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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.

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

In a decision dated 18 July 2025, the Mannheim Division of the Court of First Instance of the Unified Patent Court took jurisdiction to hear a claim filed against three companies domiciled in Germany for infringement of a classic European patent with effect in Germany and the United Kingdom. The court's jurisdiction to hear the infringement of the UK national part of European patents is not affected by the fact that the validity of the patent is disputed by the defendants. However, this conclusion does not apply to Spanish national parts of European patents.