The European Biotech Act seeks to boost European biotech competitiveness through strategic financial backing and targeted regulatory and IP reforms. In this blog, we assess the proposed changes to Supplementary Protection Certificates: a 12-month extension for some novel biotech medicines.

Context

Although the European Union ("EU") is a scientific powerhouse rivalling the US and China in the field of clinical and biomedical research, it lags behind other global regions when translating that world-class scientific base into product pipelines. Several reasons are to blame: scarce venture capital; a complex, slow and fragmented regulatory regime for clinical trials and drug approval; shortcomings in data policy and lack of long-term strategic vision beyond local biotech clusters are often seen as the key factors. And yet, the biotech industry is one of the drivers of the European high-added value economy.

On 16 December 2025, the European Commission published its Proposal for a Regulation to establish measures to strengthen the Union's biotechnology and biomanufacturing sectors ("European Biotech Act"), which is part of the EU authorities' broader drive towards increasing the block's competitiveness in the field of pharma and biotech, alongside the EU Pharma Package (the first complete overhaul of EU pharmaceutical regulations in two decades).

The sprawling European Biotech Act establishes a wide number of changes, ranging from high specific amendments to existing rules (e.g. targeted simplification and shortening of approval for clinical trials) to the creation of a new EU Health Biotechnology Support Network, as well as a EUR 10 billion investment pilot project steered by the EU Commission and the European Investment Bank.

In this blog, we will examine a highly specific proposed amendment in the field of IP: the extension of Supplementary Protection Certificates ("SPCs") for "best-in-class" biotechnology medicines developed in the EU (Art. 27 European Biotech Act). 

The existing rules on SPCs

SPCs are sui generis IP rights which extend patent rights in respect of human and veterinary medicinal products by up to five years, thus compensating innovators –at least partially– for the lengthy period that usually elapses between the filing of a patent application and the grant of a marketing authorization in the EU. These rules attempt to afford innovators in the pharmaceutical industry around 15 years of patent protection. Back in 1993 when SPCs were introduced in the EU, this was seen as sufficient to recover the oversized investments required by pharmaceutical R&D.

Currently, the benefits of SPCs are available on an equal footing for all human and veterinary drugs, provided that they comply with the requisites laid down in Article 3 of Regulation (EC) No 469/2009 ("SPC Regulation"), as well in the equivalent regulation for veterinary products. In short, the product must be protected by a basic patent in force; it must not have been the subject of a previous SPC; it must be authorized in the EU and, moreover, said authorization must be the first to place the product on the market in the EU as a medicinal product.

The new extension for "best-in-class" biotechnology medicines envisaged by the European Biotech Act

Now, the European Biotech Act –if approved– will allow holders of SPCs to enjoy an additional 12-month extension of their term of protection (thus raising the total patent term extension to up to 6 years), provided that the following conditions are met:

1. The medicinal product contains a "new active substance distinctly different from that of an authorised medicinal product" in the EU.
2. 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 product in the EU "for the same disease".
3. The clinical trials showing the efficacy of the medicinal product and supporting its marketing authorisation were conducted in more than two Member States.
4. At least one manufacturing step, excluding packaging, quality testing and certification, is performed in the EU.

Although the innovative pharmaceutical industry has welcomed the proposed SPC extension, some voices in the industry have found it unambitious, since it does not apply to all complex biological drugs, but only to a restrictive sub-group of distinct active substances with distinct mechanisms of action. In addition, some have labelled the new regime, which favours EU-manufactured products over foreign ones, as protectionist.

Policy considerations aside, the complexity of the extension's requirements is eye-catching. The grant conditions for regular SPCs, despite being apparently simple, have become one of the most complex and contentious topics in European IP law –patent cliff strategies for blockbuster products often live and die on issues of SPC law–. Now, terms such as "new active substance [that is] distinctly different", "distinct mechanism of action" and "same disease" etc. are likely to become embroiled in litigation.

In this regard, Article 27(2) of the proposal tasks the European Medicines Agency ("EMA") with assessing compliance with the extension requirements, issuing a statement to that effect. Such statement shall be included in the SPC applications filed before the national patent offices of the Member States. Hence, the procedural routes for biosimilar competitors to challenge an extension are not clearly established under the current proposal. In particular, it is as yet unclear whether the EMA's statement or lack thereof may preclude a subsequent challenge in SPC invalidity proceedings before the national courts and/or the Unified Patent Court, assuming that the General Court of Justice (and, ultimately, the Court of Justice of the European Union) have not ruled on appeal on the findings of the EMA. Thus, the legal architecture of the SPC extension may necessitate further fine-tuning during the upcoming legislative period.

Overall, it remains to be seen whether the suggested SPC extension will be a meaningful incentive for the European biotech industry. We will be watching with interest to see how the draft of the European Biotech Act (as published by the EU Commission on 16 December 2025) evolves as it progresses through thethe legislative process. Our Healthcare & Life Science and our Intellectual Property teams are uniquely positioned to support your needs in relation to the current and future rules. For more on the European Biotech Act, see this blog post by leading partner Gunnar Sachs.