EU Biotech Act: The Coming EU IP Shake-Up? Part II: The "clear, confirm & control" system proposed by EFPIA - 3 questions for 3 Cs

The EU Biotech Act is a legislative initiative aimed at simplifying biotech regulation, boosting innovation and investment, and strengthening Europe’s competitiveness and biotech ecosystem, which we covered in general terms in this blog. This legislative initiative has triggered widespread discussion across the sector, with companies expressing concern and showing eagerness to engage so they can help shape what the framework ultimately becomes.

The call for evidence, which was open until June 2025, received feedback from 225 companies, individuals, government bodies or other organisations and, as discussed in our previous post, EFPIA was among them. The public consultation phase that followed (recently closed in November 2025), was even more participative, with 464 valid submissions provided – and again, EFPIA used this opportunity to give its views.

One point that is worth concretely addressing – albeit briefly – is EFPIA’s proposal to enhance IP enforceability through what it has coined the “clear, confirm & control” system. Beyond the catchy name (which we suggest could fondly become known among practitioners as the “triple C system”), the proposal brings to the European stage a well-known discussion on the interplay between patent enforcement and regulatory approvals, and the different systems that have been designed to effectively govern these two closely intertwined realities – including mechanisms such as pre-authorisation patent status reviews or Orange Book-style listings that condition or coordinate regulatory decisions with the underlying patent landscape.

We should read EFPIA’s proposal together with its underlying rationale. In their words, “without the ability to readily and efficiently enforce granted IP rights, the value of the rights themselves is significantly undermined”; but “generics/biosimilars [should be] able to launch on “day one,” which is the first day after all of the patents to the innovative product are expired, have been finally invalidated, or the inventions contained in those patents are not infringed or included by the generic/biosimilar product”. So while Europe “must strive for predictable, strong and enforceable IP”, it must also ensure “maximum transparency and certainty to innovators, generics/biosimilars, payers and patients by setting a concrete “day one” for follow-on launch whilst taking account of the dynamics of the current generic market in terms of the so called “first mover advantage”. In the authors’ opinion, this appears to be a fair approach to the issue, for it balances the major concerns of both sides: on the one hand, the need for an effective judicial patent enforcement system, and on the other the guarantee that those rights will not be enforced beyond their scope and validity period. The question that immediately follows is how can this be achieved.

EFPIA’s triple C system proposal – the “clear, confirm & control” system – seems to be highly inspired by the so-called “Orange Book” system. In fact, the proposed triple C system would work as follows:

1. The innovator company will publicly list relevant patents covering the reference product.

2. Generic/biosimilar applicants choose between two pathways at MA application stage:

   • Path A: Commit to launch only after expiry of the last listed patent.

   • Path B: Choose not to wait until the expiry date of the last to expire of the listed patents and initiate the called “clear and confirm” pathway by initiating patent litigation to resolve validity/infringement early.

3. Within Path B, a three-month head start is awarded to the first entrant by an MA becoming operationally active before any generic/biosimilar products with MAs with the same innovator reference product.

4. Conditional operational status of MAs to align regulatory and IP enforcement timelines, guaranteeing that the medicines agency can proceed with its analysis, but the MA only becoming operational on completion of the steps set out in either path.

We appreciate that this suggestion from EFPIA is essentially a proposal to (re)launch the discussion on whether coordination between patents and regulatory marketing approvals should be imposed, rather than a concrete and finalised proposal.  However, for the benefit of a debate the authors would like to leave 3 questions that could ground the operationalization of such a regime, if it is ever regulated.

How much can be cleared?

The entire regime will hinge on the patents that patentees decide to publicly list in the [EU-colours] book. It is therefore essential to determine the legal nature of this listing obligation: is it a contractual duty (and towards whom)? Is it a burden, a statutory charge, or something else entirely? Clarifying the legal character of this responsibility is crucial for assessing the economic incentives and disincentives arising from the decision to include – or not include – a given patent in the book.

