The European regime on supplementary protection certificates could undergo a huge transformation. The EU has proposed measures such as introducing a centralized examination procedure at the European Union Intellectual Property Office (EUIPO), creating a unitary supplementary protection certificate or extending protection by a further 12 months for some medicines developed using biotech processes and for advanced therapies.
Supplementary protection certificates (SPCs) are a sui generis industrial property right under EU law that extends – by up to five years – the exclusivity conferred by a patent for pharmaceutical and plant protection products. This period may be further increased by a six‑month pediatric extension, provided for in EU legislation in certain cases.
The aim of SPCs is to offset the loss of effective patent protection in these sectors due to the time it takes to obtain the marketing authorization. These lengthy regulatory processes take up a significant portion of the patent’s effective term, limiting the ability to recoup the financial, scientific and time investments required to develop and launch new products in the market. SPCs therefore seek to restore that balance, by providing innovative industries with an additional period of exclusivity that allows them to recoup their investment and sustain R&D activity, without turning the extension into an automatic or disproportionate mechanism – an approach that both the CJEU and case law have singled out as essential to maintain the balance between protecting innovation and ensuring market access.
In the area of medicinal products, the protectable subject matter of SPCs are the active ingredients that carry out the therapeutic effect in the body, as well as their combinations, provided that:
- they are protected by a basic patent in force;
- they have a valid marketing authorization;
- the product has not already been the subject of a certificate; and
- the marketing authorization relied upon is the first one granted in the Union for that product as a medicinal product.
These requirements and, in particular, what is meant by “product protected by a basic patent or first marketing authorization” have consistently been the focus of dispute and interpretation by the Court of Justice of the European Union (CJEU), which has progressively clarified their scope in successive rulings. In fact, the CJEU will shortly have to review the Santen decision following a request for a preliminary ruling submitted in January by the German Federal Patent Court (BPatG).
The EU’s proposals:
One of the reasons why reforms and proposals have been envisaged for SPCs is because although their core legal framework is harmonized in the EU, they continue to be granted at a national level, by the respective patent offices. As a result, the reforms proposed by the lawmakers include:
- Centralized examination at the EUIPO: the revised proposals of the regulation both in relation to SPCs for medicinal products and also for plant protection products introduce a centralized examination at the EUIPO (recast proposals).
- Unitary SPC: the proposals of the new regulation on unitary supplementary protection certificates for medicinal products and for plant protection products develop the so-called unitary SPC (unitary proposals).
- 12-month extension: the European Biotech Act includes an industry incentive consisting of an additional 12-month extension for certain medicines developed using biotech processes and for advanced therapies.
- Centralized examination at the EUIPO
The recast proposals introduce a centralized examination procedure before the EUIPO, which applies to all SPC applications that are based on European patents, with or without unitary effect and in the case of medicinal products, to those linked to centralized marketing authorizations.
In the new scheme proposed, the EUIPO will carry out an examination with the participation both of this office and also of qualified examiners from national offices. It will subsequently issue an opinion, which the Member States must implement, either granting or rejecting the SPC.
- Unitary SPC
The unitary proposals create a unitary SPC, a title that is linked exclusively to European patents with unitary effect. The aim of a unitary SPC is to supplement patents with unitary effect and avoid the need – once the patent expires – to file multiple national SPC applications, which would lack unitary protection. In addition, the unitary proposals envisage a combined application mechanism that enables the applicant to designate, within a single procedure at the EUIPO, those Member States in which the basic patent does not have unitary effect, which occurs in Spain.
In any event, important aspects such as the composition of the examination panels and the linguistic regime have yet to be decided. In addition, as occurred with the proposal for a regulation on standard essential patents (SEP) and FRAND licensing – which was finally withdrawn and which we analyzed in this publication from February 2024 and in this other from February 2025 – assigning the centralized examination to the EUIPO remains a sensitive and contested matter among some stakeholders in the sector.
- The 12-month extension of the Biotech Act
The Biotech Act in turn introduces – within a broader package of measures to boost biotech – an additional 12‑month extension of SPCs for medicinal products developed through biotechnological processes, as well as for advanced therapies that meet a number of conditions. The framework provides that the European Medicines Agency (EMA) will assess compliance and issue the corresponding certificate. It also introduces a similar extension for certain innovative veterinary medicinal products aimed at diagnosing, treating or preventing zoonotic diseases – infectious diseases transmitted from animals to humans.
To grant the proposed additional extension, the marketing authorization applicant must demonstrate that the following conditions are met:
- the medicinal product contains a new active substance distinctly different from that of any authorized medicinal product in the Union;
- the medicinal product has a mechanism of action distinctly different and shows a level of safety and efficacy which is at least equivalent to that of any authorized medicinal product in the Union for the same disease;
- the clinical trials evaluating the efficacy of the medicinal product and supporting its marketing authorization were conducted in more than two Member States;
- at least a manufacturing step, excluding packaging, quality testing and certification is performed in the Union.
With this measure, the Commission aims to strengthen Europe’s industrial sovereignty and support manufacturing and clinical development in the EU by providing incentives for products developed using innovative biotech technologies that provide a therapeutic advantage for patients.
It appears likely that the additional biotech extension would be added to the main SPC, raising protection to six years (5+1). In cases in which the pediatric extension is also possible, protection could even be extended by a further six months. However, the proposal still does not clarify how these various extensions would interact with one another, nor what the maximum duration of SPC protection would ultimately be.
Conclusion
Supplementary Protection Certificates are undergoing a far‑reaching reform process, with changes aimed at modernizing and harmonizing a system that plays a key role in safeguarding innovation. In this context, it is particularly significant that biotechnology is central to European lawmakers’ agendas – a reflection of the growing importance of this sector in Europe for the future of the industry and healthcare.
Mario López Chinchilla
