- within Technology, Consumer Protection and Antitrust/Competition Law topic(s)
June 2026 – In case Kfv.VI.37.810/2025/27, the Hungarian Supreme Court (the “Supreme Court”) reviewed an administrative dispute concerning the marketing authorisation of a generic medicinal product.
The claimants were the marketing authorisation holder of the originator product and its Hungarian distributor, while the defendant was the National Public Health and Pharmaceutical Centre. Our firm represented the generic pharmaceutical company (interested party) in the proceedings (Eszter Takácsi-Nagy, Noémi Varga, and Krisztofer Borbély).
The dispute centred on the marketing authorisation of a specific generic medicinal product. The Supreme Court has, for the first time, taken a position on whether a decision adopted in the authorisation procedure of a generic medicinal product directly affects the rights or entitlements of the marketing authorisation holder or distributor of the originator medicinal product, i.e., whether such companies have legal standing.
Decision of the Supreme Court
The Supreme Court:
- rejected the claimants’ request for judicial review and held that:
- the claimants did not have legal standing, as
- they failed to demonstrate direct infringement of their rights or legitimate interests.
Key findings
Lack of legal standing
The right to initiate proceedings is not the same as having legal standing.
Claimants must demonstrate direct legal impact; purely economic interests are insufficient.
Economic interest is not sufficient
Competitive disadvantage resulting from the entry of a generic medicinal product does not establish legal standing.
The case law of the Court of Justice of the European Union does not grant a general right to challenge for originator companies.
Importance of data exclusivity
Originator companies can rely on enforceable legal rights establishing legal standing primarily during the data exclusivity period.
Practical implications
The decision of the Supreme Court:
- limits the ability of originators to challenge generic marketing authorisations;
- clarifies the concept of legal standing in administrative litigation;
- strengthens legal certainty for generic market entry.
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