Patent waivers on COVID vaccine

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.

In Judgment 1505/2025, the Supreme Court analyses the use of the term 'Donut' by a competitor that markets ring-shaped pastry under another trade mark. Although previous instances considered the use to be merely descriptive, the Supreme Court rejects this on the grounds that it is a reputed trade mark, which triggers enhanced protection. This protection requires avoiding any unfair use of the prestige or distinctive character of the trade mark. The court concludes that the use made was not fair and may involve parasitism and dilution.

The protocol, agreed jointly by the Courts of Barcelona and Alicante, provides for priority handling of applications for pre-trial examination and fact-finding orders, as well as applications for interim measures —with or without a hearing— in matters relating to patents and technological innovations, industrial designs, trademarks and copyright, as well as antitrust, unfair competition and unlawful advertising, when linked to products or presentation, display, promotion, offering or sale activities connected to MWC 2026.

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

An interesting ruling has recently been handed down in relation to a case in which a domain name holder turned to the courts after losing in the ICANN (Internet Corporation for Assigned Names and Numbers) procedure, specifically Supreme Court (Civil Division) Judgment no. 1341/2025 of 30 September (ECLI:ES:TS:2025:4206).

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

The Decision of the Hamburg Local Division of the Court of First Instance of the Unified Patent Court dated 14 August 2025 grants interim relief because it claims jurisdiction to hear the substance of the matter (both the infringement of the unitary patent in the States party to the UPC Agreement and the Spanish validation of the European patent on which the unitary patent is based). To this end, the court offers a series of observations on its international jurisdiction, not all of which are accurate.

There is no doubt that the registered name of a plant variety may be used by anyone who markets plant material of that variety. However, in this specific case, the Supreme Court's statement that “the term ‘Persimmon’ was used by the defendant to identify a specific variety of caqui” is noteworthy.