GA_P advises on Grifols’ €1.300m bond issue

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.

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

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 Court of Justice of the European Union (Fourth Chamber), in its judgment of 1 August 2025, case C-665/23, IL v. Veracash SAS, concludes that a payer is deprived of the right to reimbursement of the amount of an unauthorised transaction if he or she delayed in notifying his or her payment service provider of the unauthorised payment transaction, even though he or she did so within 13 months from the debit date. This interpretation of the Payment Services Directive is applicable in Spain (Art. 43 RDL 19/2018) and appears to be retained in the future Regulation on payment services.

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

In its judgment of 19 June 2025 (European Commission v Republic of Poland, C‑200/24, ECLI:EU:C:2025:459), the Court of Justice has held that the introduction by national legislation of a total prohibition on advertising for pharmacies infringes European Union law.

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