Drawing a parallel with the UPC system and the opt-out mechanism helps illustrate the point: the very first step of the system must be tightly regulated, transparent, and predictable. Without legal certainty regarding what must be listed and the consequences of an incorrect or incomplete listing, the entire downstream process becomes unstable.

This question also arises for patents (typically secondary ones) granted after the approval of the reference medicinal product. Leaving aside, for now, the transitional phase and regime and how it would be put in place (applicable to products already on the market or in late-stage regulatory review), the practical difficulties associated with “post-grant” patents are easy to anticipate. In a regime whose central aim is to deliver an effective, coordinated, and legally secure timeline for all players — setting a clear “day one” for follow-on entry while accounting for the dynamics of the current generic market, including the so-called “first-mover advantage” — the handling of later-granted patents becomes a critical design element.

A key issue will be whether such patents must be added to the list automatically, within a defined time window, or only when they are intended to be enforced. Each option carries different implications: for innovators, in terms of strategic behaviour; and for generics and biosimilars, in terms of the predictability and stability of their launch planning. A transparent and enforceable mechanism for updating the list is therefore indispensable to ensuring that the “clear” component of the regime functions in practice, and not merely on paper.

Who confirms and how?

The second fundamental question in an EU market – particularly one emerging in the wake of the UPC system – concerns the level of “integration” or “globality” that this regime should have.

First, identifying the appropriate supervising body becomes especially relevant. The institutional design will largely determine the operational clarity and legitimacy of the entire regime.

Equally important, if not more, is the definition of the responsibilities and powers entrusted to such a body. Will it merely perform a recording function, collecting the information provided by patentees without exercising substantive oversight? Or should it be given verification duties, collaborating actively with system users to ensure the highest level of accuracy, transparency and efficiency?

A further question is whether this body should be empowered to impose sanctions for non-compliance - for example, failing to list a patent, listing it late, or providing incomplete or misleading information. The answer directly affects the incentives and behaviours of stakeholders: a system without meaningful enforcement mechanisms risks becoming purely declaratory, while an overly stringent approach could create disproportionate administrative burdens.

Ultimately, the effectiveness of the “confirm” pillar depends on finding a credible and operationally coherent balance: an authority with enough powers to guarantee predictability and trust, but without compromising procedural efficiency or adding unnecessary regulatory layers.

What exactly is being controlled?

The framework underpinning the “Control” component of this regime is pivotal in determining whether its objectives – notably the establishment of a predictable, effective timeline for follow-on entry – can actually be achieved. Beyond procedural questions such as the availability of appeals (number of instances), the effect of an appeal on the enforceability of a marketing authorisation, and other similar rules, the proposal raises a deeper substantive question about which acts of potential infringement are to be regulated, distinguished, and ultimately controlled under the regime.

A regime built around the impact on a marketing authorisation and driven by the objective of securing a concrete “day one” for follow-on launch” cannot limit itself to such notion of infringement (launch/sale). It must also clarify how it treats pre-launch activities, threats of infringement, and preemptive remedies – including the conditions under which these are recognised and adjudicated, especially given that the relevant routes to market can be very different from country to country within the EU.

Initial conclusions:

Practically, EFPIA’s “triple C” proposal seeks to align the enforcement of intellectual property rights with marketing authorisation timelines and conditions in a predictable, transparent manner, establishing a clear “day one” for generic/biosimilar entry. Its success could hinge on three pillars: (i) a robust, transparent, and updatable listing regime to ensure the “clear” (including a system to address post‑MA‑application patents); (ii) an authority with appropriate verification powers and proportionate sanctions to deliver the “confirm,” without adding unnecessary bureaucratic layers; and (iii) clear substantive and procedural rules on what is “controlled” (not only launch/sale, but also pre‑launch activities that may constitute a threat of infringement), tying the operational status of marketing authorisations to the timeline of patent litigation. While much would still need to be debated to ensure fair competition and legal certainty for all parties involved, EFPIA’s “triple C” proposal will certainly form part of broader discussions on potential approaches to improving the enforcement of pharmaceutical patents in Europe.