Patent waivers on COVID vaccine

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

Royal Decree 415/2026 establishes a unified framework for the assessment of health technologies in Spain, distinguishing between the technical assessment and the administrative decision regarding funding, pricing or inclusion in the service catalogue, and incorporating the requirements of Regulation (EU) 2021/2282. The aspect that raises the most legal questions in this new piece of legislation is the connection between the assessment regulated by the Royal Decree and the procedures for funding, pricing, and inclusion in the service catalogue.

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

We analyse the problems that arise when a claim is filed with the UPC for infringement of a unitary patent and, at the same time, for infringement of the validation of the basic European patent in States that are not party to the Agreement on a Unified Patent Court, and the claimant solely limits the unitary patent (because the defendant only files a counterclaim for revocation of the unitary patent with said court, but does not initiate any parallel revocation proceedings with the competent national court against the validations of the basic European patent in States that are not party to said agreement).

This paper analyses the decision of the Mannheim Local Division of 2 October 2025, where the Unified Patent Court (UPC) justifies its jurisdiction on the basis of shipment of products from a UPC territory by company listed as authorized representative in the EC and UK markets as event giving rise to damage. Furthermore, although the applicable law with regard to the infringement of the European patent validated in States that are not party to the Agreement on a Unified Patent Court is the national law of those States, with regard to the scope of patent protection, the UPC imposes on the defendant—unduly—the burden of proving the specifics of national law.

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.