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During the transitional period of the Agreement on a Unified Patent Court, national courts retain jurisdiction to hear cases concerning classic European patents, without the need for the proprietor to have exercised the opt-out option, i.e. without the need to have excluded the jurisdiction of the Unified Patent Court over such patents. However, the Venice Court ruling discussed here considers that national courts may only be used if the opt-out has been exercised, contradicting the provisions of Article 83 of the Agreement.

Royal Legislative Decree 1/2015, of 24 July, approving the recast version of the Medicinal Products and Medical Devices (Guarantees and Rational Use) Act, prohibits healthcare professionals with prescribing powers from having a direct pecuniary interest in activities related to medicines. This prohibition does not extend to indirect interests, as distinguished in Article 4 of said legislative decree. Judgment no. 483/2025 of the High Court of Justice of the Basque Country concludes that mere membership of a group of companies does not entail incompatibility if each entity retains real autonomy.

The Bolar clause allows studies and trials necessary to obtain marketing authorisations for medicinal products to be carried out without infringing patents. Its scope has grown during the passage of the pharmaceutical legislative package, incorporating more actors and more activities, to include participation in public tenders before the patent expires. This extension raises questions about compatibility with the TRIPS Agreement, which only allows limited exceptions to patent rights. Participation in tenders could be considered an offer to sell, thus violating the limits set by that agreement.

The newsletter covers the main developments in Pharma & Healthcare legislation and case law.

Royal Decree 997/2025, of 5 November, approving urgent measures to strengthen the electricity system, aims to "establish urgent measures that contribute to a more resilient and decarbonised electricity system" and amends several statutory instruments that govern the electricity system. This paper details the main areas of change.

“Royal Decree 997/2025, of 5 November, approving urgent measures to strengthen the electricity system, has been published in the Official Journal of Spain on 6 November 2025. It will broadly come into force on the date of its publication”.

Regulation (EU) 2025/2083 simplifies the carbon border adjustment mechanism in order to reduce burdens as of 1 January 2026. This paper explains the obligations imposed by this mechanism on the importers it applies to and the simplification measures introduced, including the de minimis exemption based on mass for small importers, excluding electricity and hydrogen.

The application of the rule of precedence requires, firstly, that a given product falls within the legal definition of a medicinal product, whether it is a medicinal product by function or by presentation, and secondly, that there are doubts as to whether it also falls within the legal concept of other types of products (food supplements, cosmetics, etc.).

The Agreement on the interpretation and application of the Energy Charter Treaty gives the force and effect of law to the case law of the Court of Justice of the European Union, according to which Article 26 of the Energy Charter Treaty does not and could not apply as a legal basis for intra-EU arbitration proceedings as a mechanism for the settlement of disputes between a contracting State and an investor of another contracting State.