Patent waivers on COVID vaccine

The Court of Appeal of the Unified Patent Court has ruled that a patent invalidity defence cannot be raised before the Unified Patent Court, with only a counterclaim being possible. This calls into question the way in which the ‘long arm’ is being applied with regard to European patents validated in States that are not party to the Agreement on a Unified Patent Court (UPCA), whether or not they are members of the European Union, since no counterclaim for revocation or plea of invalidity as a defence can be filed or raised with regard to such patents. This raises significant doubts about the compatibility of how the ‘long arm’ is applied in the Unified Patent Court system, given its own Rules of Procedure.

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

In preparation for the Alimentaria and Hostelco 2026 trade fairs, the Commercial Section of the Barcelona First Instance Court has approved a rapid response protocol to deal promptly with any potential conflicts relating to intellectual and industrial property rights (patents,trademarks, designs, and copyright), as well as trade secrets and unfair competition issues that may arise during these events.

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.

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.