Hungarian supreme court on legal standing to challenge generic marketing authorisations

The case concerned a dispute between the marketing authorisation holder of an originator medicinal product and a generic manufacturer seeking approval for a generic version of the same active substance. The originator also held a patent relating to a specific use of the active substance. Following expiry of the eight-year data exclusivity period, the generic applicant relied on the originator product as the reference medicinal product and sought approval on a so-called "carve-out" basis, excluding the patent-protected dosage form from the scope of the application.

On 3 October 2024, the National Centre for Public Health and Pharmacy (NNGYK) granted the application with the relevant carve-out.

First, it argued that approval of the generic product directly affected its rights and legitimate interests, as the two products would compete in the same market. Secondly, it argued that, as the holder of the reference medicinal product's marketing authorisation, it had a legally protected interest in preserving the integrity of the reference medicinal product's Summary of Product Characteristics (SmPC). Thirdly, relying on Olainfarm (C-104/13), it argued that EU law entitled it to effective judicial protection to ensure compliance with the requirements governing generic marketing authorisations. The claimant also requested a preliminary reference to the CJEU. The generic manufacturer and the authority argued that the originator lacked standing and that its substantive objections were unfounded.

The Budapest-Capital Regional Court (Fővárosi Törvényszék) dismissed the claim. The claimant subsequently sought judicial review before the Hungarian Supreme Court.

The Hungarian Supreme Court held that originators may challenge generic marketing authorisations only where they can demonstrate a direct legal interest. Examining each of the claimant's arguments separately, the Court found that none was capable of establishing such an interest. Economic concerns arising from generic competition were insufficient to establish standing, as they were not linked to any specific legally protected right affected by the challenged decision. The Court further found that neither Hungarian nor EU pharmaceutical legislation confers a general right to the integrity of the reference medicinal product's SmPC, and that the claimant had failed to show how the carve-out affected any legally protected interest.

As regards Olainfarm, the Court clarified that the judgment does not establish a general right for reference medicinal product holders to challenge generic marketing authorisations. Rather, judicial protection is available only where the claimant seeks to protect specific rights recognised under Article 10 of Directive 2001/83/EC. In the present case, the claimant neither demonstrated that any such right had been affected nor established that the carve-out impacted any industrial or commercial property right. As the relevant patent specification was not submitted, the Court was unable to assess whether any intellectual property right or other legally protected interest was affected.

The Supreme Court declined to refer the matter to the CJEU, finding that the relevant provisions of Directive 2001/83/EC had already been interpreted by the CJEU in Olainfarm (acte éclairé).

Key takeaways:

• Generic competition alone is not enough. Originator companies cannot challenge generic marketing authorisations merely because generic entry affects their market position.
•  Regulatory exclusivities remain central. Once exclusivity periods expire, standing requires another directly affected right or legally protected interest (e.g. intellectual property right).
• Greater certainty for generic market entry. Provided regulatory requirements, including carve-outs, are properly implemented, the judgment strengthens legal certainty for generic entry.