deadline to file an appeal against a decision.
  • 3 months: deadline to file grounds of appeal.
  • five years after the date of application: first evaluation of Chapter III.

Legal basis: Article 294(2) and Article 114(1) of the Treaty on the Functioning of the European Union.