Proposed regulations for a unitary SPC for medicinal products under the microscope

In addition to the Pharmaceutical Strategy for Europe, the European Commission adopted a new Action Plan for Intellectual Property in November 2020, which is intended to support companies in protecting their intellectual property (IP) and envisaged to contribute to the promotion of the use of IP rights by SMEs and better enforcement of IP rights through further measures.

Additional information on the European Commission’s proposal and the European pharmaceutical strategy can be found in Maiwald blog articles posted on March 8 2023 and January 4 2021, respectively.

A previous Managing IP article by Maiwald dealt with the proposed amendments to data protection and market protection in the proposals for new pharmaceutical legislation. This article explains the planned changes regarding supplementary protection certificates (SPCs) for medicinal products.

The duration of the mandatory approval procedures for medicinal products prior to market launch is generally very long, which means that sales of a new active ingredient can only begin several years after the patent application has been filed. Accordingly, a large part of the patent protection period has therefore already expired before a drug is approved for sale.

To ensure that the high R&D costs can be amortised and that the search for new active ingredients is worthwhile, the European legislator has provided concepts in the form of data protection and market protection, and the option of applying for an SPC. These are located in different areas of competence. The so-called data protection and market protection is subject to the Pharmaceutical Strategy for Europe, the amendments to SPCs to the Action Plan for Intellectual Property.

While data protection – the period during which an applicant cannot rely on data in support of another marketing authorisation for the purpose of submitting an application, obtaining marketing authorisation, or placing the product on the market – and market protection – the period during which generics, hybrids, or biosimilars cannot be placed on the market, even if the medicinal product has already received a marketing authorisation – delay access to the market, SPCs effectively extend patent protection by up to five years, and by a further six months if approved as a medicinal product in all EU states.

On April 27 2023, the European Commission presented two proposals for regulations on SPCs for medicinal products (COM(2023) 222 final and COM(2023) 231 final). The aim is to promote investment in new active substances that require long development times for approval and to create a transparent, efficient, and pro-competition SPC system (Commission Staff Working Document, Impact Assessment Report, SWD(2023) 118 final, 3, 4).

The rules concerning SPCs are set forth in Regulation (EC) No. 469/2009. According to Article 5 of the regulation, they grant the same protection as the patent on which the SPC is based. However, according to Article 4 of the regulation, the protection is not for individual patent claims but for a product in the form of a medicinal product authorised in the EU (a patented active ingredient or a combination of active ingredients), for up to five additional years after the expiry of patent protection (with a further six-month extension for paediatric medicinal products, according to Article 36 of Regulation (EC) No. 1901/2006).

SPCs are currently only intended for pharmaceutical patents and therefore only grant protection for a specific purpose within the scope of the marketing authorisation under pharmaceutical law.

The term of the certificate is determined by the period between the patent application and the authorisation of the medicinal product minus a period of five years, limited to a maximum of five years (see Article 13(1) and (2), Regulation (EC) No. 469/2009).

SPCs, even if they are based on a European (unitary) patent, are always granted by the national patent offices; i.e., in Germany by the German Patent and Trademark Office (see Section 49a of the German Patent Act). So far, there is no unitary SPC, only national SPCs, even for unitary patents. However, according to Article 32 of the Agreement on a Unified Patent Court, the Unified Patent Court, which was created with effect from June 1 2023, is responsible for disputes concerning an SPC on the basis of a European (unitary) patent (unless an opt-out has been declared).

To simplify the system for granting protection certificates, the European Commission has proposed the creation of a unitary SPC (COM(2023) 222 final) and the introduction of a centralised application obligation for SPCs for European (unitary) patents (Article 20 ff., COM(2023) 231 final). National applications for SPCs would then only be possible for national patents. A single examination office is to be created for unitary SPCs, which, in turn, can involve national authorities in the examination procedure. According to the proposal, the EUIPO would assume this function.

Just as with the existing protection certificates, the unitary SPC should grant the same protection as the underlying patent (see Article 5(1) of the proposed Unitary SPC Regulation). As with the existing regulation for national protection certificates, the term of the unitary protection certificate is to be up to five years, thus enabling patent protection to be extended to 25 years. The calculation is to be carried out in accordance with Article 10(1) and (2) of the proposed Unitary SPC Regulation. The duration of national SPCs is also not supposed to be changed and the existing six-month extension rule for paediatric medicinal products mentioned above is to continue to apply to the unitary SPC (see Article 20(3), COM(2023) 222 final).

A further advantage of this granting concept would be the possibility of a combined application, in accordance with Article 39 of the draft Unitary SPC Regulation. According to this, it should be possible to obtain a unitary SPC for all EU member states in which the basic patent has unitary effect and national protection certificates for the other member states in a single examination procedure.

While the European Parliament made extensive changes to the European Commission’s proposals for the revision of pharmaceutical legislation, it adopted the proposal to create a unitary SPC and the revision of the existing regulation on SPCs with only a few, mostly formal, changes.

According to Article 6 of Regulation (EC) No. 469/2009, it is possible, under certain circumstances, for a patent holder to apply for a protection certificate even if they are not the holder of the marketing authorisation, even against the will of the marketing authorisation holder. The current ambiguities are to be erased by the insertion of Article 6(2) of the two proposed regulations (COM(2023) 222 final and COM(2023) 231 final), which provides for the necessity of consent of the marketing authorisation holder to the granting of the protection certificate.

It remains to be seen whether the regulations approved by the European Parliament on February 28 2024 will be retained in the further ordinary legislative procedure. On November 13 2024, the committee referral was announced in parliament and the Committee on Legal Affairs appointed on November 18. Now that the composition of the new European Commission has been finalised, it is very likely that the matter will regain momentum. The next step will be awaiting the Council of the European Union’s first reading position.