Patent waivers on COVID vaccine

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

The Court (Grand Chamber) defines the scope of derogations from the principle of supervision in the home Member State for information society services on grounds of public policy, security and safety, clarifying the distinction between general prohibitions and individualized measures directed at specific providers. It also provides important criteria regarding the liability of digital platforms, holding that control exercised by means of algorithms may preclude the application of the exemption from liability provided for data hosting services.

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.