Here’s a breakdown of Regulation (EU) 2025/2645:
**1. Essence of the Act:**
This regulation establishes a system for the EU to issue compulsory licenses for patented products or processes during crises or emergencies. It allows the European Commission to authorize the use of protected inventions without the patent holder’s consent, but only as a last resort when voluntary agreements are insufficient to ensure the supply of essential products. The goal is to ensure the availability of crisis-relevant products throughout the Union’s internal market during times of crisis.
**2. Structure and Main Provisions:**
* **Objective and Scope (Articles 1-2):** Defines the regulation’s aim to enable Union compulsory licensing during crises and specifies the types of intellectual property rights it covers (patents, utility models, and supplementary protection certificates).
* **Definitions (Article 3):** Clarifies key terms like “Union compulsory license,” “crisis-relevant product,” and “competent advisory body.”
* **Conditions for Granting a License (Article 4):** Sets out the conditions that must be met before the Commission can issue a Union compulsory license, including the declaration of a crisis or emergency, the necessity of using the protected invention, and the failure of alternative solutions.
* **General Requirements (Article 5):** Specifies that Union compulsory licenses must be non-exclusive, limited in scope and duration, and subject to adequate remuneration for the right holder.
* **Competent Advisory Body (Article 6):** Establishes the role of an advisory body to assist the Commission in assessing the need for a license and its content. It also describes the composition and tasks of this body.
* **Procedure for Granting a License (Article 7):** Outlines the steps involved in granting a Union compulsory license, including the publication of a notice, consultation with the advisory body, and consideration of comments from interested parties.
* **Content of the License (Article 8):** Details the information that must be included in the Union compulsory license, such as the intellectual property rights covered, the right holder, the licensee, and the remuneration to be paid.
* **Remuneration (Article 9):** Specifies that the licensee must pay adequate remuneration to the right holder, as determined by the Commission.
* **Obligations of the Licensee (Article 10):** Sets out the obligations of the licensee, including ensuring that the products are clearly identified as being manufactured under a Union compulsory license and that they are only distributed within the Union.
* **Prohibition of Export (Article 11):** Prohibits the export of products manufactured under a Union compulsory license, with an exception for Regulation (EC) No 816/2006.
* **Customs Control (Article 12):** Requires customs authorities to monitor and prevent the export of products manufactured under a Union compulsory license.
* **Conduct of the Right Holder and the Licensee (Article 13):** Requires the right holder and the licensee to refrain from actions that could undermine the Union compulsory licensing process.
* **Review and Termination of the License (Article 14):** Allows the Commission to review and modify or terminate a Union compulsory license if the circumstances that led to its granting cease to exist.
* **Fines and Periodic Penalty Payments (Articles 15-21):** Authorizes the Commission to impose fines and periodic penalty payments on licensees for non-compliance with their obligations.
* **Reporting on National Compulsory Licenses (Article 22):** Requires Member States to inform the Commission of any national compulsory licenses granted for crises or emergencies.
* **Committee Procedure (Article 23):** Establishes a committee to assist the Commission in implementing the regulation.
* **Amendments to Regulation (EC) No 816/2006 (Article 24):** Amends Regulation (EC) No 816/2006 to allow for the granting of Union compulsory licenses for the export of pharmaceutical products to countries with public health problems.
* **Evaluation (Article 25):** Requires the Commission to evaluate the application of the regulation and submit a report to the European Parliament, the Council, and the European Economic and Social Committee.
* **Entry into Force (Article 26):** Specifies that the regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union.
**Changes Compared to Previous Versions:**
This is a new regulation, so there are no previous versions to compare it to. It establishes a completely new framework for Union compulsory licensing.
**3. Main Provisions Important for Use:**
* **Article 4 (General conditions for granting a Union compulsory licence):** This article is crucial because it outlines the specific conditions that must be met before a Union compulsory license can be granted. Understanding these conditions is essential for determining whether the regulation can be invoked in a particular situation.
* **Article 7 (Procedure for granting a Union compulsory licence):** This article details the step-by-step process for obtaining a Union compulsory license. It is important for right holders, potential licensees, and other interested parties to understand this procedure in order to participate effectively in the process.
* **Article 8 (Content of the Union compulsory licence):** This article specifies the information that must be included in the Union compulsory license. This information is important for ensuring that the license is clear and enforceable.
* **Article 10 (Obligations of the licensee):** This article outlines the obligations of the licensee, which are essential for ensuring that the Union compulsory license is used in a responsible and effective manner.
* **Article 11 (Prohibition of export):** This article prohibits the export of products manufactured or marketed under a Union compulsory license. This provision is important for ensuring that the Union compulsory license is used to address crises or emergencies within the Union, rather than to facilitate exports to other countries.
* **ANNEX:** . The annex lists the Union crisis or emergency mechanisms that can trigger the use of this regulation. It also identifies the relevant advisory body for each mechanism. This annex is essential for determining whether the regulation is applicable in a particular situation.
