On the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
A-9-2024-0019
Committee on Legal Affairs · Rapporteur: Tiemo Wölken
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 the Commission proposal for a regulation on the unitary supplementary certificate for medicinal products. It sets up a centralised electronic application and examination system run by the Office, with national examiners, and lays down rules on protection, opposition, appeal and fees.¶¶¶ It limits the certificate's protection so that making a product for export to third countries, and making for storage before expiry, do not require the holder's consent. It also encourages holders to license rights in markets where they do not intend to launch products.¶¶¶ It requires applications, observations, oppositions, appeals and other communications to be filed electronically, and sets time limits for examination opinions, oppositions and appeals.¶¶¶ It creates a register of applications and certificates, and bans public authorities from using register information for patent linkage or for decisions on generics and biosimilars.¶¶
Committee position. The Committee on Legal Affairs adopts Parliament's position at first reading with amendments to the Commission proposal, setting up a centralised electronic system for unitary certificates, limiting protection for export and storage, and requiring electronic filings and register transparency.¶¶¶
Key points
- The certificate should protect a product only if it falls within the scope of the basic patent as interpreted by a skilled person in light of the description, drawings, general knowledge and prior art.¶
- No more than one certificate, national or unitary, may protect the same product in a Member State, and the product or a derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars must not have been the subject of a prior certificate.¶
- Holders of unitary certificates are encouraged to allow supply in markets where they do not intend to launch products, including through voluntary licensing agreements.¶
- For a biological medicinal product identified by its International Nonproprietary Name, protection extends to biosimilars with the same name, irrespective of minor differences.¶
- The certificate does not confer protection against making a product for export to third countries, related acts strictly necessary for that making or export, making no earlier than 6 months before expiry for storage, or related acts for that storage.¶¶¶
- Applications for a unitary certificate must be lodged electronically using the Office's formats, and the Office must ensure electronic exchanges that protect commercially confidential information.¶¶
- The Office must publish applications in the Register no later than five working days after lodging, and must issue an examination opinion within six months of publication, or four months under an expedited procedure.¶¶
- Third parties may submit written observations electronically, and in expedited cases observations must be submitted within six weeks after publication of the application.¶¶¶
- The Office must issue a decision on opposition within 6 months unless complexity requires longer, publish its full decision in the Register, deal jointly with multiple oppositions, and ensure transparency and electronic exchanges.¶¶¶
- Examiners must have relevant expertise and sufficient experience, including at least one examiner with a minimum of five years of experience in examining patents and supplementary protection certificates.¶¶
- Appeals must be filed electronically within 2 months of notification, with grounds and evidence within three months, and the Boards of Appeal must annul or alter an examination opinion that is not in line with their decision.¶¶
- Public authorities must not use Register information for patent linkage or for decisions on marketing authorisations, pricing, reimbursement or tender bids for generics and biosimilars.¶
Who is affected
- Applicants for unitary supplementary protection certificates, who must file electronically and may request expedited examination.¶¶
- Holders of unitary certificates, whose protection is limited for export and storage and who are encouraged to license in unused markets.¶¶¶
- Makers of generics and biosimilars, who benefit from the export and storage exception and from the ban on patent linkage.¶
- National patent offices and their examiners, who participate in examination and must meet expertise and experience criteria.¶¶¶
- The Office, which runs the electronic application, examination, opposition, appeal and register system.¶¶¶
Figures and deadlines
- No more than one certificate, national or unitary, may protect the same product in a Member State.¶
- Making for storage is allowed no earlier than 6 months before expiry of the certificate.¶¶
- The Office must publish the application no later than five working days after it was lodged.¶
- The Office must issue an examination opinion within six months of publication, or within four months under an expedited procedure.¶
- In expedited cases, observations must be submitted within six weeks after publication.¶
- The Office must issue a decision on opposition within 6 months unless complexity requires longer.¶
- Notice of appeal must be filed within 2 months of notification, and grounds within three months.¶
- At least one examiner must have a minimum of five years of experience in examining patents and supplementary protection certificates.¶
Legal basis: Article 294(2) and Article 118, first paragraph, of the Treaty on the Functioning of the European Union.¶