Industrial property,Intellectual property,Legislation,Patents

European Parliament Adopts Proposals for Unitary SPC and SPC Reform: A New Era for the Protection of Medicinal Products

[Welcome Aboard] Blip! SPC: Uniting the SPC Community

It has been a few years since the SPC community had its own place on the internet, dedicated entirely to its guilty pleasure.

Well, rejoice SPC addicts! We have the pleasure of introducing Blip! SPC, which we hope will help satisfy that craving.

Blip! SPC is part of the Blip! intellectual property blog offered by the International Centre for Intellectual Property Studies (CEIPI) at the University of Strasbourg.

The blog is intended to be a forum open to all SPC specialists to share their thoughts on national and EU jurisprudence, legislation and, more generally, any topic related to supplementary protection certificates.

We welcome all types of contributions: long analyses, op-eds, short reports or simple translations of national decisions, as long as they relate to… SPCs (as you may have guessed).

We wish to foster fruitful discussions between us, especially in view of the major changes that the EU reform of the SPC regime will bring, as our first guest post exposes.

Great News! On February 28, 2024, the European Parliament’s plenary adopted the reports on the proposals for the creation of a Unitary Supplementary Protection Certificate (Unitary SPC for medicinal products) and the recast of SPC for medicinal products regulation.

Unitary SPCs was adopted with 518 in favour, 29 against, 70 abstentions.

The SPC recast was adopted with 526 in favour, 23 against, 70 abstentions.

Those votes mark a significant milestone.

SPCs are crucial for pharmaceutical companies to extend the protection of their patented medicinal products and to maximize their return on investment made in developing a new medicine. The new regulation aims to create a more efficient and harmonized system for granting SPCs and Unitary SPCs across the European Union. Currently, each member state has its own rules and regulations, leading to complexities and inconsistencies for companies operating in multiple countries. By establishing a uniform and transparent framework, the proposed modification will ensure a level playing field for all pharmaceutical companies. It will simplify the application process, reducing administrative burdens and costs, providing more clarity and consistency for companies, promoting innovation, ensuring fair competition, and ultimately benefit patients by facilitating access to new and improved medicines.

With the plenary vote successfully concluded, the next step in the legislative process is for the proposed legislation to undergo further scrutiny and negotiation. The European Parliament will work closely with the European Commission and the Council of the European Union (Re. “trialogue”) to refine the details of the legislation and address any remaining concerns notably regarding the pre-grant opposition provisions.

Today, we cannot be certain on what the future of European SPCs will look like. Stay tuned for further updates as the proposed legislation progresses through the next stages of the legislative process.

European Parliament Adopts Proposals for Unitary SPC and SPC Reform: A New Era for the Protection of Medicinal Products

Brigitte Carion-Taravella, Lead Biologics IP EU, Sanofi

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One thought on “European Parliament Adopts Proposals for Unitary SPC and SPC Reform: A New Era for the Protection of Medicinal Products

  1. To the list of concerns that remain, I would add at least the following.
    1. Contravention of Article 296 TFEU (absence of reasoning for proposed amendments).
    2. Contravention of the principle of legal certainty (absence of transitional provisions).
    3. Absence of a “safety net” for unitary SPCs (where Art 3 provisions are not satisfied in all unitary states).
    4. Problems with the “clarification” of unitary patent term (including a lack of antecedent basis under EU law, and inconsistency with Euratom principles).

    As they are fundamental to the successful (and lawful!) implementation of the proposed Regulations, it is a shame that these issues have not yet been addressed – despite being discussed in detail in the feedback provided by CIPA on 15 September 2023 (

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