EU Biotech Act: The Coming EU IP Shake-Up?

It is increasingly difficult to discuss Intellectual Property (IP) without immediately bumping into questions of Artificial Intelligence (AI). The EU has been busy legislating in this field in recent years. Yet, while AI dominates headlines, the COVID-19 pandemic — now seemingly behind us — renewed Europe’s awareness of something older, but equally strategic: biotechnology. This is why the EU Biotech Act should be at the centre of the policy discussion, especially now that the call for evidence and the public consultation is closed (10 Nov) and industry groups such as EFPIA (the European Federation of Pharmaceutical Industries and Associations) are calling for a major overhaul of the IP framework in the sector, including with respect to pharmaceutical patent enforceability.

General overview

Biotechnology is a key driver of Europe’s competitiveness, particularly in the health sector and has been long identified as of paramount importance for EU strategic autonomy. Yet Europe still lags behind global peers such as the US and China, held back by fragmented technology-transfer mechanisms, complex regulation, financing gaps at the scale-up stage, and a still-fragmented system of IP protection.

Against this backdrop, Ursula von der Leyen in her Political Guidelines presented to the European Parliament announced in July 2024 a new European biotech act (EU Biotech Act), being also one of the flagship action in the European Life Science Strategy. Although still closely intertwined with the AI agenda, the initiative finally brings biotech back to the centre of the policy conversation. Its goal is to streamline the “lab-to-fab-to-market” pathway, reduce fragmentation, and operationalise enabling tools such as regulatory sandboxes, an EU Biotech Hub, AI Factories, and improved data infrastructures.

From the IP perspective, the EU Communication stresses the importance of a stable, predictable and balanced framework for protecting and valorising biotech innovation, while ensuring access. The UP system and the ongoing reform of Supplementary Protection Certificates (SPCs) are positioned as cornerstone tools to support breakthrough biotech innovation, enabling innovators to reap the full benefits of their efforts within the EU.

EU Biotech ACT: public consultation

The proposal was, after an earlier call for evidence, open for public consultation, until November 2025, with adoption expected in 2026, and interim preparatory work to be carried out by the Commission.
Diving into the EFPIA (the European Federation of Pharmaceutical Industries and Associations) press release on its position, the group is urging the Commission to anchor the EU Biotech Act in a predictable, innovation-friendly regulatory and IP environment.

In their comments EFPIA was brief calling:

·         To reinforce internationally competitive IP protection rules.

·         Simplify, speed up and harmonise the EU framework for clinical trials.

·         Establish a center of excellence for manufacturing innovation.

·         Modernise the EU regulatory ecosystem.

·         Boost digitalisation for biotech development

·         Unlock broader use of private investments.

·         Boost digitalisation for biotech development.

Following this position, on 12 November, EFPIA published a new and highly relevant document titled “EFPIA resources to inform and support the development of the EU Biotech Act”. For anyone working in pharmaceutical patent litigation, this document (together with the comments from EFPIA”) is particularly exciting considering it is deeply IP-centric.

EFPIA makes it clear that, although the current European IP framework is functional, it still contains significant gaps that prevent the EU from being regarded as a best-in-class jurisdiction when compared with global peers. Moreover, the ongoing policy reforms — including the revision of the General Pharmaceutical Legislation (see, for example here or here) and the Patent Package (see, for example, on SPCs here) — do not substantially improve Europe’s competitiveness. In some areas, they may even introduce new uncertainties or weaken existing incentives.

The EU Biotech Act, however, is presented by EFPIA as representing a unique opportunity to reverse this trend. It could allow Europe to build an IP system that is genuinely fit-for-purpose: predictable, innovation-enabling, and capable of supporting a more competitive future for Europe. In EFPIA’s view, this is essential to ensure that scientific and technological advances translate into timely benefits for European patients.

So, what concrete measures does EFPIA propose?

EU Biotech ACT: EFPIA concrete reforms

FPIA calls for coordinated, urgent action across several domains, particularly regarding RDP and the broader IP framework. Below is a concise summary of the main points, each of which would warrant separate, in‑depth discussion:

·         Regulatory Data Protection (RDP)

Strengthen the RDP baseline (and orphan market exclusivity for orphan medicinal products) and reduce the uncertainty created by conditionalities in the General Pharmaceutical Legislation.

·         Supplementary Patent protection duration cap adjustment

EFPIA proposes to remove the 5-year cap on SPC duration, while keeping the existing 15-year cap after first EU marketing authorisation (MA).

·         Paediatric rewards

Allow up to two SPC extensions per product where two distinct Paediatric Investigation Plan (PIPs) in two different conditions/indications are completed and grant 12 months of extension per Mechanism of Action-based PIP, up to 24 months of maximum total extension available if two of this PIPs completed.

·         Patent Enforcement: Predictable and Transparent Market Entry

EFPIA advocates for a modernised “clear, confirm & control” system, which represents a novel approach in the EU context.

In short, the “clear, confirm & control” model requires the innovator to publicly list relevant patents and allows generics/biosimilars to either commit to launch after the last patent expires (Path A) or initiate early litigation to clarify validity/infringement (Path B). The first Path B entrant gains a three-month head start, and the marketing authorization becomes operational only upon completion set out in either paths, aligning regulatory and IP enforcement timelines.

·         Modernise the protection of Commercially Confidential Information (CCI) and data-driven innovation

In this regard, EFPIA propose to:

                    i.            Expanding database rights to cover structured, high-effort datasets and recognizing proprietary datasets and annotations as trade secrets (related discussion is possible to read here or here).

                  ii.            Modernizing copyright laws to incentivize the digital and data economy.

                 iii.            Embedding clear opt-outs and safeguards in laws like the Clinical Trial Regulation, the EHDS and Data Act to preserve and strengthen the protection of trade secrets, CCI and intellectual property rights.

                iv.            Supporting progress on substantive patent law harmonization efforts and the introduction of a grace period or non-prejudicial disclosure provision type in the European patent system to mitigate the concerns with mandated transparency obligations in the context of the EU Clinical Trials Regulation (EU) no. 536/2014.

Conclusion:

Europe stands on the threshold of a decisive shift in how it governs biotechnology and the intellectual property that sustains it. The EU Biotech Act has the potential to move beyond incremental adjustments and deliver a coherent, forward-looking framework capable of restoring Europe’s competitiveness in a sector driven by long development cycles, high scientific complexity, and substantial investment risk.

EFPIA’s proposals underscore the extent of this challenge. Strengthened RDP, recalibrated SPCs, robust protection of CCI and high-effort datasets, a functional grace period, substantive patent-law harmonisation, and a “clear, confirm & control” system for market entry are not cosmetic reforms. They could represent the foundations of a shift in the IP ecosystem.

Whether the EU Biotech Act becomes the catalyst for this transformation will depend on the political choices made over the upcoming years. If the EU seizes the moment, the Biotech Act could mark the most significant restructuring of Europe’s biopharmaceutical and IP landscape after the UPC system — with innovation, investment and patient access all standing to benefit.