On March 16, 2023 the Court of Justice of the European Union (CJEU) rendered an important judgment for the pharmaceutical industry as it brings some clarification on the test to assess if two products have the ‘same active substance’ and therefore belong to the same Global Marketing Authorisation (GMA). This is a crucial determination as products falling within the GMA of an existing product do not benefit from an independent period of regulatory data protection (RDP) and marketing protection.
The question at stake was whether the test applied by the Commission to determine whether or not a previously authorised combination product with active ingredients A and B (Product 1) and a mono-substance product with active ingredient A (Product 2) belong to the same GMA within the meaning of Article 6(1) second subparagraph of Directive 2001/83/EC (the Medicinal Code), which provides that “when a medicinal product has been granted an initial marketing authorisation, any additional strengths, pharmaceutical forms, administration routes, presentations as well as any variations and extensions must also be granted an authorisation or be included in the initial marketing authorisation. All these marketing authorisations are considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10 of the Medicinal Code [which lays down rules on RDP and market protection]”.
In the present case, a generic manufacturer had submitted a request to the European Medicines Agency (EMA) seeking confirmation that it was eligible to submit a marketing authorisation application for a generic medicinal product of Product 2, the reference medicinal product. The EMA responded that it was unable to validate the application, as Product 2 benefited from its own period of RDP, which had not yet expired. Therefore, the generic manufacturer could not rely on the data submitted in support of the application of a marketing authorisation for Product 2. The position of the EMA was based on the conclusion of the Committee For Medicinal Products for Human Use (CHMP) that the therapeutic moiety of the active substances of Product 1 and Product 2 was different and therefore the two products did not belong to the same GMA.
The generic manufacturer disagreed with the test used by the Commission and claimed that the relevant test is whether the combination of substance A and B brings a therapeutic contribution versus substance A alone. The General Court agreed with the generic manufacturer but the CJEU, on appeal, reversed the General Court’s ruling holding that the CHMP’s assessment was “sufficient for the purpose of determining whether the medicinal products in question belong to ‘the same GMA’”.
Another important aspect of this case was the question of admissibility of the application for annulment by the generic manufacturer of the Commission Decision granting a marketing authorisation for Product 2 years after it had been issued.
The CJEU confirmed the General Court’s ruling that there is nothing preventing the generic manufacturer from bringing an action for annulment under Article 263 TFEU raising a plea of illegality in respect of an act of general application on the grounds that, the generic manufacturer did not have a current and vested interest in bringing proceedings against that decision at the time, namely during the prescribed period for bringing an action for annulment against the grant of the marketing authorisation for Product 2.
The fact that a competitor could challenge a decision granting a marketing authorisation years after its grant when a vested interest in challenging the legal status of a granted marketing authorisation materialised raises some concerns. Indeed, this may deter investors for whom the existence and duration of IP regulatory rights such as RDP is a key element in the decision-making process of investing in or acquiring a medicinal product whose status as a distinct product is borderline. At the very least, we would expect investors to conduct further due diligence on whether the product belongs to a GMA rather than relying on the fact that the period of bringing an action in annulment has expired.
 Joined cases C‑438/21, C‑439/21 and C‑440/21
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